Podcasts about endpoints

Guests Dr. Andrea Necchi, Dr. Ashish Kamat and host Dr. Davide Soldato discuss JCO article "End Points for the Next-Generation Bladder-Sparing Perioperative Trials for Patients With Muscle-Invasive Bladder Cancer," focusing on the evolving treatment landscape of MIBC (muscle-invasive bladder cancer) and the need to properly design novel trials investigating non-operative management while including the incorporation of biomarkers and patient perspectives in clinical trials. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Davide Soldato: Hello and welcome to JCO After Hours, the podcast where we sit down with authors from some of the latest articles published in the Journal of Clinical Oncology. I am your host, Dr. Davide Soldato, medical oncologist at Ospedale San Martino in Genoa, Italy. Today we are joined by JCO authors Andrea Necchi, Associate Professor of Medical Oncology at University San Raffaele and Medical Oncology at Ospedale San Raffaele in Milan, Italy, and Ashish Kamat, Professor of Urologic Oncology and Cancer Research at University of Texas MD Anderson Cancer Center. Both Professor Necchi and Professor Kamat are internationally recognized experts in the field of genitourinary malignancy and particularly in bladder cancer. Today we will be discussing the article titled "Endpoints for the Next Generation Bladder-Sparing Perioperative Trials for Patients with Muscle-Invasive Bladder Cancer." So thank you for speaking with us, Professor Necchi and Professor Kamat. Dr. Andrea Necchi: Thank you, Davide, and thank you JCO for the opportunity. Dr. Ashish Kamat: Yeah, absolutely. It is a great honor and privilege to be discussing this very important article with you. So thank you for the invitation. Dr. Davide Soldato: The article that you just published in JCO reports the results of a consensus meeting that was held among experts in the field of genitourinary malignancy and particularly for bladder cancer. So the objective was really to define endpoints for a novel generation of trials among patients diagnosed with muscle-invasive bladder cancer. So my first question would be: what is the change in clinical practice and in clinical evidence that we have right now that prompted the start of such consensus in 2025? Dr. Andrea Necchi: So, we are living so many changes in the treatment paradigm of patients with muscle-invasive bladder cancer. In general, patients diagnosed with bladder cancer or urothelial cancer today, thanks to the advent of immunotherapy or immunotherapy combinations, and today thanks to the advent of novel antibody-drug conjugates like enfortumab vedotin in combination with immunotherapy that are actually changing the landscape of treatment of patients with metastatic disease and also are entering quite fast into the treatment paradigm of patients with organ-confined disease with a lot of clinical trials testing these combination therapies, neoadjuvantly or adjuvantly, before or after radical cystectomy. Having said that, by potentiating the efficacy of systemic therapy, an increasing number of patients that receive neoadjuvant therapy of any kind, at a certain point in time, result to have achieved a deep response to systemic therapy, evaluated radiologically with conventional imaging, CT scan or MRI, or with cystoscopy or with other urology-based techniques, urinary cytology, and so. And based on the fact that they achieve a complete response, so no residual viable disease after systemic therapy, they raise concern about the fact that they have to undergo surgery like radical cystectomy that is quite impactful for their quality of life and for the future of their lives after the surgery. So the point that the patients are raising, and the patients are raising this point, is primarily due to the efficacy of systemic therapy. And we have seen so many cases fortunately achieving a deep response. So the question about what to do with the patient that at a certain point, at the start with the commitment to radical cystectomy, but at a certain point in time change their mind towards something else if possible, depending on the fact that they have achieved a deep response, is something that is a question and is a need to which we have to provide data, information, and guidance in general to the patients. Dr. Davide Soldato: If we look at the population that the recommendations were formulated for, we are mainly speaking about patients who would be fit for cystectomy, and this is a very distinct population compared to those who are not fit for cystectomy, both from a medical oncology point of view but also from a urologic point of view in terms of surgery. So, can you explain a little bit to our listeners why you think that this distinction is critical and why you developed this recommendation especially for this population? Dr. Ashish Kamat: That is a very important distinction that you made. To build upon what Professor Necchi mentioned earlier, this question that we get from patients after neoadjuvant therapy or systemic therapy is not a new question. It has been something that they have been asking us for the last 20 or 30 years. "Do I really need to have my bladder taken out?" And patients who are especially not fit for surgery will sometimes say, "Do I need to have my bladder taken out? And if I cannot have my bladder taken out, am I going to just not have anything done?" Because the eligibility for radical cystectomy is also a moving target. Over the years with improvement in surgical technique, improvement in perioperative therapy, ERAS protocols, et cetera, it is really unusual for us to deny a patient the opportunity to have major surgery unless clearly they have very significant comorbid conditions. So I think this endeavor is more broadly encompassing of the patient population than what was evident in previous years. And I really want to give a shout out to Professor Necchi because what we did was, as part of the International Bladder Cancer Group and Professor Necchi is an integral part of the scientific advisory board, we broached this topic broadly during one of our discussions. And of course, Andrea always does this, he picks on a topic and then he says, "Okay, we need to discuss this really in detail," put together a multinational, multicenter collaborative group, but the driving force was our patients. Because our patients are constantly asking, "Do I need to lose my organ? Do I need to have radiation therapy?" which again, also, has a lot of side effects. So this was really to answer the question in today's day and age as to do we need to do local consolidation, and if so, in what way? It is not a new question, but we have newer therapies, newer technology, and better ways to answer this. So it is a much needed question that needs to be answered. And I think the distinction between non-surgical candidates and surgical candidates is a little bit blurred in today's day and age. Dr. Davide Soldato: What about the eligibility, for example, for cisplatin-based chemotherapy? Because I think that that is a very fundamental part of this type of strategy that we apply to patients with muscle-invasive bladder cancer. So we know that there are some caveats for proposing such treatment. And also this population was specifically defined inside this recommendation. Dr. Andrea Necchi: I think that the focus of our work is just to analyze what is happening after any type of systemic therapy the patient may get neoadjuvantly. So it is not actually a question of treatment eligibility or including cisplatin eligibility. This is an old question of today's practice and clinical trials. But regardless of what the patient received neoadjuvantly, the point that we have addressed in our consensus meeting was what to do next as a further step after systemic therapy or not. So basically we are- the consensus guidance includes all-comers, so patients to get any type of systemic therapy. So really non-selected based on specific features that determine a special eligibility to a special or a particular therapy. But an all-comer approach is always the winning approach for the translation to be in practice, an all-comer approach just focusing on what has happened after treatment and that we are assessing by the use of conventional imaging, MRI or CT, cystoscopy, urinary cytology, and trying to merge all together this information, all these features in a unique, shared, reliable definition of clinical complete response that could be used as a biomarker for the selection of newer therapies instead of pathological response that has been historically used, and maybe surrogate for the outcome, the long-term outcome and survival of these patients. Dr. Davide Soldato: A very specific point of the consensus was actually the definition of clinical complete response. As you were saying, this is actually a combination of several parameters including urinary cytology, the use of cross-sectional imaging, for example CT scan, but also the evaluation in cystoscopy of the bladder. Do you foresee any potential problems when applying this type of recommendation, not inside clinical trials, but in the context of routine clinical practice? Dr. Ashish Kamat: Absolutely. And that was the whole reason we had this consensus meeting. What happens nowadays in daily practice, and we see this every day at our center, we see patients referred to us. This definition or this sort of attempt to define clinical complete response is an ongoing issue. And urologists, medical oncologists, radiation oncologists are always looking to see, does my patient have a complete response? That definition and those paradigms have changed and evolved over the years. The FDA had a workshop many years ago looking at this very question. And it was to address the proposal that complete clinical response, which is a clinical definition, a clinical state, does this correlate with pathologic response? And with the technology and the systemic therapies we had then, the answer was 'no'. In fact, more patients got recurrent disease than did not get recurrent disease. And that is why, of course in the paper we mention the trials that looked at this question, the trials that evolved around this question. And I think the distinction between a clinical trial and daily practice is extremely important when we are looking at this definition per se. Because essentially what happens with this issue is that if the patient is not appropriately counseled, and if the physician does not do the appropriate clinical complete response assessment as Professor Necchi mentioned, right, cystoscopy, cytology, imaging, use of markers that are still in evolvement, we risk doing harm to the patient. So we caution in the paper too that this definition is not ready for prime time use. It is something that needs to be studied. It is a rigorous definition and currently we are recommending it for clinical trials. I am sure eventually it will trickle down into clinical practice, but that guidance was not the purpose of this consensus meeting. Dr. Davide Soldato: There are several parameters that are potentially evolving and could potentially enter inside of clinical practice. For example, you mentioned pelvic MRI and we have now very specific criteria, the VI-RADS criteria, we're able actually to diagnose and also to provide information. So along with these novel imaging techniques, we also know that there are novel biomarkers that could be explored, for example ctDNA and urinary DNA. So what I was wondering is, why were not these included inside the definition that you provide for clinical complete response? And do you think that, as we are designing these trials to potentially spare cystectomy for this patient, we should include these biomarkers very early so that we can actually provide better stratification for our patients and really propose this type of cystectomy-sparing strategy only to those where we are very confident that we have obtained a clinical complete response? Dr. Andrea Necchi: I would say you have just to wait. So a follow-up is ongoing and hard work is ongoing. At the time we met, at the time we established the meeting in mid-December last year, we had no information on the ctDNA data from major trials, with only a few exceptions. So we were just at the beginning of a story that was more than likely to change but still without numbers and without data from clinical trials. Now in just nine months or 10 months time, we have accumulated important data and newer data will be presented during just a few weeks and a few days regarding the ctDNA, circulating tumor DNA in particular, as a prognostic marker assessed baseline or assessed after neoadjuvant therapy. So the point is certainly well made and ctDNA is certainly well shaped to be incorporated in a future definition of clinical complete response. But you have to consider the fact that most of the data that we are accumulating related to ctDNA are about the post-cystectomy field or the metastatic field. So regarding neoadjuvant therapy, you know, we have neoadjuvant therapy in the context of bladder-sparing approach, basically we have no information. And the point that is emerging in our daily practice when using these biomarkers or in clinical trials, and the impression in general, is that it is a very strong biomarker