Podcasts about Drug development

“Very often, doctors try to suppress what they feel or don't even have the vocabulary to describe their emotions,” says Professor Alicja Galazka of the University of Silesia, an observation based on decades of work with physicians to enhance their emotional intelligence and resilience. Galazka, a psychotherapist, psychologist, lecturer and coach, believes this deficit is rooted in part in a lack of instruction in the internal and external psychological dimensions of being a medical provider. “There is not enough space created in medical school for teaching and training students about how to deal with their own stress and all of the skills connected to building relationships with patients,” she tells host Michael Carrese. Those same skills are also critical to working effectively as a member of a care team, which is an increasingly common arrangement in hospitals and clinics. Galazka employs simulations, dramatic role-playing, mindfulness, Acceptance and Commitment Therapy and other methods in her work with an eye on increasing the emotional agility and sensitivity of her trainees and clients. Tune in to this thoughtful episode of Raise the Line to hear Galazka's ideas on how to reshape medical training, why she is a proponent of narrative medicine, and the merits of embedding psychologists on care teams as a resource for both patients and providers. Mentioned in this episode:University of SilesiaInternational Association of Coaching Institutes If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, host Zac Lloyd engages with expert in the field Colleen Johnson to discuss critical considerations in designing in vivo nonclinical programs for dermal and topical products. Through this conversation we aim to enhance understanding of key aspects in this specialized area of toxicology.  This podcast is designed to offer listeners an introduction to dermal product drug development.

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we 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. Follow today's speakers:    Dr. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

"Older adults have this special clarity about who they are and what they want, which is incredibly inspiring," says Dr. Julia Hiner, explaining, in part, why she loves her work as a geriatrician in Houston, Texas. She also enjoys the challenge of the medical complexity these patients present and the opportunity it creates to see the patient as a whole person. In fact, as you'll hear in this upbeat conversation with Raise the Line host Lindsey Smith, there's almost nothing about geriatrics that Dr. Hiner does not enjoy, which explains her passion for teaching the subject at McGovern Medical School at the University of Texas Health Science Center in Houston and trying to convince more students to pursue it as their specialty.  The need is great, given that there are only 8,000 geriatricians in the US despite a rapidly growing senior population. Tune in to learn why Dr. Hiner thinks clinicians avoid the field and the steps that can be taken to improve the situation, including requiring courses in geriatrics. You'll also learn about the importance of capacity assessments, the troubling, and under-reported, problem of elder mistreatment, ageism among health professionals and much more in this super informative episode. Mentioned in this episode:University of Texas Health Science Center at Houston McGovern Medical School  If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, we speak with Jean-Philippe Therrien, a senior director of R&D, to discuss critical considerations in designing nonclinical programs for dermal and topical products. Through this conversation, we aim to enhance understanding of key aspects in this specialized area of toxicology. This podcast offers listeners an introduction to dermal product drug development.

LINK TO ACRO'S RBQM SUMMARY REPORT: https://www.acrohealth.org/rbqm-summary-report/In this episode, ACRO RBQM Working Group members Lauren Garson (Veeva), Cris McDavid (Parexel), and Jennifer Stewart (Premier Research) joined ACRO's Good Clinical Podcast to discuss key takeaways from ACRO's annual RBM/RBQM Landscape Survey. Since 2019, ACRO's RBQM survey has dug into trial-level data on industry adoption of RBM and RBQM components. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies' adoption of risk-based monitoring to better understand how the larger framework of risk-based quality management (RBQM) are being adopted across the clinical trial industry.  

In this episode of Idea Collider, host Mike Rea interviews Paul Peter Tak, CEO of Candel Therapeutics, discussing his remarkable journey from a clinician in Amsterdam to leading cutting-edge biotech companies. Paul shares pivotal moments in his career, the challenges of transitioning from academia to big pharma, and the innovative principles he applied. He dives deep into Candel's promising work in viral immunotherapies for cancers and the unique leadership and management philosophies that have guided his journey. Additionally, Paul Peter touches on his passion for leveraging collective intelligence and his unconventional hobbies that keep him grounded and creative. 00:00 Introduction and Guest Welcome00:59 Early Career and Passion for Medicine02:09 Transition to Industry and GSK Experience04:50 Building Successful Organizations07:42 Innovative Models in Pharma19:03 Joining Candel Therapeutics and Vision for the Future25:15 Transforming Cancer Treatment27:24 Challenges in Biotech Market28:45 Strategic Decisions and Prioritization31:39 Collaborations and External Partnerships33:07 Innovative Approaches and Future Prospects44:23 Leadership and Personal Insights Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Paul Peter Tak;LinkedIn: https://www.linkedin.com/in/paul-peter-tak-md-phd-fmedsci-1b44749/ Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

Just about the hottest thing in longevity science right now is partial reprogramming - using Yamanaka factors to rewind the biological clock in our cells. Billion-dollar giants like Altos, Retro and New Limit are betting on it.But in this episode a far smaller player, Shift Bioscience, argues that the field may be looking in the wrong place. CEO Daniel Ives explains how his team used AI-powered virtual cells to uncover a single gene that seems to match OSK-level rejuvenation without the tumor risk that haunts classical reprogramming - and why their just-released data could change the game for aging research.

