Podcasts about onc

A la Quinta va la vencida. José Manuel Tejedor y Juan Yagüe. Pedro Subijana. Entrevista: Fernando Aguirregomezcorta, Oncólogo pediátrico.Escuchar audio

#BesameDeNoche: ¡No te asustés! Hablemos de quistes en los ovarios ¿Te pasa? Hoy aclaramos este tema a fondo. Te esperamos, a partir del 89.9 Fm o en www.mmradio.com, a las 20:00 horas Costa Rica. con el Dr. Rafael Ramos, junto al Dr. Roberto Morales Ginecólogo - Oncólogo.

In this episode, you'll hear about the latest developments in tailoring cancer treatments to individual patients using Precision Oncology.  Two thought leaders, Simone Ndujiuba, a Clinical Oncology Pharmacist at Prime Therapeutics, and Karan Cushman, Head of Brand Experience and host of The Precision Medicine Podcast for Trapelo Health, discuss real-world research that is paving the way for Prime and our partners to help providers reduce turnaround times so patients can start treatment as soon as possible.  Join your host Maryam Tabatabai as they dig into this evolving topic of precision oncology. www.primetherapeuitics.com ⁠Chapters⁠Defining precision medicine (08:50)Evaluating real-world operational process of biomarker testing (14:36)Turnaround times are crucial (17:40)A patients view into the importance of time (24:39)Technology and process aid in time and process (29:30)Helping bridge knowledge gaps for providers and payers (33:55) The focus is on Precision Oncology right now (37:00)Precision medicine in other disease categories (40:09)Future of precision oncology is bright (42:07) References Singh, B.P., et al. (2019). Molecular profiling (MP) for malignancies: Knowledge gaps and variable practice patterns among United States oncologists (Onc). American Society of Clinical Oncology. https://meetings. asco.org/abstracts-presentations/173392 Evangelist, M.C., et al. (2023). Contemporary biomarker testing rates in both early and advanced NSCLC: Results from the MYLUNG pragmatic study. Journal of Clinical Oncology, 41(Supplement 16). https://doi.org/10.1200/JCO.2023.41.16_suppl.9109. Ossowski, S., et al. (2022). Improving time to molecular testing results in patients with newly diagnosed, metastatic non-small cell lung cancer. Journal of Clinical Oncology, 18(11). https://doi.org/10.1200/OP.22.00260 Naithani N, Atal AT, Tilak TVSVGK, et al. Precision medicine: Uses and challenges. Med J Armed Forces India. 2021 Jul;77(3):258-265. doi: 10.1016/j.mjafi.2021.06.020.  Jørgensen JT. Twenty Years with Personalized Medicine: Past, Present, and Future of Individualized Pharmacotherapy. Oncologist. 2019 Jul;24(7):e432-e440. doi: 10.1634/theoncologist.2019-0054.  MedlinePlus. What is genetic testing? Retrieved on April 21, 2025 from https://medlineplus.gov/genetics/understanding/testing/genetictesting/. MedlinePlus. What is pharmacogenetic testing? Retrieved on April 21, 2025 from https://medlineplus.gov/lab-tests/pharmacogenetic-tests/#:~:text=Pharmacogenetics%20(also%20called%20pharmacogenomics)%20is,your%20height%20and%20eye%20color.  Riely GJ, Wood DE, Aisner DL, et al. National Cancer Comprehensive Network (NCCN) clinical practice guidelines: non-small cell lung cancer, V3.2005. Retrieved April 21, 2025 from https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.  Benson AB, Venook AP, Adam M, et al. National Cancer Comprehensive Network (NCCN) clinical practice guidelines: colon cancer, V3.2025. Retrieved April 21, 2025 from https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Rosenberg PS, Miranda-Filho A. Cancer Incidence Trends in Successive Social Generations in the US. JAMA Netw Open. 2024 Jun 3;7(6):e2415731. doi: 10.1001/jamanetworkopen.2024.15731. PMID: 38857048; PMCID: PMC11165384. Smeltzer MP, Wynes MW, Lantuejoul S, et al. The International Association for the Study of Lung Cancer Global Survey on Molecular Testing in Lung Cancer. J Thorac Oncol. 2020 Sep;15(9):1434-1448. doi: 10.1016/j.jtho.2020.05.002.The views and opinions expressed by the guest featured on this podcast are their own and do not necessarily reflect the official policy or position of Prime Therapeutics LLC, its hosts, or its affiliates. The guest's appearance on this podcast does not imply an endorsement of their views, products, or services by Prime Therapeutics LLC. All content provided is for informational purposes only and should not be construed as professional advice.

¿Qué Hace Un Dermatólogo Oncólogo? | Episodio # 478 |Dr. Franco Krakaur | Cirujano Oncólogo

Oncólogos denuncian presiones para no recetar fármacos caros contra el cáncer y ahorrar costes.

New guidelines for health care privacy and consent, extending data sharing to new types of organizations, ensuring the clinical usability of data, and just lots and lots of growth—these are on the agenda of The Sequoia Project in the upcoming year. In this video, CEO Mariann Yeager concisely explains in this interview their recent achievements, how they work with the ONC and other stakeholders on TEFCA and QHINs, and some of their upcoming plans.Yeager has been CEO of The Sequoia Project since it began in 2012. It is Assistant Secretary for Technology Policy's (ASTP – Formerly ONC) recognized coordinating entity (RCE) to implement the government's Trusted Exchange Framework and Common Agreement (TEFCA), which went live a year ago. While they have gotten a lot of attention for being the TEFCA RCE, The Sequoia Project has almost a dozen healthcare interoperability projects they are working on.Learn more about The Sequoia Project:https://sequoiaproject.org/Health IT Community:https://www.healthcareittoday.com/

Talked with Teresa Zabik and Jeanette Mitchell from the Friends of Okeeheelee Nature Center (ONC).  The Friends of ONC is a non-profit that provides support to Okeeheelee Nature Center, it's staff, volunteers and animal ambassadors.  They put on fundraisers to enhance exhibits, trails, facilities as well as educational programs that provide an enriching experience for nature center visitors.  Teresa and Jeanette are volunteers who are working on the upcoming fundraiser, 2nd Annual Gopher Tortoise Gallop 5k Run/Walk.  It's happening on Saturday March 22 with a 7:30am start.  The park will open at 6:15am that day and packet pick up with be at the Micanopy Pavillion. They've added a pre-walk warm up and they have lots of fun events, and animal encounters after the race.  Listeners can sign up their teams at www.Victorysportsmgt.com/gophertortoisegallop5k/  For info about becoming a member of the Freinds of ONC, Volunteer, becoming a sponsor they can call 561-233-1400.

Según estudio: Combinar 2 fármacos ayuda a prolongar la vida de los pacientes con melanoma metastásico.Para hablar de ello nos acompañó el Dr. Jerónimo Rodríguez Cid, Oncólogo, Jefe de Oncología del Instituto Nacional de Enfermedades de Ciudad de México.La combinación de dos fármacos de inmunoterapia puede ser un tratamiento para los enfermos con melanoma metastásico avanzado, un cáncer agresivo y mortal, cuando es resistente a la terapia estándar actual, según un estudio que publicó, Nature Medicine.En los ensayos clínicos, los investigadores descubrieron que la terapia combinada puede extender la cantidad de tiempo que los pacientes viven sin que el cáncer empeore (supervivencia libre de progresión) y ayuda a superar la resistencia a las inmunoterapias anteriores, lo que permite que más personas se beneficien del tratamiento.El enfoque combinado de ambos fármacos “debería ser el régimen farmacológico preferido para las personas con cáncer que no han respondido a un tratamiento previo de inmunoterapia”, se comentó en un comunicado de la UCLA.El estudio, en el que participaron 91 personas, combinó los medicamentos de inmunoterapia Ipilimumab y Nivolumab.