associated with survival, but we absolutely do not know what is the performance of the test in the prediction of superficial bladder relapses, high-grade pTa relapse in the bladder that is left untouched in the patient. We are considering, and maybe it will be just a matter of further discussion, not just what is happening within the immediate endpoint of clinical CR, but also what is happening later with other survival endpoints. And for example, when looking at the type of events that we may see in this kind of bladder-sparing approaches, most of the events, also in the trials that have been published including the RETAIN study published in JCO, most of the events are related to superficial high-grade superficial non-muscle invasive relapses. So the ability to predict these types of events with ctDNA is completely unknown. Maybe, maybe other liquid biomarkers like urinary tumor DNA, utDNA, could be a bit better shaped in the prediction of this kind of events, you know. But we have still to build the story. So the question is good. The answer is yes, we will likely, more than likely incorporate liquid biomarkers in the definition, but we have to wait at least more data and more robust data in order to translate this information in routine practice, you know. Another consensus meeting is organized by IBCG and the same folks for November. This meeting will be primarily focused on the liquid biomarkers, the interpretation and use and approval and so of liquid biomarkers including bladder cancer. And we will likely be able to address all these, most of these open issues, so most of these points in the next meetings. Dr. Davide Soldato: In the consensus you say that probably clinical complete response is now ready to be included in early phase trials, so actually to test what is the efficacy of the regimens that is being evaluated inside of these trials. But you actually do very in-depth work of defining what are the most appropriate endpoints for later phase trials. So to be very specific, the phase three registrational trials that bring new regimens inside of this space. So I just wanted to hear a little bit about what was the definition for event-free survival, which you define as the most appropriate one for this type of trials. And as you were mentioning before, Professor Necchi, there is a very specific interest on the type of events that we observe, especially when we look at these superficial relapses inside of the bladder. So was this a very urgent matter of debate as we define which type of events should actually trigger event-free survival? And did you make a very thoughtful decision about why using this type of endpoint instead of others, for example metastasis-free survival? Dr. Ashish Kamat: Yeah, this was a matter of intense debate as you might imagine. And again, this is a moving target. So as Professor Necchi mentioned, we tend to partner with each other, our organizations, on having definitions of clinical complete response, biomarker, retreats, and then using that as a marker, and you might imagine this definition of what is appropriate event-free survival, what events matter to the patient, is something we have been talking about for two years. It was not just something that came up at the retreat. But at the retreat there was intense discussion. One of the things that we talked about was bladder-intact event-free survival because we are trying to spare the patient's bladder. And do we count bladder-intact event-free survival as something that is relevant? The patient advocates absolutely liked that, right? They wanted that. But then we also learned from some of the studies, for example from the RETAIN study, that the non-muscle invasive recurrences can actually lead to metastatic disease. It is not as benign when you have a patient with muscle-invasive bladder cancer that then develops a non-invasive tumor because maybe there is cancer growing underneath the surface that we don't detect when we look in the bladder. So a lot of those discussions were held, debated. It was a consensus. I have to say it was not 100% agreement on that particular definition, but it was broad consensus. And Andrea, do you want to clarify a little bit as to how we came about that consensus? Because I think this is a very important point we need to make. Dr. Andrea Necchi: We focused on a bit different definition of BI-EFS, Bladder-Intact Event-Free survival. Just stating EFS as an all-inclusive parameter including all type of high-grade relapse or progression or death that may happen to the patient. So that we were counting high-grade pTa, pT1, CIS relapses to the bladder and of course more deeper involvement in the muscle layer and so, and metastatic disease as a relapse. But the point is that as compared to the classical bladder-intact EFS definition of chemoradiation bladder-sparing approaches that is including muscle-invasive relapses only or death as events, we tried to be as inclusive as possible in order to be as much conservative as possible and to raise as higher the bar as possible for the success. And this is actually what the patients are asking us. So they are asking, "Okay, I can save my bladder, sparing radical cystectomy, but at which cost?" So in order to provide an answer, we have to be very, very cautious and be on the right shape, on the right position to say, "Okay, we have accomplished the most, the safest points, you know, by which you can proceed with the bladder-sparing." This is the first point. The other point is related to the MFS, metastasis-free survival that you have mentioned. For sure, it was recognized as a very important point for sure. But in the discussion was clear that our focus was in saving patients, curing the patient, and saving the bladder. Any single event, superficial event that may occur in the bladder-saving approaches of this kind may expose the patient to an extra risk of developing distant metastases, as it happened for example in the RETAIN study. So EFS defined as we have agreed and published, is actually a way of including or anticipating in a safest position the MFS. Because most or if not the entirety of the events of metastasis development in patients undergoing bladder-sparing after neoadjuvant systemic therapy were preceded by a superficial phase of disease relapse, you know. So I remember very, very few, or we can count just on the finger of one hand, the cases that have been reported in the literature developing de novo metastatic disease in the similar bladder-sparing approaches, in particular when using a maintenance immunotherapy strategy, you know, after they reach TURBT. So this is the reason why with all the limitation that Ashish has mentioned, with all the uncertainties that are still there, the nervousness that is still there, EFS, as defined in the protocol, as put in the paper, is to us at the moment is the safest way to use a primary endpoint in potentially registration trials of this kind with perioperative systemic therapy and response-adapted surgery. Dr. Ashish Kamat: And David, just to be absolutely clear for our listeners, right, so what was the event-free survival that we defined? Essentially it was a very inclusive definition. Event was defined as high-grade tumor persistence, recurrence, or progression during or after perioperative therapy, and receipt of any additional standard of care treatment including radical cystectomy, radiotherapy or even intravesical therapy. So this was done at the behest of our patient advocates because we really wanted to make a very robust definition that could be utilized appropriately as an adequate primary endpoint for both early and late phase bladder preservation trials. Dr. Davide Soldato: I think that it really highlights one of the points that I liked the most about this consensus is that it really incorporated the patient vision and a sort of shared decision making process when we are deciding how we want to design these trials that will explore this bladder-sparing surgery. And Professor Necchi mentioned something that I think will be also a very interesting question for trials that will be developed considering the activity of this combination that we are seeing right now, which is maintenance. Because right now our approach in the few cases where patients do not do any type of treatments after an induction with neoadjuvant treatments is basically represented by observation. So I was wondering if you think that the field will actually evolve to a sort of maintenance strategy even in patients that will achieve a complete clinical response? Dr. Andrea Necchi: We just mentioned briefly in the paper, this is a very important point that was touched during the discussion, and in particular was raised and discussed by FDA people participating in the meeting. And when looking at the data from the trials that were available and are still available thus far, we could provide a suggestion that maintenance immune therapy is the preferred approach in this kind of approach as it currently stands, as the data currently stand. Because the cleanest data towards the successful part of this journey is related to the studies that provided a kind of maintenance therapy, like the study with nivolumab or the RETAIN-2 study with maintenance immune therapy instead of RETAIN study that was just stopping treatment until surgery with MVAC chemotherapy. So in general the impression is that maintenance therapy may help in reducing the type of events, including the events that we incorporate in the EFS definition that we mentioned in the paper. The point that you mentioned is very important because on the other side we have a problem, a big problem of affordability and cost of the treatment. The de-escalation trials are an urgent need and represent a call for the studies. Unfortunately, as you mentioned, this is something that moves beyond the possibilities of this type of consensus because we don't have data and we have to accumulate data from clinical trials prior to saying, "Okay, certain patients could de-escalate therapy and stop therapy and some other not." So we are still at the very beginning. So we can do- we can discuss about this in the radical cystectomy paradigm but not in the bladder-sparing paradigm, you know. But this is for sure a point, a discussion point that will be taken, pretty well taken in one year or two year projection. Dr. Davide Soldato: I was wondering if in the consensus, considering that patient advocates and patient associations were also involved, did you decide to actually suggest the inclusion of patient-reported outcomes or the evaluation of shared decision-making in the development of this trial really as endpoints that should matter as much or as much as possible as event-free survival and clinical complete response? Dr. Ashish Kamat: Oh yeah, absolutely. We had patient advocates, we had the World Bladder Cancer Patient Coalition, Bladder Cancer Advocacy Network, patient representatives. And we always consider this. Shared decision-making is actually the impetus behind why these efforts have been launched, right? So it is the shared decision-making that is very, very important. It is the driving force behind what we do. And it is worth noting, for example, for the design of such studies, regulatory agencies consider response-based endpoints or overall survival as primary endpoints. But the patient advocates consider quality of life to be just as important, if not more important sometimes than overall survival numbers. Because patient advocates will say, "Well if I live longer but I'm miserable living longer, yes that works for regulatory agencies but doesn't work for us." So PROs clearly are very, very important. And, in fact, we just literally had a meeting in Houston, the IBCG meeting where PROs were a main point of what we discussed. So incorporating PROs in everything we do, not just this but everything we do, Dr. Necchi, myself, everybody involved in these fields realizes it is very, very important. So absolutely. Dr. Davide Soldato: I want to thank again Professor Necchi and Professor Kamat for joining us today. Dr. Andrea Necchi: Thank you. Dr. Ashish Kamat: It is our pleasure. Dr. Davide Soldato: Thanks again and we appreciate you sharing more on your JCO article titled "Endpoints for the Next Generation Bladder-Sparing Perioperative Trials for Patients with Muscle-Invasive Bladder Cancer." If you enjoy our show, please leave us a rating and review and be sure to come back for another episode. You can find all ASCO shows at asco.org/podcast. 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.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines: Steffen Thirstrup: Chief Medical Officer at European Medicines Agency. Richard Bergstrom: Head of Policy at IQVIA. They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments. Key Topics Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments. Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance. Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem. Key Topics: Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment. Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints. Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe. HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states. Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