In 2024, ACRO announced its D&I Site Resource Grants Program. Designed to support an innovative 12-month pilot project, the site resource grants act as a platform to incubate innovative strategies for improving representative enrollment in clinical research.  On this episode, site grantee representatives Dr. Ammara Mushtaq, MD (Brooklyn Clinical Research), Dr. Lovie Negrin, APRN (Randomize Now), and Sandra Carmona Torres, BSN (K2 Medical Research) join the podcast to discuss the lessons learned through implementing their pilot projects so far. They dive deeper into how sites can address barriers to participation, the need for consistent investment in building trust and engaging local community members, and the state of clinical research from a site perspective.

My guest today is Dinakar Singh. Dinakar is the founder and CEO of Axon, the family office successor to TPG-Axon, which was a successful global long-short hedge fund. We wanted to share his story on Father's Day to honor the person and the dad that Dinakar is. He shares one of the most extraordinary stories at the intersection of finance and medicine I've ever encountered. This conversation explores the highest-stakes investment themes—timing, concentrated conviction, exceptional team building, and deploying resources toward outcomes that matter most. I will let him tell you his story. Please enjoy my conversation with Dinakar Singh.  For the full show notes, transcript, and links to mentioned content, check out the episode page⁠⁠⁠ here.⁠⁠⁠ ----- This episode is brought to you by⁠⁠⁠ Ramp⁠⁠⁠. Ramp's mission is to help companies manage their spend in a way that reduces expenses and frees up time for teams to work on more valuable projects. Go to⁠⁠⁠ Ramp.com/invest⁠⁠⁠ to sign up for free and get a $250 welcome bonus. – This episode is brought to you by⁠⁠⁠ Ridgeline⁠⁠⁠. Ridgeline has built a complete, real-time, modern operating system for investment managers. It handles trading, portfolio management, compliance, customer reporting, and much more through an all-in-one real-time cloud platform. Head to⁠⁠⁠ ridgelineapps.com⁠⁠⁠ to learn more about the platform. – This episode is brought to you by⁠⁠⁠ AlphaSense⁠⁠⁠. AlphaSense has completely transformed the research process with cutting-edge AI technology and a vast collection of top-tier, reliable business content. Invest Like the Best listeners can get a free trial now at⁠⁠⁠ Alpha-Sense.com/Invest⁠⁠⁠ and experience firsthand how AlphaSense and Tegus help you make smarter decisions faster. ----- Editing and post-production work for this episode was provided by The Podcast Consultant (⁠⁠⁠https://thepodcastconsultant.com⁠⁠⁠). Show Notes: (00:00:00) Welcome to Invest Like the Best (00:06:17) The Diagnosis and Initial Reactions (00:07:29) Understanding SMA and the Scientific Challenge (00:09:15) The Drive to Fund Research and Find a Cure (00:14:10) Building a Virtual Company for Drug Development (00:19:02) Breakthroughs and the First Approved Drugs (00:24:16) Personal Reflections and the Impact of the Journey (00:40:25) Challenges in the Biotech Industry and Future Hopes (00:46:43) The Kindest Thing Anyone Has Ever Done For Dinakar

"It was pretty apparent to me that something was going on with him," says Kristi Levine, describing the realization that, based on her experience as a Montessori teacher, her infant son, Trey, was missing developmental milestones. Unfortunately, Kristi's hunch turned out to be correct and Trey was later diagnosed with a rare genetic mutation called CACNA1A which is impacting his motor skills, balance, coordination and speech. Kristi and her husband, Eric, join host Michael Carrese on this installment in our Year of the Zebraseries to help us understand the disorder and its implications for Trey and their family, which includes Trey's older sister Stella.  “There's a lot of guilt involved in being a parent of a child who has a disability because you never feel like you're doing enough,” shares Eric, even though they both work full time and have becoming experts at juggling work, caregiving, advocating, and volunteering with the CACNA1A Foundation. In this candid interview, Eric and Kristi discuss the challenges of parenting a child with complex medical needs, the importance of community support, the ongoing search for treatment options, and share some advice for clinicians caring for patients and families living with rare disorders. “We just want medical professionals to respect and understand what we're dealing with on a day-to-day basis and to see our kids holistically, and not just try to fix the problem medically. Understand that for us, the biggest thing that we want for our kids is just their quality of life.”Mentioned in this episode:CACNA1A Foundation If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) join the podcast to discuss how artificial intelligence is transforming today's clinical operations. They dive deeper into how AI can be used to improve protocol design, drive efficiency in localization processes, and modernize clinical operations to expand access to trials and get treatments to patients sooner. 

Today's guest is Damion Nero, Head of Data Science at Takeda Pharmaceuticals. With over 15 years of experience applying AI, machine learning, and real-world data to drug development and precision medicine, Damion joins Emerj Managing Editor Matthew DeMello to explore the evolving role of AI in drug development and supply chain management. He breaks down how AI is currently streamlining administrative and regulatory tasks, improving efficiency across clinical trials, and saving valuable time for healthcare professionals. Damion also discusses why broader, transformative supply chain efficiencies are still on the horizon, as AI continues to evolve and scale in the pharmaceutical industry. This episode is sponsored by Arkestro. Learn more about Arkestro's upcoming Advisory Council event here. Find out more about sponsored content and how to engage with the Emerj audience at emerj.com/ad1.