Send us a textInteroperability has long been a buzzword in healthcare In an ideal world, our healthcare system would exchange timely, high-quality data to empower patients, improve clinical quality, and keep costs under control. How close are we to making this a reality?In this episode of the HealthBiz Podcast, host David E Williams talks with Dr. Donald Rucker, Chief Strategy Officer at 1upHealth, about how their health data management platform is transforming the way healthcare organizations access, share, and leverage patient data to improve outcomes, enhance efficiency, and drive more personalized care.TOPICS(0:25) Introduction(0:52) How Dr. Donald Rucker Got Into Healthcare(2:54) Rucker's Educational Path and Career(11:14) What Does 1upHealth Do?(21:13) Why Are CMS APIs So Important?(25:15) How Do APIs Affect Prior Authorization?(31:37) Book Recommendations from Dr. Donald Rucker

El Día Mundial de la lucha contra el Cáncer Infantil fue establecido en el año 2002 por la Organización Internacional de Cáncer Infantil, con el objetivo de crear conciencia y sensibilizar sobre esta enfermedad que afecta a muchas niñas, niños y adolescentes en el mundo. También busca promover la detección oportuna, para incrementar las posibilidades de recuperación y mejorar la calidad de vida en las y los menores. En este podcast de El Expresso de las 10 escucha las voces del Dr. Fernando Sánchez Zubieta, Médico Oncólogo, Fundador y Jefe del Servicio Hematología-Oncología Pediátrica Hospital Civil de Guadalajara Con sede en el Nuevo Hospital Civil Dr. Juan I. Menchaca, quien nos brinda orientación en torno a la detección, atención y tratamiento de Cáncer Infantil. Además de Leticia Casillas González y Anabel López en vivo y a Alejandro Villanueva y Everardo González en grabación; quienes nos comparten sus historias de esperanza…

In Part 2 of this two-part series, we continue the conversation about how Manifest MedEx ensures seamless data sharing across diverse healthcare providers, including opioid treatment and mental health services, while adhering to strict privacy and security standards such as HIPAA. We explore successful integration examples that have aided in combating the opioid crisis, discuss the significant challenges of achieving interoperability between different EHR systems, and examine the strategies Manifest MedEx has employed to overcome these obstacles and improve care coordination.MODERATOR: Bill Cioffi, MPPA, CHCIO, ITIL Chief Information Officer, C10 Consulting Bill Cioffi is also an Advisor at StarBridge Advisors, LLC, and is a nationally recognized leader in health IT. With over 15 years of experience in healthcare IT management, Bill has served as CIO at CenCal Health and North Sonoma County Healthcare District, where he spearheaded strategic technology initiatives, EHR implementations, and IT infrastructure improvements.GUEST: Erica Galvez Chief Executive Officer, Manifest MedEx Erica Galvez is CEO of Manifest MedEx (MX), California's largest nonprofit health information organization, and has extensive experience in health information exchange (HIE) and interoperability. She has been with Manifest MedEx since 2017, previously serving as Chief Strategy Officer and Chief of Staff. She has been instrumental in guiding the organization's growth and expansion while ensuring MX delivers increasing value to participants. Erica has helped MX achieve a 500 percent increase in health records shared across the health data network. MX now shares information for 38 million Californians across more than 140+ hospitals, 17 health plans, and 2500+ ambulatory providers. Erica came to the HIE space through years of healthcare quality and patient safety research at The Joint Commission.  Before joining MX, Erica led the HIE efforts at Aledade that tripled the company's hospital connectivity and evolved the use of health information to reduce avoidable hospitalizations and emergency department encounters. Prior to Aledade, she led the Office of the National Coordinator for Health IT's (ONC's) Interoperability Portfolio, held a leadership position as one of the directors of ONC's State HIE Program, and served as the program manager for AHIMA's State-Level HIE Consensus Project.   GUEST: Josh Longiaru IT Director, United Services, Inc.As a champion for behavioral health and integrated care, Josh is passionate about advancing the conversation on interoperability and its critical role in transforming patient outcomes. With over 20 years' experience in leading innovative programs at United Services and fostering collaboration among healthcare providers, he is committed to bridging gaps between physical and behavioral health systems to foster comprehensive care solutions. His hope is to get to a point where everyone has access to integrated care models that prioritize the whole person, ensuring that stigma and barriers are eliminated so that every patient can access the compassionate support they deserve. 

Invitados: Dr. Ernestos Santillán, Traumatólogo / Ortopedista Dr. Alejandro Ramos, Anestesiólogo / Oncólogo Facebook: SALUD PARA TODOS RADIO Spotify: Salud para todos podcasts Twitter: @Salud_TodosMx YouTube: Salud para Todos Instagram : @sptodos Déjanos saber tus dudas y nuestros especialistas las estarán contestando. Whatsapp o Telegram 55 16 48 87 67

#Bésameenlanoche Aprender a conocer el cuerpo, reconocer que es sano y que no lo es, es fundamental para nuestra salud mental, emocional, física y sexual. Hoy hablamos de Anatomía de la Vulva con el Dr. Rafael Ramos y el Ginecólogo - Obstetra y Oncólogo Dr. Roberto Morales.

Magazine de Madrid, presentado por Pepa Gea, en el que te contamos las noticias de la mañana con Oscar Plaza, la previsión del tiempo con Javier Hernández “El Borrascas” y la actualidad deportiva con Felix Jose Casillas. Lunes, donde hablaremos con la Oncóloga, Delia Cortes.  Jorge Granullaque nos hablará sobre los aseos en el intercambiador de Moncloa El Corazón de Madrid lo pondrá Maria Aparicio. El Villano nos contará una nueva placa de la ciudad e Ignacio Marín nos presenta el III Festival de Novela negra de Vallekas.  

About Erin Weber:Erin Richter Weber is a healthcare leader with 14 years at CAQH. She oversees CAQH CORE, advancing healthcare automation, and CAQH Insights, producing the annual Index report. Erin unites stakeholders to address industry challenges through data-driven innovation. Previously, she consulted for PwC and led research at the Advisory Board Company. She holds a Master's from Harvard and a Bachelor's from Cornell, making her a pivotal voice in healthcare standards and policy.About Don Rucker:Dr. Donald Rucker is the Chief Strategy Officer of 1upHealth and former National Coordinator for Health IT at HHS (2017–2021). He led the ONC's 21st Century Cures Act Interoperability Rule, enabling secure patient access to health data via standardized FHIR APIs. A board-certified physician with clinical informatics expertise, he co-developed the first Windows-based electronic medical record. Dr. Rucker holds degrees from Harvard, the University of Pennsylvania, and Stanford, blending medicine, technology, and leadership.Things You'll Learn:Provider data is the backbone of the healthcare system, powering everything from patient care to billing, and requires standardization to ensure accuracy.The healthcare industry needs to learn from the internet and establish a system similar to domain name services to reduce friction.Data quality is paramount for interoperability, requiring standardized definitions of data elements like location. To improve data, AI should be included. AI can be used to standardize the multiple sources of provider data by merging them and enhancing the quality of that data. The healthcare industry is behind other industries, and boldness comes from adopting solutions that have already been implemented elsewhere. Resources:Connect with and follow Erin Weber on LinkedIn.Follow CAQH on LinkedIn and visit their website.Connect with and follow Don Rucker on LinkedIn.Learn more about 1upHealth on their LinkedIn and website.Check out the latest annual CAQH Index Report here. 

For the past 20 years, under both Republican and Democratic administrations, the ONC has played a pivotal role shaping and regulating the health tech market. On the eve of the election, Micky Tripathi joined me to discuss the agency's recently expanded role. Now, two months later—though it feels like a decade—the future is uncertain. Will the ONC and ASTP continue as market regulators and opportunity catalysts, or is a new direction on the horizon?Here's what we covered:The government's role in shaping and regulating the health tech ecosystemAI in healthcare: balancing the risks of misuse vs. the risk of “missed uses” Health information sharing: why Micky is optimistic about the future Can technology take the pain out of prior auth?Micky thinks we are standing on the edge of a transformative era:“We are just at the beginning of the most exciting decade...health information technology can really start to show… the return on investment for patients. We've done a lot of hard work over the last 10 years… [With that foundation in place] we have the opportunity to say there's an ROI here for patients.”Relevant LinksBlog post on ONC reorganization: ONC's Next ChapterTEFCA overviewForbes interview: Where is interoperability headed?Healthcare Dive: HHS AI Task Force Takes Shape (March 2024)Blog post by Micky: Getting real about information blocking and APIs (October 2024)About Our GuestMicky Tripathi is the Assistant Secretary for Technology Policy, National Coordinator for Health Information Technology, and Acting Chief Artificial Intelligence Officer at the U.S. Department of Health and Human Services, where he leads the formulation of HHS technology and data strategy and coordinates technology policies, standards, programs, and investments.Dr. Tripathi has over 20 years of experience across the health IT landscape. Prior to joining the federal government he served as Chief Alliance Officer for Arcadia, a health care data and software company focused on population health management and value-based care, the project manager of the Argonaut Project, an industry collaboration to accelerate the adoption of FHIR, and a board member of HL7, the Sequoia Project, the CommonWell Health Alliance, and the CARIN Alliance.Dr. Tripathi served as the President and Chief Executive Officer of the Massachusetts eHealth Collaborative (MAeHC), a non-profit health IT advisory and clinical data analytics company. He was also the founding President and CEO of the Indiana Health Information Exchange, a statewide HIE partnered with the Regenstrief Institute, an Executive Advisor to investment firm LRVHealth, and a Fellow at the Berkman-Klein Center for Internet and Society at Harvard University.He holds a PhD in political science from the Massachusetts...