Basada en inteligencia artificial que centraliza la telemetría de seguridad de endpoints, redes y entornos en la nube, GravityZone Security Data Lake de Bitdefender tiene como objetivo optimizar la detección de amenazas y reducir los costos de los sistemas tradicionales de gestión de eventos (SIEM).

In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions. They also explore evolving trial endpoints in oncology (including surrogate measures and ctDNA), transparency moves such as the public release of Complete Response Letters and the industry's reactions, updates on the National Priority Voucher Program, and the FDA Pre-Check initiative to boost domestic drug manufacturing. Tune in for an in-depth discussion offering timely updates and expert perspectives on what may be ahead for drug development stakeholders.

Apple @ Work is exclusively brought to you by Mosyle, the only Apple Unified Platform. Mosyle is the only solution that integrates in a single professional-grade platform all the solutions necessary to seamlessly and automatically deploy, manage & protect Apple devices at work. Over 45,000 organizations trust Mosyle to make millions of Apple devices work-ready with no effort and at an affordable cost. Request your EXTENDED TRIAL today and understand why Mosyle is everything you need to work with Apple. In this episode of Apple @ Work, Chris Chapman from MacStadium joins the show to discuss their recent CIO survey, which reveals that Apple now accounts for 63% of enterprise endpoints. Listen and subscribe Apple Podcasts Overcast Spotify Pocket Casts Castro RSS Listen to Past Episodes

The segment explores different endpoints of the Viking Age. 1066 AD is often cited, but this is Anglocentric. That year saw Harald Hardrada, King of Norway (whose claim descended from Cnut's North Sea Empire), killed by Harold Godwinson at the Battle of Stamford Bridge. Normans (Northmen) like William were culturally assimilated Vikings, meaning Vikings were effectively fighting Vikings. A later ending point is the 1263 AD Battle of Largs, a series of skirmishes between King Hákon of Norway and King Alexander III of Scotland over control of the Norse-inflected Western Isles. Hákon's subsequent death in Orkney led to Norwayrelinquishing the Isles to Scotland. 1893 

MD Anderson fellows discuss AML, MRD endpoints, and evolving trial strategies in a dynamic grand rounds–style presentation.

Nobody knows ALS better than people living with the disease. Therefore, it’s crucial for scientists to utilize the perspectives of people with lived experience in their research. Earlier this year, ALS TDI joined with Her ALS Story—a group of women diagnosed with ALS before the age of 35—to put on a series of Town Hall webinars that highlighted the importance of this connection. The three-part series featured discussions about ALS risk factors, lesser-known symptoms, and stories of diagnosis. In each session, researchers from ALS TDI’s ALS Research Collaborative, or ARC Study, presented information about our current scientific understanding of each topic, while Her ALS Story members shared their own personal experiences. Today, on Endpoints, we’ll hear some highlights from each episode of the series. We’ll also be joined by Dr. Danielle Boyce, ALS TDI’s Principal Investigator, Real World Evidence, and Alan Premasiri, our Director of Clinical Operations, to discuss what they learned from the discussions and how conversations like these can help shape the way they approach their research. If you'd like to learn more about ALS TDI's research and how we are incorporating lived experience to advance research, consider attending the ALS TDI Summit on October 17th, 2025 in Boston, MA or online. Register here: https://fundraise.als.net/alssummit/Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Jonathan Barratt, PhD, FRCP - The Nephrology Journal Club: B-Cell Modulators and eGFR Endpoints in IgA Nephropathy

Jonathan Barratt, PhD, FRCP - The Nephrology Journal Club: B-Cell Modulators and eGFR Endpoints in IgA Nephropathy

Jonathan Barratt, PhD, FRCP - The Nephrology Journal Club: B-Cell Modulators and eGFR Endpoints in IgA Nephropathy

Jonathan Barratt, PhD, FRCP - The Nephrology Journal Club: B-Cell Modulators and eGFR Endpoints in IgA Nephropathy

### About the episode:Join Nataraj as he interviews Matt DeBergalis, CEO of Apollo GraphQL, about the evolution of GraphQL from an open-source project to a product company. Matt shares insights on building and scaling APIs, the challenges of transitioning open-source tech into a viable business, and how AI is reshaping API development. Discover how Apollo is helping companies of all sizes leverage GraphQL to build agentic experiences and modernize their API strategies.### What you'll learn- Understand the journey of GraphQL from open source to a product-driven company.- Explore the challenges of adopting and scaling GraphQL in enterprise environments.- Discover how GraphQL simplifies complex data combinations with its declarative language.- Learn how Apollo GraphQL helps companies accelerate the development of robust APIs.- Examine the role of GraphQL in building modern agentic experiences powered by AI.- Understand how to balance short-term shipping pressures with long-term architectural considerations.- Identify when GraphQL makes sense for a company based on its API size and consumption needs.- Discover how AI is driving increased API consumption and transforming user interfaces.### About the Guest and Host:Guest Name: Matt DeBergalis is the Co-founder and CEO of Apollo GraphQL, previously CTO and Co-founder at Meteor Development Group.Connect with Guest:→ LinkedIn: https://www.linkedin.com/in/debergalis/→ Website: https://www.apollographql.com/Nataraj: Host of the Startup Project podcast, Senior PM at Azure & Investor.→ LinkedIn: https://www.linkedin.com/in/natarajsindam/→ Twitter: https://x.com/natarajsindam→ Substack: ⁠https://startupproject.substack.com/⁠→ Website: ⁠⁠⁠https://thestartupproject.io⁠⁠⁠### In this episode, we cover(00:01) Introduction to Matt DeBergalis and Apollo GraphQL(00:37) Matt's journey and the origins of Apollo GraphQL(03:24) The transition from open source to a company(05:02) GraphQL as a client-focused API technology(07:22) Meta's approach to open source technologies(10:11) Challenges of converting open source to a business(13:11) Balancing shipping speed with architectural considerations(15:52) The risk of adopting the wrong technology(19:13) The evolution of full-stack development(23:57) When does adopting GraphQL make sense?(26:45) Apollo's customer scale and focus(31:48) Acquiring customers and marketing to developers(33:52) Matt's transition from CTO to CEO(37:02) Apollo's sales motion and target audience(40:24) Matt's thoughts on AI and its impact(47:12) How AI is changing business metricsDon't forget to subscribe and leave us a review/comment on YouTube Apple Spotify or wherever you listen to podcasts.#GraphQL #ApolloGraphQL #API #OpenSource #Enterprise #AI #AgenticAI #APIDevelopment #Startup #Technology #SoftwareDevelopment #GraphQLAdoption #Kubernetes #React #FullStack #DataAnalytics #Innovation #DigitalTransformation #TechStrategy #Podcast

