Podcasts about roivant

On this week's episode, Sam Fazeli, Eric Schmidt, and Brian Skorney are joined by Roivant's Matthew Gline to discuss data, deals and the latest policy updates. The episode kicks off with concerns over potential U.S. Department of Health and Human Services (HHS) funding cuts for domestic HIV programs, with the group analyzing the impact on companies like Gilead and GSK, whose HIV prevention drugs have driven significant investor enthusiasm. They then discuss the uncertainty surrounding the new administration's commitment to public health initiates, considering Robert F. Kennedy Jr.'s appointment as HHS Secretary and his past controversial views on vaccines and HIV prevention. The conversation then shifts to data, including positive results from Immunovant and Roivant's Phase 3 study of batoclimab for myasthenia gravis. The group also examines the surprising absence of short sellers engaging with Roivant post-data release, highlighting shifts in biotech trading strategies. In the muscular dystrophy space, new exon-skipping therapies from Avidity and Dyne show unprecedented dystrophin restoration, suggesting potential functional benefits. However, the tragic death of a patient treated with Sarepta's gene therapy, Elevidys, reignites concerns about accelerated approvals and the FDA's risk-benefit calculus in rare disease research. On the deal-making front, AstraZeneca's $425M acquisition of stealth-mode cell therapy startup EsoBiotec and Sanofi's $600M deal with Dren Bio underscore biotech's valuation disconnect, where early-stage private assets command premium prices while public biotechs struggle. The episode closes with insights into Alnylam's broad label win for Amvuttra in ATTR cardiomyopathy and AstraZeneca's $2.5B investment in biotech agreements and manufacturing in China, reflecting its long-term strategic vision despite ongoing geopolitical tensions. *This episode aired on March 21, 2025

The journey from scientific discovery to commercial success takes more than just a breakthrough - it requires strategic biotech leadership and vision. Steve Swan, a seasoned executive recruiter with 26 years in the biotech industry, reveals how companies navigate the complex path from laboratory research to market success. Swan shares insights on what makes biotech leaders effective, from securing funding in today's challenging economic climate to building teams that combine scientific expertise with business acumen.You'll learn how successful biotech ventures like Roivant found opportunity in overlooked drug candidates, why gene therapy faces manufacturing challenges despite scientific progress, and which geographic hubs are leading biotech innovation in America. Whether you're considering a career transition to biotech or simply interested in how the industry can keep pushing for a brighter future, this conversation offers valuable perspective on leadership at the intersection of science and business.Love the show? Subscribe, rate, review, and share! http://thefuturistsociety.net/

Dr. John Sweetenham and Dr. James Foran discuss the evolving treatment landscape in acute myeloid leukemia, including new targeted therapies, advances in immunotherapy, and the current role for allogeneic transplantation. TRANSCRIPT Dr. John Sweetenham: Hello, I'm Dr. John Sweetenham, the host of the ASCO Daily News Podcast. There has been steady progress in the therapies for acute myeloid leukemia (AML) in recent years, largely based on an increasing understanding of the molecular mechanisms which underlie the disease. On today's episode, we'll be discussing the evolving treatment landscape in AML. We'll explore risk group stratification, new targeted therapies, advances in immunotherapy for AML, and also a little about the current role for allogenic transplantation in this disease.  I'm delighted to welcome Dr. James Foran to this discussion. Dr. Foran is a professor of medicine and chair of the Myeloid Malignancies and Blood and Marrow Transplant Disease Group at the Mayo Clinic Comprehensive Cancer Center. He's based in Jacksonville, Florida.  Our full disclosures are available in the transcript of this episode.  James, it's great to have you join us on the podcast today, and thanks so much for being here. Dr. James Foran: I'm delighted and thank you for the invitation. Thank you very much. Dr. John Sweetenham: Sure, James, let's get right into it. So, our understanding of the molecular mechanisms underlying AML has resulted not only in new methods for risk stratification in this disease, which have added refinement to cytogenetics, but also has resulted in the development of many new targeted agents. Understanding that this is a complex area of investigation, and our time is somewhat limited, can you give us a high-level update on the current state of the art in terms of how risk factors are being used for treatment selection now? Dr. James Foran: Absolutely. I think in the past, you know, we had things broken down pretty simply into make a diagnosis based on morphology, do cytogenetics, break patients into the groups of those who were more likely to benefit from therapy – so-called favorable risk – those where the intensive therapies were less likely to work – so-called poor adverse risk, and then this large intermediate group that really had variable outcomes, some better, some worse. And for a long time, the progress was in just identifying new subtle cytogenetic risk groups. And then, late 1990s, we began to understand that FLT3 mutations or NRAS mutations may be more adverse than others that came along. In the first part of this millennium, in the, you know, 2000-2010 range, a lot of work was being done to understand better or worse risk factors with single genes. The ability to do multiplex PCR, and then more recently NGS platforms, have allowed us to really look at many genes and identify many mutations in patients. At the beginning that was used just to sort of refine – who did a little better, who did a little worse with intensive therapy – helped us decide who may benefit more from an allogeneic transplanter for whom that would not be necessary.  But the good news is that really, we're now starting to target those mutations. One of the first molecularly targeted treatments in leukemia was FLT3 mutations, where we knew they were adverse. Then along came targeted treatments. I was involved in some of those early studies looking at sunitinib, sorafenib, more recently midostaurin, now quizartinib, FDA approved, and gilteritinib in the relapse refractory setting.  So we're moving into a state where we're not just refining prognosis, we're identifying targets. You know, it's been slow progress, but definite incremental progress in terms of outcomes by looking for FLT3 mutations, then looking for IDH mutations, and more recently, mutations involving NPM1 or rearrangement of what we used to call the MLL gene, now the lysine methyltransferase 2A or KMT2A rearrangement, where we now have targets. And it's not just for refinement of prognosis, but now we're identifying therapeutic targets for patients and ways to even look for measurable residual disease which is impacting our care. Dr. John Sweetenham: That's great, James. And I'm going to expand on that theme just a little bit and perhaps ask you to elaborate a little bit more on how the introduction of these new therapies have specifically impacted frontline therapy. And a couple of ancillary questions maybe to go along with that: First of all, is ‘7+3' a standard therapy for anybody in 2025? And maybe secondly, you know, could you comment also maybe briefly on older patients with AML and how you think maybe the treatment landscape is changing for them compared with, say, 5 or 10 years ago? Dr. James Foran: I'll start with the therapy and then work my way back. So we've had ‘7+3' cytarabine daunorubicin or cytarabine anthracycline since 1976, and we're still using it as the backbone of our intensive therapy. There is still an important role for it, particularly in younger or fitter patients, and particularly for those with intermediate or favorable risk genetic groups or cytogenetic risk groups just because we achieve high rates of remission. Our 30-day induction mortality rates are lower now than they were 10 and 20 years ago. Our supportive care is better. And we still have a busy inpatient hospital service here at Mayo Florida and my colleagues in Rochester and Arizona as well giving intensive therapy. So that remains the backbone of curative therapy for younger adults. We are trying to be a little more discriminating about who we administer that to. We are trying to add targeted agents. We know from, now, two different randomized trials that the addition of a FLT3 inhibitor, either midostaurin or more recently quizartinib, has a survival advantage in patients with a FLT3 mutation, or for quizartinib, a FLT3/ITD mutation. And so yes, ‘7+3' remains important.  Off protocol for somebody who just comes in with acute leukemia in a 40-year-old or 30-year-old or even early 60s and fit, we would still be considering ‘7+3' therapy and then waiting for an expedited gene mutation panel and an expedited cytogenetics panel to come back to help us discriminate is that a patient for whom we should be giving a FLT3 inhibitor? I think there's a little more nuance about when we do a day 14 bone marrow, do they really matter as much anymore? I still do them. Some of my colleagues find them less important. But we're still giving intensive therapy. We're still giving high-dose ARA-C consolidation for younger patients who achieve complete remission.  In older adults, it's a different story. You know, it was only in the early part of the 2000s – 2004, 2007 range – where we really got buy-in from randomized studies that low-dose therapy was better than no therapy. There was a lot of nihilism before then about therapy for older adults, especially over age 75. We know that low-dose ARA-C is better than nothing. It looked like azacitidine was better than ARA-C or at least equivalent or slightly better. But with the advent of venetoclax it was a game changer. I ran a national randomized study of intensive therapy in AML. It was the last national randomized study of intensive therapy in older patients right before venetoclax got approved. And we were very excited about our results, and we thought we had some really interesting clinical results. And suddenly that's a little bit obsolete in patients over 70 and particularly over age 75 because of the high remission rates with azacytidine venetoclax or hypomethylating agents, so-called HMAs and venetoclax and the survival advantage. Now, it's not a home run for everybody. We quote 60% to 70% remission rates, but it's a little different based on your cytogenetics and your mutation profile. You have to continue on therapy so it's continuous treatment. It's not with curative intent, although there are some people with long-term remission in it. And the median survival went from 10 months to 15 months. So home run? No, but definitely improved remissions, meaningful for patients off transfusions and better survival. So right now it's hard to find an older adult who you wouldn't give azacitidine and venetoclax or something similar, decitabine, for instance, and venetoclax, unless somebody really was moribund or had very poor performance status or some reason not to. And so ‘7+3' is still relevant in younger adults. We're trying to get better results with ‘7+3' by adding targeted agents and azacitine and venetoclax in older adults.  I think the area of controversy, I guess there are two of them, is what to do in that overlap age between 60 and 75. Should people in that age still get intensive therapy, which we've used for years – the VIALE-A trial of aza-venetoclax was age 75 plus – or with cardiac comorbidities? And I think if you're 68 or 72, many of us are starting to bias towards aza-venetoclax as generally being better tolerated, generally being more outpatient, generally being slow and steady way to get a remission. And it doesn't stop you from going to transplant for somebody who might still be a candidate.  The other area of controversy is somebody under 60 who has adverse cytogenetics where we don't do very well with ‘7+3,' we still give it and we might do just as well with decitabine venetoclax. A lot of us feel that there's equipoise in the 60 to 75 group where we really can ask a question of a randomized study. Retrospective studies might suggest that intensive therapy is a little better, but there are now a couple of randomized studies happening saying, “Can we replace ‘7+3' in that intermediate age with aza-venetoclax?” And for younger adults similarly, we're looking to see how we apply that technology. Those are the areas where we're really trying to investigate what's optimal for patients and that's going to require randomized trials. Dr. John Sweetenham: Oh, that's great, thank you. And I'll just extend that question a little bit more, particularly with respect to the new targeted therapies. How much are they impacting the treatment of these patients in the relapse and refractory setting now? Dr. James Foran: Oh, they're definitely impacting it. When I trained and probably when you trained, AML was still a medical emergency. But that was the thing that you admitted to the hospital immediately, you started therapy immediately. The rule was always that's the one thing that brings the fellow and the consultant in at night to see that new patient on a Friday or Saturday. Now, we'll still admit a patient for monitoring, but we try not to start therapy for the first three or five or seven days if they're stable, until we get those genetics and those genomics back, because it helps us discriminate what therapy to pursue. And certainly, with FLT3 mutations, especially FLT3/ITD mutations, we're adding FLT3 inhibitors and we're seeing a survival advantage. Now, on the surface, that survival advantage is in the range of 7% or 10%. But if you then pursue an allogeneic transplant in first remission, you're taking disease where we used to see 30%, 40% long-term survival, maybe less, and you're pushing that to 60%, 70% in some studies. And so we're now taking a disease that– I don't want to get off topic and talk about Ph+ ALL. But that's a disease where we're actually a little excited. We have a target now, and it used to be something really adverse and now we can do a lot for it and a lot about it.  The other mutations, it's a little more subtle. Now, who knew until 2010 that a mutation in a sugar metabolism gene, in isocitrate dehydrogenase, or IDH was going to be so important, or even that it existed. We know that IDH1 and IDH2 mutations are still a minority of AML, certainly less than 10% to 15%, maybe overall. But we're able to target those with specific IDH1 and IDH2 inhibitors. We get single-agent responses. There are now two approved IDH1 inhibitors on the market. We don't yet have the randomized data that adding those to intensive therapy is better, but we're getting a very strong hint that it might be better in older adults who have an IDH mutation, maybe adding those is helpful and maybe adding those to low-intensity therapy is helpful. Those studies are ongoing, and we're also trying with low-intensity treatments to add these agents and get higher remission rates, deeper remissions, longer remissions. I think a lot of work has to be done to delineate the safety of that and the long-term efficacy. But we're getting hints it's better, so I think it is impacting.  The other area it's impacting is when you pick up adverse mutations and those have crept into our classification systems like an ASXL1 mutation or RUNX1 mutation for instance, or some of the secondary AML mutations like BCOR and others, where that's helping us discriminate intermediate-risk patients who we think aren't going to do as well and really helping us select a group who's more likely to get benefit from allogeneic transplant or for whom at least our cure rates without allo transplant are low. And so I think it's impacting a lot. Dr. John Sweetenham: Great. And I'm going to pick up now, if I may, on a couple of things that you've just mentioned and continue the theme of the relapsed and refractory setting. We've started to see some reports which have looked at the role of immune strategies for patients with AML, in particular CAR T or NK cells. Can you comment a little on this and let us know whether you think either these two strategies or other immune strategies are likely to have a significant role in AML in the future? Dr. James Foran: They are, but I think we're still a step behind finding the right target or the right way to do it. If you think of allogeneic transplantation as the definitive immune therapy, and we know for adverse AML we can improve survival rates and cure rates with an allotransplant, then we know inherently that immune therapy matters. And so how do we do what they've done in large cell lymphoma or in CD19 targeting for B cell malignancies? How do we bring that to acute myeloid leukemia? There have been a number of efforts. There have been at least 50 trials looking at different targets. CD33, CD123, CD7, others, CLL-1. So, there have been a number of different trials looking at how to bind a CAR T or a CAR T construct that can be active. And we have hints of efficacy. There was kind of a provocative paper in the New England Journal of Medicine a year ago in April of last year from a Chinese group that looked at a CD7-based CAR T and it was 10 patients, but they used CD7 positive acute leukemia, AML or ALL and had a CD7-targeted CAR T and they actually incorporated that with a haploidentical transplant and they had really high remission rates. People tolerated it quite well. It was provocative. It hasn't yet been reproduced on a larger scale, but the strong hints that the strategy is going to work.  Now, CD33 is a little tricky to have a CAR T when CD33 is expressed on normal hematopoietic cells. CD123 likewise. That's been something where there's, I think, still promise, but we've struggled to find the trials that make that work. Right now, there's a lot of interest in leveraging NK cells and looking, for a couple of reasons, but NK cells are attractive and NK cell markers might be attractive targets. NK cells might have similar degrees of immune efficacy. It's speculative, but they are likely to have less cytokine release syndrome and less neurotoxicity than you see with CAR T. And so it's kind of attractive to leverage that. We have had some ongoing trials looking at it with bispecifics and there certainly are trials looking at it with CAR NK-based strategies. One of the antigens that people looked at is the NK group 2D. NK group 2D or NKG2D is overexpressed in AML and its ligands overexpressed. And so that's a particular potential target. So, John, it's happening and we're looking for the hints of efficacy that could then drive a pivotal trial to get something approved.  One of the other areas is not restricting yourself just to a single antigen. For instance, there is a compound that's looking at a multi-tumor-associated antigen-specific T-cell therapy, looking at multiple antigens in AML that could be overexpressed. And there were some hints of activity and efficacy and actually a new trial looking at a so-called multi-tumor associated antigen-specific T cell therapy. So without getting into specific conflicts of interest or trials, I do think that's an exciting area and an evolving area, but still an investigational area. I'll stop there and say that we're excited about it. A lot of work's going there, but I'm not quite sure which direction the field's going to pivot to there. I think that's going to take us some time to sort out. Dr. John Sweetenham: Yeah, absolutely. But as you say, exciting area and I guess continue to watch this space for now.  So you've mentioned allogeneic stem cell transplants two or three times during this discussion. Recognizing that we don't have an imatinib for AML, which has kind of pushed transplant a long way further back in the treatment algorithm, can you comment a little on, you know, whether you think the role of stem cell transplantation is changing in AML or whether it remains pretty much as it was maybe 10 years ago? Dr. James Foran: By the way, I love that you use imatinib as an introduction because that was 6 TKIs ago, and it tells you the evolution in CML and you know, now we're looking at myristoyl pocket as a target, and so on. That's a great way to sort of show you the evolution of the field.  Allogeneic transplant, it remains a core treatment for AML, and I think we're getting much smarter and much better about learning how to use it. And I'm just going to introduce the topic of measurable residual disease to tell you about that. So I am a little bit of a believer. Part of my job is I support our allogeneic transplant program, although my focus is acute myeloid leukemia, and I've trained in transplant and done it for years and did a transplant fellowship and all that. I'm much more interested in finding people who don't need a transplant than people who do. So I'm sort of looking for where can we move away from it. But it still has a core role. I'll sidestep and tell you there was an MDS trial that looked at intermediate or high-risk MDS and the role of allogeneic transplant that shows that you about double your survival. It was a BMT CTN trial published several years ago that showed you about double your three-year survival if you can find a donor within three months and get to a transplant within six months. And so it just tells you the value of allotransplant and myeloid malignancy in general. In AML we continue to use it for adverse risk disease – TP53 is its own category, I can talk about that separately – but adverse risk AML otherwise, or for patients who don't achieve a really good remission. And I still teach our fellows that an allotransplant decreases your risk of relapse by about 50%. That's still true, but you have to have a group of patients who are at high enough risk of relapse to merit the non-relapse mortality and the chronic graft versus host disease that comes with it. Now, our outcomes with transplant are better because we're better at preventing graft versus host disease with the newer strategies such as post-transplant cyclophosphamide. There are now new FDA-approved drugs for acute and chronic graft versus host disease, ruxolitinib, belumosudil, axatilimab now. So we have better ways of treating it, but we still want to be discriminating about who should get it.  And it's not just a single-minded one-size-fits-all. We learned from the MORPHO study that was published in the JCO last year that if you have FLIT3-positive AML, FLIT3/IDT-positive AML, where we would have said from retrospective studies that your post-transplant survival is 60% give or take, as opposed to 15% or 20% without it, that we can discriminate who should or shouldn't get a transplant. Now that trial was a little bit nuanced because it did not meet its primary endpoint, but it had an embedded randomization based upon MRD status and they used a very sensitive test of measurable residual disease. They used a commercial assay by Invivoscribe that could look at the presence of a FLT3/ITD in the level of 10 to the minus 5th or 10 to the minus 6th. And if you were MRD-negative and you went through a transplant, you didn't seem to get an advantage versus not. That was of maintenance with gilteritinib, I'll just sort of put that on there. But it's telling us more about who should get a transplant and who shouldn't and who should get maintenance after transplant and who shouldn't.  A really compelling study a year ago from I don't know what to call the British group now, we used to call them the MRC and then the NCRI. I'm not quite sure what to call their studies at the moment. But Dr. Jad Othman did a retrospective study a year ago that looked at patients who had NPM1 mutation, the most common mutation AML, and looked to see if you were MRD positive or MRD negative, what the impact of a transplant was. And if you're MRD negative there was not an advantage of a transplant, whereas if you're MRD positive there was. And when they stratified that by having a FLT3 mutation that cracked. If you had a FLT3 mutation at diagnosis but your NPM1 was negative in remission, it was hard to show an advantage of a transplant. So I think we're getting much more discriminating about who should or should not get a transplant by MRD testing for NPM1 and that includes the patients who have a concomitant FLT3 mutation. And we're really trying to learn more and more. Do we really need to be doing transplants in those who are MRD-negative? If you have adverse risk genetics and you're MRD-negative, I'll really need good data to tell me not to do a transplant, but I suspect bit by bit, we'll get that data. And we're looking to see if that's really the case there, too. So measurable residual disease testing is helping us discriminate, but there is still a core role of allogeneic transplant. And to reassure you, compared to, I think your allotransplant days were some time ago if I'm right. Dr. John Sweetenham: Yes. Dr. James Foran: Yeah. Well, compared to when you were doing transplants, they're better now and better for patients now. And we get people through graft versus host disease better, and we prevent it better. Dr. John Sweetenham: That's a great answer, James. Thanks for that. It really does help to put it in context, and I think it also leads us on very nicely into what's going to be my final question for you today and perhaps the trickiest, in a way. I think that everything you've told us today really emphasizes the fact that the complexity of AML treatment has increased, primarily because of an improved understanding of the molecular landscape of the disease. And it's a complicated area now. So do you have any thoughts on what type of clinical environment patients with AML should be evaluated and treated in in 2025? Dr. James Foran: Yeah, I want to give you a kind of a cautious answer to that because, you know, I'm a leukemia doctor. I work at a leukemia center and it's what we focus on. And we really pride ourselves on our outcomes and our diagnostics and our clinical trials and so on. I am very aware that the very best oncologists in America work in private practice and work in community practice or in networks, not necessarily at an academic site. And I also know they have a much harder job than I have. They have to know lung cancer, which is molecularly as complicated now as leukemia, and they have to know about breast cancer and things that I don't even know how to spell anymore. So it's not a question of competence or knowledge. It's a question of infrastructure. I'll also put a little caveat saying that I have been taught by Rich Stone at Dana-Farber, where I did a fellowship a long time ago, and believe Rich is right, that I see different patients than the community oncologists see with AML, they're seeing different people. But with that caveat, I think the first thing is you really want to make sure you've got access to excellence, specialized hematopathology, that you can get expedited cytogenetics and NGS testing results back. There was a new drug, approved just a few months ago, actually, for relapsed AML with a KMT2A rearrangement, revumenib. We didn't talk about the menin inhibitors. I'll mention them in just a second. That's a huge area of expansion and growth for us. But they're not found on NGS platforms. And normal cytogenetics might miss a KMT2A-rearrangement. And we're actually going back to FISH panels, believe it or not, on AML, to try to identify who has a KMT2A-rearrangement. And so you really want to make sure you can access the diagnostic platforms for that.  I think the National Referral Labs do an excellent job. Not always a really fast job, but an excellent job. At my institution, I get NGS results back within three days or four days. We just have an expedited platform. Not everybody has that. So that's the key, is you have to be able to make the diagnosis, trust the pathologist, get expedited results. And then it's the question of trying to access the targeted medications because a lot of them are not carried in hospital on formulary or take time to go through an insurance approval process. So that's its own little headache, getting venetoclax, getting gilteritinib, getting an IDH1 inhibitor in first line, if that's what you're going for. And so I think that requires some infrastructure. We have case managers and nurses who really expedite that and help us with it, but that's a lot of work. The other piece of the puzzle is that we're still with AML in the first month and maybe even the second month. We make everybody worse before we make them better. And you have to have really good blood bank support. I can give an outpatient platelet transfusion or red cell transfusion seven days a week. We're just built for that. That's harder to do if you're in a community hospital and you have to be collaborating with a local blood bank. And that's not always dead easy for somebody in practice. So with those caveats, I do find that my colleagues in community practice do a really good job making the diagnosis, starting people on therapy, asking for help. I think the real thing is to be able to have a regional leukemia center that you can collaborate with, connect with, text, call to make sure that you're finding the right patients who need the next level of diagnostics, clinical trial, transplant consults, to really get the best results.  There was some data at ASH a couple of years ago that looked at – the American Society of Hematology and ASCOs had similar reports – that looked at how do we do in academic centers versus community practice for keeping people on therapy. And on average, people were more likely to get six cycles of therapy instead of three cycles of therapy with azacitidine venetoclax at an academic center. Now, maybe it's different patients and maybe they had different cytogenetics and so on, but I think you have to be patient, I think you have to collaborate. But you can treat those patients in the community as long as you've got the infrastructure in place. And we've learned with virtual medicine, with Zoom and other platforms that we can deliver virtual care more effectively with the pandemic and beyond. So I think we're trying to offer virtual consults or virtual support for patients so they can stay in their home, stay in their community, stay with their oncologists, but still get access to excellent diagnostics and supportive care and transplant consults, and so on. I hope that's a reasonable answer to that question. It's a bit of a nuanced answer, which is, I think there's an important role of a leukemia center, and I think there's a really fundamental role of keeping somebody in the community they live in, and how we collaborate is the key to that. And we've spent a lot of time and effort working with the oncologists in our community to try to accomplish that.  John, I want to say two other things. I didn't mention in the molecular platforms that NPM1 mutations, we can now target those on clinical trials with menin inhibitors. We know that NPM1 signals through the Hoxa9/Meis1 pathway. We know that similar pathways are important in KMT2A rearrangements. We know that there are some other rare leukemias like those with NUP98 rearrangement. We can target those with menin inhibitors. The first menin inhibitor, revuminib, was approved by the FDA for KMT2A. We have others going to the FDA later this year for NPM1. There are now pivotal trials and advanced expanded phase 1/2 studies that are showing 30% response rates. And we're looking to see can we add those into the first-line therapy. So, we're finding more targets.  I'll say one last thing about molecular medicine. I know I'm a little off topic here, but I always told patients that getting AML was kind of like being struck by lightning. It's not something you did. Now, obviously, there are risk factors for AML, smoking or obesity or certain farm environments, or radioactive exposures and so on. But bit by bit, we're starting to learn about who's predisposed to AML genetically. We've identified really just in the last five or eight years that DDX41 mutations can be germline half the time. And you always think germline mutations are going to cause AML in a younger patient, but the median age is 60 to 70 just like other AMLs. They actually might do pretty well once they get AML. We've reported that in several papers. And so we're trying to understand who that has a RUNX1 mutation needs germline testing, who with a DDX41 needs germline testing. And we're trying to actually come up with a cleaner pathway for germline testing in patients to really understand predisposition, to help with donor selection, to help with family counseling. So I think those are other areas where a leukemia center can contribute for somebody in who's community practice to understand genomic or genetic complexity in these patients. And we're starting to develop the databases that support that. Dr. John Sweetenham: Yeah, great. Thanks, James. I loved your answer about the clinical environment too. And I know from a patient-centric perspective that I know that patients would certainly appreciate the fact that we're in a situation now where the folks taking care of them will make every effort to keep them close to home if they possibly can.  I want to thank you, James, for an incredible review of a very complex subject and I think you did a great job. I think we all will have learned a lot. And thanks again for being willing to share your insights with us today on the ASCO Daily News Podcast. Dr. James Foran: John, it's my pleasure. And as you know, I'll do anything for a latte, so no problem at all. Dr. John Sweetenham: Okay. I owe you one, so thank you for that.  And thank you to our listeners for your time today. You'll find links to the studies we've discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:  Dr. John Sweetenham  Dr. James Foran Follow ASCO on social media: @ASCO on Twitter ASCO on Bluesky ASCO on Facebook  ASCO on LinkedIn  Disclosures:    Dr. John Sweetenham:    No relationships to disclose Dr. James Foran: Stock and Other Ownership Interests: Aurinia Pharmaceuticals Consulting or Advisory Role: Peerview, CTI BioPharma Corp, Remix Therapeutics, Cardinal Health, Medscape, Syndax, Autolus Therapeutics Research Funding (Inst.): Chordia Therapeutics, Abbvie, Actinium Pharmaceuticals, Kura Oncology, Sellas Life Sciences, Novartis, Roivant, Celgene/Bristol-Myers Squibb, Astellas Pharma, SERVIER Travel, Accommodations, Expenses: Peerview