Shutdown..... AVERTED Mergers - Auto Industry big move Lots of Trump Talk The Market's new favorite stocks PLUS we are now on Spotify and Amazon Music/Podcasts! Click HERE for Show Notes and Links DHUnplugged is now streaming live - with listener chat. Click on link on the right sidebar. Love the Show? Then how about a Donation? Follow John C. Dvorak on Twitter Follow Andrew Horowitz on Twitter DONATIONS ? Thank you for all who gave to the Thanksgiving Holiday Campaign... Warm-Up - Shutdown..... AVERTED - Mergers - Auto Industry big move - Lots of Trump Talk - Deli Stock Scheme - Update - Holiday Tidings! - Markets - S&P 500 Equal weight down 6% MTD, Small Caps down 8% - The New favs? Quantum Computing Stocks - Santa Like them..... - Index inclusion has become a thing Checking out the early CTP Cup Standings EVERYONE IS IN! - 7 Contestants.... Fed Meeting Dec 18th - Fed freaked out markets - All of a sudden they are projecting that inflation is not going to come down to their 2% level into 2026 - DJIA was donw 1000 points and it was an ugly day overall. - Onc day later, PCE comes out not too far aay from assumptions and market takes off - Just goes to show that DJIA - Records? - Follow up - it was 10 days and the last time that happened was 1974 Meanwhile - XMAS Rally - Once big day down, then a test and BOUNCE - Most of the Fed Day losses have been wipe out - still much damage in December --- Once again - Mega cap holding things up ---- EVEN though 10Yr >4.6%  - this is an important price point... Failed  couple of times before. Quantum Computing Stocks - Ever since Alphabet (Google) announced that they made progress, been some crazy moves on a few names - with YTD returns -- D-Wave Quantum Inc  QBTS  (825%) -- Rigetti Computing Inc   RGTI  (1,050%) -- Quantum Computing Inc   QUBT  (1,900%) -- Defiance Quantum ETF   QTUM (51%) -- IONQ Inc    IONQ   (240%) ---(none seem to be making any money  - actually losing a ton) More Quantum - Willow's speed is almost incomprehensible — according to Google, it's able to perform a computation in under five minutes that would take one of today's fastest supercomputers 10 septillion years to solve. Ten septillion is 10,000,000,000,000,000,000,000,000 years. - Concern has turned to the potential for this technology to break down crypto (or other) cryptography. --- It may take years - but this could be something we need to watch as a byproduct, the need for better security from quantum hacks Auto Merger - Japanese automakers Nissan and Honda on Monday announced they had entered into official talks to merge and create the world's third-largest automaker by sales. - The deal would aim to share intelligence and resources and deliver economies of scale and synergies while protecting both brands - Nissan's strategic partner Mitsubishi has been offered the chance to join the new group and will take a decision by the end of January 2025. - Lots of things to iron out before this deal gets done Index Traders - Hang on... - Huge moves to reset these days - Companies are competing to get to NASDAQ and NYSE to gain inclusion as they know share prices will potentially pop - Palatntir is banking on that as they said in their recent announcement and one reason was to get inclusion in the NASDAQ 100 - These kind of index changes has buig impacts on stocks - - ALSO, there should be some movement over the next month as there will be re-balancing going on as 2024 big run for markets/stocks Trump Talk/Plans - Trump said he will not let the canal fall into the 'wrong hands' - Trump accused Panama of charging excessive fees to use the canal - Panama's President Mulino defends canal's independence and fees - US handed over control of the canal in 1999 - Talk that we could take it back - Twitter: "Every square meter of the Panama Canal and the surrounding area belongs to Panama and will c...

Host Dr. Jay Anders invites back Micky Tripathi, PhD, MPP, the current Assistant Secretary for Technology Policy, National Coordinator for Health Information Technology, and Acting Chief Artificial Intelligence Officer for a look back and forward for the ONC. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Matt Lowe, MDiv, MSN, APRN, FNP-C, ONC is joined by Jimmy Dascani and Dan Veronie from Arthrex, a medical device company and leader in new product development and medical education in orthopedics. Jimmy is a licensed RN and the Healthcare Administrator Relations Director for Arthrex. Dan is a PA and serves as the Senior Clinical Specialist with Arthrex. They talk about Arthex's new product, OrthoPedia, a free web-based platform designed for clinicians, academics and patients for all things orthopedic surgery education. Jimmy and Dan share their insights on the development of OrthoPedia, and how it is changing the game in the way healthcare providers and patients can easily access orthopaedic education at any level.