The Children's Tumor Foundation has been effective in working with drug developers to advance new therapies for neurofibromatosis, a group of rare, genetic conditions that cause tumors to grow on nerves throughout the body. Part of its success has been its ability to get biopharmaceutical companies to reposition assets once in development for other conditions as potential treatments for neurofibromatosis. We spoke to Annette Bakker, CEO of the Children's Tumor Foundation, about the complexities of neurofibromatosis, the foundation's role in advancing research and drug development, and what other patient organizations can learn from its strategic approach.

Rafael Fonseca is a distinguished Haematologist at Mayo Clinic, specialising in multiple myeloma and related plasma cell disorders. He earned his medical degree at Universidad Anáhuac in Mexico, and went on to complete his residency in Internal Medicine at the University of Miami, Florida, USA followed by a Hematology and Oncology fellowship at Mayo Clinic in Rochester, Minnesota, USA.     Timestamps  01:44 – Quickfire questions  07:25 – CAR-T cell therapy  10:48 – Anti-CD38 antibodies  13:31 – Minimal residual disease  14:30 – Bispecific antibodies  15:31 – Antibody-drug conjugates  19:04 – ASCO 2025  21:24 – Genetic discoveries  26:28 – Fonseca's three wishes 

What happens when cutting-edge science meets compassion? In this episode of Sounds of Science, host Mary Parker sits down with two pioneers reshaping the future of research: Elizabeth Nunamaker, Executive Director of Global Animal Welfare and Training at Charles River, and Dr. Megan LaFollette, Executive Director of the 3Rs Collaborative. From digital biomarkers to environmental health monitoring, they reveal how innovation and collaboration are redefining what's possible in animal welfare — and raising the bar for ethical, high-quality research. Tune in to explore the tools, strategies, and bold ideas driving meaningful change across the scientific community.Show NotesAdvancing Alternatives | Charles RiverEvolving Animal Welfare: Science, Ethics, and Innovation | Sounds of Science Can You Practice High-quality Science and 3Rs? | Eureka BlogAnimals in Research | Charles RiverResearch Models & Services | Charles River

In the latest collaboration between ACRO and TransCelerate BioPharma, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week's episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. They dive deeper into their experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance. FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/ 

We have a special guest on today's episode whose voice will be familiar to regular listeners. Last year at this time, Dr. Raven Baxter occupied the Raise the Line host chair for a special ten-part series we produced in collaboration with the Cohen Center for Recovery from Complex Chronic Illness (CoRe) at Mount Sinai in New York City, where she serves as the Director of Science Communication. The series explored the latest understandings of post-acute infection syndromes -- such as Chronic Lyme and Long COVID -- with an array of experts from the Center and other researchers and providers. In this episode, we check-in with Dr. Baxter to get an update on the work of the Cohen Center, especially with regard to its mission to educate providers. “We're building programs so that clinicians can earn credit for learning about chronic illnesses that are infection associated, and we've also developed a 200-page provider manual. I really think that we will be able to shift the narrative that currently exists,” Dr. Baxter tells host Michael Carrese. That narrative includes lingering skepticism among providers of some infection-associated illnesses, which Dr. Baxter witnessed herself as a Long COVID patient, an experience that has added meaningful perspective to her work. Dr. Baxter is also working on her own time to advance knowledge and combat misinformation through a robust social media presence as “The Science Maven” and helps other scientists and clinicians to do the same. "If we're not there to fill in that void, other people will fill it for us and the narrative may not be consistent with the truth or facts." This is a great opportunity to learn about the art and science of communications that can reach clinicians and patients alike.Mentioned in this episode:Cohen Center for Recovery from Complex Chronic IllnessThe Science Maven If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, Dr Neil Fish and Dr Ami Patel dive into the real-world challenges of drug development - from early-stage planning to regulatory hurdles and everything in between. Drawing on decades of experience, they share personal stories and expert insights that reveal why a solid strategy and the ability to pivot are essential for success. They explore the value of strategic flexibility, the importance of engaging with regulators early, and how to approach patent protection and manufacturing for advanced therapies. Whether you're preparing an IND or planning scale-up, this episode delivers clear, actionable guidance grounded in industry know-how. A must-listen for biotech teams, clinical leads, and anyone involved in the drug development process.

In December 2017, the FDA approved a new injectable drug to treat type 2 diabetes called semaglutide, which you likely know by its brand name: Ozempic. A few years later, during the pandemic, Wegovy, a drug with a higher dose of the same active ingredient, was approved specifically for chronic weight management. Soon after, people taking Ozempic started reporting a dramatic, even “life-changing” weight loss. Ozempic is now a bona fide blockbuster. So what's the science behind these “wonder drugs” that apparently 1 in 10 of us could end up using? They have the potential to have so many positive effects on our lives, from treating Alzheimer's disease and addiction to changing our relationship with consumption but, like with most things, they also come with risks.Send us your science facts, news, or other stories for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode. And, while you're at it, subscribe to our newsletter!Links to the Tiny Show and Tell stories are here and here. All Tiny Matters transcripts and references are available here.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In this webinar, CRO regulatory leaders will summarize the collective experience of the biotech companies we've spoken to recently. We will explore: • The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities. • Trends we're observing from biotech sponsors on the decision of whether or not to keep trials in the US. • The broader implications for industry investment, pipeline prioritization strategies, and international responses. This episode is part 1 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we'll continue exploring the key forces shaping the future of clinical trials.