Brain-computer interfaces, or BCIs, aim to enable people to control various adaptive devices directly with their thoughts. There are many BCI devices currently in various stages of development, with the potential to help people with ALS and similar conditions across many different activities of daily life. One particular area in which BCI devices may be able to support people with advanced ALS symptoms is communication. Many people with ALS rely on devices such as smartphones, tablets, and laptops to write or speak. All tools like these, collectively known as augmentative and alternative communication or AAC devices, need some kind of input to work. This could mean using a keyboard, a touchscreen, or, for people with advanced paralysis, an eye-gaze device. As ALS progresses, however, even eye gaze devices may become difficult for some people to use. BCIs—by allowing people to control AAC devices with their minds—could be a potential solution to this problem. Today, on Endpoints, we’re joined by two experts to discuss BCI technology and, in particular, its potential to help people with ALS continue to communicate. The views expressed in this podcast are those of the speakers and do not represent official endorsements by any organization. Kate Nilsen currently serves as an advisor to Synchron, a company developing a brain-computer interface (BCI) device. This device is investigational and is currently in clinical trials approved by the U.S. Food and Drug Administration (FDA). For those interested in staying informed about Synchron’s ongoing work and updates, please join the Synchron community: https://link.edgepilot.com/s/4239f747/ca21cbCpKkOSLI5ZXNqTdQ?u=https://www.synchronbci.com/StayConnected.htmlSupport the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Maddie Regis speaks with Tom Bowyer, Director of Security at Automox, about the intersection of IT and cybersecurity. Tom shares his career journey, the importance of collaboration between IT and security teams, and insights into SOC compliance reports. He emphasizes the need for transparency, experimentation, and proactive problem-solving in enhancing cybersecurity. This episode originally aired October 17, 2024

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Arsalan Arif, founder of Endpoints News, for a wide-ranging conversation on the business of biotech. From his early days bootstrapping a media company to Endpoints' recent partnership with the Financial Times, Arsalan shares his journey and reflections on what it takes to build trust in an evolving industry.Together, they unpack today's cell and gene therapy landscape, where clinical success alone isn't enough. Arsalan offers his perspective on investor sentiment, why scaling remains the biggest challenge in CGT, and how economic models, not efficacy, will shape the next chapter of growth.Learn more about Arsalan: https://www.linkedin.com/in/arsalanarif/

Ashley sits down with Steve Engler from the Oklahoma Farm Bureau to explore his journey from taking apart his first computer to becoming a certified Automox expert and system admin.Stephen shares how he:Transitioned from the Air Force into ITUnlocked the full potential of Automox in a previously underused environmentBuilt a hands-on lab to test Linux and Windows automationEarned all three Automox University certificationsBecame a go-to expert through community collaboration and scriptingThis episode originally aired July 21, 2024

Merry Marwig is the VP Global Communications & Advocacy at Privacy4Cars. Merry is a pro-consumer, pro-business privacy advocate who is optimistic about what data privacy rights mean for everyday people — and for the companies they do business with. At Privacy4Cars, she helps protect drivers' and passengers' personal data while creating business opportunities for automotive companies. In this episode… Modern cars are like computers on wheels, collecting and storing data just like smartphones or laptops. Unlike those devices, however, vehicle data is often left unencrypted and persists long after a car is sold, rented, or reassigned. This is especially problematic for businesses that use corporate cars, rental vehicles, fleet vehicles, or personal vehicles for work purposes. Sensitive information such as contact lists, text messages, navigation history, and even security credentials can remain stored in vehicles long after they change hands, posing significant privacy, security, and even physical safety risks. To take control of sensitive data, companies need to establish data deletion policies for all vehicles used in a business context. This includes requiring rental agencies and fleet management providers to delete stored data and offer certificates of deletion when cars are returned or decommissioned. Companies should also require automotive providers to provide VIN-specific data disclosures so drivers understand what data the vehicle collects and how it's used and shared. Additionally, companies need to consider how privacy regulations like GDPR and CCPA apply to vehicle data collection and use it to inform their internal policies and third-party contracts. In today's episode of She Said Privacy/He Said Security, Jodi and Justin Daniels talk with Merry Marwig, VP Global Communications & Advocacy at Privacy4Cars, about the privacy and security risks of data collected and stored in vehicles. Merry explains how cars used for work, whether rental, fleet, or personal, retain unencrypted personal and company data that can be exploited when vehicles change ownership or are decommissioned. She shares real-world case studies involving sensitive information left behind in cars, including banking credentials, contact lists, and patient health records. Merry also outlines how data deletion policies and VIN-specific disclosures, required through contracts with automotive providers, help companies reduce privacy and security risks.

Connect to John Gilroy on LinkedIn   https://www.linkedin.com/in/john-gilroy/ Want to listen to other episodes? www.Federaltechpodcast.com Sometimes, one plus one is three. Back in 2021, McAfee's Enterprise business merged with FireEye to form Trellix. Today, the net result is a company that generates $1.2 billion globally and $400 million in the public sector. In today's interview, Ken Karsten details how federal leaders can use Trellix to improve cybersecurity in a federal world with rapidly increasing end points. Setting the stage, Ken Karsten reviews an Executive Order 14028  from 2021 that encouraged federal agencies to aggressively protect endpoints, sometimes called Endpoint Detection and Response. In four short years, AI has transformed the way malicious actors attack end points and the defense had to be improved. Enter, Extended Detection and response. During the interview, Ken Karsten gives listeners an overview of XDR's continuous monitoring, advanced analytics, and rapid threat assessment and response capabilities. Advances in AI have allowed Trellix to deliver EDR and XDR capabilities at a drastically reduced cost. Topics in the discussion include Operational Technology, 5G, and Trellix's recent DoD IL5 authorization. Provide a link to download the Trellix Cyber Threat Report.

In this new edition of the EASL DeepDive, expert faculty guide participants through a focused and forward-looking discussion on key aspects of advanced MASLD, setting the stage for a deeper understanding of evolving clinical challenges and opportunities.This EASL DeepDive webinar is supported by Boehringer Ingelheim. Boehringer Ingelheim has had no input into the content of this EASL DeepDive.Learning objectivesUnderstand the Pathophysiology: Describe the key pathophysiological mechanisms of MASLD and its progression to advanced liver disease and portal hypertension.Identify Unmet Clinical Needs: Recognise the current gaps in diagnosis, management, and treatment of advanced MASLD, highlighting the challenges of healthcare professionals in clinical practice.Evaluate Valuable Endpoints: Discuss the importance of selecting and utilising valuable clinical endpoints in managing MASLD to improve patient outcomes.Explore Emerging Therapies: Review the latest therapeutic strategies and potential interventions for advanced MASLD, focusing on how they address the unmet needs in patient care.All EASL DeepDive are available on EASL Campus.

David Peterson has a 2.74 ERA over the past two seasons (3:47). ... Jesus Luzardo bounced back in a big way (9:54). ... Marcelo Mayer had his breakout game (15:43). ... Schwellenbach turned in his first complete game (21:55). ... News (23:40): Jackson Jobe is set for Tommy John surgery. ... Let's have fun with arbitrary endpoints (30:26). ... Lane Thomas had a big game (43:46). ... Walker Buehler and David Festa had strong outings (48:53). ... Kris Bubic and Matthew Liberatore both ran into a brick wall on Wednesday (58:00). ... We wrap up with leftovers, bullpens and streamers (1:02:45). Fantasy Baseball Today is available for free on the Audacy app as well as Apple Podcasts, Spotify and wherever else you listen to podcasts.  Subscribe to our YouTube channel: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠youtube.com/FantasyBaseballToday⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Download and Follow Fantasy Baseball Today on Spotify: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://sptfy.com/QiKv⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Get awesome Fantasy Baseball Today merch here: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠http://bit.ly/3y8dUqi⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow FBT on TikTok: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.tiktok.com/@fbtpod?_t=8WyMkPdKOJ1&_r=1⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow our FBT team on Twitter: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@FBTPod⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@CPTowers⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@CBSScottWhite⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@Roto_Frank⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Join our Facebook group at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.facebook.com/groups/fantasybaseballtoday⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Sign up for the FBT Newsletter at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.cbssports.com/newsletters/fantasy-baseball-today/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ For more fantasy baseball coverage from CBS Sports, visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.cbssports.com/fantasy/baseball/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ To hear more from the CBS Sports Podcast Network, visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.cbssports.com/podcasts/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ You can listen to Fantasy Baseball Today on your smart speakers! Simply say "Alexa, play the latest episode of the Fantasy Baseball Today podcast" or "Hey Google, play the latest episode of the Fantasy Baseball Today podcast." To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices

Superpowers for Good should not be considered investment advice. Seek counsel before making investment decisions. When you purchase an item, launch a campaign or create an investment account after clicking a link here, we may earn a fee. Engage to support our work.Watch the show on television by downloading the e360tv channel app to your Roku, AppleTV or AmazonFireTV. You can also see it on YouTube.Devin: What is your superpower?Nicole: Willingness to take bold leaps and embrace the unknown.Imagine a world where cancer is as treatable as the flu. That's the vision Nicole Paulk, the founder and CEO of Siren Biotechnology, is working tirelessly to bring to life. Driven by groundbreaking science, Nicole's company is on the brink of launching clinical trials for a revolutionary cancer treatment.Nicole's work leverages engineered viruses—those that don't make you sick—to deliver genetic medicines directly to cancer cells. These “good viruses” act as a delivery system for anti-tumor drugs, targeting difficult-to-treat cancers like recurrent high-grade gliomas, a fatal brain cancer. “We started to see data that looked really promising in this space,” Nicole explained, adding, “We felt a moral obligation to go after this cancer where there's just this huge unmet need.”Siren Biotechnology's approach is designed to have broad applications. Unlike treatments that target specific genetic mutations, their method has the potential to work on various tumor types. Nicole describes it as using viruses like a “little FedEx delivery truck” that can be engineered to deliver medicine precisely where it's needed in the body.This innovation didn't happen overnight. Nicole, a former professor of virology at UCSF, took the bold step of leaving academia to launch Siren Biotechnology. “I decided to resign from my faculty position and go be the founder and CEO just because I was so excited about the data and what we had so far,” she shared.In addition to traditional venture capital funding, Siren Biotechnology is inviting the public to invest through a regulated investment crowdfunding campaign. This unique opportunity allows patients, families, and supporters touched by cancer to be part of their journey. “We wanted to bring patients and their families onto our cap table,” Nicole said. “It's a way to involve them in the conversation much earlier.”Siren Biotechnology's work could redefine cancer care and inspire a new model for patient-centered innovation. With clinical trials just months away, the future looks brighter for those battling cancer—and for all of us who dream of a world where cancer is no longer a death sentence.tl;dr:Nicole Paulk's Siren Biotechnology transforms viruses into targeted cancer therapies with universal potential.The company focuses on recurrent high-grade gliomas, a fatal brain cancer with no standard treatment.Nicole left academia to lead Siren, leveraging her groundbreaking virology research to launch the company.Siren's unique crowdfunding campaign lets patients and families invest in the fight against cancer.Nicole's superpower, fearless innovation, drives her bold mission to revolutionize cancer care.How to Develop Fearless Innovation As a SuperpowerNicole's superpower is her willingness to take bold leaps and embrace the unknown. After spending nearly two decades building her academic career, Nicole left her position as a virology professor at UCSF to start Siren Biotechnology. She explained, “I feel like my superpower is just kind of being willing to jump off the cliff without a parachute and be like, we're going to figure it out. We're going to make it work.”Nicole exemplified fearless innovation when her research led to a groundbreaking discovery about the biology of a virus, one that required rewriting existing textbooks. Initially met with skepticism, her work was later validated and became a foundation for Siren Biotechnology's cancer treatment. This pivotal moment highlights Nicole's courage to challenge conventional knowledge and pursue transformative ideas.Tips for Developing This Superpower:Be willing to question conventional wisdom and explore new paths.Take calculated risks, even if it means stepping away from a well-defined career path.Embrace discomfort and uncertainty as a necessary part of innovation.Engage others by communicating your vision in relatable and accessible ways.By following Nicole's example and advice, you can make fearless innovation a skill. With practice and effort, you could make it a superpower that enables you to do more good in the world.Remember, however, that research into success suggests that building on your own superpowers is more important than creating new ones or overcoming weaknesses. You do you!Guest ProfileNicole Paulk (she/her):CEO, Founder, President, Siren BiotechnologyAbout Siren Biotechnology: We are combining two transformative therapeutic technologies – AAV gene therapy and cytokine immunotherapy – into a single, reimagined modality that overcomes key challenges and redefines how we destroy tumor cells and elicit anti-tumor immunity.This is the first AAV gene therapy drug product that can be made once and used in numerous indications – a huge leap forward for the field. This drastically reduces clinical development times, manufacturing timelines, and capital needs for each clinical trial. Most importantly, ‘universal' means countless solid tumor cancer patients – regardless of tumor type or mutations – may benefit from this breakthrough approach.Website: sirenbiotechnology.comX/Twitter Handle: @SirenBioCompany Facebook Page: facebook.com/SirenBiotechnologyOther URL: wefunder.com/siren.biotechnologyBiographical Information: Dr. Nicole Paulk is the CEO, Founder, and President of Siren Biotechnology and has dedicated her career to advancing the field of gene therapy. With nearly two decades of expertise, Nicole has been at the forefront of developing cutting-edge advances to propel the field of gene therapy forward for a wide range of diseases.Before founding Siren, Nicole held various leadership positions in academia and industry and most notably was an Assistant Adj Professor of AAV Gene Therapy in the UCSF Department of Biochemistry & Biophysics before leaving to found Siren. Nicole has a B.S. in Medical Microbiology, a Ph.D. in Viral Gene Therapy and Regenerative Medicine from OHSU, and completed her Postdoctoral Fellowship and Instructorship in Human Gene Therapy at Stanford University prior to starting her lab at UCSF. Nicole is a pioneer in the development of next-generation AAV platforms for gene repair, gene transfer and gene editing, directed evolution for novel engineered capsid evolution, and comparative multi-omic approaches to interrogate translational AAV biology.Nicole is a renowned expert in gene therapy and has consulted extensively for big pharma, written draft CMC guidance for the FDA, and sits on the Scientific Advisory Boards for Sarepta, Astellas, Metagenomi, Dyno Therapeutics, CEVEC, GRO Biosciences, Excision BioTherapeutics, WhiteLab Genomics, Johns Hopkins Gene Therapy Initiative, the Gene Therapy for Rare Disorders Searchlight Program, and several stealth startups. She has been quoted in The Wall Street Journal, The Economist, The Boston Globe, Endpoints, STAT, Phacilitate, GEN, BioPharma Dive, Evaluate Vantage, SF Business Times, WIRED, Drug Discovery World, MIT Tech Review, C&EN, and more. She sits on the Scientific Editorial Boards of the journals Gene Therapy, Human Gene Therapy, and Biopharma International Gene Therapy. She is the Chair of the American Society of Gene and Cell Therapy (ASGCT) Translational Science Committee, and a member of the ASGCT Cancer Cell and Gene Therapy Committee and the Biocom California Cell and Gene Therapy Committee. She has invented numerous AAV gene therapy technologies that have been shared or licensed to dozens of gene therapy companies and nonprofit groups working in rare diseases.Outside of work, you can find Nicole adventure traveling (think whitewater rafting meets backcountry trekking), snowboarding, planning elaborate Halloween parties complete with animatronics and ghoulish menus, tending her vegetable garden, and obsessing over the latest wearable gadgets. If you're trying to track her down at a conference and can't find her, it's because she snuck off to an oyster bar.X/Twitter Handle: @Nicole_PaulkLinkedin: linkedin.com/in/nicolepaulkInstagram Handle: @sirenbioSupport Our SponsorsOur generous sponsors make our work possible, serving impact investors, social entrepreneurs, community builders and diverse founders. Today's advertisers include FundingHope, Kingscrowd and Crowdfunding Made Simple. Learn more about advertising with us here.Max-Impact MembersThe following Max-Impact Members provide valuable financial support:Carol Fineagan, Independent Consultant | Lory Moore, Lory Moore Law | Marcia Brinton, High Desert Gear | Paul Lovejoy, Stakeholder Enterprise | Pearl Wright, Global Changemaker | Ralf Mandt, Next Pitch | Scott Thorpe, Philanthropist | Matthew Mead, Hempitecture | Michael Pratt, Qnetic | Sharon Samjitsingh, Health Care Originals | Add Your Name HereUpcoming SuperCrowd Event CalendarIf a location is not noted, the events below are virtual.Impact Cherub Club Meeting hosted by The Super Crowd, Inc., a public benefit corporation, on June 17, 2025, at 1:00 PM Eastern. Each month, the Club meets to review new offerings for investment consideration and to conduct due diligence on previously screened deals. To join the Impact Cherub Club, become an Impact Member of the SuperCrowd.SuperCrowdHour, June 18, 2025, at 12:00 PM Eastern. Jason Fishman, Co-Founder and CEO of Digital Niche Agency (DNA), will lead a session on "How to Spin $1 of Advertising into $10!" He'll reveal proven strategies and marketing insights drawn from years of experience helping successful crowdfunding campaigns. Whether you're a founder planning a raise or a supporter of innovative startups, you'll gain actionable tips to boost visibility, drive engagement, and hit your funding goals. Don't miss it!Join us on June 25, 2025, at 8:00 PM Eastern for the Superpowers for Good Live Pitch—streaming on e360tv, where purpose-driven founders take the virtual stage to present their active Regulation Crowdfunding campaigns to a national audience of investors and changemakers. Selected startups are chosen for their commitment to community, alignment with NC3's Community Capital Principles, and their drive to create real-world impact. Thanks to sponsors DNA and DealMaker, this event is free to watch and amplifies the voices of underrepresented and mission-aligned entrepreneurs. Don't miss this inspiring evening where capital meets purpose—tune in to discover and support the next wave of impact-driven innovation.SuperCrowd25, August 21st and 22nd: This two-day virtual event is an annual tradition but with big upgrades for 2025! We'll be streaming live across the web and on TV via e360tv. Soon, we'll open a process for nominating speakers. Check back!Community Event CalendarSuccessful Funding with Karl Dakin, Tuesdays at 10:00 AM ET - Click on Events.Devin Thorpe is featured in a free virtual masterclass series hosted by Irina Portnova titled Break Free, Elevate Your Money Mindset & Call In Overflow, focused on transforming your relationship with money through personal stories and practical insights. June 8-21, 2025.Join Dorian Dickinson, founder & CEO of FundingHope, for Startup.com's monthly crowdfunding workshop, where he'll dive into strategies for successfully raising capital through investment crowdfunding. June 24 at noon Eastern. Regulated Investment Crowdfunding Summit 2025, Crowdfunding Professional Association, Washington DC, October 21-22, 2025.Call for community action:Please show your support for a tax credit for investments made via Regulation Crowdfunding, benefiting both the investors and the small businesses that receive the investments. Learn more here.If you would like to submit an event for us to share with the 9,000+ changemakers, investors and entrepreneurs who are members of the SuperCrowd, click here.We use AI to help us write compelling recaps of each episode. Get full access to Superpowers for Good at www.superpowers4good.com/subscribe

In this episode of Automox Insiders, host Maddie Regis chats with Adam Whitman, Manager of Solutions Engineering at Automox, about all things IT spring cleaning. From patch management and software audits to business continuity planning and endpoint hygiene, Adam shares practical, real-world tips for tidying up your tech stack and staying ahead of IT clutter.  Along the way, he reflects on his career journey from marketing to IT leadership and reveals some personal spring cleaning confessions. Tune in for expert advice and a fresh perspective to help you refresh your IT environment this season.