Dr. Ryan Augustin and Dr. Jason Luke discuss neoadjuvant immunotherapy and the importance of multidisciplinary team coordination, promising new TIL therapy for advanced melanoma, and the emerging role of CD3 engagers in treatment strategies. TRANSCRIPT Dr. Ryan Augustin: Hello, I'm Dr. Ryan Augustin, your guest host of the ASCO Daily News Podcast today. I'm a medical oncology fellow at Mayo Clinic in Rochester, Minnesota. Joining me today is Dr. Jason Luke, an associate professor of medicine and the director of the Cancer Immunotherapeutic Center at the University of Pittsburgh Hillman Cancer Center. I had the privilege of working as a postdoc in Jason's translational bioinformatics lab, where we investigated mechanisms of resistance to immunotherapy in melanoma and other cancers.  Today, we'll be discussing 3 important topics, including neoadjuvant immunotherapy and the importance of multidisciplinary team coordination, the impact and practical considerations for incorporating TIL therapy into melanoma, and the current and future use of CD3 engagers in both uveal and cutaneous melanoma.  You'll find our full disclosures in the transcript of this episode.  Jason, it's great to have this opportunity to speak with you today. Dr. Jason Luke: Absolutely. Thanks, Ryan. It's great to see you. Dr. Ryan Augustin: So, to kick things off, Jason, we, of course, have seen tremendous advances in cancer immunotherapy, not only in metastatic disease but also the perioperative setting. Recent data have shown that the use of neoadjuvant therapy can provide not only critical prognostic information but can also help individualize post-resection treatment strategies and potentially even eliminate adjuvant therapy altogether in patients who achieve a pathologic, complete response. This signifies a conceptual shift in oncology with the goal of curing patients with immunotherapy. In triple-negative breast cancer, the KEYNOTE-522 regimen with pembrolizumab is standard of care. In non-small cell lung cancer, there are now four FDA approved chemo-IO regimens in both the neoadjuvant and perioperative settings. And, of course, in melanoma, starting with SWOG S1801 utilizing pembro mono therapy, and now with combined CTLA-4 PD-1 blockade based on results from the NADINA trial, neoadjuvant IO is the new standard of care in high-risk, resectable melanoma. It's important to highlight this because whereas other tumor types have more mature multidisciplinary care, for example, patients with breast cancer are reviewed by the whole team in every center, and every patient with lung cancer certainly benefits from multidisciplinary care conferences, that's not always the case with melanoma, given the relative frequency of cases compared to other tumor types.  Jason, would you say that we have now moved into an era where the integration of a multidisciplinary team and melanoma needs to be prioritized. And why is it important to have multidisciplinary team coordination from the onset of a patient's diagnosis? Dr. Jason Luke: Well, I think those are great questions, Ryan, and I think they really speak to the movement in our field and the great success that we've had integrating systemic therapy, particularly immunotherapy, into our treatment paradigms. And so, before answering your question directly, I would add even a little bit more color, which is to note that over the last few years, we've additionally seen the development of adjuvant therapy into stages of melanoma that, historically speaking, were considered low-risk, and medical oncologists might not even see the patient. To that, I'm speaking specifically about the stage 2B and 2C approvals for adjuvant anti-PD-1 with pembrolizumab or nivolumab. So this has been an emerging complication.  Classically, patients are diagnosed with melanoma by either their primary care doctor or a dermatologist. Again, classically, the next step was referral to a surgeon who had removed the primary lesion, with discussion around nodal evaluation as well. And that paradigm has really changed now, where I think integration of medical oncology input early on in the evaluation of the appropriate treatment plan for patients with melanoma is quite a pressing issue now, both because we have FDA approvals for therapeutics that can reduce risk of recurrence, and whether or not to pursue those makes a big difference to the patient for discussion early on.  And, moreover, the use of systemic therapies now, prior to surgery, of course, then, of course, requires the involvement of medical oncology. And just for an emphasis point on this, it's classically the case, for good reason, that surgeons complete their surgery and then feel confident to tell the patient, “Well, we got it all, and you're just in really good shape.” And while I understand where that's coming from, that often leaves aside the risk of recurrence. So you can have the most perfect surgery in the world and yet still be at very high risk of recurrence. And so it's commonly the case that we get patients referred to us after surgery who think they're just in totally good shape, quite surprised to find out that, in fact, they might have a 20% to 50% risk of recurrence. And so that's where this multidisciplinary integration for patient management really does make a big difference.  And so I would really emphasize the point you were making before, which is that we need multidisciplinary teams of med onc with derm, with surgery early on, to discuss “What are the treatment plans going to be for patients?” And that's true for neoadjuvant therapy, so, for palpable stage 3, where we might give checkpoint inhibitors or combinations before surgery. But it's true even in any reasonably high-risk melanoma, and I would argue in that state, anything more than stage 1 should be discussed as a group, because that communication strategy with the patient is so important from first principles, so that they have an expectation of what it's going to look like as they are followed out over time. And so we're emphasizing this point because I think it's mostly the case at most hospitals that there isn't a cutaneous oncology disease management meeting, and I think there needs to be.  It's important to point out that usually the surgeons that do this kind of surgery are actually either the GI surgeons who do colon cancer or the breast surgeons. And so, given that melanoma, it's not the most common kind of cancer, it could easily be integrated into the existing disease review groups to review these cases. And I think that's the point we really want to emphasize now. I think we're not going to belabor the data so much, but there are enormous advantages to either perioperative or adjuvant systemic therapy in melanoma. We're talking about risk reduction of more than 50%, 50-75% risk reduction. It's essential that we make sure we optimally offer that to patients. And, of course, patients will choose what they think is best for their care. But we need to message to them in a way that they can understand what the risks and benefits of those treatments are and then are well set up to understand what that treatment might look like and what their expectations would be out over time.  So I think this is a great art of medicine place to start. Instead of belaboring just the details of the trial to say, let's think about how we take care of our patients and how we communicate with them on first principles so that we can make the most out of the treatments that we do have available. Dr. Ryan Augustin: That's great, Jason. Very insightful points. Thank you.  So, shifting gears now, I'd also like to ask you a little bit about TIL therapy in melanoma. So our listeners will be aware that TIL is a promising new approach for treating advanced melanoma and leverages the power of a patient's cytotoxic T cells to attack cancer cells. While we've known about the potential of this therapy for some time, based on pioneering work at the NCI, this therapy is now FDA approved under the brand AMTAGVI (Lifileucel) from Iovance Biotherapeutics, making it the first cellular therapy to be approved for a solid tumor. Now, I know TIL therapy has been administered at your institution, Jason, for several years now, under trial status primarily for uveal melanoma using an in-house processing. But for many cancer centers, the only experience with cellular therapy has come under the domain of malignant hematology with CAR T administration. At our institution, for example, we have only recently started administering TIL therapy for melanoma, which has required a tremendous multidisciplinary effort among outpatient oncology, critical care, and an inpatient hematology service that has expertise in cytokine release syndrome.  Jason, where do you see TIL therapy fitting into the metastatic space? Which patients do you think are truly candidates for this intensive therapy? And what other practical or logistical considerations do you think we should keep in mind moving forward? Dr. Jason Luke: Well, thanks for raising this. I think the approval of lifileucel, which is the scientific name for the TIL product that's on the market now. It really is a shift, a landscape shift in oncology, and we're starting in melanoma again, as seems to be commonly the case in drug development. But it's really important to understand that this is a conceptually different kind of treatment, and therefore, it does require different considerations. Starting first with data and then actualization, maybe secondarily, when we see across the accelerated approval package that led to this being available, we quote patients that the response rate is likely in the range of 30%, maybe slightly lower than that, but a meaningful 25% to 30% response rate, and that most of those patients that do have response, it seems to be quite durable, meaning patients have been followed up to four years, and almost all the responders are still in response. And that's a really powerful thing to be able to tell a patient, particularly if the patient has already proceeded through multiple lines of prior standard therapy. So this is a very, very promising therapy.  Now, it is a complicated therapy as well. And so you highlighted that to do this, you have to have a tumor that's amenable for resection, a multidisciplinary team that has done a surgery to remove the tumor, sent it off to the company. They then need to process the TIL out of the tumor and then build them up into a personalized cell product, bring it back, you have to lympho-deplete the patient, re-introduce this TIL. So this is a process that, in the standard of care setting under best circumstances, takes roughly six weeks. So how to get that done in a timely fashion, I think, is evolving within our paradigms. But I think it is very important for people who practice in settings where this isn't already available to realize that referring patients for this should be a strong consideration. And thinking about how you could build your multidisciplinary team in a way to be able to facilitate this process, I think is going to be important, because this concept of TIL is relevant to other solid tumors as well. It's not approved yet in others, but we kind of assume eventually it probably will be. And so I think, thinking through this, how could it work, how do you refer patients is very important.  Now, coming back to the science, who should we treat with this? Well, of course, it's now an air quotes “standard of care option”, so really it ought to be available to anybody. I will note that currently, the capacity across the country to make these products is not really adequate to treat all the patients that we'd want. But who would we optimally want to treat, of course, would be people who have retained a good performance status after first line therapy, people who have tumors that are easily removable and who have not manifested a really rapid disease progression course, because then, of course, that six-week timeline probably doesn't make sense. The other really interesting data point out of the clinical trials so far is it has looked like the patients who got the least amount of benefit from anti-PD-1 immunotherapy, in other words, who progressed immediately without any kind of sustained response, those patients seem to have the best response to TILs, and that's actually sort of a great biomarker. So, this drug works the best for the population of patients where checkpoint inhibitors were not effective. And so as you think about who those patients might be in your practice, as you're listening, I think prioritizing it for primary progression on anti PD-1, again and giving it ahead thought about how would you get the patient through this process or referred to this process very quickly is really important because that lag time is a problem. Patients who have melanoma tend to progress reasonably quickly, and six weeks can be a long time in melanoma land. So, thinking ahead and building those processes is going to be important moving into the future Dr. Ryan Augustin: Definitely appreciate those practical considerations. Jason, thank you.  Moving on to our final topic, I was hoping to discuss the use of immune cell engagers in melanoma. So, similar to CAR T therapy, bispecific T-cell engagers, or BiTEs, as they're commonly known, are standard of care in refractory myeloma and lymphoma. But these antibodies engaging CD-3 on T cells and a tumor specific antigen on cancer cells are relatively new in the solid tumor space. Tarlatamab, which is a DLL-3 and CD-3 bispecific antibody, was recently approved in refractory small cell lung cancer, and, of course, tebentafusp, an HLA-directed CD-3 T cell engager was approved in uveal melanoma in 2022. Both T and NK cell engaging therapies are now offering hope in cancers where there has historically been little to offer. However, similar to our discussion with TIL therapy, bispecifics can lead to CRS and neurotoxicity, which require considerable logistical support and care coordination.  Jason, I was wondering if you could briefly discuss the current landscape of immune cell engagers in melanoma and how soon we may see these therapies enter the treatment paradigm for cutaneous disease. Dr. Jason Luke: I think it is an exciting, novel treatment strategy that I think we will only see emerge more and more. You alluded to the approval of tebentafusp in uveal melanoma, and those trials were, over the course of a decade, where those of us in solid tumor land learned how to manage cytokine release syndrome or the impact of these C3 bispecifics, in a way that we weren't used to. And what I'll caution people is that CRS, as this term, it sounds very scary because people have heard of patients that, of course, had difficult outcomes and hematological malignancies, but it's a spectrum of side effects. And so, when we think about tebentafusp, which is the approved molecule, really what we see is a lot of rash because GP100, the other tumor antigen target, is in the skin. So, patients get a rash, and then people do get fevers, but it's pretty rare to get more than that. So really what you have to have is the capacity to monitor patients for 12 hours, but it's really not more scary than that. So it really just requires treating a few people to kind of get used to these kinds of symptoms, because they're not the full-on ICU level CRS that we see with, say, CAR T-cells.  But where is the field going? Well, there's a second CD3 bispecific called brenetafusp that targets the molecule PRAME, that's in a phase 3 clinical trial now for frontline cutaneous melanoma. And tebentafusp is also being evaluated in cutaneous melanoma for refractory disease. So, it's very possible that these could be very commonly used for cutaneous melanoma, moving into, say, a two-to-four-year time horizon. And so therefore, getting used to what are these side effects, how do you manage them in an ambulatory practice for solid tumor, etc., is going to be something everyone's going to have to learn how to deal with, but I don't think it should be something that people should be afraid of.  One thing that we've seen with these molecules so far is that their kinetics of treatment effect do look slightly different than what we see with more classic oncology therapies. These drugs have a long-term benefit but doesn't always manifest as disease regression. So, we commonly see patients will have stable disease, meaning their tumor stops growing, but we don't see that it shrank a lot, but that can turn into a very meaningful long-term benefit. So that's something that we're also, as a community, going to have to get used to. It may not be the case we see tumors shrink dramatically upfront, but rather we can actually follow people with good quality- of-life over a longer period of time.  Where is the field going? You mentioned tarlatamab in small cell lung cancer, and I think we're only going to see more of these as appropriate tumor antigens are identified in different tumors. And then the other piece is these CD3 engagers generally rely upon some kind of engagement with a T cell, whether CD3 engagers, and so they can be TCR or T-cell receptor-based therapies, although they can be also SCFV-based. But that then requires new biomarkers, because TCR therapy requires HLA restriction. So, understanding that now we're going to need to profile patients based on their germline in addition to the genomics of the tumor. And those two things are separate. But I would argue at this point, basically everybody with cutaneous melanoma should be being profiled for HLA-A(*)0201, which is the major T-cell receptor HLA haplotype that we would be looking for, because whether or not you can get access immediately to tebentafusp, but therefore clinical trials will become more and more important.  Finally, in that T-cell receptor vein, there are also T cell receptor-transduced T cells, which are also becoming of relevance in the oncology community and people listening will be aware in synovial sarcoma of the first approval for a TCR-transduced T cell with afamitresgene autoleucel. And in melanoma, we similarly have TCR-transduced T cells that are coming forward in clinical trials into phase 3, the IMA203 PRAME-directed molecule particularly. And leveraging our prior conversation about TILs, we're going to have more and more cellular based therapies coming forward, which is going to make it important to understand what are the biomarkers that go with those, what are the side effect profiles of these, and how do you build your practice in a way that you can optimally get your patients access to all of these different treatments, because it will become more logistically complicated, kind of as more of these therapies come online over the next, like we said, two to four years kind of time horizon. So, it's very exciting, but there is more to do, both logistically and scientifically. Dr. Ryan Augustin: That's excellent. Thanks, Jason, and thank you so much for sharing your great insight with us today on the ASCO Daily News Podcast. Dr. Jason Luke: Thanks so much for the opportunity. Dr. Ryan Augustin: And thank you to our listeners for your time today. You will find links to the abstracts discussed today in the transcript of this episode, and you can follow Dr. Luke on X, formerly known as Twitter, @jasonlukemd. And you can find me, @RyanAugustinMD. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Follow today's speakers: @ryanaugustinmd Dr. Jason Luke @jasonlukemd   Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn   Disclosures: Dr. Ryan Augustin: No relationships to disclose Dr. Jason Luke: Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof) Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