Malaikannan Sankarasubbu (Chief Technology & AI Officer, Saama) and Jonathan Shough (Chief Information Officer, Parexel) join this week's episode to discuss how the strategic use of AI technologies is transforming clinical development. They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

In this episode of The Clinical Research Coach, host Leanne Woehlke sits down with trailblazer Nasha Fitter—tech entrepreneur, rare disease advocate, and co-founder of both the FOXG1 Research Foundation and Citizen Health.After Nasha's daughter was diagnosed with FOXG1 syndrome, an ultra-rare neurological disorder, her world shifted. Instead of accepting the limitations of the current research landscape, she took action- building a foundation, galvanizing the scientific community, and redefining what's possible for families facing rare disease.What began as a grassroots foundation now drives innovative drug development, redefines data collection, and challenges the status quo in drug development.In this conversation, Nasha shares:How a small, determined parent community raised $10M and launched a gene therapy programWhy traditional research models fail rare disease patients—and how to fix themThe power of patient-owned data and how platforms like Citizen Health are transforming access and insightsHow to build empathy for families navigating special needsWhat pharma gets wrong (and right) in working with advocacy groupsHer vision for a precision medicine future—starting with ultra-rareThis is a story about courage, creativity, and a more inclusive, patient-driven future of medicine. Nasha's bold vision and action oriented approach will leave you inspired and hopeful.To Find Out More:Nasha Fitterhttps://www.linkedin.com/in/nashafitter/FOXG1 Research Foundation: https://www.foxg1research.org/Citizen Health:https://www.citizen.health/

Dr. Doug Thamm discusses the development and use of Tanovea, a drug for treating lymphoma in dogs. He explains the drug's origins, initially researched as a human cancer therapeutic in collaboration with Gilead Sciences, and its transition to veterinary use.   Dr. Thamm provides insights into Tanovea's application, dosage, and effectiveness compared to the CHOP protocol, as well as its potential side effects and other possible uses in different cancer types like multiple myeloma. The episode also delves into related immunotherapy research and personal reflections from Dr. Thamm, a double cancer survivor, on his career choice in veterinary oncology. Your Voice Matters!   If you have a question for our team, or if you want to share your own hopeful dog cancer story, we want to hear from you! Go to https://www.dogcancer.com/ask to submit your question or story, or call our Listener Line at +1 808-868-3200 to leave a question. Related Videos:  https://www.youtube.com/watch?v=G0iRyKshzq8  Related Links:  Our article on lymphoma: https://www.dogcancer.com/articles/types-of-dog-cancer/lymphoma-in-dogs/  Our article on Tanovea: https://www.dogcancer.com/articles/drugs/tanovea-rabacfosadine-chemotherapy/  Get the facts on dog cancer remission: https://www.dogcancer.com/articles/stats-and-facts/dog-cancer-remission/  Chapters:  00:00 Introduction  00:13 Interview with Dr. Doug Thamm  00:26 The Early Involvement with Tanovea  00:41 Challenges and Discoveries in Drug Development  02:16 Transition from Human to Veterinary Use  02:48 Clinical Trials and Dosage Experiments  06:45 FDA Approval and Practical Use  08:05 Comparing Tanovea and CHOP Protocol  15:23 Exploring Alternative Treatments: Laverdia  18:43 Off-Label Uses and Future Research  23:46 Exploring Tanovea's Effectiveness in Blood Cancers  25:14 Cost Comparison: Tanovea vs. CHOP  26:15 Side Effects of Tanovea  28:47 Pulmonary Fibrosis and Breed-Specific Risks  32:52 Personal Cancer Journeys: Dr. Doug and His Wife  38:23 Debunking Myths About Dog Cancer Treatment  42:24 The Future of Cancer Treatment: Immunotherapy  45:23 Conclusion and Resources    Get to know Dr. Doug Thamm: https://www.dogcancer.com/people/doug-Thammm-v-m-d-diplomate-acvim-oncology/   For more details, articles, podcast episodes, and quality education, go to the episode page: https://www.dogcancer.com/podcast/   Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of Idea Collider, we sit down with Susan Galbraith from AstraZeneca, a leading figure in oncology R&D. Susan shares her journey from medical training in Manchester and Cambridge to spearheading transformative cancer treatments at AstraZeneca. She discusses pivotal moments in her career, AstraZeneca's vision for eliminating cancer as a cause of death, the role of patient stories in motivating R&D efforts, and the integration of emerging technologies like AI and digital health tools.  With a focus on collaboration and continuous learning, Susan provides insights into how successful oncology drugs are developed and the importance of equitable representation in clinical trials. Stay tuned for an engaging conversation that highlights the future of personalized cancer therapies and the collaborative efforts driving innovations in oncology.Chapter Summaries;00:00 Introduction and Guest Welcome00:27 Susan Galbraith's Career Journey02:37 Defining Success in Oncology R&D05:01 Early Phase Drug Development07:09 Digital Health and Patient Experience12:37 Global Collaboration and Innovation15:05 AI and Future of Oncology28:08 Diversity and Inclusion in Clinical Trials33:46 Mentorship and Career Advice37:45 Challenges and Future Outlook in Oncology42:06 Closing Remarks and Call to Action Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Susan Gabraith;LinkedIn: https://www.linkedin.com/in/susan-galbraith-584a195/?originalSubdomain=uk Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

On this episode, Tania Simoncelli (Vice President, Translational Impact and Engagement, Chan Zuckerberg Initiative) and Nasha Fitter (Co-founder & CBO, Citizen Health and Co-founder & CEO, FOXG1 Research Foundation) join forces to discuss how rare disease patient advocacy has transformed over time and how the biopharmaceutical industry should adapt to better meet the needs of today's patients. They dive deeper into the evolution of rare disease patient advocacy groups, why industry must move beyond the hyperfocus on “blockbuster drugs” to make progress in rare disease research, and how advancements in rare disease treatments can benefit the clinical research ecosystem for all.