On this episode, Daphne Zohar, John Maraganore, Josh Schimmer, Eric Schmidt and Sam Fazeli are joined by Endpoints' Zach Brennan for a discussion on the election results and what we can expect with a Trump administration, including the negatives/risks for the biotech industry as well as the positives and potential opportunities. The hosts also cover other news from the week including Moderna's Q3 earnings and the company's CEO Bancel stepping down as sales chief, as well as BioNTech's Q3 earnings and the potential softening of vaccine pricing. The group recapped the ASH conference and readouts including Arcellx's early data and related stock movement. The discussion turns to ObesityWeek highlights including data from AstraZeneca, Vertex, Zealand and Novo Nordisk. Other topics covered this week include Sarepta's SRP-5051 discontinuation, the death of gene editing and the impact to the fledgling field. This episode aired on November 8, 2024. 

Today on Endpoints, Dr. Danielle Boyce joins us to explore how data science is transforming our understanding of ALS and why the ALS Research Collaborative (ARC) Study presents an exciting opportunity for research. As ALS TDI’s Principal Investigator for Real-World Evidence, Dr. Boyce brings extensive expertise in analyzing big data to uncover key insights about ALS. Her work focuses on harnessing the vast amount of information collected through ALS TDI’s ARC Study, turning data into discoveries that could drive ALS research forward.Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Can a misconfigured prompt spark a massive data breach?On this episode of Your AI Injection, host Deep Dhillon and Keith Hoodlet, Director of AI/ML and Application Security from Trail of Bits reveal the critical vulnerabilities hiding in your AI chat systems. Keith explains how RAG systems and other API endpoints, if not rigorously secured, can create unintended data portals, allowing hackers to extract everything from HR records to confidential strategic documents. The two navigate the complexities of prompt injection vulnerabilities, dynamic adversarial testing, and the balancing act between rapid innovation and robust security. As they discuss the human and technical factors that contribute to these risks, Deep and Keith challenge the industry to view security not as an afterthought, but as an integral feature of every AI-driven product. Tune in for a deep dive into safeguarding your digital future!Learn more about Keith here: https://www.linkedin.com/in/securingdev/and Trail of Bits here: https://www.trailofbits.com/Check out some of our related podcast episodes: Your Code Base Is Already Gen AI—Now What? with Matt Van Itallie of SemaWhy Generative AI Could Make Programming Languages Obsolete with Austin Vance of FocusedExploring Artificial General Intelligence: Intent, Intellect, and Innovation with Lucas Hendrich of the Forte Group

25 years ago, Steven Ascher and Jeanne Jordan began filming a documentary about a new, one-year-old organization and the family that founded it. That organization was called the ALS Therapy Development Foundation, and its mission was to find treatments for ALS. It was started by Jamie Heywood, whose brother Stephen had been diagnosed with the disease at the age of 29. The film they made, So Much So Fast, came out in 2006. It received critical acclaim and was screened at the Sundance Film Festival. It documents five years in the lives of the Heywood family as they dealt with Stephen’s progressing disease while simultaneously building what would eventually become ALS TDI, the world’s most comprehensive drug discovery lab dedicated solely to ALS. Today, on Endpoints, Steven and Jeanne join us to talk about what it was like during the earliest days of ALS TDI, what it's been like watching the organization evolve, and how their own story helped inspire the film. Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Drs. Komrokji and Kuykendall review the evolution of clinical trial endpoints in myelofibrosis studies. They discuss traditional measures of disease control, such as spleen volume reduction and hematologic response, as well as expanded endpoints that reflect the biological and symptomatic aspects of myelofibrosis.

In this episode, Meg Ashby, a senior cloud security engineer shares how her team tackled AWS's centralized VPC interface endpoints, a design often seen as an anti-pattern. She explains how they turned this unconventional approach into a cost-efficient and scalable solution, all while maintaining granular controls and network visibility. She shares why centralized VPC endpoints are considered an AWS anti-pattern, how to implement granular IAM controls in a centralized model and the challenges of monitoring and detecting VPC endpoint traffic. Guest Socials: ⁠Meg's Linkedin Podcast Twitter - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@CloudSecPod⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ If you want to watch videos of this LIVE STREAMED episode and past episodes - Check out our other Cloud Security Social Channels: - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cloud Security Podcast- Youtube⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cloud Security Newsletter ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cloud Security BootCamp Questions asked: (00:00) Introduction (02:48) A bit about Meg Ashby (03:44) What is VPC interface endpoints? (05:26) Egress and Ingress for Private Networks (08:21) Reason for using VPC endpoints (14:22) Limitations when using centralised endpoint VPCs (19:01) Marrying VPC endpoint and IAM policy (21:34) VPC endpoint specific conditions (27:52) Is this solution for everyone? (38:16) Does VPC endpoint have logging? (41:24) Improvements for the next phase Thank you to our episode sponsor Wiz. Cloud Security Podcast listeners can also get a free cloud security health scan by going to wiz.io/csp

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The FDA's accelerated approval pathway, established in 1992, has allowed over 200 new drugs to come to market based on surrogate endpoints. While many products have later received full FDA approval, recent withdrawals like Pfizer's Oxbryta and Takeda's Exkivity have raised concerns about the risks of this pathway. Despite some high-profile failures, the program has a strong track record, with over half of accelerated approvals converting to full approval. The pathway has been used primarily for cancer treatments but is now expanding to other disease areas like neurological and rare diseases. Recent failures of confirmatory trials for drugs like Sarepta's Elevidys have prompted experts to call for tighter timelines and better biomarkers for surrogate endpoints in order to improve the program. The future of the accelerated approval pathway is under scrutiny, with questions arising about how often it should be used and what areas it should focus on next.AbbVie's Tavapadon showed improvement in motor and daily living complications in a Phase III trial, following the failure of another key cerevel asset, Emraclidine. Relmada Therapeutics is considering strategic alternatives, including a potential sale, after halting two Phase III trials for a major depressive disorder drug. Other news includes BioAge discontinuing a Phase II obesity study, Merck's promising anti-ROR1 ADC data for lymphoma treatment, and Novo and Catalent's $16.5 billion deal receiving EU approval. Additionally, Vertex and Beam report advances in SCD cell and gene therapies, while evidence grows for the potential of GLP-1s in Alzheimer's disease.Recent studies have shown that GLP-1 receptor agonists, commonly used for weight loss and diabetes, may have potential in treating Alzheimer's disease. Phase III results from Novo Nordisk are expected next year. Additionally, amylin analogs are emerging as a potential alternative or complement to GLP-1 receptor agonists for weight loss with a cleaner tolerability profile. Other news includes a weight loss victory claimed by Lilly over Novo in a head-to-head study, FDA action alerts, and promising cancer therapies from companies like AstraZeneca and Merus. The FDA is also investigating the safety of Bluebird's gene therapy Skysona for hematologic malignancies. Applied Therapeutics recently faced a crash after FDA rejection of a rare disease drug. Overall, the potential of GLP-1s in Alzheimer's disease and the emergence of amylin analogs in weight loss are significant developments in the biopharma industry.