Artificial intelligence continues to gain popularity as society identifies its uses and benefits. AI has shown promise despite being in the early phases of implementation in sarcoma care. For this episode we discuss Artificial intelligence, its present and the future in sarcoma care. Bozzo A, Tsui JMG, Bhatnagar S, Forsberg J. Deep Learning and Multimodal Artificial Intelligence in Orthopaedic Surgery. J Am Acad Orthop Surg. 2024 Jun 1;32(11):e523-e532. Bozzo, A., Hollingsworth, A., Chatterjee, S. et al. A multimodal neural network with gradient blending improves predictions of survival and metastasis in sarcoma. npj Precis. Onc. 8, 188 (2024). sarcomaAIhub.com Find out More about our Doctors: Dr. Izuchukwu Ibe: www.linkedin.com/in/izuchukwu-ibe-a073537a/ Dr. Elyse Brinkmann: www.linkedin.com/in/elyse-brinkmann/

In this episode of The Dish on Health IT, Tony Schueth, CEO of Point-of-Care Partners, and Kim Boyd, Regulatory Resource Center Lead, are joined by Pam Schweitzer, former Assistant Surgeon General of the United States and current Chair of the NCPDP Foundation Board of Trustees. Together, they deliver an in-depth discussion on critical topics impacting the health IT landscape, including interoperability, public health data modernization, and evolving healthcare regulations.The episode begins with introductions from Tony and Kim, highlighting Pam's extensive career in healthcare, ranging from her leadership roles in the Indian Health Service and the Veterans Affairs (VA) system to her current position as chair of the NCPDP Foundation. Pam reflects on her experience overseeing the transition from paper to electronic health records and how this complex shift required the coordination of multiple healthcare departments, including radiology and labs.Pam shares her insights into how policy changes, such as CMS 0057 and the HTI-2 proposed rule, are shaping the future of healthcare interoperability. The trio discusses how these regulations, aimed at improving data sharing between payers, providers, and public health systems, will ultimately drive real-time data exchange. They also emphasize the importance of infrastructure, standards, and innovation to support these efforts.As the discussion moves forward, Pam talks about her work on public health initiatives, particularly around pharmacy interoperability, maternal health, and the broader impacts of nutrition and food supply on community health. Kim and Pam also explore the evolving role of pharmacists in public health, especially in rural areas where they often serve as the primary healthcare providers.The conversation includes key steps for modernizing public health data systems, such as addressing the data silos between healthcare and public health systems. Pam emphasizes the need for greater collaboration and data sharing to enable a more effective public health response, especially during crises like pandemics or natural disasters.Pam, Kim, and Tony also touch on the role of the Trusted Exchange Framework and Common Agreement (TEFCA) in promoting data fluidity and expanding the integration of pharmacists and other healthcare stakeholders into the broader healthcare ecosystem.The episode wraps up with Pam expressing her optimism for the future of health IT and public health interoperability, while stressing the importance of ongoing collaboration between stakeholders, from policymakers to healthcare technology vendors. Kim adds that the evolution of pharmacy practice and regulatory changes are driving significant improvements in patient care and medication management.Listeners can tune in for a deep dive into the intersections of health IT policy, pharmacy standards, and public health modernization, with practical insights from leaders in the field. This episode is a must-listen for those interested in healthcare interoperability, the impact of CMS and ONC policies, and the future of public health and pharmacy integration.Catch the full episode on your preferred podcast platform, including Apple Podcasts, Spotify, and Healthcare Now Radio, or watch the video version on YouTube.Other resources you may be interested in:Healthy People 2030 – Data and Information Systemshttps://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructurePublic Health Infrastructure - Healthy People 2030 | health.govhttps://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructureStrategies for Public Health Interoperability | PHDI | CDChttps://www.cdc.gov/data-interoperability/php/public-health-strategy/index.htmlMarch 27, 2024 – Draft 2024-2030 Federal Health IT Strategic Planhttps://www.healthit.gov/sites/default/files/page/2024-03/Draft_2024-2030_Federal_Health_IT_Strategic_%20Plan.pdf2023 – Infrastructure for Scaling and Spreading Whole Health – Health Informaticshttps://www.nationalacademies.org/our-work/transforming-health-care-to-create-whole-health-strategies-to-assess-scale-and-spread-the-whole-person-approach-to-health 