Analyzing Trump's plan to roll back soaring drug prices for Americans; Sports bras eliminate bounce but may take a toll on women's backs; RFK Jr. targets the chemicals in our food; Do Americans really eat more animal protein than any other of the world's nations? Causes and treatments for pulmonary hypertension.

Stéphane Budel, founding partner at DeciBio, joins the Talking Precision Medicine Podcast to explore the future of the field. He unpacks how liquid biopsy, multi-omics, and AI are opening new doors for personalized care, why the diagnostics business model is holding innovation back, and what it will take to make complex tech usable for clinicians and patients alike.⁠TPM E46 highlights >⁠⁠⁠⁠⁠⁠⁠⁠Episode 46 links:DeciBioStephane Budel on LinkedInDeciBio's White Paper on AI in Drug Development (with contributions from Rafael Rosengarten)

Episode 57 of the Ask AI podcast features a conversation with Eric Sigel, a data scientist and biotech innovator with over 20 years of experience.The discussion delves into how artificial intelligence is reshaping the future of scientific research, particularly in drug discovery, but not always at the expected pace or in anticipated ways. Eric shares insights from his work at X-Chem, where he developed the scientific computing and data science infrastructure for their DNA-Encoded Library platform, and at ZebiAI, a spin-off company that applied machine learning to DEL technology and was acquired by Relay Therapeutics. The episode explores the challenges of integrating AI into laboratory workflows, the bottlenecks that persist despite technological advancements, and the evolving skill sets required for scientists to keep pace with AI's rapid evolution. For more details, please visit the episode post.ABOUT ASK AI PODCASTAsk AI is an independent nonprofit that collaborates with volunteers, industry experts, and AI innovators to share free content and resources that help people spot the opportunities and navigate the challenges associated with the increased adoption of artificial intelligence at work. Visit: askai.org

On this episode of “Raise the Line” we welcome Dr. Sheldon Fields, a trailblazer in the nursing field and the president of the National Black Nurses Association. In a candid conversation, Dr. Fields shares his inspiring journey from the bedside to becoming a prominent figure in nursing, HIV/AIDS prevention and academia and also shares the challenges he faced as a Black man in a predominantly white and female field. "I fell in love with a profession that has not always loved me back," he tells host Kelsey Lafayette. Dr. Fields brings over thirty years of experience as an educator, researcher, clinician, administrator, consultant, health policy specialist, and entrepreneur to his current role at NBNA, and as the inaugural associate dean for equity and inclusion at the College of Nursing at Penn State University, where he also serves as a research professor. Listeners will find Dr. Fields' insights on navigating a career in healthcare particularly valuable, as he stresses the importance of resilience, continuing education, and mentorship. It's a compelling listen for anyone interested in the intersection of health, policy, and social justice.Mentioned in this episode:National Black Nurses Association If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

Over the last 200 years or so, vaccines have come a long way, for a number of viruses. We've made so much progress, in fact, that in 2017 scientists began the early stages of vaccine development for some virus families they believed could pose a future pandemic threat. One of those families was Coronaviridae: coronaviruses. Not many people know that before SARS-CoV-2 started making its way into people in 2019, there was already a project underway in the U.S. to create a vaccine for a looming coronavirus (we didn't!), but even that would not have been possible without the decades of vaccine and drug research that came before it, particularly for HIV. Send us your science facts, news, or other stories for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode. And, while you're at it, subscribe to our newsletter!Link to the Tiny Show & Tell stories are here and here. All Tiny Matters transcripts and references are available here.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this episode, Logan is joined by Zach Weinberg (Co-Founder/CEO @ Curie.Bio) and Derek Thompson (writer at The Atlantic) for a candid discussion on the state of U.S. healthcare and scientific progress. They unpack what went right, and wrong, with COVID vaccine policy, the public backlash against mRNA technology, and the ripple effects on trust in science. The conversation also dives into the real reasons behind NIH budget cuts, the economics of drug discovery, and the business incentives in medical R&D. It's a sharp, thought-provoking look at the intersection of policy, innovation, and public perception. (00:00) Introduction to Drug Pricing in the US (00:23) Broad Healthcare Topics and Open-Ended Discussion (02:37) COVID-19 Vaccines: Successes and Public Perception (06:21) The Evolution of COVID-19 and Vaccine Efficacy (07:59) Public Policy and Vaccine Mandates (13:10) Impact of School Closures and Public Sentiment (19:23) NIH Funding and the Importance of Basic Research (25:04) Challenges in Science Funding and Public Perception (35:19) Government vs. Private Investment in Science (36:40) Operation Warp Speed: A Case Study (39:07) Antibiotic Resistance Crisis (43:22) The Drug Pricing Debate (44:05) Challenges in Drug Discovery (54:06) Regulatory Hurdles in Medical R&D (58:06) The Future of Drug Development (01:04:19) Concluding Thoughts Executive Producer: Rashad Assir Producer: Leah Clapper Mixing and editing: Justin Hrabovsky Check out Unsupervised Learning, Redpoint's AI Podcast: https://www.youtube.com/@UCUl-s_Vp-Kkk_XVyDylNwLA