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CVS is laying off 2,900 employees as part of a cost-cutting plan and potential business breakup. Humana's Medicare Advantage star ratings have dropped significantly, impacting profits. Healthcare workers face burnout, while the payer-provider relationship is evolving. Mission Hospital in North Carolina is struggling after Hurricane Helene, and Steward CEO Ralph de la Torre is being sued by senators. Healthcare companies are urged to prioritize patient-centric experiences. The text also highlights upcoming healthcare conferences, telehealth trends, and insights into the relationship between providers and payers.The FDA has officially declared the end of the shortage of Zepbound and Mounjaro, putting pressure on companies selling compounded alternatives. Biopharma conferences in 2025 are important for showcasing clinical trial results. The FDA is set to make several key decisions in the fourth quarter, including approving a rival to a popular Pfizer heart drug. Roche plans to address an $8 billion sales gap due to biosimilar competition. Lilly is investing $4.5 billion in a "foundry" for advanced drug manufacturing. Additionally, there are resources available on topics such as AI in clinical research, genetic screening, gene therapy, and biosimilars. Other industry news includes potential sales of pharma units by Chinese company Wuxi, and the US's commitment to African manufacturing in HIV programs.Sanofi has sold the global rights to a rare autoimmune drug for cold agglutinin disease to Recordati in a potential $1 billion deal. Recordati will make an upfront payment of $825 million to Sanofi, with milestone payments of up to $250 million. Meanwhile, Novo's lowest dose of Wegovy remains on the FDA's drug shortage list. AbbVie has trimmed its full-year earnings guidance due to R&D milestone costs, following the success of its Parkinson's disease candidate Tavapadon. Relay Therapeutics is laying off 10% of its workforce to streamline its research organization. The pharma industry is prioritizing scaling GLP-1 manufacturing capacity to meet the demand for weight loss drugs. Lilly has ended its obesity drug shortage, while Novo continues to face shortages. WBL's proprietary library prep for cfDNA whole genome sequencing aims to enhance specificity, sensitivity, and data quality at low concentrations. In other news, BMS has received FDA approval for an Opdivo regimen in NSCLC and Bavarian Nordic's MPox shot shows antibody responses wane after 6 to 12 months.Dr. Matthew Schrag, a vascular neurologist at Vanderbilt University, is not prescribing the new Alzheimer's disease treatments, Kisunla and Leqembi, due to concerns over risks and costs. Schrag has a history of challenging prevailing science in Alzheimer's and has exposed instances of potential misconduct by researchers. In 2021, he raised allegations of data manipulation against Cassava Sciences, leading to ongoing scrutiny and calls for their phase 3 trials to be stopped. Despite distancing himself from the controversy, Schrag's findings have had a significant impact on the company. The article also discusses Roivant's unique approach to drug development, the latest advances in oncology research, and the challenges in navigating the path from preclinical studies to regulatory approval for gene therapies. The text highlights the importance of efficient therapeutic development processes and increasing diversity in clinical trials. Additionally, it provides links to resources on selecting clinical trial sites, unlocking partnerships for small biotech firms, and optimizing AAV manufacturing processes. The newsletter also includes updates on Medicare drug price talks, a groundbreaking trial for lung cancer treatment, and a map of a fruit fly's brain that has impressed neuroscientists.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Democrats have introduced a bill to make increased Affordable Care Act (ACA) subsidies permanent, arguing that if the enhanced tax credits expire, healthcare costs for millions of Americans will suddenly increase. Meanwhile, the Senate has voted unanimously to hold Steward Health Care CEO Ralph de la Torre in criminal contempt, marking the first time in over 50 years that such a charge has been sent to the U.S. Department of Justice. Additionally, the Centers for Medicare & Medicaid Services (CMS) is holding Accountable Care Organizations harmless for "highly suspect" Medicare billing practices. A home care agency has settled allegations that it accommodated "race-based requests" for aides, with the Equal Employment Opportunity Commission stating that the agency terminated assignments of black and Hispanic aides to adhere to patients' and family members' racial preferences. The top tech trends transforming healthcare today include leveraging new technologies to navigate workforce shortages, economic pressures, and consumer demands.Arch Venture Partners has raised $3 billion for a new fund to support AI biotech startups. Pfizer has pulled its sickle cell therapy, Oxbryta, from the market due to safety concerns. A study suggests that Novo Nordisk's Ozempic may lower the risk of opioid overdose in diabetics. Research has cast doubt on the benefit of anti-CD20 therapies in multiple sclerosis. The setback with Oxbryta has caused frustration among investors regarding Pfizer's business development track record. Novo and Evotec have partnered for stem cell research, while cancer and diabetes drugs are expected to dominate Medicare negotiations in 2025.Pfizer is pulling its sickle cell drug from the market and shutting down trials due to safety concerns. BioAge successfully priced a $198 million IPO, focusing on obesity drug research. An Italian biotech received $52 million to advance pediatric gene therapies. Arch raised another $3 billion biotech fund to pursue innovative science. The industry is seeing advancements in GLP-1 drugs and exploring new treatments for obesity.Roivant, led by CEO Matt Gline, has found success in the biotech industry by taking a unique approach to acquiring and selling assets from big pharma companies. Despite Gline's lack of experience in biotech, Roivant has weathered the tough biotech climate and generated substantial cash flow. The company's strategy involves investing in products that do not fit into the traditional categories of big pharma, leading to successful acquisitions and partnerships.Placer.ai's latest report explores the potential benefits of offering healthcare services in grocery stores to increase foot traffic and customer loyalty. The report delves into how the addition of a healthcare clinic can impact grocery store visitation patterns, which types of consumers are most likely to visit grocery stores with healthcare offerings, and how loyalty rates differ between stores with wellness centers and those without.Abcam offers antibodies, proteins, kits, and reagents for life science research, with a focus on immunoassays that accelerate throughput. Their SimpleStep ELISA kits provide fast results in 90 minutes or less with high sensitivity, specificity, flexibility, and reproducibility. The 384-well format allows for efficient scaling up with consistent results across labs. For more information on their immunoassays and advertising opportunities, contact Abcam directly. This message is part of a complimentary newsletter subscription to Biopharma Dive, a product of Industry Dive, Inc.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Amazon has partnered with Talkspace to expand its digital health benefits program, which also includes Omada Health. Community Health Systems (CHS) subsidiary is acquiring 10 urgent care centers, following in the footsteps of other for-profit health systems. Steward Health Care auctioned off Glenwood Regional Medical Center for $500,000, but there are concerns about the continued involvement of hospital landlord Medical Properties Trust in operations. The text also includes sponsored content on safeguarding healthcare against ransomware and cybercrime, as well as information on trends in telehealth and strategies for improving provider data accuracy for payers. Healthcare Dive provides news and insights for healthcare leaders and is a publication operated by Industry Dive.Roivant's subsidiary, Dermavant, is being acquired by Organon, giving Organon access to a psoriasis and eczema cream called Vtama. This acquisition will provide Roivant with additional cash to fund its research and development plans. Meanwhile, biotech M&A activity has plateaued, with private company acquisitions continuing while public company acquisitions have slowed down. One biotech, Ratio Therapeutics, backed by Bristol Myers Squibb, is optimistic about the boom in radiopharma and the pharmaceutical industry's shift towards targeted radiation drugs. In other news, Novartis' Kisqali has received expanded FDA approval which could double its market for breast cancer treatment. Additionally, Express Scripts is suing the FTC over a report critical of pharmacy benefit manager business practices. The industry is also exploring new ways to deliver genetic therapies and improve clinical trial execution through systems thinking. Overall, the biopharma industry is experiencing exciting times with various developments and advancements in drug development and healthcare technology.Zimmer has decided to pull its hip implant off the market due to fracture risk, with plans to phase out its use by December. Merit Medical has acquired Cook's lead management business for $210 million, adding devices used in heart rhythm device procedures to its portfolio. Synchron has connected brain-computer interface technology to Amazon Alexa, allowing patients to control various functions without using their hands or voice. Senseonics has received FDA clearance for a one-year continuous glucose monitoring system, and Boston Scientific has closed its acquisition of Silk Road Medical. The wearables market is expected to grow by 13% annually between 2024 and 2030, highlighting the importance of adhesives in wearable device development. AI is increasingly influencing the value chain of medical device companies, and manufacturers are exploring ways to utilize AI throughout the product lifecycle. These developments reflect the ongoing innovation and evolution within the medtech industry.Roivant has sold Dermavant to Organon in a deal worth up to $1.2 billion, allowing Roivant to focus on their autoimmune-focused Immunovant and upcoming trials. Summit Therapeutics' bispecific for non-small cell lung cancer has shown promise against Keytruda but still needs more data. Other news includes the FDA approving Keytruda for pleural mesothelioma, Bernie Sanders claiming generics companies can offer a cheaper alternative to Ozempic, Novartis expanding Kisqali's use in breast cancer, and HRSA threatening sanctions against J&J. In the world of enzyme development, SignalChem Biotech offers tailored services. Additionally, new gene therapies for sickle cell disease are reaching patients, and the race for an obesity pill is heating up among companies like Novo, Roche, and Terns.The FDA is facing challenges with conducting overseas drug manufacturing inspections, with 42% of registered plants overdue for inspections. Indian drugmaker Zydus Lifesciences received a warnin

In this special student-hosted episode of the “Weinberg in the World” podcast, student host Seora Kim, a junior majoring in economics, interviews Keith Haan, the senior vice president at Roivant Sciences. Keith graduated with a major in Biological Studies. Keith shares his journey from studying biology and playing baseball at Northwestern University to working in a lab at the medical school, which influenced his career path. He discusses his research on B cell signaling and Epstein-Barr virus, and how his interest in biotechnology led him to the finance industry. Keith explains his transition from equity research to venture capital and portfolio management, highlighting the interdisciplinary nature of his career! https://www.linkedin.com/in/keith-haan-9886a069/ Transcript: Seora Kim: Welcome to the Weinberg in the World podcast where we bring stories of interdisciplinary thinking in today's complex world. My name is Seora Kim, and I am your student host of this special episode of the podcast. I am a junior majoring in economics and minoring in data science and global health studies. Today, I am excited to be speaking with Keith Haan, who is the senior vice president at Roivant Sciences. Thank you, Keith, for taking the time to speak with me today. Keith Haan: Thank you, Seora. I'm happy to be here. Seora Kim: Awesome. To start us off today, I'm wondering if you can tell us a little bit more about your time at Northwestern as an undergraduate. What did you study? What were the impactful experiences for you that led to your current career path? Keith Haan: I was an undergraduate major in biology sort of focusing on cell and molecular biology, but my experience at Northwestern was also shaped a lot by the fact that I played baseball for Northwestern. And as part of trying to figure out what to do for the summers, the athletic department does have reach out, and certainly when I was going there, had reach out to sort of help place students with internships that would be interesting. And I ended up working doing research in a lab at the medical school a couple of summers. And I think that really influenced sort of where I wanted to go, and I ended up going and getting my PhD at the grad school down at the medical school campus. Seora Kim: Awesome. That is amazing. Can I ask a little bit more about what kind of research you did at the medical school that helped you pivot? Keith Haan: Yeah, so I worked in a lab that had two focuses. One was on B cell signaling and one was on the cellular factors that allowed Epstein-Barr virus to enter cells. So the two were sort of related. Epstein-Barr virus encodes some proteins that sort of co-opt B cell signaling, and so part of the group focused on that. And then another group of which I was part of really studied the host cell proteins that were involved in mediating entry of the virus to the cell. Seora Kim: Amazing. That sounds super cool. And I was also wondering, were there any pivotal moments for your decisions that shaped your different parts of your journey in your career path? Because I know that you had several experiences before coming to Roivant Sciences. Keith Haan: Yeah, so I would say during grad school, viral entry was a hot topic and was actually very topical for HIV entry and HIV treatments. And so, because some of those newer drugs were being studied in the clinic at that point in time, it sort of got me interested in the biotechnology field in general. But I was also looking at the company and saying, "Hey, this is a company that I think I know well because I understand viral entry well. It's a publicly traded company. That is also interesting." And so, I think given the pace of where the biotech field, where it was going and looking at equities as a way to really be exposed to a lot of what the industry was doing, not just from a single company standpoint, but from an industry-wide standpoint, I got interested in biotech stocks. Which led me into the finance industry starting in equity research, and then moving on in my career to being a partner at a venture firm, and then portfolio manager at a hedge fund. Seora Kim: Awesome. That is super cool because I know that there's a lot of students at Northwestern interested in like economics or finance, but then also the bio side of things. So it's super cool to learn about your experience and how you combined biology as well as finance-related careers in your path and how you did biotech-related stocks equity research. So can you share a little bit more about what you think was the most attractive elements in each part of those roles, like was the more interesting parts in equity research or venture capital's portfolio management, so the students can understand what are differences between those jobs? Keith Haan: Sure. So I can start with the equity research first. It was my foray into finance, and that time was really sort of spent leveraging what I knew and what I had gained just in either biological insights and then translating that to how I thought value could be created from companies. And obviously, at that point in time, there was a pretty big backfill for me in learning the financial building models. I mean, that was something that I had not done at Northwestern. So that was a very good learning experience to be able to combine both as well as to learn how stocks move independent of what you might consider to be an intrinsic value. So that whole learning experience I thought was very valuable. And ultimately, I wanted to be able to, instead of being on the analytical side in equity research, I wanted to move on to being in a place where I could be deploying capital against those ideas. And where my initial interest was, it was sort of the earlier stage, probably earlier in the clinic or preclinical, which was more attuned to what I had learned in my background in my PhD, but also in the small company and the company formation. And so, I chose to go to a venture capital firm where I thought I could really build on the skills that I had already developed in equity research. Seora Kim: Definitely. So I think something that is really interesting is that you're focusing on biotech stocks or biology related financials. So can you share a little bit more about what is different between regular stocks or health tech stocks with biotech stocks? Keith Haan: I think one thing that is different about the biotech sector in general is it is something that is, first of all, highly volatile. There can be very large price swings depending on whether the results from a clinical trial allows a company to move forward to the next step of the clinical studies or to get approved. And when you are putting things in the human body, sometimes you get the results you are expecting and sometimes you don't. So there is a lot of volatility around just those stocks in general. And because of that, it is not something that a lot of funds will necessarily allocate a lot of time or people to, unless they have people that have deep experience doing it. So it is, as opposed to funds that may have a lot of their portfolio invested in tech or other industries that are a little bit better understood, healthcare is a little bit [inaudible 00:08:22], and biotech in particular is a little bit different. Seora Kim: Totally. That makes a lot of sense. And since you mentioned it requires a lot of knowledge and also because of the clinical trial stages, do you think that it's important for students who want to focus on biotech related finance roles to do bio majors or PhD? Or what kind of level of education would be required for these kind of roles? Keith Haan: I think it is helpful, but I have sat next to incredibly intelligent and very, very good people from all different backgrounds. So I have sat next to people that have finance or econ majors and have sort of picked up the biology, the clinical aspects, or the regulatory overlay over time. And then, there are many people that I've worked alongside that have a biology or have a medical background that sort of supplement and backfill with the financial overlay. Seora Kim: Definitely. So it's not necessary to have a bio background, but it can be a very diverse background and anyone who is interested can have a shot at this role? Keith Haan: Yeah, I mean, if you are sort of interested in that nexus, you can come into it from various backgrounds. Seora Kim: Perfect. That's amazing. That's great news for our students. And I guess going on with that, I wanted to learn a little bit more about your current company, Roivant Sciences. So can you maybe elaborate a little bit more on what are some of the current day-to-day in the job right now? Keith Haan: Sure. So in my role, I lead the group that is responsible for the licensing and acquisitions at Roivant. So Roivant is a little bit unique in that the licensing and acquisition plays a very large role in our strategy. So we look really industry-wide and where the innovation is, and a big part of where we find the innovation is external. And so, what we do is try to find collaborators and partner with those assets, and then found very nimble small companies that are really charged with bringing those forward in developing and commercializing them. Seora Kim: Well received. So regarding this kind of business model, would you say your investment strategy or how you find these smaller companies be based on certain criterias or standards? Keith Haan: Yeah, I mean, I think what we ultimately want to do is have something that we believe sort of meets our bar for having a reasonable likelihood of clinical and commercial success. And that can be we can get comfort with that in different ways. But in a lot of instances we can pull from maybe data sets for similar compounds or something has similar mechanism or maybe get comfort from extrapolating some early clinical data. Seora Kim: Sounds good. So regarding that, I think it's super cool to learn about how you bring these smaller companies to the market and commercialize them. Are there any significant trends or innovations currently that you are focused on, or what are some of the recent companies that you've brought on? Keith Haan: I think one of the things that is sort of part of the foundation of Roivant is being nimble and being able to go where the innovation is. So we don't constrain ourselves to looking in a particular therapeutic area or looking at a particular modality, whether it is small molecules or large molecules like antibodies or even other things like gene or cell therapy. What we are looking for is something that can truly be transformative for patients and therefore for Roivant. And the way we are set up, I think we are operationally set up to be able to go where the innovation is and where the field is going. Seora Kim: For sure. So it's super cool to learn how there's no restriction on which specific field that you guys are focused on, but just following the trend of innovation. So was wondering if you could maybe describe what are some of the more recent trend or innovations that you are seeing currently that is kind of the hot field in biotech world? Keith Haan: Yeah, so maybe I can use one of our recent sort of licensing deals to highlight some of those things. So we licensed a program from Pfizer in late in 2022. And part of what drew us to that asset was it had a unique biology where many drugs for inflammatory bowel disease or for inflammatory disorders in general can have the ability to really suppress the immune system. And we saw this asset as something that really had very strong efficacy, some of the strongest efficacy that had been shown in inflammatory bowel disease, but we also thought it maybe had a mechanism that wouldn't be associated with this immune suppression. So I think that was a very strong part of why we decided to bring that asset in. But another layer to that was we also had a biomarker which we felt could predict for even better responses. And I think that is something that really the field is trying to move toward is being able to really deliver the best outcomes for patients. And in inflammatory disorders, that is starting to, I think the field is trying to start to segregate patients who will respond to therapy better. That has been done in oncology, and so there is precedent there. But I think as we learn more about some of these diseases, there's something that certainly we are interested, but also the field is interested in as well. Seora Kim: Totally. That is amazing to learn about. And I think the inflammatory disorders is something that is super important to address, and it's really cool how Roivant Sciences is working towards patient improvement and patient experience. I think it's all leading to a much better world in the healthcare field. So thank you for sharing that example. And to close us out today, I have one last question for you. What do you wish you could tell yourself when you were in our shoes as college students? Keith Haan: Ah. Seora Kim: I'm sorry. Keith Haan: That's a good question. I think I guess what I would probably tell myself is what I would tell students at Northwestern or quite frankly the new employees that are coming into Roivant that are either fresh or relatively fresh out of undergrad is, one is be comfortable that your career is going to be, especially in this field, is going to be really based on sort of a lifetime of learning. It's a field that changes. And as you get more experience, you'll be able to develop expertise in those particular areas, but you will also be exposed to additional things that you might not necessarily have seen before. So just being comfortable with being in a field that is constantly changing and being comfortable with the fact that you just need to sort of be a bit of a lifelong learner. I think I would probably tell my younger self that, but it's something that is also important, and I would say to new employees coming in from undergrad as well. Seora Kim: Totally. That is super helpful for us to consider. Thank you so much for this great advice and for joining us today. Keith Haan: Thank you so much for having me. I appreciate it. Seora Kim: Thank you for listening to this special episode of the Weinberg in the World podcast. We hope you have a great day and go Cats!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. This week's commercialization news includes Dupixent's success in a chronic hives study, Lilly's development of a weekly insulin shot, and BioMarin's plans for growth. The House backs a bill restricting China's role in US biotech, while Lykos CEO is set to depart after FDA rejection and layoffs. The newsletter also discusses key developments in cell therapy and offers insights on utilizing a direct-to-patient model in the healthcare industry. Various resources and upcoming events in the biopharma industry are also highlighted. Biopharma Dive provides in-depth journalism and insights into the latest news and trends shaping the biotech and pharma industries.BridgeBio has reduced its gene therapy budget after data from a trial on an adrenal gland medicine did not meet the company's investment threshold. GlaxoSmithKline has discontinued a herpes vaccine after it did not meet efficacy goals in a phase 2 study. Roivant has launched a new 'vant' focused on a hypertension drug. Centessa's sleepiness drug has shown promising results in early studies, leading to a rise in the company's shares. Additionally, Dupixent has succeeded in a chronic hives study, giving Sanofi and Regeneron a chance to resubmit their application for approval. Investors are also paying attention to Centessa's sleepiness drug. This news comes alongside updates on other pharmaceutical developments, such as Saxenda's effectiveness for children as young as 6 and Roche's expansion of R&D labs. Additionally, the newsletter covers upcoming events and resources for biopharma professionals. Biopharma Dive provides in-depth coverage of news and trends in the biotech and pharma industries, including clinical trials, FDA approvals, gene therapy, drug pricing, and research partnerships.Iowa has awarded Centene's subsidiary, Iowa Total Care, a Medicaid managed care contract worth $2.8 billion. Telehealth groups are urging Congress and the White House to extend controlled substance virtual prescribing before pandemic-era flexibilities expire. The Biden administration has finalized a rule raising mental health coverage standards for private plans. Steward Health Care received court approval to sell its three most valuable hospitals to Orlando Health for $439 million. The importance of data quality in realizing value from medical imaging data is emphasized by Enlitic. Payers are encouraged to optimize quality and grow revenue through key strategies in an upcoming webinar. Healthcare Dive provides in-depth journalism and insight into the most impactful news and trends shaping healthcare across various sectors like health IT, policy & regulation, insurance, digital health, payer-provider partnerships, and value-based care.Novo Nordisk showcased its investigational GLP-1 pill that resulted in a remarkable 13% weight loss. This comes after positive Phase I results for the pill, which analysts compared to weight loss pills being developed by Lilly and Pfizer. Expanded coverage for cardiovascular disease under Medicare could have significant implications for Novo's obesity drug, Wegovy. Analysts estimate that the expansion of Wegovy's label beyond obesity could lead to an annual Medicare spending of $145 billion. Meanwhile, GSK has abandoned the development of its herpes vaccine after disappointing Phase I/II results, and Crispr Therapeutics and Vertex Pharmaceuticals are facing challenges in making their sickle cell gene therapy profitable. Novo's other drug, Saxenda, was found to effectively and safely lower BMI in children, according to a study published in NEJM. Additionally, Lilly continues to make progress with its once-weekly insulin, while Bain has raised $3 billion for a fund supporting life sciences companies. The biopharmaceutical industry continues to see changes, with Biomarin facing challenges and Terns moving forward in the obesity spac