Cyber threats evolve rapidly, making it challenging for MSPs to stay ahead. How can we further empower MSPs to simplify security while scaling their businesses? That's where Senteon Cybersecurity steps in, transforming endpoint security into a scalable, automated solution. Zach Kromkowski, Chief Customer Officer at Senteon and the winner of the PitchIT 2024 competition, shares his insights into revolutionizing cybersecurity for MSPs by focusing on endpoint hardening. Highlights include: Simplifying the process of hardening endpoints and automation to streamline compliance. Success stories from the MSP community. Embracing an adventurous RV lifestyle Educational webinar series. Having the mindset of expecting to win and the support needed for entrepreneurs and early stage organizations. Experience being a part of the PitchIT Accelerator Program and being named the Winner of PitchIT 2024. Follow Zach on LinkedIn and visit senteon.co/ to learn more about solutions to safeguard and optimize your endpoints. --- more --- If you are looking to learn the art of audience engagement while listening for methods to conquer speaking anxiety, deliver persuasive presentations, and close more deals, then this is the podcast for you. Twins Talk it Up is a podcast where identical twin brothers Danny Suk Brown and David Suk Brown discuss leadership communication strategies to support professionals who believe in the power of their own authentic voice. Together, we will explore tips and tools to increase both your influence and value. Along the way, let's crush some goals, deliver winning sales pitches, and enjoy some laughs. Danny Suk Brown and David Suk Brown train on speaking and presentation skills. They also share from their keynote entitled, “Identically Opposite: the Pursuit of Identity”. Support and Follow us: YouTube: youtube.com/channel/UCL18KYXdzVdzEwMH8uwLf6g Instagram: @twinstalkitup Instagram: @dsbleadershipgroup Twitter: @dsbleadership LinkedIn: linkedin.com/company/twins-talk-it-up/ LinkedIn: linkedin.com/company/dsbleadershipgroup/ Facebook: facebook.com/TwinsTalkitUp Facebook: facebook.com/dsbleadership/ Website: dsbleadershipgroup.com/TwinsTalkitUp

We need more – likely many more – effective treatments to end ALS. Progress in ALS research has been too slow for too long but, in 2024, we're witnessing significant advances and a new pace of progress. The past few years have see more treatments for ALS in clinical trials than ever before. Still, most drugs that reach trial fail, in any disease. However, the more experimental treatments that make it to trials – with good preclinical evidence to support them – the more likely there are to be successes. Recently, we have even seen approvals for new ALS treatments, such as tofersen, a genetic treatment developed by Biogen for SOD1-related ALS, sold under the brand name Qalsody. Dr. Stephanie Fradette was one of the people behind milestone. As the VP Head of Neuromuscular Development at Biogen, she oversees the company's research and development of treatments for ALS and related diseases. Today, on Endpoints, Dr. Fradette joins us to talk about the current state of ALS research ­- the biggest challenges facing researchers, the developments that give her hope for the future, and how the ALS research community could better serve people with the disease.Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Maddie Regis speaks with Tom Bowyer, Director of Security at Automox, about the intersection of IT and cybersecurity. Tom shares his career journey, the importance of collaboration between IT and security teams, and insights into SOC compliance reports. He emphasizes the need for transparency, experimentation, and proactive problem-solving in enhancing cybersecurity. 

In 1999, Stephen Heywood, who was 29 years old at the time, was diagnosed with ALS. His family was devastated when they learned that there were no treatments that could slow or stop his disease. His brother Jamie decided that he had to do something about it, founding the organization that would eventually become ALS TDI – the world's first nonprofit biotech – in the basement of his parents' Newton, MA home. The first hire Jamie made as he worked to get this new organization off the ground was Rob Bonazoli. In those days, Rob was responsible for, in his words, “everything non-scientific.”  Part of this included building the team that would carry out Jamie's lofty research goals. Many of the people he helped recruit at that time are still with the organization twenty-five years later. Two of those early employees were Ken Thompson, now ALS TDI's Vice President of Facility Operations, and Fernando Vieira, our CEO and Chief Scientific Officer. Today, on Endpoints, we're joined by Rob – as well as Ken and Fernando – to talk about what it's been like to see ALS TDI grow from its humble beginnings to one of the world's leading ALS research institutions.Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Wed, 21 Aug 2024 21:30:00 GMT http://relay.fm/connected/515 http://relay.fm/connected/515 "Endpoints" 515 Federico Viticci, Stephen Hackett, and Myke Hurley It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. clean 6047 It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. This episode of Connected is sponsored by: NetSuite: The leading integrated cloud business software suite. Vitally: A new era for customer success productivity. Get a free pair of AirPods Pro when you book a qualified meeting. ExpressVPN: High-Speed, Secure & Anonymous VPN Service. Get an extra three months free. KRCS: Get your new Mac with all your preferred specs, with pricing you won't find anywhere else Links and Show Notes: Get Connected Pro: Preshow, postshow, no ads. Submit Feedback Dr. Drang's Follow Up Unwatched: RSS Video Player on the App Store Winston for Reddit Performa Month: The Transition to PowerPC and a New All-in-One – 512 Pixels ten. | the movie. - YouTube Departures #12: 2024 Q&A: Relay Turns 10 - Relay FM New image reveals iPhone 16 Pro in new 'bronze' color - 9to5Mac Bronze-Like iPhone 16 Pro Color Could Be Called 'Desert Titanium' - MacRumors Ungeniused #218: The Dave Matthews Band Bus Incident - Relay FM Upgrade #525: Best of U3 - Relay FM Who is New Martina, the tiktoker who makes smartphone covers – Cosmopolitan Monument Valley 3 Is Heading To Netflix Games Along with the Series' First Two Installments - MacStories Developers Claim Apple Arcade is 'Directionless' - MacStories Netflix Games | Netflix Help Center Netflix has a great video game catalog, actually | Polygon Netflix Considers Ways to Make Money From Videogames in Possible Pivot - WSJ Can Netflix Profit from Video Games? | Nasdaq Stephen's HomeKit Page Is this the slow decline of the Apple “cult”? - Birchtree The Slow Decline of the Apple

Wed, 21 Aug 2024 21:30:00 GMT http://relay.fm/connected/515 http://relay.fm/connected/515 Federico Viticci, Stephen Hackett, and Myke Hurley It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. clean 6047 It's a busy week on the show. The guys cover some iPhone rumors, changes at Apple Podcasts, the announcement of Monument Valley 3, and iOS 18's final days in beta, all before discussing the idea of the "Apple cult" starting to fade. This episode of Connected is sponsored by: NetSuite: The leading integrated cloud business software suite. Vitally: A new era for customer success productivity. Get a free pair of AirPods Pro when you book a qualified meeting. ExpressVPN: High-Speed, Secure & Anonymous VPN Service. Get an extra three months free. KRCS: Get your new Mac with all your preferred specs, with pricing you won't find anywhere else Links and Show Notes: Get Connected Pro: Preshow, postshow, no ads. Submit Feedback Dr. Drang's Follow Up Unwatched: RSS Video Player on the App Store Winston for Reddit Performa Month: The Transition to PowerPC and a New All-in-One – 512 Pixels ten. | the movie. - YouTube Departures #12: 2024 Q&A: Relay Turns 10 - Relay FM New image reveals iPhone 16 Pro in new 'bronze' color - 9to5Mac Bronze-Like iPhone 16 Pro Color Could Be Called 'Desert Titanium' - MacRumors Ungeniused #218: The Dave Matthews Band Bus Incident - Relay FM Upgrade #525: Best of U3 - Relay FM Who is New Martina, the tiktoker who makes smartphone covers – Cosmopolitan Monument Valley 3 Is Heading To Netflix Games Along with the Series' First Two Installments - MacStories Developers Claim Apple Arcade is 'Directionless' - MacStories Netflix Games | Netflix Help Center Netflix has a great video game catalog, actually | Polygon Netflix Considers Ways to Make Money From Videogames in Possible Pivot - WSJ Can Netflix Profit from Video Games? | Nasdaq Stephen's HomeKit Page Is this the slow decline of the Apple “cult”? - Birchtree The Slow Decline of

July 26, 2024: Michael Robinson, VP of Healthcare Solutions for the Americas at Omnissa, joins Bill for the news. They delve into the current state of cybersecurity in healthcare, emphasizing the rise in ransomware demands and the crucial need for mature security postures in health systems. How can health systems better manage the increasing threat vectors from device proliferation? What role does AI play in enhancing security measures, and how effective is the adoption of zero-trust architecture in preventing breaches? The conversation also touches on the evolving use of Gen AI in healthcare, particularly in administrative versus clinical applications. As Gen AI tools become more prevalent, what are the implications for patient interactions and the necessity of human oversight in AI-driven healthcare solutions?Key Points:00:28 Michael Robinson from Omnissa00:58 Omnissa: Company Background and Offerings02:56 Ransomware and Security in Healthcare06:52 Password Management and Zero Trust11:03 Gen AI: Opportunities and ChallengesNews articles:Ransomware Extortion Demands Soar to $5.2M per AttackAI Ushers in New Era of Global Healthcare Equity and Efficiency

Welcome to the Heroes of IT podcast, hosted by Automox's Ashley Smith. In this podcast, Ashley interviews IT heroes ready to share their insights, successes, challenges, and stories from the field. Join us as we talk endpoint management tips and tricks, how to overcome hurdles, and celebrate IT heroes' contributions to modern technology. 

All links and images for this episode can be found on CISO Series. This week's episode is hosted by me, David Spark (@dspark), producer of CISO Series and Andy Ellis (@csoandy), operating partner, YL Ventures. Joining us is our guest and winner of Season 2 of Capture the CISO, Russell Spitler, CEO and co-founder, Nudge Security. In this episode: The Gordian knot of EDR Can we keep up with patching? Making AI practical Standardization or granularity? Thanks to our podcast sponsor, ThreatLocker! ThreatLocker® is a global leader in Zero Trust endpoint security offering cybersecurity controls to protect businesses from zero-day attacks and ransomware. ThreatLocker operates with a default deny approach to reduce the attack surface and mitigate potential cyber vulnerabilities. To learn more and start your free trial, visit ThreatLocker.com.