Today's guest is Patricio La Rosa, Head of End-to-End Decision Science at Seed Production Innovation in Bayer Crop Science. With over 20 years of experience developing AI and data science solutions across healthcare and agriculture, Patricio joins Emerj Managing Editor Matthew DeMello to explore how machine learning can drive better outcomes across the drug development lifecycle, from research design to clinical deployment. Patricio discusses how AI is optimizing early trial planning, improving participant engagement, and supporting ethical, human-centered decisions at scale. Drawing lessons from both agriculture and life sciences, he emphasizes the importance of connecting technical models with real-world workflows. The conversation also delves into key barriers to AI adoption in clinical settings, including behavioral friction, model transparency, and challenges in orchestrating decision-making across global teams. Patricio offers a grounded perspective on what it takes to move from experimentation to enterprise impact in AI-driven R&D. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on Emerj's flagship ‘AI in Business' podcast!

What does clinical trial monitoring have in common with growing a field of corn? Amy Kroeplin (PPD™ clinical research business of Thermo Fisher Scientific), Shailesh Madel (ICON plc), and Nicole Stansbury (Premier Research) join the podcast to discuss the importance of risk-based quality management, centralized monitoring, and strategic SDV/SDR sampling strategies. They dive deeper into the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

On this week's episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better prepare our AI models and other technologies to meet the needs of patients in the present and future. They dive deeper into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO's ongoing efforts to promote the responsible use of AI in clinical research.

We're honored to continue our global tour of medical education today with Professor Katarzyna Taran, MD, PhD, a pioneering interdisciplinary researcher of tumor cell biology, an award winning educator noted for her focus on student engagement, and -- in a first for a Raise the Line guest -- a shooting sports certified coach and referee. As Professor Taran explains to host Michael Carrese, these seemingly disparate professional activities require the same underlying attributes: patience, the ability to overcome barriers, openness and adaptation. She believes those last qualities are especially important for today's medical students to acquire given the accelerated pace of change in healthcare. “They need to be equipped with the ability for critical thinking, to analyze and synthesize, and to search for unconventional solutions.” Professor Taran tries to impart these skills, in addition to the medical and scientific knowledge students must know, through a high level of engagement. “Teaching is relational, so try to be familiar with students' concerns. Talk to them, listen to them and you will become someone they trust.” In this wide-ranging and engaging conversation, Professor Taran also discusses her work as the head of the Laboratory of Isotopic Fractionation in Pathological Processes in Chair of Oncology, the use of neurodidactics in teaching, and the connection between the science of pathology and the future of humans in space. Mentioned in this episode:Medical University of Lodz If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

It can take up to 15 years for a new drug to reach the market, and with only 20% of pharmaceutical professionals adopting AI, one thing is clear: innovation in drug development is lagging behind. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Andrew Stelzer, head of business development at Unlearn.AI, about how the real hurdle in clinical research lies in effectively integrating AI. Stelzer discusses the need for greater coordination within the pharmaceutical industry, particularly between life sciences and software engineering and explains how bridging the cultural divide can significantly enhance the adoption of emerging technologies like AI. Of course, the conversation also touches upon the importance of collaboration, which can positively empower pharmaceutical companies to overcome existing challenges and drive significant advancements in drug development. You can listen to episode 176a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Amazon Music, Podbean, and pretty much wherever you get your other podcasts!

On this week's episode, host Sophia McLeod is joined by Danilo Branco (Associate Director, Risk Based Quality Management Lead, BeOne Medicines) and Amanda Coogan (Associate Director, Customer Experience, Remarque Systems) to discuss the value of centralized monitoring implementation by sharing case studies from today's clinical trials. They dive deeper into how centralized monitoring can help detect adverse events more quickly and identify underreporting, the benefits of holistically monitoring trial data using centralized monitoring, and how a targeted SDV/SDR sampling strategy can help organizations to conserve resources while maintaining quality and safety.

In the latest episode of Let's Talk Rare, Owen Bryant & Georgie Rack delve into the world of drug development in rare diseases.They are joined by the brilliant Rob Freishtat, president of Uncommon Cures. Rob brings unique insights on who the key stakeholder are in developing drugs and the many ways that we can bring them together in order to improve and enhance the delivery of much-needed therapies.