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.EPRO, or electronic patient-reported outcomes, is increasingly used in clinical trials to improve data accuracy, patient compliance, and reduce administrative burdens. Swing Therapeutics achieved 98% patient compliance in their pilot trial using EPRO, leading to an FDA de novo marketing authorization. EPRO boosts efficiency, saves costs, and improves trial outcomes.The BioSecure Act, which restricts contracts with certain Chinese companies in the US biotech industry, has advanced in the House but still needs Senate support. Bain Capital closed a $3 billion biotech fund and has been acquiring startup companies. Centessa's sleepiness drug showed promising results, lifting the company's shares. New data raise doubts about AstraZeneca and Daiichi's cancer treatment successor. Candid aims to prove the worth of bispecifics in autoimmune diseases.Roivant Sciences has acquired the rights to develop and commercialize Bayer's pulmonary hypertension drug, Mosliciguat, under an in-license agreement worth up to $294 million. Roivant has created a new "vant" called Vant to focus on this project. The Biosecure Act has passed through the U.S. House of Representatives and is set for a Senate vote. AstraZeneca and Daiichi Sankyo's Dato-Dxd failed to significantly improve overall survival in Phase III NSCLC trials, but there is still potential for FDA approval. Terns Pharmaceuticals announced a $125 million raise following positive Phase I data for their oral GLP-1 candidate for obesity.Old Navy is celebrating its 30th anniversary by throwing back to the '90s in a new collection and campaign to enhance its iconic brand. PayPal has launched its largest-ever US ad campaign featuring Will Ferrell, promoting the use of PayPal for both in-store and online transactions. Angela Zepeda, former Hyundai CMO, has been appointed as the global head of marketing for X. Pizza Hut is turning TikTok content into real-world currency for a promotion in the UAE, while Target is targeting pet owners with a collection designed by "fur-fluencers." Marketers are leveraging AI on mobile platforms and genAI is impacting marketing strategies.Merck's Keytruda, a leading immuno-oncology drug, has been highly successful in treating various cancers and has become the world's top-selling drug. However, determining the true value of a drug like Keytruda involves more than just sales numbers. U.S. drug pricing watchdog ICER tracks pricing decisions and their impact, but the industry is exploring new methods to factor in aspects like disability and income disparity. A new formula that considers "standard of living" is being explored to offer a different perspective on pricing in the pharmaceutical industry. As Keytruda celebrates its 10-year anniversary on the market, the impact of this cancer drug and other immunotherapies is being analyzed, along with the future direction of the field.

Send us a textBen Zimmer is CEO of Priovant Therapeutics ( https://www.priovanttx.com/ ), a clinical-stage biotechnology company focused on delivering novel therapies for autoimmune diseases associated with the greatest morbidity and mortality. Priovant is developing oral brepocitinib, a potential first-in-class dual inhibitor of TYK2 and JAK1, across multiple severe autoimmune indications, unlocking new treatment options for patients who are underserved by existing therapies.Ben joined Priovant from Roivant, where he was a member of the founding team in early 2015 and held multiple leadership roles across the organization, including President, Roivant Health, Chief Operating Officer, and Head, Public Affairs. As President, Roivant Health, Ben led and oversaw the launch of Roivant's Chinese biopharmaceutical subsidiaries, healthcare technology companies (including Datavant), and computationally powered drug discovery platform (including VantAI). Earlier in his career, Ben was a consultant at McKinsey & Co and co-founded and led a public policy non-profit. He holds a BA magna cum laude from Harvard College and a JD from Yale Law School.#BenZimmer #PriovantTherapeutics #AutoimmuneDiseases #Brepocitinib #TYK2 #JAK1 #Dermatomyositis #NonInfectiousUveitis #Pfizer #Roivant #VivekRamaswamy #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #STEM #Innovation #Technology #Science #ResearchSupport the show

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Yaron Werber, Luba Greenwood and Dawn Bell start the show with a look at the XBI and M&A activity from the week, including multiple deals topping over $1 billion. The hosts highlight a few of these big transactions, including Biogen acquiring Hi-Bio for $1.15 billion, Merck acquiring Eyebio for $1.3 billion, J&J buying Yellow Jersey for $1.25 billion, and Novartis buying out Mariana for $1 billion, among others. With private acquisitions in the spotlight, the group digs into some of the high caliber private companies emerging in biotech. The group also covers data updates and related stock price reactions from Summit (the company's shares tripled after cancer treatment data), Insmed (shares rocketed following Phase 3 trial results for the company's experimental airway disease drug), Biohaven (its protein-degrader drug falls short of investor expectations), and Roivant's update on FcRn development plans. In a lively discussion, the hosts share varying viewpoints on whether a CEO should respond or comment to criticism on social media, plus they look ahead to ASCO, and more. This episode aired on May 31, 2024.

On this week's Biotech Hangout, Chris Garabedian, Josh Schimmer, Dawn Bell, Paul Matteis and Yaron Werber discuss the white hot ADC space as Genmab pays $1.8 billion to acquire Profound Bio and its ADC portfolio, Ispen's $900 million pact with Sutro and Merck KGaA's $1.4 billion ‘BioBucks' AI deal with Caris Discovery. The hosts also cover the week's big private deals including Metsera $350 million funding, Oruka's $275 million PIPE, Obsidian's $175 million Series C, Alterome's $132 million Series B and Neurosterix $63m spinout from Addex. The group also discusses Amylyx's decision to withrawl ALS drug and Acorda and Eiger both file for bankruptcy. On the data and regulatory front, the hosts discuss Roivant's positive Phase 2 study results in eye disease, Gritstone's Phase 2 neoantigen cancer vaccine results, LENZ's Phase 3 data for Presbyopia and Vertex's Phase 3 kidney disease trial. *This episode aired on April 5, 2024.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 April 2024. In this episode: Genmab buys into ADCs; Roivant set to take on AbbVie in uveitis; Ipsen signs firs ADC pact; South Korea looks to build biotech momentum; and the end of the road for Acorda. https://scrip.citeline.com/SC150062/Quick-Listen-Scrips-Five-MustKnow-Things

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.This week's Commercialization Weekly highlights Bristol Myers' success with a Kras drug trial, Astrazeneca's FDA approval for a rare disease drug acquired from Alexion, FDA approval for Akebia's anemia pill after a previous rejection, and Acorda's bankruptcy filing. The FDA is also set to make decisions on expanding the use of two multiple myeloma cell therapies, a top-selling medicine, and Pfizer's gene therapy work. Risant Health has launched after Kaiser closed the acquisition of Geisinger, with plans to acquire more nonprofits. Surescripts is reportedly exploring a sale, with a private equity buyer being a potential option.Genmab acquired ProfoundBio for $1.8 billion, joining the trend of increased M&A activity in the development of antibody-drug conjugates. Paragon's hub-and-spoke biotech model resulted in another reverse merger with Oruka Therapeutics going public. Diagonal has raised $128 million to develop more efficient 'activator' antibody drugs. A dementia-focused venture capital firm is exploring new brain drugs beyond anti-amyloid therapies. Roivant reported positive immune drug data and announced share buyback plans.Genmab recently acquired the company ProfoundBio for $1.8 billion, expanding its presence in the antibody-drug conjugate (ADC) space with a focus on gynecologic cancers and solid tumors. Meanwhile, Diagonal Therapeutics secured $128 million in funding for their unique approach to developing agonist antibodies for rare diseases. In other news, Vanda Pharmaceuticals received FDA approval for their antipsychotic drug Fanapt for bipolar disorder, while Eli Lilly's diabetes treatment Mounjaro will be in short supply due to high demand.The text discusses the impact of tensions in U.S.-China research and development (R&D) relations on the Chinese antibody-drug conjugate (ADC) investment boom. With the departure of Chinese biotech company Wuxi from Bio, concerns over national security implications of U.S.-China R&D relationships are growing. The text also mentions the appointment of a new CEO at Lonza and Avenzo's pursuit of a licensing strategy with a new $150 million investment. Overall, the biopharma industry is experiencing significant developments in drug development, mergers and acquisitions, and regulatory decisions. Stay updated with Healthcare Dive for more insights into healthcare trends and news.Thank you for tuning in to Pharma and Biotech daily. Stay informed!

ROI serves as an important benchmark for all life sciences companies, whether it involves a pipeline candidate, new products, or marketing strategies. But what does ROI have to do with creating a culture of care?In this episode of Moving Forward, Giving Back, our guests Troy Wilson, CEO of Kura Oncology, Kate Wilson, President of the Gilead Foundation, Matt Gline, CEO of Roivant, and Tom Croce, Vice President of Global Patient Advocacy at Jazz Pharmaceuticals join host Morgan Berman, Executive Director of Life Science Cares Philadelphia, to explore how creating a culture of care ensures overall business success, achieves a competitive advantage within their specific business landscape, creates a supportive work environment for employees, and maintains a genuine, distinct corporate identity.This is an insightful, information rich conversation on an essential topic that you do not want to miss. To learn more go to lifesciencecares.org.

Roivant Sciences's Q3 2023 earnings call, unedited

Chris DeMuth Jr. is still really bullish on the commodity uranium (0:56) and cannabis fintech company SHF Holdings (5:24). He also shares 3 new litigation ideas for investors (8:50).Subscribe to Chris' Sifting The WorldEpisode transcriptsShow Notes:SHF Holdings: My One StockChris DeMuth Jr. On Energy Exposure, Uranium's Dry Spells, SHF Holdings BullishnessChris DeMuth Talks Cannabis, SAFE Banking + SHF Holdings2024 - Liquidia, Burford, And RoivantFor full access to analyst ratings, stock quant scores as well as dividend grades, subscribe to Seeking Alpha Premium at seekingalpha.com/subscriptions

Roivant Pharma is reinventing the discovery, development, and commercialization of new medicines. Mayukh Sukhatme, M.D. was recently appointed to Roivant's board of directors and has served as Roivant's President and Chief Investment Officer since January 2021. He is responsible for identifying, performing diligence on, devising development strategies for, and transacting on new therapeutic programs for the company. He also informs Roivant's view of its existing biopharmaceutical subsidiary companies for capital allocation decisions across the Roivant portfolio. Mayukh joined Roivant in 2015 and previously served as President of Roivant Pharma and as Chief Business Officer. Programs that he has in-licensed or acquired for Roivant have produced all 10 of Roivant's positive Phase 3 studies and have garnered 6 FDA approvals. Before joining Roivant, Mayukh was a healthcare-focused analyst and portfolio manager for several large institutional investment firms, including both public markets and venture capital firms. He earned his M.D. from Harvard Medical School and his B.S. in Biology and B.S. in Literature from MIT.Hosted by Joe Varriale.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have several developments in the industry to discuss.First, Structure, a biotech company focused on obesity treatments, experienced a setback. The results from a phase 2 trial of their obesity pill fell short of expectations, causing the company's shares to plummet. Similarly, Radiopharma's drug for prostate cancer did not meet analysts' predictions for its benefit, which could accelerate a planned takeover by Eli Lilly.In other news, Illumina has decided to part ways with Grail, ending their battle with regulators. Activist investor Carl Icahn, who is suing Illumina over its acquisition of Grail, continues to push for the removal of several board members. Additionally, Pivotal Life Sciences has reloaded with $389 million and is now hunting for deals in a downturn, tracking startups in the biotechnology sector that need fresh funds to move their programs forward.Moving on, Zimvie is selling its spine business to H.I.G. Capital for $375 million. This strategic move allows Zimvie to focus on its dental business and reduce its debt. BTIG analysts are optimistic that the medtech industry will rebound in 2024 after a "string of rough years," despite rising interest rates and concerns about the impact of GLP-1 drugs and supply chain issues.Glaukos has received FDA approval for its drug-releasing eye implant to treat glaucoma. This product has the potential to revolutionize glaucoma treatment by addressing noncompliance with eye drops. Freenome has also started a 20,000-subject study of its lung cancer blood test, which could provide an alternative to CT imaging and reduce radiation exposure.Moving on to the healthcare industry, Elevance and Blue Cross Blue Shield of Louisiana (BCBSLA) are reviving their proposed $2.5 billion merger after addressing regulatory concerns. The No Surprises Act's dispute portal has reopened as the CMS faces challenges in rolling out the policy. A lawsuit has been filed in New Jersey alleging that the state's telehealth licensure rules hinder access to care, especially for patients with rare conditions.Cybersecurity concerns remain as connected devices used in telemedicine enable real-time patient monitoring and advanced care. CMS has sent a letter urging health plans and PBMs to ease up on independent pharmacies before a new policy goes into effect.In the biopharmaceutical sector, Roivant has faced setbacks but remains focused on expanding its pipeline. Babson Diagnostics has received FDA clearance for its blood testing technology, bringing us closer to Theranos-like blood testing.Overall, these developments highlight the challenges and strategic decisions made by companies in the Pharma and Biotech industry. Stay tuned for more updates in our next episode. Thank you for listening to Pharma and Biotech Daily.

On this week's episode of Biotech Hangout, hosts Daphne Zohar, Tim Opler, Josh Schimmer, Brian Skorney and guest Matthew Gline, Roivant CEO discuss the current market for public biotechs plus Pharma performance including Sanofi, Pfizer, Bristol Myers Squibb, Roche, Biogen and Abbvie. The hosts also discuss Sarepta's trial miss, and Matt shares additional commentary to Roivant's deal with Roche. They also share thoughts on Lexeo Therapeutics' IPO ($100M), 4D Molecular Therapeutics' CF Phase 1 data and AstraZeneca's investment in Cellectic ($245M). There were several large funds from the week including Abingworth's fundraise ($365M), Blue Owl- Cowen Investments acquisition (~$1B) and Bioluminescence Ventures' fundraise ($477M). Other topics include Bluebird Bio presells its PRV to Novartis, Amgen stops selling PSMA BiTE, Crispr Therapeutics/Vertex adcomm and Pfizer closes several sites. *This episode aired on November 3, 2023 Josh Schimmer disclosures: The disclosures for companies that I cover can be found on the Hangout homepage and none of the comments should be construed as investment advice.

Roivant Sciences Q3 2023 earnings call, unedited

Daiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury's editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi's pipeline strategy.The editors break down Monday's $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A space; and offer highlights from BioCentury's deep dive into how academics and biotechs are expanding the therapeutic potential of base editors.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Express Scripts, a pharmacy benefit manager owned by Cigna, is currently facing a lawsuit from independent pharmacies for alleged price fixing. It is claimed that Express Scripts collaborated with rival Prime Therapeutics to overcharge these pharmacies. This case highlights the ongoing challenges and controversies within the pharmaceutical industry.In other news, Blue Cross North Carolina has announced plans to acquire 55 FastMed urgent care clinics. The nonprofit insurer aims to restore these clinics to pre-pandemic standards after experiencing staffing shortages. This acquisition demonstrates the importance of accessible and high-quality healthcare services in the current climate.Supply chain challenges in the healthcare industry have been a major concern during the COVID-19 pandemic. Four health system executives recently shared their strategies for managing disruptions in the supply chain. These innovative approaches are crucial for ensuring the continuous availability of essential medical supplies.Meanwhile, healthcare workers at Providence St. Joseph Medical Center in California and PeaceHealth in Washington have gone on strike to demand better working conditions. This highlights the need for improved labor practices and support for frontline healthcare workers.Transitioning to industry news, Roche has made a significant move by agreeing to acquire Televant, a subsidiary of Roivant and Pfizer, in a $7.1 billion deal. This acquisition will provide Roche with access to a promising inflammatory bowel disease treatment currently in late-stage clinical trials. It demonstrates Roche's commitment to expanding its portfolio and addressing unmet medical needs.Seagen's trial data presented at the European Society for Medical Oncology (ESMO) conference has impressed investors, leading to a boost in shares for both Merck and Pfizer. The combination of Seagen and Astellas' antibody-drug conjugate Padcev, along with Merck's Keytruda, has shown significant improvements in survival rates for first-line bladder cancer. This breakthrough offers new hope for patients and showcases the potential of innovative treatment approaches.Verve Therapeutics has received FDA approval to conduct a base editing study for heart disease treatment in the US. This approval comes after the FDA requested more information about Verve's in vivo treatment. It is a significant step forward in the development of effective therapies for cardiovascular diseases.Pfizer has also received FDA approval for its new meningococcal vaccine, Penbraya. This addition to Pfizer's infectious disease portfolio will contribute to the prevention and control of meningococcal infections.Despite a recent slowdown in biotech companies going public, two new players, Invea Therapeutics and Cargo Therapeutics, have joined the IPO queue. Invea Therapeutics focuses on immune diseases, while Cargo Therapeutics develops cancer drugs. This demonstrates the continued interest and investment in innovative biotech solutions.In conclusion, the biosimilars market has experienced slow growth since its inception in 2015. However, recent developments, including the entry of new companies, are contributing to its evolution. These insights and news updates are provided by Biopharma Dive, a trusted source for in-depth journalism and analysis of the biotech and pharma industry.Thank you for joining us on this episode of Pharma and Biotech Daily. Stay tuned for more important updates from the world of pharmaceuticals and biotechnology.

On this week's Biotech Hangout, guest Matt Gline, CEO of Roivant, joins hosts Daphne Zohar, Tim Opler, Mike Yee and Yaron Werber to discuss recent Phase 1 data from Immunovant, part of the Roivant family of companies & Igg degraders broadly (BHVN & ARGX). The hosts also cover biotech sentiment, M&A and the state of the XBI. They discuss BridgeBio PIPE funding, Alfasigma acquires Intercept Pharmaceuticals, setbacks for two CD47s (Abbvie and Gilead) and Morphic Therapeutic's controversy. Other topics of discussion include Apellis Favus short report, and Bristol Myers Squibb and AstraZeneca drug pricing negotiations. *This episode aired on September 29, 2023*

Alle Infos zu ausgewählten Werbepartnern findest du hier. Das Buch zum Podcast? JETZT BESTELLEN. Lieber als Newsletter? Geht auch. Costco verkauft neuerdings Gold. Netflix verkauft neuerdings keine DVDs. Peloton verkauft neuerdings Lululemon und vice versa. Ansonsten hat CureVac Stress mit BioNTech, AMS-Osram braucht zu viel Geld und bei Schott Pharma läuft. Walmart und Costco kennt jeder. An der Börse ist aber ein anderer Shopping-Club führend - aka BJ's Wholesales Club (WKN: A2JPDX). Roivant Sciences (WKN: A3C4MS) kann mehr als 300% Rendite in zwölf Monaten machen und Milliarden-Medikamente entwickeln. Was aber viel wichtiger ist: Roivant Sciences kann den Präsidentschaftswahlkampf von Vivek Ramaswamy finanzieren. Diesen Podcast vom 29.09.2023, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung. Learn more about your ad choices. Visit megaphone.fm/adchoices