Reed Smith partners share insights about U.S. Department of Health and Human Services initiatives to stave off misuse of AI in the health care space. Wendell Bartnick and Vicki Tankle discuss a recent executive order that directs HHS to regulate AI's impact on health care data privacy and security and investigate whether AI is contributing to medical errors. They explain how HHS collaborates with non-federal authorities to expand AI-related protections; and how the agency is working to ensure that AI outputs are not discriminatory. Stay tuned as we explore the implications of these regulations and discuss the potential benefits and risks of AI in healthcare.  ----more---- Transcript: Intro: Hello, and welcome to Tech Law Talks, a podcast brought to you by Reed Smith's Emerging Technologies Group. In each episode of this podcast, we will discuss cutting-edge issues on technology, data, and the law. We will provide practical observations on a wide variety of technology and data topics to give you quick and actionable tips to address the issues you are dealing with every day.  Wendell: Welcome to our new series on AI. Over the coming months, we'll explore the key challenges and opportunities within the rapidly evolving AI landscape. Today, we will focus on AI in healthcare. My name is Wendell Bartnick. I'm a partner in Reed Smith's Houston office. I have a degree in computer science and focused on AI during my studies. Now, I'm a tech and data lawyer representing clients in healthcare, including providers, payers, life sciences, digital health, and tech clients. My practice is a natural fit given all the innovation in this industry. I'm joined by my partner, Vicki Tankle.  Vicki: Hi, everyone. I'm Vicki Tankle, and I'm a digital health and health privacy lawyer based in Reed Smith's Philadelphia office. I've spent the last decade or so supporting health industry clients, including healthcare providers, pharmaceutical and medical device manufacturers, health plans, and technology companies navigate the synergies between healthcare and technology and advising on the unique regulatory risks that are created when technology and innovation far outpace our legal and regulatory frameworks. And we're oftentimes left managing risks in the gray, which as of today, July 30th, 2024, is where we are with AI and healthcare. So when we think about the use of AI in healthcare today, there's a wide variety of AI tools that support the health industry. And among those tools, a broad spectrum of the use of health information, including protected health information, or PHI, regulated by HIPAA, both to improve existing AI tools and to develop new ones. And if we think about the spectrum as measuring the value or importance of the PHI, the individuals individuals identifiers themselves, it may be easier to understand that the far ends of the spectrum and easier to understand the risks at each end. Regulators in the industry have generally categorized use of PHI in AI into two buckets, low risk and high risk. But the middle is more difficult and where there can be greater risk because it's where we find the use or value of PHI in the AI model to be potentially debatable. So on the one hand of the spectrum, for example, the lower risk end, there are AI tools such as natural language processors, where individually identifiable health information is not centric to the AI model. But instead, for this example, it's the handwritten notes of the healthcare professional that the AI model learns from. And with more data and more notes, the tool's recognition of the letters themselves, not the words the letters form, such as patient's name, diagnosis, or lab results, the better the tool operates. Then on the other hand of the spectrum, the higher risk end, there are AI tools such as patient-facing next best action tools that are based on an individual's patient medical history, their reported symptoms, their providers, their prescribed medications, potentially their physiological measurements, or similar information, and they offer real-time customized treatment plans with provider oversight. Provider-facing clinical decision support tools similarly support the diagnosis and treatment of individual patients based on individual's information. And then in the middle of the spectrum, we have tools like hospital logistics planners. So think of tools that think about when the patient was scheduled for an x-ray, when they were transported to the x-ray department, how long did they wait before they got the x-ray, and how long after they received the x-ray were they provided with the results. These tools support population-based activities that relate to improving health or reducing costs, as well as case management and care coordination, which begs the question, do we really need to know that patient's identity for the tool to be useful? Maybe yes, if we also want to know the patient's sex, their date of birth, their diagnosis, date of admission. Otherwise, we may want to consider whether this tool can be done and be effective without that individually identifiable information. What's more is that there's no federal law that applies to the use of regulated health data in AI. HIPAA was first enacted in 1996 to encourage healthcare providers and insurers to move away from paper medical and billing records and to get online. And so when HIPAA has been updated over the years, the law still remains outdated in that it does not contemplate the use of data to develop or improve AI. So we're faced with applying an old statute to new technology and data use. Again, operating in a gray area that's not uncommon in digital health or for our clients. And to that end, there are several strategies that our HIPAA-regulated clients are thinking of when they're thinking of permissible ways to use PHI in the context of AI. So treatment, payment, healthcare operations activities for covered entities, proper management and administration for business associates, certain research activities and individual authorizations, or de-identified information are all strategies that our clients are currently thinking through in terms of permissible uses of PHI in AI. Wendell: So even though HIPAA hasn't been updated to apply directly to AI, that doesn't mean that HHS has ignored it. So AI, as we all know, has been used in healthcare for many years. And in fact, HHS has actually issued some guidance previously. Under the White House's Executive Order 14110, back in the fall of 2023, which was called Safe, secure, and trustworthy development and use of artificial intelligence, jump-started additional HHS efforts. So I'm going to talk about seven items in that executive order that apply directly to the health industry, and then we'll talk about what HHS has done since this executive order. So first, the executive order requires the promotion of additional investment in AI, and just to help prioritize AI projects, including safety and privacy and security. The executive order also requires that HHS create an AI task force that is supposed to meet and create a strategic plan that covers several topics with AI, including AI-enabled technology, long-term safety and real-world performance monitoring, equity principles, safety, privacy, and security, documentation, state and local rules, and then promotion of workplace efficiency and satisfaction. faction. Third, HHS is required to establish an AI safety program that is supposed to identify and track clinical errors produced by AI and store that in a centralized database for use. And then based on what that database contains, they're supposed to propose recommendations for preventing errors and then avoiding harms from AI. Fourth, the executive order requires that all federal agencies, including HHS, focus on increasing compliance with existing federal law on non-discrimination. Along with that includes education and greater enforcement efforts. Fifth, HHS is required to evaluate the current quality of AI services, and that means developing policies and procedures and infrastructure for overseeing AI quality, including with respect to medical devices. Sixth, HHS is required to develop a strategy for regulating the use of AI in the drug development process. Of course, FDA has already been regulating this space for a while. And then seventh, the executive order actually calls on Congress to pass a federal privacy law. But even without that, HHS's AI task force is including privacy and security, as part of its strategic plan. So given those seven requirements really for HHS to cover, what have they done since the fall of 2023? Well, as the end of July 2024, HHS has created a funding opportunity for applicants to receive money if they develop innovative ways to evaluate and improve the quality of healthcare data used by AI. HHS has also created the AI task force. And many of our clients are asking us, you know, about AI governance. What can they do to mitigate risk from AI? And HHS has, the task force has issued a plan for state, local, tribal, and territorial governments related to privacy, safety, security, bias, and fraud. And even though that applies to the public sector, Our private sector clients should take a look at that so that they know what HHS is thinking in terms of AI governance. Along with this publication, NIST also produces several excellent resources that companies can use to help them with their AI governance journey. Also important is that HHS has recently restructured internally to try to consolidate HHS's ability to regulate technology and areas connected to technology and place that under ONC. And ONC, interestingly enough, has posted job postings for a chief AI officer, a chief technology officer, and a chief data officer. So we would expect that once those roles are filled, they will be highly influential in how HHS looks at AI, both internally and then also externally, and how it will impact the strategic thinking and position of HHS going forward with respect to AI. Our provider and tech clients have also been interested in how AI and what HHS is saying affects certified health IT. And earlier this year, actually, ONC published the HTI-1 rule, which, among other things, is establishes transparency requirements for AI that's offered in connection with certified health IT. And that rule, the compliance deadline for that rule is December 31st of this year. HHS has also been involved in focusing on non-discrimination just as the executive order requires. And so our clients are asking, can they use AI for certain processes and procedures? And in fact, it appears that HHS strongly endorses the use of AI in technology, improving patient outcomes, etc. They've certainly not published anything that says AI should not be used. And in fact, CMS issued a final rule this year and FAQs that clarify that AI can be used to process claims under Medicare Advantage plans, as long as there's human oversight and all other laws are compliant. So there is no indication at all from HHS that using AI is somehow prevented or companies should be worried about using it as long as they comply with existing law. So after the White House executive order in the fall of 2023, HHS has a lot of work to do. They've done some, but there's still a lot to do related to AI. And we should expect more guidance and activity in the second half of 2024.  Outro: Tech Law Talks is a Reed Smith production. Our producers are Ali McCardell and Shannon Ryan. For more information about Reed Smith's Emerging Technologies Practice, please email techlawtalks@reedsmith.com. You can find our podcasts on Spotify, Apple Podcasts, Google Podcasts, reedsmith.com, and our social media accounts.  Disclaimer: This podcast is provided for educational purposes. It does not constitute legal advice and is not intended to establish an attorney-client relationship, nor is it intended to suggest or establish standards of care applicable to particular lawyers in any given situation. Prior results do not guarantee a similar outcome. Any views opinions or comments made by any external guest speaker are not to be attributed to Reed Smith LLP or its individual lawyers.  All rights reserved. Transcript is auto-generated.