00:00:00 Surf's Up, Season 6, Episode 6.On April 23, 2024, our colleague and co-founder, Stephen Harrison, passed away suddenly. This week, Surfing the MASH Tsunami remembers Stephen with two of his closest associates and continues our annual MASH Drug Development roundtable held in his honor. 00:00:04:24 - A Deep Dive into Drug Development, Part 2The second portion of the Drug Development roundtable primarily focuses on three key issues. The first, uptake of resmetirom, starts with Naim Alkhouri discussing his experience in the Arizona Liver Health Clinics with over 650 patients in the year since resmetirom was approved and shifts to the various European panelists (Jörn Schattenberg, Louise Campbell and Sven Francque) estimating when it might be approved in their countries and how widely it might be reimbursed.  The second topic, incretin agonists, focuses on exciting prospects for other incretin agonists in development, as well as some semaglutide combination therapies. The third, NIT clinical trials, covers prospects that non-biopsy clinical trials might be approved sometime in the near future.00:16:20 - Remembering Stephen Harrison I: An Interview with Summit Clinical Research CEO Gail HinksonSummit CEO Gail Hinkson joins Roger Green for the first time on SurfingMASH to discuss her business partner. Gail discusses how the two originally formed Pinnacle Clinical Research and how Pinnacle led to Summit. She proceeds to discuss the current size and reach of both Pinnacle and Summit. Focusing on Summit, Gail describes the company as an Integrated Research Organization (IRO), highlighting its distinct role within the MASH firmament. In the final section of the interview, Gail discusses how Stephen's personality, goals, and vision continue to live on at Summit today.00:34:31 - Remembering Stephen Harrison II: An Interview with Naim Alkhouri Announcing That He Is Joining SummitNewly announced Summit Chief Academic Officer Naim Alkhouri joins this episode for a second time, but in a very different role. Naim discusses his personal history with Stephen and what he loved and respected about his "dear friend." He then makes a major announcement: he is joining Summit as Chief Academic Officer. He shares the many elements of this role, particularly his excitement that Summit can become the entity that educates a wide range of healthcare and commercial professionals on what MASH is and how it is treated. The scope of this vision, combined with what Gail discussed, portrays a level of energy, ambition and vision worthy of Stephen Harrison.00:55:55 - ConclusionAs part of this memorial week, Roger Green forgoes the usual business report, which will return next week.

ACRO's Good Clinical Podcast is back for season 3! To kick off the season, host Sophia McLeod is joined by Clare Campbell-Cooper (Global Head, Digital Health and Innovation, Fortrea) and Michael J. Cohen (Sr. Director, Lead, Environmental Sustainability, PPD™ clinical research business of Thermo Fisher Scientific) to discuss the continued evolution of environmental sustainability in clinical research. They dive deeper into how the clinical research industry can use renewable energy to help meet environmental goals, the importance of promoting more environmentally sustainable shipping and logistics practices, and how our industry can decentralize trial elements responsibly to minimize the environmental impact of the clinical supply chain.

This conversation is the opening segment of SurfingMASH's April discussion, in memory of Stephen A. Harrison, on drug development. In addition to co-hosts Jörn Schattenberg, Louise Campbell and Roger Green, panelists include hepatologists and key opinion leaders Sven Francque and Naim Alkhouri. This opening discussion focuses on exciting advances in one drug class (FGF-21s) and, more broadly, on exploring ways to treat cirrhosis. As Naim points out in his opening comment, these two issues— cirrhosis as a challenge and FGF-21s as a possible solution path —intersect in clear and exciting ways. He notes that the FGF-21 efruxifermin has been reported to have significant improvement in patients with cirrhosis, while the FGF-21 pegozafermin has shared positive results in a small cohort of patients. He also notes that a third FGF-21, efimosfermin alfa, has results in advanced non-cirrhotic MASH that suggest potential for similar efficacy in patients with cirrhosis, but this must be studied and confirmed in clinical trials. He mentions that resmetirom may also be showing signs of efficacy in some patients with cirrhosis. The entire package, he says, is a "game changer."Jörn notes that we are having parallel advances in treatment for advanced, non-cirrhotic patients. Sven concurs and comments that we are seeing effects that are not strictly related to metabolic disease. There is exceptional power that we can demonstrate one-level regression in sicker patients. The three agree that, at the same time, we are seeing cirrhosis trials that will lead to outcomes data; outcomes trials in non-cirrhotic medications may not be far away.Roger asks whether we are making progress in treating patients living with decompensated cirrhosis. Sven discusses what we are learning about treating portal hypertension, which is an important benefit unrelated to fibrosis regression. Simply improving portal hypertension will have an impact on endpoints. Naim points out that some ongoing trials include patients with cirrhosis, including survodutide and belapectin. Louise notes it will require "great P.R." to reverse some of the current perceptions about cirrhosis, but that this is "great." Naim states that even today, we have "a lot to offer" patients with portal hypertension or other symptoms of decompensation. As he concludes, he notes that this is underappreciated today. 

Part 2 of our series dives deeper into the explosion of ADC clinical drug development in China

00:00:00 - Surf's Up: Season 6 Episode 5Host Roger Green briefly describes this episode's three sections and introduces Roundtable guests. The Roundtable panel shares groundbreakers. 00:10:39 - Roundtable: A Deep Dive Into Drug Development, Part OneThe opening portion of this month's roundtable centers around two issues: exciting data for FGF-21s and, more generally, treating patients with cirrhosis. Naim Alkhouri sets the tone in his opening comments, which start by focusing on the exciting SYMMETRY data from efruxifermin and then hones in on FGF-21s and resmetirom in cirrhosis. The rest of the conversation features Jörh Schattenberg, Sven Francque and Naim discussing therapies in development for compensated and decompensating cirrhosis.00;24:44 - Newsmaker: Naga Chalasani on Real-World Experience Prescribing ResmetiromNaga joins Roger to discuss the paper Early Experience with resmetirom to treat Metabolic Dysfunction-Associated Steatohepatitis With Fibrosis in a Real-World Setting from his group at Indiana University, which his group authored and Hepatology Communications recently posted. The paper, based on IU Health's experience with its first 113 resmetirom patients, shares the group's practical experience developing processes to work closely with the specialty pharmacies dispensing resmetirom and, finally, concludes that a more engaged patient management strategy might reduce drug discontinuation to a level comparable with clinical trials.  00:47:21 - Expert: Scott Friedman on Gene Therapy, Diversity of Stellate Cell Types, Other Basic Liver ScienceScott and Roger cover a range of basis science topics in a fast-moving 19-minute discussion. It starts with Scott discussing the increasing acceptance that gene therapy is an acceptable way to treat a range of liver diseases, many of which are orphan or ultra-orphan but, in fact, include potential gene therapies for non-cirrhotic MASH and MASH cirrhosis. He notes that in addition to classic gene therapy, which introduces protective gene variants into the systems of patients with the risky variants, gene therapy is now looking to introduce FGF-21 into patients through genetic modification. From there, the conversation covers CAR-T therapy, the increasing ability to identify many different types of stellate cells and the idea that the most effective therapy for eary fibrosis, advanced fibrosis and cirrhosis might require fundamentally different kinds of interventions. The two final elements are the idea that what we now call "MASH" may be several diseases with different etiologies with similar manifestations and a passionate call for all of us to support maintaining NIH funding in whatever ways we can.01:06:45 - Business ReportAs Roger copes with his laryngitis, AI voices deliver an abbreviated business report 