In today's explosive episode, we're pulling back the curtain on Vivek Ramas Swami, the "golden boy" of next-gen politics. You know, the guy everyone and their grandma is singing praises about? Well, hold onto your hats, because this isn't your run-of-the-mill campaign fluff piece. We're diving deep, and I mean Mariana Trench deep, into the hidden corridors of Ramaswamy's life—from his George Soros-funded stint at Yale Law School to his oh-so-coincidental feature on the World Economic Forum website. But wait, there's more! We kick off this jam-packed episode with a bizarre tale you've got to hear to believe. Ever heard of the "Don't Tread on Me" flag? Of course you have. Well, some woke school district tried to ban a 12-year-old from sporting it on his backpack. Yep, apparently it's now "racist." But don't worry, we've got a happy ending to this madness, and it's one you'll want to hear. So before you blindly jump on the Ramaswamy hype-train, you might wanna know who's conducting it, right? Trust me, you don't want to miss this no-holds-barred, tell-it-like-it-is episode. It's time to shake up the echo chamber, question the narrative, and expose the truth.   All links: https://linktr.ee/theaustinjadams Substack: https://austinadams.substack.com   ----more----  Full Transcription Hello, you beautiful people and welcome to the Adams Archive. My name is Austin Adams, and thank you so much for listening. Today. On today's episode, we are going to be doing a deep, deep dive into presidential candidate Vivek Ramas Swami. Now, you might be saying why we love this guy, and I get it. I've been singing his praises for quite some time now. Uh, I have, have had many, many times told many people about how excited I was for his candidacy, but I'm not just going to blindly follow what everybody else is doing, and I'm not just going to buy into the hype when I see some red flags. So that's what we'll going over today is just some of those red flags and I'll let you make your own decision. But by the end of this, I hope to have a conclusion for you from my perspective. Okay. So this episode will be going into all of the history of Avek Ramas Swami from his George Soros funded time at Yale Law School to his alleged, uh, mishap where he just so happened to find himself listed on the World Economic Forum website. Hmm. And then even deeper into his time in a fraternity at Yale until now. So we'll watch some of the clips. I'll tell you why I like the guy. I'll tell you why I think the guy could be a great candidate, but I'll also tell you why there's some red flags being waved in my book now. The only other topic that we will discuss before that is going to be that there was a 12 year old child going to school who was told, if you've ever seen the flag, the yellow flag, I know you've seen it with a snake on it that says, don't tread on me. Right. Everybody knows that flag. Most people like me correlate it with the United States Marine Corps, but we'll look at the history of that because it came into question during a school district telling a child that they could not walk around school with that patch on their backpack because it was allegedly racist. Hmm. But we do have a conclusion to this and one that I'm actually proud to share in a world of so much wokeness. So stick around for that. First, I need you to head over to the CK Austin Adams, do sub stack.com. Sign up for the podcast companion. Then I need you to subscribe and leave a five star review. Alright guys, I appreciate it a lot. We've been getting some great reviews recently. I can't tell you how much I appreciate it. It's the only way that you can give back right now for all of the hard work that I'm putting into this. This is now the 84th episode, which means almost over a hundred hours that we've spent here together. And there's no way to pay me back other than just leaving a review. That's all I want. Just spread the message, send this video, send this out to two different people. The podcast, subscribe on YouTube, do whatever you can to get the message out. Uh, as you know, a lot of times on social media, I am either shadow banned. Or completely banned like TikTok. Uh, so there's only a few ways that I can get the message out, and that's through you guys sharing my stuff with people that you know and love. All right. So without further ado, today's deep dive on the Adams archive is on Vivek Ramas Swami, the Adams Archive. All right. In another win for freedom, a school has reinstated the 12 year old in Colorado who is kicked out of class for sporting the Don't Tread on me flag. Otherwise known as the Gadsden flag. I didn't actually know the name of that until now when this happened. I guess I should have. Uh, but I always just correlated this with the Marine Corps for some reason. I know that's a very, uh, consistent flag flown for the Marines. However, learning the history of this, I am a big fan of the history of this flag. So it actually dates back to the Revolutionary War, and it was something that was, came up with, and maybe we can go into the history of this just a little bit, um, but it has its place in history, right? It, it, it basically was a, a show of power against the British clergy to show that we will not stand idly while you strip us of our freedoms. That's the history. That's it. Revolutionary war. There's nothing other than that about it. Okay. Now there was a teacher who took that flag and decided that it was now going to be racist and went as far as to having a parent teacher meeting about it, and then even had somebody from her district back her up. So let's go ahead and watch this video. And again, you can always see it right here with me on the YouTube. All right, so here we go. Oh, okay. Hold on. Thank you.  Do they know what the Gadson flag is? That's a historical flag. So there, um, the reason that they do not want the flag, the reason we do not want the flag slave mm-hmm. Is due to its origins with the re slavery and slave tribe. That is what was, um, as the reasoning behind them. Not like the Gadsden blood, the don't tread on me. Okay. Which is the Gadsden blood. Okay. Um, okay. So he, he um, now this kid has the best smile on his face right now. What's happen if he doesn't take it off? He, I mean, he is able to go, I was actually just telling him like I was upset that he was missing so much school. I'm like, ah. So I asked if, can he just take his stuff out of his bag and go back to class? Like I just want him to go back to class. The bag can't go back. It's got patch on it. 'cause we can't have that in and around other kids. So that's what I was trying And then he said, you were close. So I was like, oh, okay. Yeah. It has nothing to do with slavery. That's like the Revolutionary War patch that was enslaved when they were fighting the British. Like that wasn't, that's the revolution. Maybe you're thinking of like the, um, the Confederate pe arm Confederate flag. Okay. I so. I'm just here to enforce, is there, tell me. No, I am here to enforce the policy that was provided Okay. By the district. Okay. And definitely you have every right to not agree with it. I mean, I, yeah, because the c u says that he's allowed to wear that if you like, go on their website, it's like, says in the big letters. So I all, I, all I'm saying is that unless there's like a ban on patches period, like if you said there's no patches allowed at the school, you cannot display what you think or anything like that or what cheer or anything like that. Um, I, I don't, I think it's like one sided, you know, because you allow some patches, but not other patches. Other kids have patches like other names and like these American flag backpacks. Yeah. That was like flown during the revolution with, um, yeah. I, I just don't wonder stand that at all. So what I can do is, and if you, if you go onto the ACLU's website, Yeah, let's, let's talk to someone speak, because I don't have a lawsuit. I really don't. I can speak, I can have you speak to our Jeff Yoko again. Okay. Um, and then he can refer you to our person at the district. Okay. Um, because like I said, we're following district policy. Okay. Is what we're doing. Okay. So the last thing I want is him out of class. Yeah. I know that. That's all my, the last thing I want takes his classes seriously. He studies, he does. He wants to get straight A's he did that he made honor roll when he was here before. He intends to do that again right now. But it's hard 'cause he keeps missing class for this. So I understand that. Yeah. And I mean, we teach him to always stick up for your beliefs and I mean, you're going over the revolution. This for seventh grade, I mean the founding fathers stood up for what they believed in against unjust laws.  This is unjust. 100%. Get it mama. We are upholding a policy that was provided to us, which we have to avoid. Okay. Can you show me where the policy. I absolutely applaud this mother for everything that she just did there, stood her ground, articulately stated her case, said, I don't understand why you guys would ever think that this is anything to do with slavery. This is a flag that was flown against the British during the Revolutionary War. Now what would happen if he didn't? So she did her research on this. She knew exactly what to say, and, and I applaud her even more so because she's sitting there with another child, like a baby sitting in a car seat in front of her while making this case. Um, and so here's the update on this. Alright, so they eventually, uh, sent a letter. To the district. So it says, meet 12 year old Jayden, who was kicked out of class yesterday in Colorado Springs for having a Gadsden flag patch, which the school claims has origins with slavery. The school's director via email, uh, said that the patch was disruptive to the classroom environment. Now, the receipts from this with the Jeff Yokum that was, uh, told in reference to this mother was about, uh, dress code. Now, this actually happened yesterday and this email back and forth from the Vanguard School District. The, uh, individuals is Jeff Do Yokum, Y O U, or Y O C U m@thevanguardschool.com said, Mrs. Rodriguez, I, as I discussed, I'm providing you the rationale for determining the Gadsden flag is considered an unacceptable symbol, first case when E E O C required the complaint to be reviewed. This was the Washington Post. Saying Wear don't wearing, don't tread on me. Insignia. Could be punishable. Racial harassment then posts the tied to the Confederate flag and other white supremacist groups, including Patriot groups. Huh? Patriot groups. How dare you. Uh, then there's additional photos. Let's see if we can get the bottom of this. No. Okay. So then basically what ended up happening with this, the, what they ended up citing on this was somebody who is a graphic design scholar from the conversation.com. Hmm. So it also says that rattlesnake imagery in the United States, or the American Revolution was hosted and fueled by Ben Franklin's papers and interest in Massachusetts and Pennsylvania. Franklin spent the latter part of his life petitioning Congress to free South slaves. But assistant Dean equity doesn't. Know that hmm many anx were quick to side with Jaden and his mother pointing out that the rattlesnake imagery of the gadson flag was inspired by Benjamin Franklin, who spent the latter part of his life petitioning Congress to free the South's slaves, the Epper Minutemen, who had also used the symbol Incorporated eight 14 black and native men in black flag bearer, a greater diversity than many other regimens, according to Tony Cannet, an investigative colonist of the Daily Signal. Uh, so the result of this was that the district reached out and had a message because this spread like wildfire. And it said yesterday, the student was returned. The student returned with the patch still visible on his backpack. Following the district's direction, Vanguard administration or administrators pulled the student aside so that they could speak with his parents in the district. Upon learning that they have these events to the today, the Vanguard School Board of Directors called an Emergency Meeting From Vanguard's founding, we have proudly supported our constitution, the Bill of Rights, and the ordered liberty that all Americans have enjoyed for almost 250 years. The Vanguard School recognizes the historical significant of the Gadsden flag in its place in history. This is incident is an occasion for us to reaffirm our deep commitment to a classical education in support of these American principals. At this time, the Vanguard School Board and the district have informed the student's family that he may attend school with the Gadsden flag patch visible on his pack, on his backpack. Sincerely, the va Vanguard School Board of Directors of. Good. Good. Finally, some decency and some, you know, reasonable conversations being happening now. There was actually a picture that came out of this child with his backpack standing in front of a teacher's car, which said, make America Green again. So the teachers were allowed to post these things on their vehicles and drive around with them, but a student can't wear this on his backpack. Very, very interesting. So chalk it up for another win for freedom, as I said earlier. Right. We've seen it with Target, we've seen it with, uh, all Bud Light. We've saw it with all of the things that we've seen pop up recently. All of the, the music that is topping the charts, the Richmond, north of Richmond, um, all of it has, has culminated to show that there is power in numbers. There is power in speaking out. I saw this. I saw this graphic the other day that showed a, like what looked like a, a authoritarian Egyptian slave bearer with a whip whipping a group of people. It was like a row of people. And then the next column was one person of that group standing up and the slave bear still, or owner, still whipping that person. And then the next group of people behind that, one person starts to stand up. There's a group of them now, and then the slave bear, the slave owner whips them again, and then everybody stands up and the the slave owner runs. And this is such a good graphic, such a good. Picture of what it means to go through what we all went through in the last three, four years, where we went from, nobody's standing up against this, nobody's speaking out against it, nobody. It wasn't cool to be, you know, talking out against C O V I and you know, it wasn't, it wasn't cool. We were getting banned and shadow banned and getting our accounts ripped away from us not led into airports and, and not allowed to get a job and or keep your job even if you had one already. We saw so many instances where nobody was standing up. There was very few of us, and that was the very precipice of when I started this podcast was because I saw that there was so few people standing up during this crazy time while the curtains were being pulled back of authoritarianism. Once we were learning what was really going on in these institutions, So little people were standing up, but now we're seeing there's a massive group standing up against these things. Standing up for freedom, standing up for liberty, standing up for the rights of our children and their schools to display their support for our constitution and what it stands for. So really happy to see this once again, another win. Alright, so with that, let's dive into our conversation about Vivek Ramis Swami. Now, I have been for a very long time, months now since he announced his candidacy almost, it seems like been saying how interested I was in Vivec as a candidate and there was really one thing for me. There was one thing for me about Vivec. Made me really question him. That has kind of made a little, it was the thread on the sweatshirt that started to unravel it for me. And again, I'm not coming to any conclusions on this yet. Uh, I still don't know how I feel about it fully, but I just wanna show you what, to me, has been the red flags. And maybe you've seen some of them, and maybe you haven't. And maybe because I mentioned him, you started to pay attention to him and support him. So, I, I just wanna be transparent here, guys. I don't know how to feel about Vivek. There's been several red flags, far more red flags than I would like to see about a candidate at this stage of the race. The biggest red flag for me of Vivek was his Obama opener at the debate stage. Now you must be wondering, who's this skinny guy with a funny last name doing, standing on a presidential debate stage? That, to me, started it all. I. And here it's, so first, lemme just address a question that is on everybody's mind at home tonight. Who the heck is this skinny guy with a funny last name? And what the heck is he doing in the middle of this debate stage, the hope of a mill worker's son who dares to defy the odds, the hope of a skinny kid with a funny name, who believes that America has a place for him too. So first, lemme just address a question that is on everybody's mind at home tonight. Who the heck is this skinny guy with a funny last name? And what the heck is he doing in the middle of this debate stage? The hope of a mill worker's son now dares to defy the odds there is the, there is the back to back between those sounds. Pretty familiar, huh? For a Republican candidate to verbatim, verbatim, Rip off. Barack Obama's just, this was one of the most famous statements in presidential history, right? That there's a reason that this was immediately followed up by, uh, Chris Christie on stage with him calling him out for it was because everybody knows this statement. This was a statement that everybody went wild for. Who is this skinny guy with a funny last name and what is he doing on this debate stage? I don't think anybody was asking that about Vivek. I think he was a little out of touch. And then to actually re I, I don't know if this was supposed to be a quirky, funny nod to that statement. Maybe that's the case. Maybe we can, we can attribute naivety or, uh, comedy where malice is being attributed instead. But it doesn't seem like, like that was the case here. To me, it seemed like he was legitimately using this as his opening as on, on the biggest floor that he's had so far next to podcasts, which is crazy that, you know, there's some podcasts that are far bigger than this debate stage. Uh, but that's how you open the debate for the Republican party. Now, I could see if he was a Democrat doing that, I could see him pulling that quote, but just to, to, there, there was no, the, the follow up to this was not, I bet you've heard somebody say that before, but I'm different and here's why. Now, Viva Ram Swami is more articulate than Barack Obama was, I think more presidential than Barack Obama. Was, which says a lot. Barack Obama was a great president in the way that he presented himself and presented our nation. Now you wanna get into policies and it completely unravels. But the ability that he had to speak on a stage to massive amounts of people, the, uh, intellectualism that he conveyed when he talked about certain topics was, was impressive. And that you can say the same for Vivek. And what we came to find out about Barack Obama was that he wasn't as genuine as he tried to appear to be. It was all an act. And I'm afraid that maybe just, maybe that's what Vivek is doing too. Now, I'm gonna be honest with you here, and you might, you might laugh at this, you might roll your eyes at it, but I was watching the debate. And I may or may not have had some t h c enter my system here. And I totally, in that moment, being a little bit high, watching the debates, uh, drinking a, drinking a beer. Um, I s I just felt it, the Vivek felt like a a, you know what it looks like to me for Vivek Ram Swami is that the big leagues, the BlackRocks, the Vanguards, the World Economic Forums said, wake the beast. We got 'em. Guys call in our ace of spades and Vivek just rises from like a cryo chamber and the water just drains out of his plastic, uh, surrounding his, his glass, that, uh, box that he's standing in. And, and he. Takes his first step out of the glass box into the real world to take over the next presidential race, right? It just seems all too good. He seems too good, he's too polished, he's too clean. Everything, everything he's saying is, is right spot on with how they know the disenfranchised feel on one side, everything that he's saying, his presentation is perfect. His teeth are white as can be. His smile is practiced to a t. It's all a little too perfect for me. It's not, it doesn't come off as authentic. And, and maybe I was just a little bit high, maybe that that just unraveled it for me, but it just seems a little unauthentic to me. It seems like a play. And obviously everybody on that debate stage is playing games and all of them are wearing a mask and he's just way out of everybody else's league on that stage. And guess what, Vivek, I would love to have a conversation with you and would love for you to convince me that you are not the second coming of Barack Obama drained from your cryo chamber by World Economic forum elites to come and take over the presidential race once they take down Donald Trump and be another puppet installed into our governmental system. I would love that. Come on, come on the show. We'll have a conversation. I'll even have a drink with you. And, and I would love to have that conversation with you. You're very articulate. I think, again, he's probably the most presidential candidate that I've ever seen, you know, next to John f Kennedy's speech patterns. There's nobody greater in history that I, that I've seen than the way that Vivek, uh, presents himself in, in the, the, the, the canned ness of his speeches, though the, the smiles on his face that are so practiced that articulateness, if that's a word, the, the, the way that he, how good, how clean, how perfect every response is, is just a little too on point for me. And there's a little bit, there's just a, and maybe I just don't know the guy, and maybe he's like that all the time, but he's just so, it's so salesy. Not a salesy in a bad way, but a great salesman, great salesman. And those are the most dangerous 'cause they'll talk you into anything, trust me. Um, so that, that's where this all started. To me, the Obama statement just irked me. And then it was just the way that he was just da da da. Like he knew every single question that they were gonna ask. He had the perfect response, every part of it. He's almost like a robot. And Chris Christie alluded to that. He said, uh, what did he say? Let me, let me pull up the Chris Christie, uh, response because it was just, it was just so spot on. Uh, let me go to the YouTubes here and I can show you. It actually follows up, uh, in, in retorts, vivex statement there. Uh, Christie, G P t I. It was just the, such a good retort. Here we go. I've had enough already tonight of a guy who sounds like chat, G P T standing up here, and the last person in one of these debates, Brett, who stood in the middle of the stage and said, what's a skinny guy with an odd last name doing up here was Barack Obama. And I'm afraid we're dealing with the same type of amateur standing in stage tonight. Who the heck is this skinny guy with a funny last name, and what the heck is he doing in the middle of this debate stage? The hope of a skinny kid with a funny name, who believes that America has a place for him too. I've had it. I'm just telling you, there's something about him, something about him that I just can't, I can't, there's a red flag and I can't get around it. And there's other red flags too. So let's dive in to those. So here is where, uh, there's, there's some other influencers calling this out, right? And we'll get to those in a second. Um, but let's, let's just start from the top here. Okay. Now let's vet Vive. I like that. Let's vet Vivek. Let's see if these red flags have it even merit to them. All right. So Ramas Swami was indeed nominated the sadness comes from dossier.today. Ramas Swami was indeed nominated and selected as a World Economic Forum, young global leader. In 2021, which is an obvious massive red flag. However, Ramis Swami claims an alibi explaining on his social media. Funny, you should bring this up because this all started with a tweet from Jack Poso who said, how strange. When you look at the World Economic Forum, young Global Leaders of 2021 page. Today, it appears a name has been scrubbed from the list. It'd be a shame if somebody had receipts of the original list, in which case Poso posts them. Now, Vivek retorts this and says, funny, you should bring this up. Vivek says, the first chapter of my upcoming book in April has the receipts of my exchanges with the World Economic Forum. Years ago when they repeatedly kept trying to get me to be named, I gave them a polite hell no reveals the games that the World Economic Forum plays. Now let's go to this tweet and actually read, said receipts. Uh, so there's actually the, the, uh, screenshots from the World Economic Forum. It says, meet the 2021 class of young global leaders under that, right under, uh, Terrance Kamal Vasu Vats. Achmad Zaki. Aditi Avanan is Vivek Ramas Swami. Hmm. Very interesting. And then the next day on the website, his name is Gone. Now, Vivek has come out and personally said that, yes, I had to sue them for them to take me off of their website. Now here's the better question. Why would they elect him in this way? Why would, why would that be on their website? Now, I'm not getting elected to be a World Economic Forum, young, global leader, I promise you that. But Vivek is, Vivek is clearly stated on their website until he says that, you know, nobody has been working to dismantle the Global World Economic Forum takeover more than me. You're right over the target. Stay on it. I'll send you a signal or signed book so you can learn more about it. It's worse than you can ever imagine. Jack responded and said, you've sent me like five books already, my dude, and interesting. So, What he has yet to explain is his longtime association with Soros Inc. Now, if Vivek is associated with the World Economic Forum as a global leader and he's been taking money from George Soros, maybe those are a couple red flags we should be at paying attention to. Maybe a G O P Presidential candidate is a literal Soros fellow directly on the Soros website. Right now it lists Vivek Ram Swami 2011, founder and c e O of Roy Van Sciences. Vivek is the child of immigrants from India. Fellowship awarded to support work towards a Juris doctorate in law at Yale University. Vivek Ramma Swami is the founder and c e o of Roy Van Sciences. Vivek was born in, uh, Cincinnati, the Indian parents in high school. He was a class fellow Victorian, a nationally ranked junior tennis player and accomplished pianist. Vivek graduated from Harvard College in 2007, Summa cum laude and Phi Beta Kappa with a major in biology. Later he entered Yale Law School well at Harder. Harvard, a preis of his senior thesis on the ethical questions raised by creating human animal kymera. Hmm. Was published in the Boston Globe in the New York Times. He was chairman of the Harvard Political Union and served as one of three undergraduates chosen for an advisory board for the selection of the current president of Harvard. I. Hmm. During his senior year, Vivek co-founded student businesses.com, a technology startup company, which connected entrepreneurs with the professional LI resources via the internet. And he led the company to its acquisition in 2009, after Harvard College, Vivek worked for three years in life sciences, investing in New York before pursuing his law degree. That's interesting. I didn't see that. Ethical questions raised by creating human animal chimes. That's an interesting topic. Alright. I could get behind 2007 Harvard Vivek writing that. So maybe that's a, a green check mark instead of a red flag for a second. Very interesting. Now another thing here, right on Vivex. soros.org website says, Paul and Daisy Soros fellow Vivek Ramma Swami's Rovan Sciences develops clinical stage antibody to prevent and treat acute respiratory distress syndrome in patients with C Ovid 19. So Vivek profited during COVID through creating these clinical stage antibodies. Another one is pursuing the potential of abandoned pharmaceuticals, and the other one is Havara. Swami's RO sciences stays innovative. So there's the articles from soros.com. He also showed support for George Soros in a recent, well, let's see if it's recent, a tweet from 2021. Pretty recent he said, well said, George Soros said, Vivek Rams Swami, I consider Mr. Z the most dangerous enemy of open societies in the world. Well said Mr. Soros. Hmm. For reasons unknown. Ramas Swami's Wikipedia page has recently updated that deleted information about his religion and his association with Soros Inc. Now, if you don't know, Ramas Swami is a Hindu, was raised Hindu by his family, which no surprise, he's from Indian immigrants. Um, so I'm not sure why they would remove that. Who cares? It says writing on the Wall Street Journal. In 2020, Ramas Swami unveiled his opening salvo against the World Economic Forum in BlackRock stakeholder capitalism model. However, later in the piece he confusingly declared, I would love to have BlackRock as a shareholder if my company ever goes public, said Vivek. Now on China, Ramas Swami is known for his recent tough talk on China. On Tucker Carlson's show. Ramas Swami said that as president, he would have America reorient all of its supply chains away from China. Okay, I can get down with that. Vivek. However, Ramis Swami was a featured speaker at a Shanghai Investment Conference in 2018. Moreover, he has launched companies outta China and formed partnerships with Chinese firms in one such deal. Ramas Swami's Roivant partnered with the Civic Group, a state owned investment company of a Chinese government to launch an outfit called NT Sciences. And here's the article to back that up, which says Viva Ramma Swami Strikes again. This time launching a Beijing based biotech player with a pipeline. This morning, Rove unveiled NTT along with cpi, a Chinese private equity group. Now, this is where this gets a little important when we get to some of the videos that I'm gonna show you from other people who are talking about this, um, because this is where kind of the shift of money and the, the shift of patents come from, uh, a little bit later. So pay attention to that name SYN event as recently as 2020 2nd of February, February, 2022. Ram Swami's Roy event listed subsidiary companies in China, according to SS e c filings, which are the subsidiaries being site event biotechnology CO. In China site event sciences CO in China, Cynt Sciences Limited in Hong Kong Covid 19 in the mRNA gene, the biotech entrepreneur has repeatedly tried to find a niche in the game or in the gene therapy business, and therefore he unsurprisingly, A big proponent of mRNA shots. In January of 2022, Vivek wrote an article in the Wall Street Journal declaring that social distancing and cloth masks would work to stop viruses, but that it needed to stop so that people can avoid antigenic drift. He added the most important step in fighting the C Ovid 19 pandemic was the distribution of vaccines. But new variants aren't emerging in the US said Vivek. This was January 12th, 2022. But new variants aren't emerging in the us. They're emerging in places with a higher percentage of a vaccinated individuals. Those variants are the ones that have the greatest potential to drift and possibly shift away from the strain that initial vaccines were designed to. And then it goes on to the second tweet. Ramas Swami has extensive business ties to to, to Pfizer. Extensive business ties to Pfizer Rovan, which was founded by Ramas. Swami has partnered with the taxpayer looting pharma cartel boss on several occasions. Tiva, another subsidiary says, download our free ebook. Learn how Pfizer Rovan and m AMB X accelerate their process development strategy hashtag bioprocess. Now this, this is not a subsidiary. The subsidiary within that was Roivant. Um, so correct myself there. Tiva, C Y T I V A now, uh, from Reuters in 2022. December 1st at 11:21 PM posted Rovan Pfizer team up on inflammatory disease drug. Hmm. So Vivera Swami not only said that masks work, not only said that vaccines need to be rolled out as soon as possible. Paraphrasing, but also teamed up with Pfizer in several occasions with his own businesses. A brief search of his social media history found no evidence that Ramas Swami ever critiqued Pfizer. Roy vent has also, which again is not, that's not evidence. If you haven't ever critiqued somebody via your Twitter, doesn't mean it's evidence. Rovan has also sued Moderna claiming patent infringement re related to its disastrous lipid nanoparticle delivery system, which is shown to wreak havoc on the entire human body. So here's, here's the way that I would rank my presidential candies right here is my 2023 presidential candidacy ranking and why, and I think he moves down a step here. Okay? Now, I don't agree with many things, several things about the. Robert Kennedy, Jr. But I do agree with him on his stance on Covid and his stance on vaccines. And I do think that we are going into, which I did a whole breakdown in my last episode on pandemic season two, that we're going into another season where they're going to go after lockdowns. They're going to go after a new wave of authoritarian control. So I also think that of all the presidential candidates right now, Robert Kennedy Jr. Is the most authentic. He's the most genuine. He also has a blood tie to not one, but two people who have been assassinated, allegedly by the ccia A. So there's a very good case here to say that Robert F. Kennedy Jr. Has real reason to go after the Deep State, real reason to obliterate three letter agencies into the wind. I. A real reason, a foundationally, deep-seated reason to do so. Now, from what we've seen here, the evidence suggests not the words, don't pay attention to the words, pay attention to the evidence, the actions of Vivek, which shows that he not only teams up with Pfizer, not only that he wants to push vaccines, not only that he wants to push mask mandates, but that he's also associated somehow some way with the World Economic Forum and took money from George Soros. Those things to me, are enough to knock him down several notches, several, several notches, because at this point it's only his words. It's not his actions and his words. You can tell this man is just gifted when it comes to speech. He's a great salesman. He's a great politician in the making, but that's the scary part. Right. Robert F. Kennedy Jr. Has no skills whatsoever to convince you with his tonality, to, to take a point and, and paint it with color beautifully so that you can agree with him to, to he, he loses all of that in his cadence of speech. He loses all of it within, within the way that he has. His, his vocal chords are, are damaged, but vek almost essentially his entire campaign is, is surrounded by his ability to sell you to his ability to smile, his ability to quickly and perfectly articulate exactly what you want to hear when you want to hear it. But there's a lot of red flags here. So I would say right now, Robert F. Kennedy Jr's right up there for me. Now I know his stance on gun control. I know his stance on abortion. So those things I vehemently disagree with, with him. And I'd love to see a, a, a breakdown of every one of his beliefs and every one of the policies. And maybe I'm, maybe, you know, I'm pretty far off in, in, in several, several of those. But to me, the president is basically a figurehead who represents the people and is a display of where we're moving. Are we moving more towards the deep state? Are we moving more towards, uh, a nation of authoritarianism or are we moving more towards freedom and liberty? So I would love nothing more than to see a Trump Robert F. Kennedy Jr. Ticket would love nothing more. That would be my ideal candidacy. And I don't know who I would put in which position. Uh, but because you can clearly see that the deep state that the, the individuals in power are, are obviously a. Trying to put Trump in jail over and over and over and over again. There's been a concerted effort by big, big money to get him out. And we can also see clearly the same thing is happening with Robert F. Kennedy Jr. Besides the indictments, but nothing is happening with Vivek. In fact, he's finding himself on all of the biggest shows, constantly being put on the BlackRock funded Fox News, and CNN's constantly being pushed in the public narrative, having the biggest clips from the debate stage constantly. So let's, let's keep going. Here it says, Ramis Swami has estimated to have a net worth of an impressive $500 million, though it's unclear how he accumulated these funds, or if that number, which is a bit outdated, currently stands. Perhaps it's from a series of business ventures through which he successfully cashed out, but the trail left behind leaves a lot to be desired. S o Gene Therapies, a company founded by Ramas Swami recently announced plans to dissolve after years of failing to advance any successful drug candidates once valued at billions of dollars. Millions. I o currently has a market cap of around 30 million, as it recently failed to find a buyer for the Troubled Corporation. Just so you know, this stock in 2018 plummeted from $200 a share, and then the same day it was at $200. It dropped down below 50 and then over the next three to four months or so, and over the next year, moved down to less than a dollar. It's currently sitting at 40 cents. Crazy. Roy Van Sciences founded by Ramos Swami. He was also the C e O until 2021, but remained on the board. Lost almost a billion dollars last year and has lost on average 650 million each year since 2019. According to the company's financial statements in 2018, the company has described as akin to a bloodbath efforts prized Alzheimer's drug, which formed the basis for the creation of Rovan failed clinical trials. Over the last quarter, Roivant brought in only 12 million in revenue and had a net income of negative $291 million. Remiss Swami stepped down from the board of Rovan after announcing his presidential run, according to a company statement. Crazy. How do you lead a company that loses almost $300 million? And then. Somehow make 500 million. The, the business world, once you get to that level is just pretty crazy. Ramos Swami's latest adventure is Strive Asset Management, which he founded in 2022 with the mission to combat the e s G agenda in corporate America, strive has set up a series of passively managed ETFs through which Strive takes an above average fee in order to purchase stock and Pro e s G woke companies Hmm. Promising to use customer's proxy voices to convince these corporations to depart from that agenda. Since its founding, strive has published forward letters to select companies asking them to change course. Hmm. So Ramas Swami's latest venture is Strive Management. So he founded a wealth management company, strive in a, in a hope to voice with people's funds. I. The, that we don't want them to be a part of the e s G and woke agendas. Cool. I like that. That's a very smart play. Vivek, especially if you're gonna run for office. But essentially he took in all of this money, right? Looks like many millions of dollars. And they held stock in all of these woke companies. What is that? Apple, Microsoft, Amazon, Google, Tesla, Nvidia, alphabet Inc. Or Google again. Um, UnitedHealthcare, Exxon, Johnson and Johnson. Wow. Critics of Ramos Swami have pointed out that Strive is effectively damaging its own mission right off the bat by first purchasing shares and proceeding to add value to these companies. Yeah. And later hoping to convince them by proxy letter or vote to change their behaviors. So what's the real agenda? This says it seems Vivek Ramma Swami knows full well that he will not actually be a serious contender for president. He has already spoken about wanting to merely be able to make the debate stage. His campaign website does not discuss his platform in any detail at all. It only shares clips of his media appearances and is largely nothing more than a donation page. What is Vivek actually running for? First? Maybe we can get some more clarity about who this man is and what he believes. So there's your breakdown, right? We'll watch some videos here. We'll get some other conversations going. But there's the overall breakdown of Vivek Pharma funded by BlackRocks and Vanguards World Economic Forum. Global leader, George Soros funded law degree. That is Vivek. That is his background. Those are, those are his actions that to me speak louder than his silver tongue. Now there's other people raising the flag about this, one of them being Matt Kim. Now, if you don't know Matt Kim, he's got a podcast. He's also a, a pro prominent figure on social media, and he posted this video that I will show you, uh, where he raised similar red flags. So let's pay attention to it, because he allegedly got some messages from Vivex people about his posts. So here it's when he supported Bob, let's restart it for you. Some of you won't like this, but hear me out. He seems to be everywhere. Clips of him giving it to the man and calling out the establishment All over social media skyrockets from unknown to top of the Republican polls, and I understand why. He says what we all want to hear. End the war. Secure the border during the swamp. Unity, freedom, truth, which outlets are considered untrustworthy? Propaganda Media. M S N B C, business Insider, AP Forbes, the New York Times, the New Yorker, Huffington Post, Axios, political, just to name a few, the mouthpiece of the establishment. Then why are they all so supportive of VI? Doesn't make sense. How is he considered anti-establishment when he's supported by the establishment? If you or I were to say some of the anti woke things, he says we would be shadow banned, but somehow he's trending on every single major social media platform. Hmm. Prior to politics, he was a hedge fund manager. His claim to fame was a pharmaceutical startup company called Rovan. In the nine years it's been in business, it has never been profitable or delivered a working product. Now that is where the only part of this that he was corrected with. So we'll look at that statement that he apologizes, um, quite sarcastically, rightfully, uh, about this. So let's watch it. Although RO continues to fail their clinical trials, they were able to find investors and raise money, making VI an extremely wealthy entrepreneur, good at convincing people to invest poor at delivering product and execution. Not a good sign. So what about the money? The media highlights that Vik has invested over $10 million of his own money to fund his campaign, an honorable fee. Vik announced his run for presidency in February, 2023. How long do you think it takes to make that decision and execute a plan? Six, eight months. July, 2022. The value of relevant stock is just over $3 per share. On February 21st, 2023, Vik announces his run for presidency, and on February 22, he sells 4 million shares for approximately $32 million million dollars at nearly $8 per share. Well over $15 million in profit in six months prior to him announcing presidency. Good for him, right? Make that money. Company is losing over $1 billion per year, but he got paid. Smart guy. But anytime things are just so coincidental, I'm forced to keep digging. Why did the stock price of an unprofitable failing company rise over 100%. How does it go from an all time low to nearly? Its all time high. Institutional money. You remember when Vik said the financial investment giants like BlackRock, state Street, and Vanguard represent arguably the most powerful cartel in human history? Well, guess who's on the list of institutional investment giants that started giving his company money one year ago? You wanna guess BlackRock, state Street and Vanguard. All three have added to their positions in the last quarter. And Rian, which Vik still owns 7% share in, is now up over 300% in the last year. Mm-hmm. Making it worth close to $1 billion during the Republican primary debate. Vik vowed to end the teacher's union. Guess who is also on this list of investors? California State Teacher's Retirement System. Look, his intentions may be pure, and this is all a coincidence. Maybe there's a great explanation, however, I am not a financial analyst, nor investigative reporter, but I was able to find all this out in a couple hours of sifting through publicly available data. Why is this connection to George Soros via scholarship and his involvement in the Ohio c Ovid 19 response team scrubbed from Wikipedia in 2021, he was named a young global leader by the World Economic Forum. Two years later, after using that title to raise investments for his company, he sued the W E F to remove his name from the list. Three months after that, he was able to settle with Klaus Schwas, W e f, and receive a formal letter of apology. How do you sue what many may consider evil, the World Economic Forum and win and get an apology letter in three months? He's either that good or I don't know. Any real journalist or news outlet could have easily found out all this info, but they didn't. Real question is why. Hmm. So there's the first video, right? That's one of the main reasons. Almost all of that is so suspect every single part of this journey for Vivek, everything but his words. If you didn't watch a single debate, if you didn't watch a single video of Vivek and you only looked at his actions, it paints a completely different story. If I told you there was a presidential candidate for the Republican party who was funded by George Soros, who is a World Economic Forum global leader, who went to Harvard Law School, founded a pharmaceutical company, which helped with C O V I D responses and was funded by BlackRock and Vanguard, would you vote for that person? Would that person be your number one pick? And again, I just wanna drive this point home for you. If you looked at nothing, Vivek said, if you watched none of his videos, none of the debates, and you only saw that he was a World economic forum, global leader up until the time that he decided to run, he was funded with all of his companies by BlackRock and Vanguard. He made his money in pharmaceutical companies during C O V I D. Is that the guy that you want running this country? Because I don't, that's not what I want. That's not who I want running the country. You know who I want running the country. The guy who says that you shouldn't get the vaccine, the guy who says that all of these institutions are corrupt and wants to obliterate the cia. Actually will do it if he finds office. You know why? Because two of his family members were assassinated by them. Or maybe the guy who's sitting and just got his mugshot taken three days ago from actually fighting the system, not just saying words on the debate stage. And you know, looking at, looking at you at the audience and nodding his head. And then as soon as BlackRock, Vanguard and World Economic Forum, look at him, they go, and then you look at him, right? Does that meme? But that, that's what you have to look at. What are the actions of the individual? Not just the words, because the words literally mean nothing on the debate stage. Here's the second video. Here's a second video about Vivic. I promise I need to move on to other pending social coincidences. I was wrong and I'll admit it. I said V's. Company. Rovin had no successful product, but I was mistaken. Kind of Rovin had a subsidiary called Myov Event that developed drugs with Pfizer. Myov is no longer a part of Rove's products because it was sold to Sumit, which Rovin also owned, which is sold to Sumitomo Pharma Japan, where the executives of Sumit Tovan hold bore seats. Two successful drugs are. Orvi, which is f d a, approved to treat advanced prostate cancer and mefe, which is f d a, approved to treat endometriosis severe period pain. What do the drugs actually do? Morgo. VX is a drug designed to lower your testosterone in mefe is the same drug but with estrogen mixed in. So I apologize to Vivek's campaign team. I was wrong. But please understand that since the drugs were within subsidiaries of subsidiaries, it was not easy to find. So I will formulate correct myself. Vikk has successfully manufactured with Pfizer, an estrogen filled testosterone suppressor. Hope that clears the air. What a great way to respond to that because I'm, I believe he said that, uh, he was asked, uh, for this correction by Vivex team. Uh, so masterfully done. Uh, just so you know, um, Matt Kim's Instagram account is Matt Attack 0 0 9, and he does some great work, uh, very, uh, concise and, uh, very, uh, un un, um, what's the word? Unex Explosive. Unostentatious. Unostentatious. I add a lot of color to our show folks. Um, so just like you heard him talking there, I guess is how he talks most of the time in almost every video. So there's very little color in his voice, but he does it very well and very tactfully, very dry, uh, just like he did there. So great stuff, Matt. You're doing a great job. Um, So found that to be interesting. Right? So here's uh, some other clips. Now I actually just have his Twitter account pulled up here. 'cause I think, you know, one thing we can do is just scroll the, the times of, uh, Vivex most recent posts here. Uh, but let's go the 20%. Let's go to some, let's go to some more, uh, organized stuff here. So here is Vivek Ramas Swami. Now you might ask what, what website is this? Austin. What website am I looking at with Vivek's name on it? Well, I'm glad you asked. That website is right here, which says Paul and Daisy's Soros Fellowships for New Americans. Hmm. So Vivek Swami was funded by the Soros family to attend Yale to get his Juris doctorate. Just 10 years ago. So he was what, 27 at the time? Now that's an interesting choice to move from biology to law and then not use your law degree at all. But he was a Forbes 30 under 30 honoree founder of Rovan Sciences, and we looked at that already, but I just think it's interesting to, to find his name right next to the Soros name. Now, the next thing we have here is, I'm not gonna go into that, um, is that Vivex. Ramis Swami paid Wikipedia editors to erase his Soros fellowship and his work on C O V I D. Now, this came from May. Of 2023. It's now August, June, July, August, three months Now it says he announced his 2024 presidential bid after making sure his Wikipedia page was edited. Vivek Rams Swami, this comes from new republic.com. Never heard of it. Uh, is like much of the Republican party, so pathetically desperate. This says, Ooh, the 2024 candidate who joins other elite educated Republicans in cosplaying is a truth telling populace, while offering no actual solutions to improve people's material conditions, has reportedly used some of his millions of dollars to pay a Wikipedia editor to scrub his past Mediate reports that Ramas Swami seems to have paid Wikipedia outta their Yerman to remove information from his page that he presumably thought would damage his candidacy in the Republican party. A few days later, he announced his 2024 bid. The editor scrubbed off information related to Ramos Swami receiving Paul and Daisy Soros Fellowship from New Americans in 2011 during his time as a Yale law student. Paul Soros is the older brother of billionaire Democratic donor, George Soros, who has been the subject of perennial anti-Semitic conspiracy theories Pedaled by the right. The Fellowship Ramis Swami received is dedicated to helping immigrants and children of immigrants pursue graduate degrees. Prominent right-wing figures like Jack Poso have directed attention toward Ramis Swami's past fellowship, presumably in line with the aforementioned use of Soros as a catchall for anything suspicious. Also removed from Ramis Swami's page was his work serving in the Ohio's c Ovid 19 response team. The editor claimed that Ramis Swami had explicitly asked to remove the mention of his work on the Covid team while the editor himself deemed the fellowship to be extraneous material. After some back and forth with other Wikipedia contributors information, noting Ramis Swami Soros fellowship was later added back to the page. Ramis Swami announced his bid for presidency less than two weeks after he seemingly commissioned an editor to modify his Wikipedia page. So let's repeat that 'cause that is worth it. Ramis Swami announced his pre his bid for presidency just two weeks after he paid an editor to modify his Wikipedia page. To this day, Ramas Swami's Wikipedia page begins with a disclaimer that the article has multiple issues and the neutrality of this article is disputed. This article contains paid contributions. It may require cleanup to comply with Wikipedia's content. Policy is particularly neutral point of view. Wikipedia warrants the episode is just another and a long series of Republicans Spinelessly refusing lead to stand by their past when facing Donald Trump, or to offer even a nugget of an argument as to why, Hey, maybe it's okay to care about problems like Covid. So this is a left wing company calling this out most remarkably is that any of the Republicans think their hungry embrace of conservatism. It's furthest right instincts will result in anything other than failure. Alright? So, so I would say too, I'm actually quite, I'm actually quite, uh, proud of our party. I'm, you know, and, and I say our party, I don't generally traditionally identify as strict conservative. I'm far more, I would say libertarian than I am conservative in many aspects. I believe our government should be basically utilized for a military to protect our borders and protect us against foreign enemies. Not to, you know, go to war with other countries and start proxy wars for billions of dollars. I also believe that we should have a police force which is used to, uh, enact law and order, um, under very limited circumstances. Uh, basically off of the golden rule, which is like if, hey, if you don't want that to happen to you, maybe you shouldn't do it to other people. And if you do it to other people, maybe there should be consequences if we all agree that this thing shouldn't happen. Uh, maybe some, some actually no. I wouldn't even say education systems. I think education systems in the modern day would do fairly well if it was a, a more capitalistic, uh, free, um, free market. Uh, there's very limited use cases for the government, um, very limited use cases, and it's literally just a pile of money for them to, uh, to extort you out of with the threat of violence and captivity. In order for them to be able to find how much money and to move out of that pile into their own pockets, through these little games of money laundering, that's about 86% of government spending to me. Right. You wanna talk about, um, social services? I, I think there should be some social services to be able to help people who are, uh, mentally disabled, who are physically disabled, who, uh, really need the help. Um, I, I, I don't see much other uses for the government other than those things. So traditionally probably not as Republican as many people who, uh, listen or who, uh, follow me or, you know, but that's where I'm at. That's what I think. I, I don't think the government's great at literally almost anything. I think the government's quite bad at almost everything. Um, I'll, I'll give you a story. Uh, when I was in the military, uh, I was at, uh, Biloxi, uh, Mississippi. Uh, I was going to tech school for air traffic control training. And uh, I was in the military from 18 to 22. And when I was at Air Traffic Control Tech School in Biloxi, Mississippi, we had a bowling alley. And at this bowling alley we would go there, you know, friends who would drink there and they'd get big pictures of beer and um, and it was like the shittiest bowling alley you had ever been to. And about maybe four months into my tech school, I was, I was at, at Keesler Air Force Base for eight or nine months, um, doing air traffic school. And maybe eight or nine months, three months after we got there, four months after we got there, the bowling alley closed down. The government had a monopoly on entertainment on base and could not run a business properly in order to be profitable enough, even with tax funding. It's like the most ridiculous circus show of a business being ran ever. Uh, it's unbelievably bad at literally everything it does ever. Right. The government is just horrific at every endeavor it sets out to do. There's so much red tape, there's so much bureaucracy. All the technology's super old. There's no innovation, there's, there's nothing happening from the traditional taxation based government services that is positive for the, for the people. Like maybe you can say firefighters. Police in very limited cases, I think I, I legitimately don't think there should be any traffic enforcement. Um, there's very few use cases besides violence and, um, mostly violence. Like there, there's just, there's so many things that are off about, you know, the government having its own, uh, imperialist army. So those are some of my beliefs on that. But, but so, so that's, when you hear me talk about Robert F. Kennedy Jr. I'm not like, I, I am not a hard right or a hard left. I am like somewhere in the middle with mostly a belief that our government sucks at everything it does. And the less that we can have the government do, and the more that we can have the free market do, the better off we will all be. And when I say free market, it's not like the modern day free market that we have right now, because what we have right now is a, a monopolistic oligarchy of, of capitalistic institutions who own everything, right? We talk about the Black Rocks and the Vanguards. I. Uh, uh, we don't live in a capitalist society anymore. Capitalism is dead. We live in an oligarchy. Every institution that you know, is owned by a single one, two, maybe three investment wealth companies, every politician, you know, is owned by 1, 2, 3 of those same wealth management companies. Every politician, you know, every company that you know is owned by BlackRock and Vanguard. We do not live in a capitalistic society. We live in a oligarchy a we live in a, uh, a, um, a, a monopolistic based oligarchy where all of the politicians are bought and paid for, where all of the companies are bought and paid for, and they enact the policies through the politicians that they fund, through the corporations, that it's this big shit show mess, and we're just the ones at the bottom of it getting shit on. This is just how this whole thing plays out to me. Our entire system is just flawed to, its very core as of maybe the last 80 to a hundred years, 80 to a hundred years. The Industrial Revolution, world War II was all the, the shifting of power to these elite class, uh, the, the Berg Group, the World Economic Forums, the, the BlackRocks, the Vanguards, right? You guys, if you've been listening to me long enough, you know my beliefs on these things. You hear me talk about one-off topics, but you don't really hear me talk about the systemic governmental issues that I really, you know, what I truly believe about our government, mostly just that they suck at everything. It's a proxy for politicians and corporations to siphon off government or to siphon off tax dollars. Right. Taxes weren't even implemented until like two thou 1913, right? Something like that. Like 110 years. Uh, when, when federal income tax was, was started and federal income tax was started basically just to fund, uh, you know, it was like two per, they, they were gonna, they were gonna charge, uh, people who were extremely wealthy, like two to 3% of their income just to fund some certain small services. Right? Like, we left Great Britain because they were taxing us on fucking tea. Right. We were throwing barrels. Right. The, the Sons of Liberty and John Adams and or Sam Adams and, and the Sons of Liberty were just going off having secret meetings and cool bars or pubs like the, the Green Dragon. And they were having these underground meetings with, um, you know, the Freemasons and like, how are they gonna, you know, there was all this crazy shit happening. And a lot of it, the, all of the fed up. Thoughts about the, the British clergy? Were based on the, the, the people not wanting the government to take their money from them. Don't. Maybe we should have you for a couple things, and maybe it's, don't invade my country, don't, don't, uh, kill me, don't take my shit from my house. Right? Like, these, these are the things that the government should truly be focused on. But instead they're writing you traffic tickets via autonomous cameras for profit, and they're telling you that you have to get a mRNA gene therapy in order to get a job. Like we're so far off and it's just gonna get worse and worse and worse and worse unless we, we start to win this, this culture war even more than we are today. So anyways, long tangent. Next thing that says here is, um, uh, most remarkable, uh, is, uh, okay. Yeah, that's a stupid article coming from a left wing, but not wrong in like the first half of this. Um, so originally I looked up this article, uh, about who are the famous alumni of Yale's, uh, Phi Beta Kappa Phi, beta Kappa being the, uh, the, um, the fraternity that Vivek was a part of. And, um, I was looking at Yale and, uh, I, I was looking wrongfully at Yale, so he was a part of Phi Beta Kappa at Harvard. So let's see if we can get the celebrity names of people who were a part of Phi Beta Kappa at Harvard, because I misread that. Uh, and let's see, Harvard alumni. It's so crazy to me that people like go to Harvard, right? Like that there's just like this, this completely, this university that's just like completely made up of elite families who just put a hyper emphasis on their children for academics who fund it with $120,000 or whatever the fuck it is to get your kid to go to Harvard. And then, you know, all the scandals with like telling your, saying your kid was a bad gammon defenseman in order to get them into the university. Right. If you ever saw that documentary, I forget the name of it, but it was about the scandal at, uh, all of the elite universities where, um, it might've been a singular one where they were like basically saying that these kids were, uh, In sports that they weren't because they were paying off the, the admissions individual to get them in, uh, to the university on scholarship and stuff, like pretty crazy stuff. Um, so let's see if we can find the Phi Beta Kappa Harvard alumni. Go directly to the website, harvard.edu five. The Kappa of Massachusetts at Harvard is established under a charter dated December 4th, 19 or 17, sorry, 1779. Wow. The charter was granted along with one for Yale by the original society. Founded three years earlier, the College of William and Mary in Virginia. The charter was brought from there to Harvard by Alicia Parelli, who initiated four juniors of the day before commencement in 19. In 17. Wow. 19, uh, 1781. The first meeting of the new chapter was held in September 8th, 1781. That makes Harvard's chapter the oldest and continuous existence. Interesting. Let's see. Members, literary exercises, eligibility, and election members. Let's see if we can get some famous members. Class of 2020. Class of 2024. Let's just read the names of these people. Samar Bajaj, Suha Bot Rah, Bahari, Alexander Chen. Rah. Hari Ganesh. Jay Gar. Amen Haw. Kaylee Ek. Hari Iyer. James Jolan. Ja. Ana, Madeline Kitsch. Jeffrey Kwan, Clarence Naba. Will Nichols, that's the only white guy. Uh, Mitchell Minchi Park. Uh, Joel Sdo. Atlas Sgo. Trey Sullivan. Lucy two. Eleanor Wickstrom, Dora Woodruff. Vicki, you and Eric Zoo. No white people. Maybe one. Let's look at previous years. Uh, 1980s. 1990s. Let's look. What year did he graduate? I think he said 2007. He was a graduate. So let's look at 2007 and see who he was a part of this with. Maybe there's any names that pop out to us here, so we see, see if we can even find Vivek Bally. Aaron. Vadim. Alinsky. I'll save you the names here. Let's see if we can find anybody that sticks out to us that he was a part of this. With Mary, Brad, Eric, Brian, lots of more white people back in 2007. I don't exactly see Vivek, but there's so many people on this list. Let's see, is this, uh, okay alphabetical. So Ramis Swami, there he is. Okay. The Vek Ram Swami 2007. It's a pretty long list, so I'm not sure I know any more of these people just by looking at it without doing research. Peter b Zuckerman, interesting. Maybe that's a good deep dive we could do is like, who did he actually go to? These, who is he here with? Um, but anyways, I. Digress. Um, maybe we can look at the 1980s, but that would be the thing, right? Like maybe look back at like, who are the alumni at this be? Because the other one, when I was looking at Ya