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.Key Timestamps:00:00 - 03:00 Introduction and Sponsor Message03:01 - 05:20 Introduction to Shaherah Yancy and her background05:21 - 10:30 Importance of Clinical and Regulatory Strategies10:31 - 17:15 Challenges of Securing Funding and Developing Strategy17:16 - 25:45 Differences Between Market Access and Market Adoption25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption33:51 - 39:40 Importance of Evidence and Study Design39:41 - 48:00 Examples and Case Studies from Early Stage Companies48:01 - 55:15 Endpoints for Market Adoption55:16 - 01:02:30 Strategies for Novel Technologies01:02:31 - 01:07:45 Final Advice and Contact InformationNotable Quotes:"Market access is a milestone. Market adoption is the goal." - Shaherah Yancy"Understanding the problem you're solving is crucial for your strategy." - Shaherah Yancy"Don't be afraid of clinical evidence; it's your key to success." - Shaherah YancyKey Takeaways:MedTech Trends:Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.Practical Tips:Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.References:Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC SolutionsGreenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru ClinicalEtienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedInMedTech 101:Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally...

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  The good — Gilead twice-yearly HIV shot delivers zero infections in trial  The bad — Takeda epilepsy drug misses endpoints in trials  The ugly — Eli Lilly goes after counterfeiters 

Eugenia and Jeff talk with Andy Poulter (PM for Edge DX) about what's now with Edge DX.  For instance, did you know Edge DX now has device averages? Listen in and learn what's new.

Welcome back for another new episode, Data Center Therapy aficionados!  This week, our adventurous and hard-working hosts, Matt “Master Link” Yette and Matt “Chromed Crankset” Cozzolino open up the virtual studios to IVOXY's own Ryan “Security Gusset” Grelck, who joins the fellas to talk all things endpoint-related for the first part of the podcast.In addition to discussions of all things client-related, the crew also discuss:The differences between endpoint protection (EPP) and endpoint detection and response (EDR).SentinelOne's purple.ai feature and automated root cause analysis (RCA).Microsoft's Recall feature for Copilot+ PCs, and its security implications.The browser wars, Firefox, and how Chromium code maintenance impacts modern browser platforms.With all those topics and more, including the upcoming Q3 and Q4 classes from IVOXY, the Matts and Ryan also briefly cover the newer software suites now included in VMware vSphere Foundation and VMware Cloud Foundation.  We hope you have as much fun listening to the show as much as we had making it, and if you do, be sure to tell three friends, like and subscribe wherever you find your quality podcasts.  Thanks for joining us once again and we'll see you in an IVOXY class, on a free webinar or on the next episode of DCT.  Ciao for now! 

Recorded at the first annual “HemOnc Pulse” Live meeting, this episode features a panel discussion on unanswered questions in myeloproliferative neoplasms (MPN) with Naveen Pemmaraju, MD, of the University of Texas MD Anderson Cancer Center; Ruben Mesa, MD, of the Atrium Health cancer service line; Sanam Loghavi, MD, of the MD Anderson Cancer Center; and Olatoyosi Odenike, MD, of the University of Chicago Medicine.

The latest episode of Preparing for a Cell and Gene Future features a discussion between Jamie Pierson (Program Lead within Parexel's Cell and Gene Center of Excellence) and Kim MacDonnell (Associate Director for Rare Diseases). They consider uses of surrogate markers as endpoints in rare disease development and look ahead to positive directions established by FDA's current initiatives.

Kids Quest to Cure ALS is an organization for kids, by kids. Their mission is to get young people involved in the fight against ALS. The group was founded by kids in the US and Canada – all of whom have been affected by a loved one's ALS diagnosis. They are encouraging people under the age of 18 across both countries to band together to help raise funds for ALS research and bring awareness to the disease. Today, on Endpoints, we're joined by several members of the Kids Quest steering committee to tell us more about the inspiration behind their mission, and why it's important to involve young people in the fight against ALS.Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

Today on Cyber Work, our deep-dive into manufacturing and operational technology (OT) cybersecurity brings us to the problem of endpoint security. Tom Molden, CIO of Global Executive Engagement at Tanium, has been grappling with these problems for a while. We talk about his early, formative tech experiences (pre-Windows operation system!), his transformational position moving from fiscal strategy and implementation into his first time as chief information officer and talk through the interlocking problems that come from connected manufacturing devices and the specific benefits and challenges to be found in strategizing around the endpoints. All of the endpoints.0:00 - Manufacturing and endpoint security1:44 - Tom Molden's early interest in computers4:06 - Early data usage6:26 - Becoming a CIO10:29 - Difference between a CIO and CISO14:57 - Problems for manufacturing companies 18:45 - Best CIO problems to solve in manufacturing22:51 - Security challenges of manufacturing 26:00 - The scop of endpoint issues 33:27 - Endpoints in manufacturing security37:12 - How to work in manufacturing security39:29 - Manufacturing security skills gaps41:54 - Gain manufacturing security work experience43:41 - Tom Molden's best career advice received46:26 - What is Tanium 47:58 - Learn more about Tom Molden48:34 - Outro – Get your FREE cybersecurity training resources: https://www.infosecinstitute.com/free– View Cyber Work Podcast transcripts and additional episodes: https://www.infosecinstitute.com/podcastAbout InfosecInfosec's mission is to put people at the center of cybersecurity. We help IT and security professionals advance their careers with skills development and certifications while empowering all employees with security awareness and phishing training to stay cyber-safe at work and home. More than 70% of the Fortune 500 have relied on Infosec Skills to develop their security talent, and more than 5 million learners worldwide are more cyber-resilient from Infosec IQ's security awareness training. Learn more at infosecinstitute.com.

In 2023, Insilico Medicine—a biotech company developing medications with a heavy reliance on AI—used AI to develop an experimental drug for the incurable lung disease idiopathic pulmonary fibrosis. The treatment is in mid-stage trials in the US and China, with some results expected in early 2025. Biotech is one of the fields that has been using generative AI for years, even before ChatGPT brought the technology to public view. Latest technology is essential in drug development. However, the convergence of digital health and pharma seems less clear. Digital health apps started gaining popularity around 2015, and at that time, it seemed all pharma companies were trying to figure out what they could gain from apps, so they financed accelerators and incubators one after the other. We've seen many ideas about how Pharma should or could use digital health. In the last few years, there have been many notorious cases when partnerships failed—a seemingly unicorn, Proteus, which designed digital sensors-equipped pills, went bankrupt in 2019 after Otsuka Pharmaceuticals pulled out of a funding round. Pear Therapeutics, the guiding star in the DTx space and the leader in FDA-cleared prescription digital therapeutics, partnered with Novartis, but in the end, the company filed for bankruptcy in 2023. So where is Pharma in relation to digital health and digital therapeutics? In this episode, Amir Lahav shares his thoughts about the impact of AI on biotech, the state of decentralized clinical trials, and the potential of technology for improved drug development, clinical trials, and patient responses. Newsletter: https://fodh.substack.com/ www.facesofdigitalhealth.com Show notes: [00:02:00] The Convergence of Digital Health and Pharma Discussion on the role of digital health apps in pharmaceuticals. The rise and fall of pharma and tech company partnerships, with examples like Proteus and Peer Therapeutics. [00:06:00] AI Trends in Biotech and Pharma [00:08:00] Enhancing Clinical Trials with AI and continuous patient monitoring [00:10:00] The Importance of Data in Clinical Trials [00:12:00] The Reality of Oncology Trials and Endpoints [00:14:00] Quality of Life in Medicine as the Endpoint [00:16:00] The Rise of Decentralized Clinical Trials [00:18:00] Pharma's Evolving Digital Health Strategies [00:22:00] Impact on Digital Health Industry [00:24:00] Collaboration and Sharing Knowledge in the Pharma Industry [00:26:00] The need for long-term investment and strategic piloting of digital health solutions [00:28:00] What Inspires in Pharma and Biotech in Personalized Treatments [00:30:00] The State of Precision Medicine and Targeted Therapies [00:34:00] The Role of Pharmacogenomics [00:36:00] Anticipations for 2024 and Beyond

One of the most common misconceptions about ALS is that it only affects older white men. In reality, the disease can affect anyone of any age – and of any ethnicity. Many Shades of ALS, a team within the I AM ALS organization, is working hard to dispel some of these misconceptions. Their mission is to bring attention to people of color living with ALS and the unique challenges they often face – as well as providing resources for their mental, physical, and social well-being. Juan Reyes is a veteran living with ALS, an advocate, and co-chair of Many Shades of ALS team. Lakeia Nard is a member of the team who lost her son, King'nazir, to a rare form of pediatric ALS and also runs her own nonprofit, Melanin Children Matter. Today, on Endpoints, they join us to talk about how the team came together, its mission, and how the ALS research and medical communities could be better serving people of color with the disease.Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.