We like to think of Osmosis from Elsevier as a global community of millions of learners, connected by a desire to serve humanity and an inclination to use a diverse mix of educational resources to help them become excellent healthcare practitioners. On today's episode of Raise the Line, we're going to learn how Osmosis has created an opportunity for hundreds of those students from sixty countries to actually solidify those connections through the Osmosis Health Leadership Initiative (OHLI). Our guide to this effort is Osmosis Community Specialist Alfred Collins, who brings a keen interest in developing tech solutions to power the future of human communication to his work with OHLI.“Technology collapses barriers to communication and to understanding the nuances behind culture, behind global perspectives,” he tells host Lindsey Smith. One example he cites is how OHLI members learn about variations in the way different cultures approach collaboration, an important insight to gain as they head into team-based healthcare environments. OHLI members convene regularly over video sessions to hear from leaders in healthcare and learn about hosting successful on-campus events, among other enriching content.  They also have an opportunity to provide feedback on improving the Osmosis learning platform, and this year they're participating in a “hackathon” aimed at improving the future of healthcare. Tune in to find out more about what the OHLI program offers, how to apply, and how Alfred thinks virtual reality and AI technologies will impact the future of community building. Mentioned in this episode:Osmosis Health Leadership Initiative If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

The Future of AI in Pharma & Biotech Research #aiinbiotech #pharmaresearch #drugdiscovery AI is fundamentally changing the way biotech and pharmaceutical research happens. From analyzing vast datasets to accelerating drug discovery, AI-powered solutions are making labs smarter, faster, and more efficient. But how does it actually work? Please visit our website to get more information: https://swangroup.net/ In this episode, I sit with Liran Belenzon, CEO of BenchSci, to explore how AI reshapes pharmaceutical research. We discuss:✅ The biggest challenges of working with scientific data✅ Why big pharma companies prefer AI-powered platforms over in-house solutions✅ How multimodal AI enhances lab efficiency and accelerates drug developmentLiran also shares his journey from being an MBA student to leading a company that works with 12 of the world's top 20 pharma companies. If you're curious about the intersection of AI, biotech, and research, this episode is a must-watch. Let's talk about the future of AI in biotech. What excites you the most? Let me know in the comments. Links from this episode:✅ Get to know more about Liran Belenzon: https://www.linkedin.com/in/liranbelenzon ✅ Learn more about BenchSci: https://www.benchsci.com ✅ Follow BenchSci for updates on AI in biotech: https://ca.linkedin.com/company/benchsci 

Drs. Dingwei Ye and Yao Zhu from China join the show to talk about drug development in China amid the recent surge of GU clinical trials.

Send us a textOn this Monday Morning Minute, Dr. Michael Koren draws parallels between the NCAA Final Four basketball tournament and the clinical research process. He explains that in medicine, researchers start with literally 10,000 potential molecules, which get whittled down to only three or four medications to be tested in big, phase III clinical trials. This ensures that only the most promising medical technologies get approved, just like the most promising teams get to the National Championships.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

David Game remembers the days when the use of digital technology in education publishing amounted to putting a dictionary on a compact disc. Now, as the senior vice president of Product Management, Global Medical Education at Elsevier, he oversees a suite of learning materials that use artificial intelligence, virtual reality and 3-D modeling. “We've expanded into immersive technology with Apple Vision Pro that enables you to be inside the human body, to see and explore the human heart from the inside out and it is absolutely stunning,” says Game, whose long career in publishing includes experience in North America, the United Kingdom, Europe, China and India. As Game has witnessed first-hand, advancements in ed tech, including distance learning, have provided students with an array of options and modalities to choose from that accommodate different learning styles and life circumstances, and that puts a premium on being able to meet students where they are. “We want to make sure that students find learning from our materials engaging, efficient, and aligned with how they live their lives and do their work.” Join host Lindsey Smith for this fascinating episode of Raise the Line to learn how Elsevier is leveraging the innovations offered by Osmosis, Complete Anatomy and ClinicalKey Student to enrich the learning of medical students on their journey to becoming excellent clinicians.Mentioned in this Episode:Complete AnatomyClinicalKey StudentOsmosis If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

International markets have outperformed the U.S. in a big way this year, but will the trend continue into Q2? Where are out traders see the biggest global gains, and if they're betting on more divergence between the markets. Plus NIH funding cuts putting drug development on the chopping block. The names feeling the impact, and what's at stake in the pharma space.Fast Money Disclaimer