Vivek Ramaswamy - Best Of First Class Fatherhood - This is a rebroadcast of my interview with Vivek from February 2023.  He will be on the debate stage tonight for the first GOP Presidential Debate.   Vivek Ramaswamy is a First Class Father, Entrepreneur and 2024 Presidential Candidate.  He founded multiple successful enterprises. A first-generation American, he is the founder and Executive Chairman of Roivant Sciences, a new type of biopharmaceutical company focused on the application of technology to drug development. He founded Roivant in 2014 which today has an estimated value of 6.5 Billion dollars.  He is a New York Times bestselling author of “Woke Inc.”, and “Nation of Victims”.  In this Episode, Vivek shares his Fatherhood journey which includes two children.  He discusses why he decided to run for President of the United States.  He describes why restoring the Family Unit is vital to the future success of America.  He talks about wokeism in schools and how parents can fight back against it.  He tells us what he would do first if he was President right now.  He offers some great advice for new or soon-to-be dads and more! Navy SEAL Swim Fundraiser - https://impact.navysealfoundation.org/fundraiser/4796365 The Shawn Ryan Show - https://podcasts.apple.com/us/podcast/shawn-ryan-show/id1492492083 The Alec Lace Show - https://linktr.ee/TheAlecLaceShow My Pillow - https://mystore.com/fatherhood Promo Code: Fatherhood  First Class Fatherhood: Advice and Wisdom from High-Profile Dads - https://bit.ly/36XpXNp Watch First Class Fatherhood on YouTube - https://www.youtube.com/channel/UCCD6cjYptutjJWYlM0Kk6cQ?sub_confirmation=1 More Ways To Listen - https://linktr.ee/alec_lace Follow me on instagram - https://instagram.com/alec_lace?igshid=ebfecg0yvbap For information about becoming a Sponsor of First Class Fatherhood please hit me with an email: AlecLace@FirstClassFatherhood.com