En El Gran Musical conversamos con Patricia Pogo, Oncóloga Clínica de Life and Hope, sobre el cáncer de páncreas.

Matt Lowe, MDiv, MSN, APRN, FNP-C, ONC sat down with Olivia J Wolf and Kim Wilder to discuss the current challenges, transitions and opportunities they see in orthopaedic nursing and orthopaedic nurse leadership. Olivia J Wolf, MBA, CPC is a healthcare executive, public speaker and physician advocate who sits on the board of directors for the American Association of Orthopaedic Nurses (AAOE) and is the host of The Stuck(ish) Podcast. Kim Wilder, MSN, RN, ONC, is an administrator for the Baptist Health Surgery Center in Lexington, KY. She has an extensive background in all aspects of orthopaedic nursing, is a featured presenter for NAON at various conferences and serves on the NAON Education Committee. They highlight the unique opportunity for orthopaedic nursing leadership to return purpose to the profession and the important role that associations such as AAOE and NAON play in building invaluable relationships with others in the orthopaedic nursing profession. 

For the 147th episode of the Healthcare IT Today Podcast we are taking inspiration from recent headlines! First, we take a look at the CrowdStrike outage to discuss any updates on the situation and what we have learned from this incident. Then we talk about ONC's elevation to “Assistant Secretary for Technology Policy” within HHS. […]

Hosts Colin Hung and John Lynn discuss: Ripped from the Headlines: Crowdstrike, ONC, Biden/Trump, and the Olympics To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

Ransomware attacks have prompted legislative action to classify such cyber offenses alongside terrorism. A provision authored by Sen. Mark Warner, D-Va., included in the annual intelligence authorization act, seeks to combat the surge in ransomware by naming specific gangs and designating host nations as 'state sponsors of ransomware,' subjecting them to potential U.S. sanctions. Although the U.S. Justice Department has previously prioritized ransomware investigations similarly to terrorism, this proposal would be the first law to formally link ransomware to terrorism. However, its effectiveness is debated among experts due to the complex ties between ransomware actors and their host states. In other news, the Department of State is conducting market research on customizable large language models (LLMs) that could enhance its handling of classified and unclassified data. This initiative is part of an effort to identify available AI tools that meet stringent security requirements, including the Defense Department's Impact Level 6 and moderate-level FedRAMP authorization. This reflects the department's strategic approach to augmenting its diplomatic missions with advanced technology. The Department of Health and Human Services (HHS) is restructuring its technological and AI responsibilities, transferring these from the Assistant Secretary for Administration to the Office of the National Coordinator for Health Information Technology (ONC), now also designated as the Assistant Secretary for Technology Policy. FedScoop's Madison Alder sits down with Micky Tripathi, head of ONC and the new Assistant Secretary for Technology Policy, to discuss the reorganization's goals to enhance departmental AI and tech strategies and improve integration across HHS's diverse agencies. The Daily Scoop Podcast is available every Monday-Friday afternoon. If you want to hear more of the latest from Washington, subscribe to The Daily Scoop Podcast on on Apple Podcasts, Soundcloud, Spotify and YouTube.

ONC releases USCDI version five as they continue to revolutionize data governance at a national level.

In this episode of HIPcast, Susan H. Fenton, PhD, RHIA, ACHIP, FAMIA discusses workforce development for the current workforce and current students around biomedical informatics technology. Dr. Fenton also shares about the ONC-funded project she is managing titled Gaining Equity in Training for Health Informatics and Technology. Our favorite quote from this episode is “Health Information Professionals are the center of the universe”! #HIPcast with Shannan and Seth. Show Sponsor:Datavant – a leader in data logistics for healthcare. Learn more at www.datavant.com   

Get ahead of the competition with highlights from the GOAT of Social Media — Jen Gore. Hear Jennifer live at PIMCON, the first-ever PIM Conference September 15 - 17 | The Phoenician | Scottsdale, AZ Website: Pimcon.org  Code for $200 off: PIMJEN Welcome to Gold Medal Moments on Personal Injury Mastermind, a special mini-series that highlights Chris' favorite lessons from former PIM guests.  Each of these trailblazers and thought leaders will speak live at the inaugural PIMCon, the inaugural Personal Injury Mastermind Conference.  Social Media is no longer optional. It is essential if you want leads. Creating engaging, informative content on these platforms allows you to reach a wider audience, showcase your expertise, and build trust with potential clients. Jennifer Gore knows how to do it right. The GOAT of Social media has built her law firm, Atlanta Personal Injury Law Group, into one of the fastest-growing firms in the country - securing a place on the Onc. 5000 three years in a row.  And social media has been a key driver of that success. She's mastered the art of identifying her target demographic and tailoring her content to their interests and pain points. Press play to learn how you can apply her hard-won lessons to your firm.   Past Guests Past guests on Personal Injury Mastermind: Brent Sibley, Sam Glover, Larry Nussbaum, Michael Mogill, Brian Chase, Jay Kelley, Alvaro Arauz, Eric Chaffin, Brian Panish, John Gomez, Sol Weiss, Matthew Dolman, Gabriel Levin, Seth Godin, David Craig, Pete Strom, John Ruhlin, Andrew Finkelstein, Harry Morton, Shay Rowbottom, Maria Monroy, Dave Thomas, Marc Anidjar, Bob Simon, Seth Price, John Gomez, Megan Hargroder, Brandon Yosha, Mike Mandell, Brett Sachs, Paul Faust, Jennifer Gore-Cuthbert Additional Episodes You Might Enjoy 80. Mike Papantonio, Levin, Papantonio, & Rafferty — Doing Well by Doing Good 84. Glen Lerner, Lerner and Rowe – A Steady Hand in a Shifting Industry 101. Pratik Shah, EsquireTek — Discovering the Power of Automation 134. Darryl Isaacs, Isaacs & Isaacs — The Hammer: Insights from a Marketing Legend 104. Taly Goody, Goody Law Group — Finding PI Clients on TikTok 63. Joe Fried, Fried Goldberg LLC — How To Become An Expert And Revolutionize Your PI Niche 96. Brian Dean, Backlinko — Becoming a Linkable Source 83. Seth Godin — Differentiation: How to Make Your Law Firm a Purple Cow 73. Neil Patel, Neil Patel — Digital A New Approach to Content and Emerging Marketing Channels

With Hosts Simile Miller, DNV TED Director and Renee Cecil, DNV Cardiac Service Portfolio Manager With Special Guests: Jessica Alger, MSN-INF, RN, ONC, Grady Memorial Hospital in Atlanta, GA and Sarah Schroeder, APRN. Bryan Health, Lincoln, NE

En el segmento Salud de El Gran Musical conversamos con Marcela Zamora, Oncóloga y Hematóloga de Life and Hope, sobre la Anemia, ¿cuáles son los mitos y verdades?

Matt Lowe, MDiv, MSN, APRN, FNP-C, ONC, sat down onsite at NAON's 44th Annual Congress in Louisville, Kentucky, with two first-time Congress attendees to discuss their journey in the field of orthopaedic nursing. Kellyann Kosma, DNP, APRN, NP-C, is the advanced practice program manager at Hartford Healthcare Bone & Joint Institute, and she discusses her experience as a podium and poster presenter at Congress. Amanda Hill, BSN, ONC, RN, the total joint registered nurse coordinator at Windy Hill Total Joint Center, talks about the impact that joining NAON has had on her career, enabling her to network while sharing the knowledge and passion of orthopaedic nursing with others.