On this week's episode of Biotech Hangout, guest Matthew Gline (CEO of Roivant) joins hosts Brad Loncar, Tim Opler and Brian Skorney to discuss Biogen's heavy news week, including their acquisition of Reata for $6.5 billion, their decision to cut 1,000 jobs by 2025 and their quiet stance regarding their upcoming PDUFA date to treat PPD and MDD in partnership with Sage. The hosts also cover other layoff and leadership changes, including the resignation of FibroGen's CEO and layoffs from Infinity and Mersana. The group also touches on the $2.8 billion hypertension deal between Roche and Alnylam and the impact this deal could have on patients. Additionally, they discuss Gilead being accused of slow-walking the development of a new version of an HIV therapy to extend their patent protection, British billionaire Joe Lewis being charged with insider trading and the impact that poor data readouts had on Stoke Therapeutics', Gilead's and Kodiak's shares. *This episode aired on July 28, 2023*

On this week's episode of Biotech Hangout, hosts Daphne Zohar, Tim Opler, Chris Garabedian, Mike Yee and Bruce Booth discuss the week's industry news including M&A, regulatory, data and more. They highlight the continued M&A streak with Eli Lilly acquiring Dice Therapeutics. They also discuss PhRMA's lawsuit vs. the U.S. government over IRA Medicare Drug Price Negotiations, following similar suits from Merck & Bristol Myers Squibb. They also talk about several Duchenne news items including Santhera licensing its Duchenne drug to Catalyst and Sarepta's DMD therapy approval. Additional industry news covered includes the SEC's case against biotech executives and investors and conflicts of interest with PBMs and FTC's lawsuit against Amgen. The hosts also discuss what happened to big academic tech transfer deals, Leerink is back, Intercept, Alderya and Arcellx regulatory news, plus Uniqure and Roivant data. *This episode aired on June 23, 2023*

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley. In this episode we discuss fragmentation amongst study stakeholders, the importance of real time data that's agnostic to source, and the impact of decentralized clinical trials and an increase in disparate data sources. Rohit Nabisan on LinkedIn: https://www.linkedin.com/in/rohitnambisan/ Lokavant website: https://www.lokavant.com/ Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Today's episode of the Business of Biotech covers a lot of ground with Enzyvant CEO Bill Symonds, Pharm.D. Among other things, we discuss the career moves Dr. Symonds has made within the "vant" environment since his involvement in the launch of the original Roivant,  the approval of Rethymic, the merger of Altavant and Enzyvant, and the company's intentions for a brand new regenerative medicine manufacturing facility in Research Triangle Park. From drug approvals to mergers, from internal manufacturing capacity to founders-turned-presidential candidates, this one's got it all. Subscribe to the NEW #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

It's Monday, March 13th, A.D. 2023. This is The Worldview in 5 Minutes heard at www.TheWorldview.com. I'm Adam McManus. By Adam McManus (Adam@TheWorldview.com) Nigerians kill Kaduna pastor's son and abduct pastor's wife Last Friday, gunmen suspected to be bandits killed the son of a village pastor and abducted his wife, along with three others, in an attack in Nigeria's Kaduna State, reports The Christian Post. Revelation 21:8 says that all murderers will be punished “in the lake that burns with fire and sulfur, which is the second death.” The Nigerian government continues to be criticized for its inability to curb the rising spate of murders in the region. Christian rights groups have warned for years about the deteriorating religious freedom conditions in Nigeria amid the rise of terror groups like Boko Haram and the Islamic State in the northeast. Advocates have also warned about an increase in deadly violence against predominantly Christian communities committed by radical Muslim herders in the farming-rich Middle Belt states as the country deals with desertification and erosion of natural resources. Disturbingly, last month, Biden's State Department reaffirmed its decision to remove Nigeria from its list of countries of particular concern for religious freedom violations after conducting an allegedly “careful review” following objections from Nigerian Christians, human rights groups, and members of Congress. More than 30 high profile Russians have died since Ukraine invasion Dozens of high profile Russian figures have died since Vladimir Putin launched his bloody war in Ukraine over a year ago -- with many in odd circumstances, such as sudden "suicides" and falls from windows, reports The U.S. Sun recently and The Atlantic last December. For example, Sergey Grishin, the so-called "Scarface" oligarch who sold Meghan and Harry their California mansion, died this week from sepsis after criticizing Putin. Meanwhile, Russian scientist Andrey Botikov, who created the "Sputnik V" vaccine , was strangled with a belt in his apartment last week. Both men were two of the 30 high profile deaths of people linked to Mad Vlad. Jon Sweet, a retired US Army Military Intelligence Officer, described Putin as running a "modern-day KGB version of Murder Inc." Biden eager to fund more cross-gender surgeries for veterans President Joe Biden's new 2024 budget plan, released on Thursday, proposes to funnel some of the $137.9 billion discretionary budget for the Department of Veterans Affairs into mutilating surgeries for America's veterans, reports LifeSiteNews.com. The Biden administration is ignoring new research into the use of cross-sex hormones.  Last month, the American College of Cardiology revealed studies that showed that “people with gender dysphoria taking hormone replacements as part of gender affirmation therapy face a substantially increased risk of serious cardiac events, including stroke, heart attack and pulmonary embolism.” Reports of sexual assault at military academies shot up 18% Reported incidents of sexual assault at U.S. military academies jumped 18% during the 2021-2022 school year compared to the year prior, reports The Associated Press. Nearly one in five female cadets at the Army, Navy and Air Force academies said they experienced unwanted sexual contact in the most recent school year, according to the annual report. The number of estimated instances of sexual harassment also grew to 3,939 in the 2021-2022 school year, including more than half of women and one-fifth of men. In a memo to academy administrators, Secretary of Defense Lloyd Austin wrote that the service academies “observed an alarming increase in the estimated prevalence of sexual assault, sexual harassment, and other concerning behaviors. These corrosive behaviors require your immediate attention.” Vivek Ramaswamy announces anti-woke presidential bid Vivek Ramaswamy might not have a background in politics, but that didn't stop him from becoming one of the first candidates to announce their run for the GOP presidential nomination in 2024, reports BusinessInsider.com. The biotech millionaire, who was once the CEO of Roivant, will likely struggle for exposure in the predicted crowded field for the Republican nomination, but his past shows he isn't afraid of a challenge. Ramaswamy is the son of immigrants from India and an overachiever at Harvard. Listen as he describes the problem in America today. RAMASWAMY:  “We're in the middle of a national identity crisis. Faith, patriotism, and hard work have disappeared -- only to be replaced by new secular religions like COVID-ism, climate-ism, and gender ideology. We hunger to be part of something bigger than ourselves. Yet we cannot even answer the question of what it means to be an American. “Today, the woke Left preys on that vacuum. They tell you that your race, your gender, and your sexual orientation, govern who you are, what you can achieve, and what you're allowed to think. This is psychological slavery, and that has created a new culture of fear in our country that has completely replaced our culture of free speech in America. And that is why today, I am announcing my run for President of the United States.” To be sure, Ramaswamy is a longshot for the GOP nomination, but the conservative firebrand says he has big plans to start a "cultural movement." Listen. RAMASWAMY:  “This isn't just a political campaign. This is a cultural movement to create a new American Dream for the next generation.” Learn more at his website Vivek2024.com.  That's V-I-V-E-K 2024 dot com.  Plus, check out his YouTube channel. 11 Minutes of brisk walking a day slashes premature death by 23% And finally, walking at a brisk pace for just 11 minutes a day slashes the risk of your premature death by almost a quarter, reports StudyFinds.org. The team led by researchers at the University of Cambridge showed how one in ten early deaths could be prevented if everyone managed to reach the threshold of 75 minutes per week of moderate-intensity physical activity. The study demonstrated that this would be sufficient to lower the risk of heart disease and stroke–the leading causes of death globally—as well as a number of cancers. The conclusions were drawn when the Medical Research Council Epidemiology Unit at the University of Cambridge looked at results reported in 196 peer-reviewed articles covering more than 30 million participants. 1 Corinthians 6:19-20 asks, “Do you not know that your body is a temple of the Holy Spirit within you, whom you have from God? You are not your own, for you were bought with a price. So, glorify God in your body.” Close And that's The Worldview on this Monday, March 13th in the year of our Lord 2023. Subscribe by iTunes or email to our unique Christian newscast at www.TheWorldview.com. Or get the Generations app through Google Play or The App Store. I'm Adam McManus (Adam@TheWorldview.com). Seize the day for Jesus Christ.

Episode 685 - Vivek Ramaswamy is a First Class Father, Entrepreneur and 2024 Presidential Candidate.  He founded multiple successful enterprises. A first-generation American, he is the founder and Executive Chairman of Roivant Sciences, a new type of biopharmaceutical company focused on the application of technology to drug development. He founded Roivant in 2014 which today has an estimated value of 6.5 Billion dollars.  He is a New York Times bestselling author of “Woke Inc.”, and “Nation of Victims”.  He recently announced his campaign to run for President of the United States in 2024. In this Episode, Vivek shares his Fatherhood journey which includes two children.  He discusses why he decided to run for President of the United States.  He describes why restoring the Family Unit is vital to the future success of America.  He talks about wokeism in schools and how parents can fight back against it.  He tells us what he would do first if he was President right now.  He offers some great advice for new or soon-to-be dads and more! Vivek Ramaswamy - https://www.vivek2024.com My Pillow - https://mystore.com/fatherhood Promo Code: Fatherhood  First Class Fatherhood: Advice and Wisdom from High-Profile Dads - https://bit.ly/36XpXNp Watch First Class Fatherhood on YouTube - https://www.youtube.com/channel/UCCD6cjYptutjJWYlM0Kk6cQ?sub_confirmation=1 More Ways To Listen - https://linktr.ee/alec_lace Follow me on instagram - https://instagram.com/alec_lace?igshid=ebfecg0yvbap For information about becoming a Sponsor of First Class Fatherhood please hit me with an email: AlecLace@FirstClassFatherhood.com

Synopsis: Matt Gline is the CEO of Roivant Sciences, a company that delivers innovative medicines and technologies to patients by building Vants – nimble, entrepreneurial biotech and healthcare technology companies. Matt discusses his transition from CFO to CEO at Roivant and how he prepared to step into the CEO role for the first time. He talks about Roivant's model and how it's different from other biotech companies, and how the current market conditions inform how Roivant operates across its portfolio. He also discusses some of the inefficiencies across biotech and where he sees room for improvement, how telemedicine emerged as a silver lining from the pandemic, and his thoughts on the current labor market. Biography: Matthew Gline serves as Chief Executive Officer of Roivant Sciences. Mr. Gline joined Roivant in March 2016 and previously served as Chief Financial Officer. From April 2014 to March 2016, he was a Vice President at Goldman Sachs, Fixed Income Digital Structuring, where he focused on technology and data strategy. Prior to Goldman Sachs, Mr. Gline was a co-founder of Fourthree, a risk analytics technology and consulting company. From 2008 to 2012, he served as Vice President at Barclays, Enterprise Risk Management Advisory, where he provided analysis for corporate clients related to capital markets access for financing and risk management. Mr. Gline earned his A.B. in Physics from Harvard College.

Dr. Charles Ryan, president and CEO of the Prostate Cancer Foundation (PCF), joins ASCO Daily News Editor-in-Chief Dr. Neeraj Agarwal, of the University of Utah Huntsman Cancer Institute, to assess impactful prostate cancer research from the PCF's recent conference and discuss Dr. Ryan's vision for the future, including increasing access to cutting-edge care. TRANSCRIPT Dr. Neeraj Agarwal: Welcome, to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News, and director of the Genitourinary Cancers Program at the University of Utah Huntsman Cancer Institute. Today, we'll be discussing compelling research that was featured at the recent Prostate Cancer Foundation Scientific Retreat, and I'm very pleased to welcome Dr. Charles Ryan, the president, and CEO of the Prostate Cancer Foundation. Our full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the ASCO Daily News Podcast are available on our transcripts at: asco.org/podcasts. Dr. Ryan, thank you for taking the time to be with us today. Dr. Charles Ryan: Dr. Agarwal, thank you. It's my pleasure to be with you. Dr. Neeraj Agarwal: So, Dr. Ryan, before I discuss the PCF meeting, I would like to ask you, what made you move to the PCF as the president and CEO when you had a flourishing career as a division chief of a large academic program, and as one of the top and internationally recognized investigators in prostate cancer? Dr. Charles Ryan: Well, thanks. That's a fair question, I guess. And it took me about three minutes to make the decision when I was offered the position, simply because the Prostate Cancer Foundation has been one of my intellectual homes for my entire career. I've been at the University of Wisconsin, Memorial Sloan Kettering Cancer Center, UCSF, and the University of Minnesota, and all those institutions were affected by the Prostate Cancer Foundation, or previously, CaP CURE. So, I was involved in their research during my time at all those institutions. In addition to my own personal legacy with the PCF, but more importantly, is the fact that it is an organization that funds the deepest scientific inquiry into prostate cancer and the ways that it can cause suffering and death for men with the disease and has made tremendous progress in identifying factors that lead to that lethality. It's also a community of scholars, a community of researchers, that is a platform really for collaboration. And it's also an organization with a world reach - we fund research in 28 countries around the world, and we fund research going from the scope of very basic research to correlative research, to quality of life, and health services research. Dr. Neeraj Agarwal: That is truly impressive and inspiring. So, what is the mission of the Prostate Cancer Foundation formally? Dr. Charles Ryan: Formally, it's pretty simple. The mission of the Prostate Cancer Foundation is to reduce the death and suffering from prostate cancer. Dr. Neeraj Agarwal: So, the 29th PCF Scientific Retreat was recently held on October 27 to October 29th in Carlsbad, California. What were the goals and objectives of this meeting? Dr. Charles Ryan: The meeting, we call it the retreat, it's an annual event and it always has several goals. One is, it's where we announce and hand out, if you will, our awardees of our various awards that we give. It's also a reporting-in process where those who have been using PCF funding are called to come and discuss their work. We also want it to be an open forum for individuals to come and interact - it's really a collaboration and an interaction vehicle as much as anything. So, when you come to our scientific retreat, we all stay at the same hotel, we all share meals together, nobody goes out for dinner. You don't leave the campus, essentially, of the hotel where we are. We have many, many round tables set out, it's designed to be interactive. We have a big room where people are giving their talks, but if you step outside of the room, there are likely to be many, many conversations happening, and those conversations range from collaborations being formed to people looking for jobs, to people getting advice and mentoring, and even people sharing, as I've done over the years, compelling and challenging patient stories around prostate cancer, and really engaging in what communities do - which is, share ideals, share a mission, and share a passion for what they do. Dr. Neeraj Agarwal: Very interesting. Very inspiring. Please tell us some of the highlights of the meeting. Dr. Charles Ryan: Sure. Well, there are many highlights. There are many things happening in prostate cancer research. Most notably, there are a number of papers and investigators that are looking at how prostate cancer evolves, and probably the most significant set of observations that have been made in the field in the last decade, have been understanding the diverse and numerous mechanisms that underlie the evolution of prostate cancer from a disease that responds to hormonal manipulation, to one that becomes resistant to hormonal manipulation. And so, a lot of the work that's happening now is identifying, for example, the evolution of neuroendocrine prostate cancer, or mixed types of prostate cancer, or this sort of evolution of it under constant therapy. And that is allowing the exposure of new targets that we can exploit for new therapy development, and that feeds into some of the grant-making process that's going on in the background. And so, you have a lot of individuals who are looking at this or that mechanism pathway related to disease resistance that they can exploit, and whether they can create small molecules to do that, or antibodies to do that, et cetera. At the same time, we have a strong component of discussion of how prostate cancer affects different populations. So, we had some really nice talks looking at healthcare disparities and different populations across the world, and how they're affected by prostate cancer, and how care delivery may be impacted in those groups of patients. And then you have topics ranging around survivorship and other factors that are looking at what is life like for a man with advanced prostate cancer, which is in many cases, you know, men who get prostate cancer, who have recurrent disease, who end up going on systemic therapy are frequently on the treatment for 5, 10, 15 years. And so, survivorship, and how they live their life, and what the complications are of that treatment, is tremendously important because it's such a daily experience for these men undergoing treatment. Dr. Neeraj Agarwal: So, how does the Prostate Cancer Foundation support and build the next generation of prostate cancer researchers? Dr. Charles Ryan: Right. So, the PCF supports the next generation in a very specific way, in addition to the informal way of bringing people together and inducing collaborations. We have a program called the Young Investigator Program. It started formally in 2008, but before that, there were one-off, if you will, Young Investigator Awards being given. So, our Young Investigator Awardees receive $75,000 per year to support their work, and we awarded 34 of those this year. The range is somewhere from 25 to 34 per year. We get over 100 applications for them every year. It's a straightforward application - they need to have a project that's going to be about three years in length, they need to be mentored, and they are best served by describing a mentorship plan for themselves and how that mentorship relationship will help them grow in their careers. Now, once you become a Young Investigator, it's not that we just write you a check and wish you well, we do that, but we also have annual check-ins. So, we try to visit the sites of our Young Investigators, see them in their home institution, and meet with their colleagues and their mentors. And that's one of the things I do, or Howard Soule does-- Howard Soule, is our chief scientific officer, one of those things we try to do. We also bring them to the scientific retreat that we just had last week, and we have them present their data. So, a vast number of the individuals who are presenting at the scientific retreat are in fact, Young Investigators, or they were Young Investigators when they started the projects that they are presenting. And then, the other thing we do is we have another retreat specifically for the Young Investigators, and that's called the Coffey-Holden Retreat, and that's named after Don Coffey, the late researcher from Johns Hopkins, who is really considered to be one of the grandfathers of prostate cancer research, and Stuart or Skip Holden, who is one of the founders of the Prostate Cancer Foundation, and a urologist at UCLA. So, that event that we do is designed for people to come to give highlights of the work that they're doing; it's designed to be incredibly interactive. In fact, we have 15 or so minutes of presentation, followed by sometimes 25 minutes of questions for each presenter. There's always a line of people who are waiting to ask questions, and it's designed to engage and have that dialogue with the Young Investigators, to make their science better, and to get it known. And so, the Young Investigator Program, it's about 30 individuals per year on average, and the average age is about 30. Many of these are postdoctoral PhDs, and many of them are fellows, or early-stage faculty, MDs. And I like to think that if somebody's going to work until the age of 70, we're stimulating, or launching a 40-year career with these Young Investigator awards. So, I like to think that if we give 25 out, times 40 years, that's 1,000 years of research that we're sort of stimulating with this Young Investigator program. And I bring that up for the reason that we're very proud of the fact that many of our Young Investigators may start out in prostate cancer, and their ideas, their science, takes them elsewhere. And that's what science does. And we, of course, are very, very focused on solving the problem of prostate cancer, and we want people to do that. But we also understand that by launching a scientist, by launching a scientific career, you may end up with people going off in different directions. And so, we have many examples of that. And in my talk this year, I actually highlighted a person who, let's say she won an investigator award when she was young, it was before the formal Young Investigator Award was named, and this was a person who is creating conjugates for the delivery of chemotherapy to prostate cancer cells. And this was Carolyn Bertozzi up at UC Berkeley, and she just won the Nobel Prize. She didn't win the Nobel Prize for research she did on prostate cancer, but at some point, at one point in her career, this was a direction she was going, and she got two grants from us in 1999 and 2000, that helped her work continue on and go the direction that it did. Dr. Neeraj Agarwal: Yeah. And congratulations. Dr. Charles Ryan: Sure. I'll take credit for that one. Dr. Neeraj Agarwal: Being the President and the CEO, you deserve the credit. Dr. Charles Ryan: Sure. That's my job. Dr. Neeraj Agarwal: So, we are coming to the end of the interview, but let me ask you this; the prostate cancer field is so constantly evolving. What is your vision for PCF going forward? Dr. Charles Ryan: Well, my vision for the organization is that we are going to continue on our mission to reduce the death and suffering from prostate cancer. But that's a fairly general statement, and one of the ways you can do that is you can research cancer at a molecular level, and you could try to develop new therapies - we're going to continue to do that. But there's also a real problem, especially, in the United States, and actually globally, with individuals with prostate cancer who are not receiving the cutting-edge care, not receiving the cutting-edge therapy. We have some data that in the United States, maybe upwards of 50% of men with metastatic hormone-sensitive prostate cancer are not getting the therapies that are supported by the latest findings from randomized phase III trials. And this may be for economic reasons, it may be communications or an education deficit with their treating clinicians, and there may be other factors as well. So, as we think about the vision of this, we need to be mindful of that, because if we only focus on studying the cancer molecularly, and we don't address what's happening on the other end, then we're not completing the story, and we're not completing the mission. And so, I've started calling Prostate Cancer Foundation the Global Public Square of Prostate Cancer, because I think of four sides of that square - funding research, as of what we just got done talking about, education and communication, is another one, and we do that in the same way that you are doing this today - through podcasts, and web content, and in-person meetings, as well as applied discovery, which is helping our researchers take their discoveries or their findings out into the clinic. Now, you might think, "Well, that's a small molecule, becoming a company going into a phase I clinical trial." Certainly, that's part of it, but it's also the epidemiologist who is making observations about diet and exercise, who is then empowered to do a clinical trial of exercise and diet intervention. It's also the health services researcher who is able to use their data to go talk to payers or talk to organizations about how care may be delivered differently. So, that's applied discovery. And then finally, supporting the patient is part of what we do. So, we also hold patient webinars every month, we've held patient summits at various points around the country where we bring patients together and talk to them about the latest research or about the factors we've discussed, such as survivorship, or quality of life after treatment, or treatment complications, and things like that. Dr. Neeraj Agarwal: That's wonderful. Thank you so much for sharing your insights. Any final remarks, Dr. Ryan? Dr. Charles Ryan: Dr. Agarwal, thank you so much. It's always a pleasure to speak to another Genitourinary Oncologist, of course, about the field, and the opportunity to talk about the Prostate Cancer Foundation and what we're doing, and the directions we are trying to grow. We've had a great collaboration with ASCO over the years, and I hope that that continues as well. I hope anybody who is interested would come and visit us at: pcf.org, and they can also check us out on: urotoday.com, where we have a lot of content that might be of interest to them. Dr. Neeraj Agarwal: Thank you, Dr. Ryan, for taking the time to be with us on the ASCO Daily News Podcast today. And thank you to our listeners for joining us today. If you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe, wherever you get your podcast. Thank you very much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement. Follow today's Speakers: Dr. Neeraj Agarwal @neerajaimms Dr. Charles Ryan @charlesryanmd Want more related content? Listen to our podcast on therapeutic advances in prostate cancer and other GU cancers.   Advances in Genitourinary Cancers at #ASCO22 Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn   Disclosures: Dr. Neeraj Agarwal:  Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, Gilead Sciences  Research Funding (Inst.): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck , Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, Arvinas   Dr. Charles Ryan: Honoraria: Janssen Oncology, Bayer Consulting or Advisory Role: Bayer, Dendreon, AAA, Myovant Sciences, Roivant, Clovis Oncology  

Lindsay Androski serves as President and CEO of Roivant Social Ventures. Shei joined Roivant Sciences as one of its earliest employees, and built and led the team responsible for the in-licensing or acquisition of more than 30 therapeutic programs, resulting in the launch and incubation of 16 subsidiary biotechs and several successful IPOs. Lindsay has likewise demonstrated a longstanding commitment to public service, including by serving on the MIT Alumni Association Board, as Chair of the MIT Annual Fund Board, on the Board of the Women Lawyers Association of LA, and on the Leadership Council of the LA Center for Law and Justice. Roivant Social Ventures has introduced a new model of corporate philanthropy, which couples industry expertise with donor dollars to make an outsized social impact. We provide seed funding and expert advice to startups attacking systemic barriers to health equity. We also launch programs with partners to increase the number of diverse senior executives in biotech and diverse primary investigators. On this episode, we discuss Roivant, Lindsay's upcoming TEDx Event in Dallas in October, the growing ESG movement, creating companies that push a societal good, mental health, and much more. We also welcome back co-host Bob Wierema after his long hiatus from the show! Enjoy. Links: Get your tickets to TEDxVickeryPlace: https://www.tedxvickeryplace.com/event Roivant Social Ventures: https://roivantsv.org/ Lindsay on LinkedIn: https://www.linkedin.com/in/lindsayandroski/ Michael Moore on LinkedIn: https://www.linkedin.com/in/michaelpmoore/ Bob Wierema on LinkedIn: https://www.linkedin.com/in/robert-wierema/ Topics: 1:47) - Welcoming back Co-host Bob Wierema (5:42) - The Alder Initiative (8:06) - Lindsay's background and career (15:48) - Lindsay's social impact fund (21:11) - Europe's influence on America when it comes to ESG (24:23) - The growing ESG movement (26:59) - Reversing the profit-only focus of Big Pharma (38:07) - How would you build a successful company that pushes societal good as well as make money? (41:38) - What are some of the major hurdles in impact investing? (45:06) - What's your take on the world right now and where we are headed? (48:30) - What's the best path philanthropic people can take to make the most impact? (54:24) - What advice do you have for young people to be successful? (59:04) - Thoughts on Mental Health (1:05:42) - What do you want people to know about you?

Woody is the Chief Computational Scientist at Roivant Discovery and former CSO at Silicon Therapeutics. He shared the Roivant Discovery vision for physics-driven drug design and the role of virtual reality to maximize insights. It was an honor to host more than 200 inspiring and engaged attendees. We're grateful to everyone who completed the polls and submitted thoughtful questions.  https://discovery.roivant.com/https://www.linkedin.com/in/woodysherman/

Harry's guest this week is Rohit Nambisan, CEO of Lokavant, a company that helps drug developers get a better picture of how their clinical trials are progressing. He explains the need for the company's services with an interesting analogy: these days, Nambisan points out, you can use an app like GrubHub to order a pizza for $20 or $25, and the app will give you a real-time, minute by minute accounting of where the pizza is and when it's going to arrive at your door. But f you're a pharmaceutical company running a clinical trial for a new drug, you can spend anywhere from $3 million to $300 million—and still have absolutely no idea when the trial will finish or whether your drug will turn out to be effective. Because there's little infrastructure for analyzing clinical trial data in midstream or spotting trouble before it arrives, some studies continue long after they should have been canceled, and positive data sometimes gets thrown out because of minor procedural flaws; in the end, 20 to 30 percent of the money drug makers spend on clinical trials goes down the drain, Nambisan says. Lokavant's platform allows drug makers and clinical research organizations to harmonize the results coming in from study sites, compare it to data from other trials, and discover important signals in the data before it's too late. For example, a company might discover that it's not enrolling patients fast enough to complete a trial on schedule, or that the researchers administering the study aren't following the exact protocols laid out in advance. Such headaches might sound abstract and remote, but poor data management slows down the whole drug development process, which means fewer beneficial new drugs make it to market ever year; that's the ultimate problem Lokavant is trying to fix.Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.TranscriptHarry Glorikian: Hello. I'm Harry Glorikian, and this is The Harry Glorikian Show, where we explore how technology is changing everything we know about healthcare.My guest Rohit Nimbasan comes from the worlds of biotech and data science. And during our interview he made an interesting point.These days you can use an app like GrubHub to order a pizza for twenty or twenty-five bucks, and the app will give you a real-time, minute by minute accounting of where the pizza is and when it's going to arrive at your door.But Nimbasan points out that if you're a pharmaceutical company running a clinical trial for a new drug, you can spend anywhere from $3 million to $300 million and still have absolutely no idea when the trial will finish or whether your drug will turn out to be effective.The problem is, there's just no infrastructure for analyzing clinical trial data in midstream or spotting trouble before it arrives.As a result, according to Nimbasan, twenty to thirty percent of the money drug makers spend on clinical trials goes down the drain, because of studies that continue long after they should have been canceled, or good data that gets thrown out because of some minor procedural flaw.Nimbasan is the CEO of a company called Lokavant that wants to change all that.The company is building a data platform that allows drug makers and clinical research organizations to harmonize the results coming in from study sites, compare it to data from other trials, and discover important signals in the data before it's too late.For example, a company might discover that it's not enrolling patients fast enough to complete a trial on schedule, or that the researchers administering the study aren't following the exact protocols laid out in advance.All of those problems can increase the cost of a trial.They can even lead regulators to deny approval for a drug that might have proved effective if it had been property tested.For an average healthcare consumer, these kinds of headaches might sound abstract and remote, like something only clinical trial managers would ever have to worry about. But the fact is poor data management slows down the whole drug development process, which means fewer beneficial new drugs make it to market ever year.So I think we should all be cheering companies like Lokavant who are trying to fix the process.Here's my full interview with Rohit.Harry Glorikian: Rohit, welcome to the show.Rohit Nambisan: Thanks, Harry, for having me.Harry Glorikian: You know, you and I sort of talk off and on all the time about the space and what's going on, but, you know, having it on the show, I have to step back and sort of forget everything I know about the company and start from scratch. So, you know, can you explain to people Lokavant's business in a way that would make sense to someone, say, outside of the pharmaceutical industry. In other words, you know, what are the big problems you're solving for organizations that, say, are running a clinical trial, and how are you solving them?Rohit Nambisan: Sure, I can do that. I think it bears noting that we should probably step back a little bit and talk about the industry as a whole and where it's been going, and then I can clarify where Lokavant comes in. So I think as many folks know and for those who don't, I'll fill in the blanks. I know you know this area, but in the last, I'd say 15 to 20 years, we've been moving in pharmaceutical development away from blockbuster medications, things like diabetes type 2. Right, developing therapies for that and getting each drug developer trying to find a smaller piece of market and larger pie to specialized, niche therapeutic indications. Right. So the way I could probably better started with the diabetes example is it's no longer diabetes type 2. It's let's develop the compounds or therapies for diabetes type 2 patients that are comorbid with that have also chronic kidney disease and are metformin naive, meaning they haven't taken a particular therapy known as metformin. Right. So it's a more complex filter criteria, so to speak. Right. And so what happens when the industry moves in that that direction is that when you get into these very niche therapeutic areas, you need to collect particular niche, commensurately niche types of data to validate your hypothesis whether or not this therapy is safe and efficacious through clinical trials. Right. Rohit Nambisan: And in doing that, you now increased the complexity of the trial greatly, not only in terms of the different types of data collecting, but the amount of different types of data you're collecting. So now each trial becomes a lot more specialized. Not just specialized therapeutics, but each trial becomes more specialized. Right? And so for that reason, we've seen a big challenge as we as we moved across that space. And actually, it's been really beneficial for patients because now we're going after, as an industry, we're going after really niche unmet clinical needs that previously there were no therapies for or being developed for. So it's a really good thing for a patient perspective, but from the perspective of development, it makes it that much harder. Not only is there a smaller market opportunity, there's less patients to treat, right, but the complexity, the actual costs of the trial and the complexity of trial has gotten exponentially that much greater. So what Lokavant came out of was we were actually a, shall we say, an internal initiative within Roivant Sciences, which is a company that launches a number of different biotechnology companies and tech companies as well. But better known for biotechnology companies. And we saw a great need to be able to develop therapies for niche indications much faster, much more efficient, much more cost effectively, and also meet the complexities of that trial better through novel data and tech.Rohit Nambisan: And so what Lokavant is essentially, is a data platform that allows drug developers, pharma, therapy developers, to be able to choose which data sources they need, data types they need for a trial. And we can ingest any of those data sources, we can analyze any of those data sources in a holistic manner and expose patterns or signals that could be beneficial or detrimental to the study on an ongoing basis. And when I say ongoing basis, I mean you're not waiting until the end of the study. And I guess the best way I can align this is just like my kids do sometimes. You're not waiting until the last day before your term paper is due, before the project's due to finish your work, you're actually assessing, doing bits of it along the way to assess where there may be challenges, which gives you, really, the time to correct issues to manage your trial better. And frankly, each one of these trials now, there are between, what, $2 million and $300 million we're investing in these single trials at this point. So it's egregious to me that we do not have the toolset to be able to even identify, pull in that data effectively on an ongoing basis to detect these signals so we can plan effectively to do something about it.Harry Glorikian: Anybody who's done a clinical trial knows that there's a lot of risk. Right. So, you know, can you talk about some of the types of risks you're trying to help make sure drug developers diminish, for the most part.Rohit Nambisan: Yeah. So I think the way we start with that is always at the highest level, time, cost and quality, right? So when we talk about time, it's really important to understand that you're going to be able to achieve less. For example, I'll give you a few instances. Target participant accrual, right? Obviously for you to run a trial effectively, you need to have particular types of participants or patients, if it's a sick population. In a vaccine population, they weren't necessarily sick. So that's why I use participants as the term. But you need to make sure that you have path to randomized screening and randomizing these patients for your trial in a given time period. Right. And if that's if your enrollment is is not on track for the countries and the sites you've decided to actually activate the study in, you could, your timeline for your study could be exceptionally extended. Right. So that's that's one type of one example of a thing we look at to understand how the timeline looking for the study. Another area on timeline for example and similarly is discontinuation. So you can you could enroll patients fine. But if you've high volumes of discontinuation of participants in your study, then what ends up happening is you actually don't have as many evaluable subjects in your study of some evaluable participants. So you have to recruit or enroll more subjects, right? So that could extend the timeline as well. One aspect of the timeline that really affects the overall market opportunity is oftentimes these therapies are only in under patient for a certain amount of time. So the faster you can get them to market, the faster you can get recoup your return on investment. But also on the patient side, the faster we can get these therapies out through the market to address unmet clinical needs. That's just one flavor.Rohit Nambisan: Then we have subsequent types of flavors. When we talk about data quality, making sure the data is actually collected in the way that you stated you wanted it to be collected in the plan and the protocol at the outset of the study, as well as cost implications. Right. So we look at cost implications as well, which is how, what will this, what will the extension of enrollment or bad data quality data do to the overall budget that you had planned for this study? But then when you drill down on the level further, you can get into risk categories, is something we look at quite a bit when we look at things like protocol, adherence, when you're when you're collecting this data, as I mentioned, it has to be done per a very prescriptive method that is specified a priori before starting the trial in a protocol. And if it's not collected in that manner, it can be discounted. So we are tracking the risk to protocol deviations and understanding trends and not only understanding trends within that study, but we're looking at similar types of studies in this particular therapy area, neurology or say, psychiatry or gastrointestinal type studies and saying, what has been the protocol adherence in studies like yours? And therefore, can we glean some insights about how you are doing in your study based on your comparators in the study as well? But that's just a small flavor. I could probably wax on for quite some time on this question.Harry Glorikian: Well, that that brings us to the question -- I mean, everything you just said, it brings to the question like, from what I know, the company sort of predicts how clinical trials will go by comparing it against a proprietary data set of, I think I was reading, 2000 past trials, right? So I guess the question becomes, so you're comparing one to the past of things that are similar, but you know, for everybody who's listening sort of, you know, where does that data come from in one sense, is it truly proprietary? I mean, that's what I'm you know, that's my set of questions at the moment.Rohit Nambisan: Sure. So I worked for a while, before coming to the life sciences, in the R&D space and the life sciences commercial space. And I think that data sets, are there are proprietary datasets in that space? Very much so. But there is a third party market for that data a little bit more. So then we find life sciences data. It's really hard to get access to R&D data and as you can imagine, that makes a lot of sense, right? If you're a drug developer or a pharmaceutical developer that successfully completed a trial, you never want to share that data. Thereafter, you spent millions of dollars investing in the study, if you want. If there are potentially unknown issues that you haven't identified, would you want to put that at risk? If you are similarly, if you are a therapeutics developer that didn't meet your endpoints, do you want that information to get out and maybe potentially things that issues that that you should have should not overlook, right, getting out in public, etc.? There's just a lot of business risk. There's also IP risk, right? There's a number of different risks associated with getting that data out. So it's been not a very straightforward journey to aggregate data in life sciences, R&D. That being said, I think how we approached this was we've developed models that are both used for benchmarking, as I mentioned before, comparing against similar trials for particular performance KPIs, so to speak, as well as predictive model generation and machine learning models that require a fair amount of data to train on to actually deliver value.Rohit Nambisan: And in that model, we've talked to a lot of our partners or let's say folks that leads them before their partners. And we talk to them. We say we have a growing dataset. There's precedent for this because we've done this with other partners, number one. Number two, we've worked with them to leverage their data combined with our data, write their enterprise data with our data, because it's a common, it's not just one entity's data that's going to provide that value. Your performance, your processes, the way you run trials is inherent in your data. And if we don't leverage that data to train our model to retrain some parts of our models against, we're not providing you the most value we could be with our predictive models or benchmarking. So with that approach, we've been able to do comparative analysis of our data set versus other people's datasets and then anonymize their data upon having a partnership with them to grow our data assets in a very risk-tolerant manner. Right. All the information about CROs or sponsors or other entities, people running trials is removed from the data and we only leverage that data for the purposes of analytics or generating a benchmark. So none of that data is ever shared. So through that process, over the last, I'd say two years, maybe a little two years and change since we started, we've been able to continuously grow this asset and provide greater and greater value with our descriptive diagnostic predictive analytics as well as our benchmarking.Harry Glorikian: How much money, if you had to guess just to give people like an idea, how much money do you think gets poured down the drain preventably every year, and you could save all this money if you just ran smarter, if you did smarter clinical trial management, if I had to frame it that way.Rohit Nambisan: Oh, at least I would say we've done some back calculations on this and happy to digress into the details of them if warranted, but at least somewhere between 20 to 30 percent of the trial costs right now and depending on the phase and depending on the therapeutic area, again, that could be anywhere from 20 to 30 percent of $3 million to $300 million per study.Harry Glorikian: Yeah. I mean it's you know, that's got to be, I don't know how many billions that is. I can't I don't know exactly how much is being spent annually off the top of my head.Rohit Nambisan: We believe we've done some back of the envelope calculations to show that it is in the billions for sure. Across the across the global pharmaceutical market, we're looking just just the value proposition and the signal detection we're bringing to bear is somewhere around $18 to $20 billion, in terms of market opportunity.Harry Glorikian: I mean, how would you guys run or help a team run a clinical trial in practice? Can you sort of give me a real-world example, maybe de-identified, where you helped the client avoid or mitigate some kind of risk, whether it has to do with patient enrollment or site compliance or safety issues during a trial, any one of those will do.Rohit Nambisan: Sure. So I think one example that I can bring to bear is working with a large CRO. And with this large CRO, they had a sizable data asset that was not harmonized, so to speak. It was still living in the transactional exports from the source data systems or CSPs. Et cetera. All around. So it was they had a bunch of different hypotheses about where they were proficient, where they were deficient, but nothing validated. So we spent some time with them trying to understand what all their data assets looked like. And we started collecting these different representations of former trials and ongoing trials, and we collected them and we harmonized them. In fact, as I mentioned before, one of our major differentiators is this is creation of a single source of truth. And we take that upon ourselves, too. It's not like a service, it's part of our offering, right? Our platform offering. And so what we did was we brought that data together and we it was about, I think 400 to 500 studies worth of data at that point. We harmonized it into what we call our local and canonical data format, which is a single representation for multiple different domains of data, scientific data, operational data, enrollment data, etc. And then we compared that against similar studies in our repository, our growing repository, and said, okay, we can tell you comparatively that you are deficient in these particular areas and you're very proficient at the various--for example, in this case they were very proficient in achieving first patient in on the timeline that they expected to actually, scratch that, that they were very they were very proficient in actually accruing the subjects by last patient in in the time they were expected to write so they could hit their accrual when they wanted to.Rohit Nambisan: But when we looked deeper into the data and looked at across like first patient in, the 50 percent enrollment mark for the study and then last patient in for the study, we were able to identify that there was actually a slowdown and a major overcorrection to make up for that. So they were actually hitting what they needed to hit. But as we all probably know, at least in the clinical research phase and any or any budgeting process, being over your budgeting process is bad. Being under your budgeting process is bad, right? So in this case, it's again the same. They were burning resource and cash and resources to rapidly overcorrect for for a milestone they were not hitting reliably earlier in their studies. And so we realized in that accrual situation we said, okay, what you need is, we've identified an error, you're potentially deficient. What you need is an enrollment forecasting application that brings in the data in real time from your study. Right. And it also combines historical data from our repository in your historical data to seed some prior knowledge about the study. So and it's automated, fully automated. So every day you can understand where you are in relation to where you need to be. Right? And it's not a naive straight line kind of curve. It's basically it's based on looking at thousands of historical studies in this space and understanding what the curvature of the actual model should look like.Rohit Nambisan: So we generated that and we were able to actually, in the proof of concept, and this is just one particular example of an application we've been able to generate from our clinical trial intelligence platform, we generated that and we were able to, on a study, predict two years out within one month when they would actually really hit the accrual and it was within one month accurate. Now while that was valuable in terms of understanding at the end state, what really the value was of this closed loop model, so to speak, right, is that it is closed loop. It allows them in silica to say, what happens if I open some sites here? What happens if I close some sites? So what happens if I close this country here? How will that affect my plan before I put that into action in the real world, which oftentimes is very, very, first of all, it's very risky. But second of all, it can yield a number of unknown consequences if you don't try it before in silico. So I think the approach here was we were able to not only predict these things better and also predict the impact of change orders on the study, that might actually affect the timeline of the study. But we were able to actually provide them an application, an interface by which they could test it all their hypotheses in a virtualized manner before they implemented them. And we're growing like crazy with that, with that partner right now at that point.Harry Glorikian: Yeah. And I mean, I mean, you know, in some ways it sounds like, you know, I didn't get it done and I'm pulling all nighters, like at some point so that I can get it done. Right. So there's a whole staffing model. And how do you bring this to the attention of everybody so that they don't drop the ball? Right, because there's a million other things that might be coming at them at that moment.Rohit Nambisan: That's exactly right. Actually, one thing I'll add to that, given you mentioned the staffing model around it, is that we were born within small biotech. Right. And small biotech is very resource-constrained in its ability to manage and oversee a study. That's fairly well known. So our approach has always been what I'd like to call machine-assisted human intelligence. We have experts that are human experts that know the space, but they need to be augmented. They need to be able to look at more complex streams of information and have a machine pick out particular salient insights, salient information, and provide that to them so they can process it, reducing degrees of freedom for them to process it.Harry Glorikian: So just I mean, there are a lot of statistical tools out there now that that for managing risks in clinical trials. So how is the approach that you guys are taking either different or better or both.Rohit Nambisan: It's a good question. One way we've been able to address this question is that statistical approaches generally require certain amounts of data points to be collected before you can warrant using statistical parameters or assumptions, etc. And so there's two things at play here. On top of that, I just mentioned, we're moving into more specialized therapeutic areas, right? So patients per study are smaller, right. And on top of that, when you're starting out a study which is usually the riskiest points in the study, when you're early in the study to mid-stage in a study, you cross them with the fact that you have less patients and there are more niche studies, it's hard to find those patients. Now, your early phase, your riskiest phase, is going to be extended as compared to when you were developing against blockbuster indications. So for a long time in the study, you can't really reliably use statistical parameters to identify an outlier or identify something as aberrant. And then you need to focus on so the way we've done it, we've done it in a slightly different way. There's two approaches. One is we've actually developed a pretty complex risk score system that's based on a set of very different metrics. Think of it as like an array of different KPIs, right? Those KPIs will affect risk differently depending on the type of study you're in. And they'll have different weights to those risks of time, cost and quality depending on the study you're in. So we look at the given study, we're going to deploy and we say, okay, what are the features that characterize the study? Let's look in our historical repository against those same features, pull similar, we call look alike studies and we'll understand how to set those weightings to say protocol deviations at this point in the study are going to impact the overall quality of time. That's much more for this type of study. So we can basically, for lack of a better term, I guess the simplistic way of saying is we can augment the data that we have coming in from a study, which is small at the outset of the study, with lookalike data to increase the power. Right? So that's another way to look at this. So we can actually, we have much better power to be able to detect these issues earlier on and reliably confer that to clinical operators and clinical developers who can do something about it.Harry Glorikian: It would be nice if you had enough data at some point to almost run the whole trial in silico, in a sense. But I think we need a lot more data get there. But, just for everybody that's listening, sort of as a philosophical point, the reason we put drugs through clinical trials in humans is we simply don't know whether they'll work or what the unexpected side effect they might have once you start them on a much larger population. So in that sense, it's expected, even normal for some drugs, maybe even a lot of drugs, to fail at some point in phase one, phase two or phase three. And as an investor, you know, you don't want it to fail in phase three. You want it to fail early. So is Lokavant's goal to reduce the failures or simply help drug developers get to yes or no faster, safer, more cheaply?Rohit Nambisan: Yeah. So our approach has been initially get yes or no faster, safer, more cheaply, more efficiently, right. As part of that process and actually related to some of the work we have done in the last few months on monitoring scientific risk. Right. You have to be careful about these efficacy analyses because they can unblind the study, especially when you have single or double blind blinded studies. So you have to be careful about this point. But in some circumstances we can actually leverage our analysis on blinded endpoint analysis and understand how particular endpoints are collaborating or not collaborating or trending, to understand if there is any effect whatsoever that's being generated in the study. So this is early days for us. But to your to your point about the first use case, we are starting to think about that as an opportunity as well, because we found a way to effectively blind the information and still assess the information content to understand if there is any form of efficacy signal being produced. So I think that that is a really valuable way for us to approach the market in the near future. I think the other point here is that if you are cleaning the data, if you are identifying those data quality issues on a more real time basis, you should be able to reduce the time to do an interim analysis. Right. We should be able to -- you mentioned fail fast. Right. Failing fast requires you to also assess the data, to understand if there's an efficacy signal, there's a safety issue. And if we have these long cycle times before we can actually do an interim analysis. And much of the data indicates that those long cycle times are due to not knowing where the issues are and finding those issues then cleansing them. If we can do that faster, we should be able to do interim analysis much more frequently. Therefore, being able to generate a fail fast scenario.Harry Glorikian: You could almost, you should be able to set up the system to almost be running it and sort of move the bar on where it is on, “Looks successful,” or “It's moving down towards failure.” There's got to be some sort of almost real-time indicator as data is coming in to. You just don't want humans to jump the gun on that. The interesting thing is, I was looking at one of the blogs you have and you sort of say that one of the main reasons clinical trials are so costly and inefficient is bad data management and a lack of interoperability across data repositories. And, you know, it's funny because anybody who listens to this show knows that just comes up over. And it doesn't matter who you are in health care. It is a recurrent theme that for some reason people are not willing to step up and solve. I mean, it has to be a party like yours that comes in and helps clean it up from the outside as opposed to it being cleaned from the inside the way that you would ideally like it to be.[musical interlude]Harry Glorikian: Let's pause the conversation for a minute to talk about one small but important thing you can do, to help keep the podcast going. And that's leave a rating and a review for the show on Apple Podcasts.All you have to do is open the Apple Podcasts app on your smartphone, search for The Harry Glorikian Show, and scroll down to the Ratings & Reviews section. Tap the stars to rate the show, and then tap the link that says Write a Review to leave your comments. It'll only take a minute, but you'll be doing a lot to help other listeners discover the show.And one more thing. If you like the interviews we do here on the show I know you'll like my new book, The Future You: How Artificial Intelligence Can Help You Get Healthier, Stress Less, and Live Longer.It's a friendly and accessible tour of all the ways today's information technologies are helping us diagnose diseases faster, treat them more precisely, and create personalized diet and exercise programs to prevent them in the first place.The book is now available in print and ebook formats. Just go to Amazon or Barnes & Noble and search for The Future You by Harry Glorikian.And now, back to the show.[musical interlude]Harry Glorikian: So on this show we talk about, you know, how does analytics play into this? So, how do—and I've got to start finding new words—but AI and ML come into this picture. What types of tools in the AI toolbox is Lokavant using? What special powers does AI give you to extract predictions from your data set that other people don't?Rohit Nambisan: Yeah, I think I think the first piece is, and it's going to sound interesting in relation to what folks usually talk about in terms of AI and ML, but it's a harmonized data model, right? When I was working as a data scientist a number of years back, nobody told me all the work that you have to do with data governance and data harmonization. And then when you think about fast forward today where a lot of the actual models themselves are function calls, right? You realize that a lot of the work is actually making sure that data is ready to be analyzed for this particular use case. Right. So it's not to say that we don't do a number of different, try different approaches to gradient boosted descent or support vector machines or neural nets, which is actually my background in terms of grad school and research. But we spend a lot of time thinking through how we need to harmonize, create validated data pipelines to harmonize data for use. In this case. And even in that case, a lot of the work we do is a kind of intelligence or artificial intelligence. So when we're harmonizing the data, we're looking for views on leveraging multivariate clustering algorithms to actually figure out which particular types of data attributes should be mapped to one particular field.Rohit Nambisan: So it's not to say that the data harmonization is devoid of intelligent approaches, it is full of intelligent approaches, but it is an absolute necessity to have the integrity of the data that you need to run those sophisticated front end models, which we run a ton of. But I just I want to call attention to the fact that that is a core asset for Lokavant from the get-go, that Lokavant's canonical data model and the processes we use to harmonize data to get it into that state has been a core focus because if you can do that—and that is the same model you're providing to your data science and analytics teams, your product development teams—then you really have that flywheel that you can generate a number of different analyses. For example, I just mentioned that predictive enrollment forecast model that comes off of in our our Lokavant canonical data model. That is something that is a predictive model, leveraging historical data and ongoing study data in an automated model that indexes towards the historical data early in the trial, indexes towards prediction indexes towards ongoing study data as it comes in. And we have more confidence that input over the trial, that's like an emergent benefit of having the harmonized data harmonize.Harry Glorikian: So, you know, one has to ask in the age of the coronavirus, right, how has the business of running clinical trials changed since the pandemic? I mean. And how do you guys...is that an advantage or disadvantage? I'm trying to, you know, place where you guys are in the whole realm of how things have hopefully changed for the better.Rohit Nambisan: Yeah, it's been quite a tailwind for us actually. And I would say that, number one, it's been it's been beneficial to us because there's just been a lot more scrutiny and interest in clinical research. Not to say there wasn't before, especially for niche therapeutic areas, but and the fact that we were able to develop and get novel COVID vaccines out pretty rapidly. But there was also a lot of challenges along the way in getting to that point. And also delays and trials and challenges in therapeutics development to address COVID as well. So there's just been a lot of scrutiny in the last 24 to 30 months on how efficient and how fast and how effective clinical research can be. So just that alone has been beneficial. Now let's take the next step there and say that all associated with the pandemic, there's been a great impact to clinical trials across the board, not just COVID trials or therapeutic trials. Patients, participants couldn't get to sites for site data collection, right. Site staff couldn't get in there, too, for data entry or site management or site oversight activities. Right. So in general, it's been a huge boon to those technology groups that have developed, decentralized or direct-to-patient data capture methodologies, thereby lowering the patient burden and the site burden for clinical trials to continue in a pandemic fueled environment. What's interesting about that as well, when we think about ourselves as both a data type agnostic platform for clinical research as well as an analytics engine, a platform on top of that, you see this huge movement to another type of data, another data, for example, decentralized trial data as another data source.Rohit Nambisan: And what we've seen also is that while there's been a shift to a lot of decentralized trial collection on most studies, at least 90 percent of studies and above, they're hybrid, they're not fully decentralized. So you have to have some site data collection and you have some decentralized data collection. And that makes sense for those things that may make the most sense to lower patient and site burden to administer. Let the patient let the participant be at home. For those that require like biopsies, etc., that require a participant oftentimes to come into the site, let that be the site. The challenge there is now you have these two different complex data streams that are not necessarily harmonized and aggregated. So this is, again, I think that's been an area where we've been able to come in and say we'll just as a matter of course, you're doing business, this is another data set to us. We need to bring these two in and we have to also enable comparative analysis against decentralized and traditional site based data collection, because otherwise you're going to miss insights. You're going to miss information that are critical to your study.Harry Glorikian: Yeah, a part of me was just thinking, you know, you guys should buy somebody, like Unlearn AI and go at it together where you can have, you know virtualized patients that you can put into the trial, but that's… we won't go there. So let's step back for though, for a second. So let's talk about the company's origin story. Lokavant is one of many companies launch by Roivant, as you mentioned earlier. A Lot of the companies end up with the word “vant.” So can you explain so that people understand: What is Roivant, how it operates, what are vants and and why was Lokavant born. And how did you become president and CEO?Rohit Nambisan: Sure. So Roivant started about seven years ago. And I should mention Roivant is our parent company. We were founded out of Roivant and spun out as a technology company itself. So Roivant initially started as a company that launched "vants" -- nimble, entrepreneurial biotech companies and now health tech companies as well. When I joined Roivant three and a half years ago, Roivant had about 15 different biotech companies. And what was really interesting about their approach is it was therapy agnostic, so it was not that there was a strategic focus or oncology or strategic focus on immunology. There was a focus around identifying compounds that may have been deprioritized in larger pharma companies, which says pharma companies that had a lot of potential and had could address critically unmet clinical needs. And so Roivant would in-license those therapies and start a therapy therapeutically oriented vant. So at the time Axavant it was the new neurological oriented, neurological disease oriented vant. Myovant was the human reproductive oriented, disease oriented vant. Et Cetera. And so now when you think about somebody like myself who comes from the tech world and life sciences, health care technology world, brought into Roivant three and a half years ago, the premise behind Roivant at the time was we can more efficiently develop these therapeutics and have more favorable outcomes leveraging innovative ways of addressing human talent as well as technology. And that latter piece is where obviously I came in and we were starting to look at in my team what are some of the most significant challenges and frequent challenges amongst the vants themselves in running these clinical trials? And then does that map against some of the more significant frequent challenges we see outside in the market? And not surprisingly, there were quite a few particular areas of resonance.Rohit Nambisan: At that point in time, they're about 54, 45 programs being run by Roivant. And so it was across a variety of therapeutic areas. And I guess the thing that hit us in the face primarily was I guess the best way I could say it is you can order a pizza, right? You can understand what is it, a $25 investment, $20 investment. Maybe it's gone up since then, since I ordered a pizza. But the point is that you can understand what time it was ordered, when it was when they said they were going to deliver it to you, and you can track it. And most of these apps now [show it] along its destination to a chain of custody to get to you. We were we could spend $3 to $50 million on any given trial and we were at struggling with our partners to actually identify what is the current state of enrollment in the last week? What is the current state of discontinuation? Where are we at with our with these particular sites in this region? Why are we seeing high screen failure rates, etc.? Right. That's egregious to me. That's just that should not be the case.Rohit Nambisan: We are fairly frustrated with that. And then even when we when even at Roivant or even in my former experiences at Novartis or other pharma, when we brought in a source system to say, okay, well, we're going to have a representation of data ourselves, right? So that we can understand what's going on. Invariably what happened is you would have one source system here and then a duplicate version of that sort of system at the CRO or another vendor that's working with you. You spent your entire time trying to figure out which was the source of truth, because they're spending all your time doing data reconciliation, saying, is that really accurate? Is that really the signal? So that didn't work either. So we felt pretty frustrated about this. We initially tried not to build it ourselves. We worked with a few different collaborators outside of Roivant and tech vendors, etc., and we were fairly frustrated with what we came back with there. So at that point we started thinking, if we can't buy it, we need to take a lead user innovation approach to address this. So we started out with the data platform, as I mentioned to you, and we built that capability to connect, ingest and map from any source, deliver that within a canonical data model, one single canonical data model. And then initially we did a bunch of bespoke analysis on top of that for a few different biotech vants. Rohit Nambisan: That went really well. Some of the external collaborators looked to Roivant at that point we said we'd like to work with this technology outside of the Roivant family, and we realized we were on to something, and we externally launched the company in January of 2020, which was very interesting time and year to launch a company. That being said, we spent the first, I'd say, just under two years, really focused on externally subsidized R&D phase. We're pretty fortunate to have some partners that invested in us in that phase, and we focused on first one particular application in response and we talked a lot about risk. But then we also realized that the needs across different companies, different vendors, etc. for managing clinical trials are very varied. So we realized what we need to really build as generalized on that first application we built and create a highly configurable analytics platform on top of this data platform so that we could actually analyze many different things and configure it for use for any particular customer. And so now we built across, I'd say seven or six or seven different use cases now, and we've deployed most of them and we're continuing to aggregate information in a true product sense where the biggest pain points in the market and how do we build or configure a version of the platform and the platform to address that. And at the same time, we're delivering on global trials with a number of pharma studies as well as on the side of the vendors working through them to deploy on studies as well.Harry Glorikian: So in a perfect world, right, if you had access to all the relevant data, if every drug developer in the world was taking advantage of your services, how would it change the business of clinical trials? What would the outcomes look like? Would it be like you get more drugs approved every year, at a lower cost, fewer disaster failures, I mean. What changes for the industry and for patients?Rohit Nambisan: Yeah. I think the first piece is you would reduce—and this is a lofty question so I'm going to answer with a lofty response—the first thing to note is that, and we touched on this earlier, I think you'd see fewer bigger failures in the analytics phase. You'd be able to identify earlier on, both in terms of the lifecycle of a compound, right? So from phase one to phase three or even phase four, but especially within the study itself, you'd be able to identify that there would be an issue in the study earlier on and you could kill it early on. So that's one one aspect I think would be that's important to note. The other thing I think you would identify is less operational issues. So I think one in six trials across the globe failed just because of operational issues. And when I mean operational issues, I mean the protocol and the plans at the outset of a study say need to administer the study following these steps. And when those steps are not followed, there's compliance risk. And therefore, when there's enough compliance rates to throw out the data or you have to not submit the study.Rohit Nambisan: And so one in six is, it's not that small. And so if we're tracking, if we're more rigorously tracking both what is happening and what could happen, right, based on the indication, leading indicators of risk across time, cost and quality, we should basically never see -- that's a that's one of our major goals -- never see a trial fail just because of an operational reason. Not to mention, how can you go to the patients with unmet clinical needs in a particular indication in particular disease and say, “Oh, I'm sorry, while the drug probably was effective, we just couldn't get it out into the market this time. And it's going to take us another trial, potentially.” A lot of times folks don't actually resurrect the failed study, a failed therapy. So even if they resurrected it and said it was because of an operational issue, “Oh, you've got to wait another six years.” That's just not acceptable. So I think those are the two components that come top of mind. And I think early in our in our tenure, our mission was no trial should fail due to operational error.Harry Glorikian: What is the path to financial success for a company like Lokavant? Is it to just keep growing? To go public? To get acquired by a maybe by a big pharma. What's the path?Rohit Nambisan: It's a good question. I think folks that that know exactly what their exit strategy are probably, for lack of a better term, often deluded. But I will say that we've seen a lot of growth. Not only during, there's been a lot of interest in Lokavant during the pandemic, I mentioned we were in this externally subsidized R&D phase, we were actively trying not to do too much externally. We wanted to figure out how to set up the platform for success. Coming out of that phase, in the last six months, we've seen an incredible amount of traction externally. And so I think we are still in the path of doing it on a growth trajectory ourselves. What does that mean in terms of opportunities to collaborate both commercially and partner and strategically? Well, it means that we can only do as much as we can, even if we continue to grow. There's data out in the market and partners that have access to that data that we would love to collaborate with. If that means that we need to be more strategic in our approach to what Lokavant can do or how to structure Lokavant, we'll do that just because we need to actually achieve our mission, which is to have no trials fail due to operate operational error. Right. And so I think that requires more data. That requires more data science. We have a lean, very, very proficient data science team. So I think there will be opportunities for strategic collaboration, but it's all related to the mission of bringing this clinical trial intelligence platform to address operational and other risks in a study as effectively as possible.Harry Glorikian: You know, one of the things that crosses my mind is you could also use this from an investing perspective to analyze a trial that's going through its paces against historical information and determine, give it a weighting of probability of success versus failure from an investment perspective, that that seems attractive to me.Rohit Nambisan: Yeah. So that's an interesting point to bring up. There are folks now asking us in the market about what we've been informed firmly in trial execution stage. Folks are asking us to move into feasibility and effectively feasibility. Is that the planning of the study? Tell me with this particular configuration of sites, countries and for this indication, knowing the standard of care in different countries, knowing the approach to clinical care, not just clinical research, how successful would this study be? Right. And obviously, the success of a study, when you think about biotech, the success of a study is the success of the company. When you think when you go up the market, depending on the study, it can still have incredible impacts, the success of the company. So there is definitely an afferent towards the investing world and financial. I think at first we probably take a progressive step towards that by moving into trial planning analytics in this manner and then validating our approach against progress in space and seeing how we can continue to grow in that sector.Harry Glorikian: Well, Rohit, it was great having you on the show. I hope everybody enjoyed our discussion. You know, a lot of problems to solve in this industry. So there's there's no lack of opportunity from, you know, businesses that need to get started and the data that needs to be optimized to help move the process forward. But, you know, luckily, everybody I talk to on the show, that's the direction we're all moving. So hopefully we'll get there faster, because I'm not getting any younger. So, so good drugs are going to be needed at some point. So good to have you here. And I can't wish you and the team at Lokavant, you know, more success.Rohit Nambisan: Thanks, Harry, for having me on the show. It was wonderful to be here.Harry Glorikian: That's it for this week's episode. You can find a full transcript of this episode as well as the full archive of episodes of The Harry Glorikian Show and MoneyBall Medicine at our website. Just go to glorikian.com and click on the tab Podcasts.I'd like to thank our listeners for boosting The Harry Glorikian Show into the top three percent of global podcasts.If you want to be sure to get every new episode of the show automatically, be sure to open Apple Podcasts or your favorite podcast player and hit follow or subscribe. Don't forget to leave us a rating and review on Apple Podcasts. And we always love to hear from listeners on Twitter, where you can find me at hglorikian.Thanks for listening, stay healthy, and be sure to tune in two weeks from now for our next interview.

K.T. McFarland, Former Trump Deputy National Security Advisor and the author of "Revolution: Trump, Washington and 'We The People'” Topic: Latest in the Russia-Ukraine war, Shanghai lockdowns Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: Sex education curriculum in the first grade, how Elon Musk might challenge wokeism by purchasing a stake in Twitter Steve Perillo, President and owner of Perillo Tours and Dr. Paolo Ferrini to discuss the Italy trip See omnystudio.com/listener for privacy information.

Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: Potential for Freedom Convoy in the U.S., Critical race theory-related ideas found in mandatory programs at 23 of top 25 US medical schools Michael Goodwin, Chief Political Columnist for the New York Post Topic: Talking with Donald Trump at Mar-a-Lago See omnystudio.com/listener for privacy information.

We kick off the Spring 2022 semester with a panel discussion on the future of American politics after Dobbs v. Jackson, "What Happens if Roe is (Not) Overturned?". Featuring former Congressman Dan Lipinski (D-IL), Prof. Sherif Girgis (ND Law School), and Prof. Christina Wolbrecht (ND Political Science), conversation will focus on the potential political and legal outcomes of one of the Supreme Court's most controversial cases of this term. Vivek Ramaswamy is a New York Times bestselling author and entrepreneur who has founded multiple successful enterprises. A first-generation American, he is the founder and Executive Chairman of Roivant Sciences, a new type of biopharmaceutical company focused on the application of technology to drug development. He founded Roivant in 2014 and led the largest biotech IPOs of 2015 and 2016, eventually culminating in successful clinical trials in multiple disease areas that led to FDA-approved products. Mr. Ramaswamy was born and raised in southwest Ohio. He graduated summa cum laude in biology from Harvard in 2007 and began his career as a biotech investor at a prominent hedge fund. Mr. Ramaswamy continued to work as an investor while earning his law degree at Yale, where he was a recipient of the Paul and Daisy Soros Fellowship for New Americans. He was featured on the cover of Forbes magazine in 2015 for his work in drug development. In 2020 he emerged as a prominent national commentator on stakeholder capitalism, free speech, and woke culture. He has authored numerous articles and op-eds, which have appeared in the Wall Street Journal, National Review, Newsweek, and Harvard Business Review. Mr. Ramaswamy serves on the board of directors of the Philanthropy Roundtable and the Foundation for Research on Equal Opportunity.

Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: How manmade policies to slow the spread might create a super-variant, race's role in COVID treatment, Dr. Fauci vs Rand Paul, Parents being described as “domestic terrorists”  Rafael Mangual, senior fellow with and head of research for the Manhattan Institute's Policing and Public Safety Initiative and a contributing editor of City Journal  Topic: New York City can expect more brazen crime this year  Michael Goodwin, Chief Political Columnist for the New York Post Topic: “Anyone-can-vote” madness in New York, Alvin Bragg obstruction of justice  See omnystudio.com/listener for privacy information.

Join us for a lecture by Vivek Ramaswamy on his new bestselling book, "Woke, Inc.: Inside Corporate America's Social Justice Scam." Vivek Ramaswamy is a New York Times bestselling author and entrepreneur who has founded multiple successful enterprises. A first-generation American, he is the founder and Executive Chairman of Roivant Sciences, a new type of biopharmaceutical company focused on the application of technology to drug development. He founded Roivant in 2014 and led the largest biotech IPOs of 2015 and 2016, eventually culminating in successful clinical trials in multiple disease areas that led to FDA-approved products. Mr. Ramaswamy was born and raised in southwest Ohio. He graduated summa cum laude in biology from Harvard in 2007 and began his career as a biotech investor at a prominent hedge fund. Mr. Ramaswamy continued to work as an investor while earning his law degree at Yale, where he was a recipient of the Paul and Daisy Soros Fellowship for New Americans. He was featured on the cover of Forbes magazine in 2015 for his work in drug development. In 2020 he emerged as a prominent national commentator on stakeholder capitalism, free speech, and woke culture. He has authored numerous articles and op-eds, which have appeared in the Wall Street Journal, National Review, Newsweek, and Harvard Business Review. Mr. Ramaswamy serves on the board of directors of the Philanthropy Roundtable and the Foundation for Research on Equal Opportunity.

➡️ Like The Show? Leave A Rating: https://ratethispodcast.com/successstory ➡️ About The Guest Vivek Ramaswamy is a successful entrepreneur who has founded multiple successful enterprises. A first-generation American, he is the founder and Executive Chairman of Roivant Sciences, a new type of biopharmaceutical company focused on the application of technology to drug development. He founded Roivant in 2014 and led the largest biotech IPOs of 2015 and 2016, eventually culminating in successful clinical trials in multiple disease areas that led to FDA-approved products. Vivek was featured on the cover of Forbes magazine in 2015 for his work in drug development. In 2020 he emerged as a prominent national commentator on stakeholder capitalism, free speech, and woke culture. He has authored numerous articles and op-eds, which have appeared in the Wall Street Journal, National Review, Newsweek, and Harvard Business Review. ➡️ Talking Points 00:00 - Vivek's Story. 09:08 - Shareholder vs. stakeholder capitalism. 13:18 - How did wokeness start? 22:03 - Goldman Sachs & diversity. 29:06 - The separation of church and state. 36:29 - What's the fix for corporate greed? 41:27 - Critical Race Theory & wokeness. 46:53 - Entrepreneurial lessons from one of the largest biotech IPO's. ➡️ Show Links https://www.instagram.com/vivekgramaswamy/ https://twitter.com/vivekgramaswamy https://amzn.to/3c2AV30 ➡️ Podcast Sponsors 1. Better Help —Virtual Therapy & Mental Wellness https://betterhelp.com/scottclary — 10% Off First Month 2. True Bill—Control Your Subscriptions https://truebill.com/successstory 3. Nutrafol —Increase Hair Thickness & Volume https://nutrafol.com/ (CODE: successstory) — $15 Off First Month 4. Hubspot Podcast Network https://hubspot.com/podcastnetwork

Stephen Moore, "Joe Piscopo Show" Resident Scholar of Economics, Chairman of FreedomWorks Task Force on Economic Revival, former Trump economic adviser and the author of "Trumponomics" Topic: The possibility of the IRS gaining more access to bank accounts under President Biden Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: Facebook controversy, "woke" educational system and school boards See omnystudio.com/listener for privacy information.

Dr. Nicole Saphier, board-certified radiologist, Medical contributor for Fox News and author of the new book “Panic Attack”  Topic: FDA grants full approval for Pfizer vaccine Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: Three flawed assumptions that led to the Afghanistan crisis, the current state of wokeism Congressman Lee Zeldin, Republican representing New York's 1st Congressional District Topic: Kathy Hochul becomes first female Governor, competition in the gubernatorial race See omnystudio.com/listener for privacy information.

Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Jesse Watters, host of "The Five" and "Watters' World" on Fox News Channel and the author of "How I Saved the World" See omnystudio.com/listener for privacy information.

Listen to our conversation with the executive chairman and founder of Roivant Sciences. Learn how Mr. Ramaswamy used his experience in Biotech investing to found a 7 billion dollar company, and what his insights are regarding building a start-up and how Covid-19 has impacted the industry.

Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc." Topic: his new book, the threat of wokeism in America Tom Fitton, President of Judicial Watch Topic: January 6 commission See omnystudio.com/listener for privacy information.

Filling in for Joe Piscopo this morning is Councilman Joe Borelli, Minority Whip of the New York City Council & the author of "Revolutionary Staten Island" Dr. Ian K. Smith, the host of the Emmy Award-winning "The Doctors" airing in national syndication and the author of the new book, "Fast Burn"Topic: his new book, losing weight for the summer, FDA approves Pfizer vaccine for children 12 to 15 Charles Gasparino, Senior Correspondent for the Fox Business Network Topic: Financial repercussions from the pipeline hack, relaxed COVID regulations on the trading floor Vivek Ramaswamy, Founder of Roivant and the author of "Woke, Inc."Topic: his new book, the threat of wokeism in America, Disney goes woke See omnystudio.com/listener for privacy information.

Roivant Sciences doesn't fit easily into conceptions of drug companies, venture capital firms, or accelerators. It is building highly-focused drug development companies around promising undervalued assets it licenses. In five years' time, it's raised more than $3 billion, amassed a broad pipeline of more than 35 therapies, and has more than 800 employees. We spoke to Eric Venker, chief operating officer of Roivant, about the company's business model, how it leverages its resources, and how it may be changing the industry's approach to drug development.