Dr. Diwakar Davar and Dr. Jason Luke discuss advances in the neoadjuvant immunotherapy space that were presented at the 2024 ASCO Annual Meeting, including promising outcomes in high-risk melanoma from the NADINA trial, as well as other new treatment options for patients with advanced cancers.    TRANSCRIPT Dr. Diwakar Davar: Hello and welcome to the ASCO Daily News Podcast. I'm your guest host, Dr. Diwakar Davar, and I am an associate professor of medicine and the clinical director of the Melanoma Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. I am delighted to have my colleague and friend Dr. Jason Luke on the podcast today to discuss key late-breaking abstracts and advances in immunotherapy that were presented at the 2024 ASCO Annual Meeting. Dr. Luke is an associate professor of medicine, the associate director of clinical research, and the director of the Cancer Immunotherapeutic Center at the University of Pittsburgh Hillman Cancer Center.   You will find our full disclosures in the transcript of this episode.  Jason, it's always a pleasure to hear your insights on the key trials in these spaces and to have you back as a guest on this podcast that highlights some of the work, especially advances, that were just presented. Dr. Jason Luke: Well, thanks very much for the invitation. I always love joining the podcast. Dr. Diwakar Davar: We'll start very quickly by talking about some advances and really interesting things that happened both in the context of melanoma but also in immunotherapy in general. And we'll start with what I think was certainly one highlight for me, which was LBA2, the late-breaking abstract on the NADINA trial. It was featured in the Plenary Session, and in this abstract, Dr. Christian Blank and colleagues reported on the results of this phase 3 trial of neoadjuvant ipi-nivo. This is the flipped dose of ipi1/nivo3 versus adjuvant nivolumab in PD-1 naive, macroscopic, resectable, high-risk stage 3 melanoma.  By way of background, neoadjuvant immunotherapy for those listening is an area of increasing interest for drug developers and development for both approved and novel agents. Neoadjuvant immunotherapy has been studied with multiple approved agents, including PD-1 monotherapy, PD-1 LAG-3, PD-1 CTLA-4, T-VEC, as well as investigational agents and multiple randomized and non-randomized studies. The benchmark pathologic response rates with these agents range from 17% PCR with PD-1 monotherapy, 45% to 55% PCR with PD-1 CTLA-4 combination therapy, and slightly higher 57% PCR with PD-1 LAG-3 has recently reported by Dr. Rodabe Amaria from MD Anderson. However, as we embark on phase 3 comparisons for various neoadjuvant compared to adjuvant immunotherapy trials and combinations, we're increasingly moving towards event-free survival as the primary endpoint for neoadjuvant versus adjuvant studies. And this was most recently studied in the context of SWOG S1801, a study that was led by Dr. Sapna Patel.  So, Jason, before we start on NADINA, can you briefly summarize the SWOG S1801 trial and the event-free survival statistic reported by Dr. Patel and her colleagues? Dr. Jason Luke: Well, absolutely. And these data were reported at ESMO about two years ago and then in the New England Journal last year. The S1801 study answered a very simple question: What would happen if you took three of the doses of standard adjuvant therapy with pembrolizumab and moved them prior to surgery? And on a high level, the study is as simple as that. And many of us were somewhat skeptical of this trial design because we thought that just moving the doses earlier may not actually have a major impact.  In the study, you alluded to the event-free survival statistic, and that alludes to what was considered an event. And so, without reading all of it, there were several different aspects that were included in terms of time, based on the date of randomization until the first of a series of events, such as disease progression, toxicity from treatment, if the patient was unable to go to surgery or had surgical complications, or if they had delay in starting the adjuvant therapy due to toxicity, and obviously, recurrence of melanoma or death from any cause. In that context, merely moving the 3 doses of pembrolizumab to the neoadjuvant setting saw an improvement in this two-year event free survival to 72% for the neoadjuvant therapy compared to 49% for the adjuvant therapy. That was quite an outstanding change. And again, noting the power of neoadjuvant treatment, really dictating the impact of anti PD-1, again, just with 3 doses moving from adjuvant into the neoadjuvant setting, and I think all of us were somewhat surprised to see that magnitude of a benefit. But it set up the current study very well, where we now look at combination therapy. Dr. Diwakar Davar: So let's move on to the phase 3 NADINA trial. Do you want to perhaps discuss the study design, particularly focusing on the EFS primary endpoint and maybe also touching on the different schedules? So, SWOG S1801 was a neoadjuvant study of 3 cycles of pembrolizumab and how did that compare and contrast to the neoadjuvant combination that was studied in NADINA? Dr. Jason Luke: Well, as you alluded to, NADINA investigated the regimen of nivolumab plus ipilimumab and compared that against adjuvant therapy with nivolumab alone. So, in the study, as you alluded, the dose and schedule of the two drugs used was nivolumab at 3 milligrams per kilogram, and ipilimumab with 1 milligram per kilogram. That was based on a series of signal finding and safety studies that had been previously done by the same group of authors identifying that as the optimal treatment regimen. And it's worth noting that's slightly different than the labeled indication that's generally used for those same drugs for metastatic melanoma, albeit that the NCCN also endorses this schedule. So, in the trial, 423 patients were randomized, 1:1 to receive either neoadjuvant therapy with those 2 doses of nivolumab plus ipilimumab as compared with standard adjuvant therapy with nivolumab following surgery.   Now, one interesting tweak was that there was an adaptive nature to the study, meaning that patients had a fiducial placed at the index lymph node, and after the neoadjuvant therapy in that arm, that lymph node was removed. And if the patient had a major pathological response, they did not go on to receive the adjuvant portion of the treatment. So it was adaptive because those patients who did very well to the neoadjuvant did not require the adjuvant portion. And in those patients who did not achieve a major pathological response, they could go on to have the adjuvant therapy. And that also included the BRAF therapy for those whose tumors were BRAF mutants.  It's also worth pointing out that the definition of event free survival was slightly different than in the S1801 study that was alluded to just a second ago. And here, EFS was defined from the date of randomization until progression due to melanoma or due to treatment. So that's slightly different than the definition in the S1801 trial. So, a somewhat complicated study, but I really applaud the authors because I think this study does mirror what we would likely be doing in actual clinical practice.  Dr. Diwakar Davar: So, just to briefly summarize the efficacy, and then to get your comments on this, the path response, the PCR rate was 47%. The major pathologic response rate, which is the proportion of patients with between 0% to 1/10% of residual viable tumors, was about 12%. And for a major pathologic response rate of 0% to 10% of 59%. And then the rest of the patients had either pathologic partial response, which was 10% to 50%, or pathologic non response or 50% or greater residual viable tumor, all assessed using central pathology grades. The one year RFS was 95% in the FDR patient population versus 76% in the pathologic partial response patient population, 57% in the pathologic non response patient population. So how do you view these results? Can you context the FDR rates and the EFS rates from NADINA relative to nivo-rela and also potentially SWOG 1801? Dr. Jason Luke: Well, I think these are very exciting results. I think that for those of us that have been following the field closely, they're actually not especially surprising because they mirror several studies that have come before them. When we put them in context with other studies, we see that these rates of major pathological response are consistent with what we've seen in phase 2 studies. They're relatively similar. Or I should say that the results from nivolumab and relatlimab, which was also pursued in a phase 2 study of somewhat similar design, are somewhat similar to this. So, combination immunotherapy does look to deliver a higher major pathological response than pembrolizumab alone, as was known in S1801. Which of course, the caveat being is these are cross control comparisons that we need to be careful about. So I think all of these are active regimens, and I think adding a second agent does appear to enhance the major pathologic response rates. When we look at the event free survival, we see something similar, which is that numerically it looks to be that combination immunotherapy delivers a higher event free survival rate. And that looks to be rather meaningful given the difference in the hazard ratios that were observed between these various studies. And here in the NADINA study, we see that 0.3 hazard ratio for EFS is just extremely impressive.  So the abstract then, from ourselves, out of these specific studies, what does this mean more broadly in the real world, where patients exist and the rest of the landscape for clinical trials? I think we can't take enough time to stop for a second and just think about what a revolution we've come forward in with immune checkpoint blockade and melanoma. When I started my career, now, more than 15 years ago, melanoma was the cancer that made cancer bad. And now here we say, in the highest risk of perioperative patients, we can deliver 2 doses of nivolumab and ipilimumab, and essentially half of the patients then don't need to go on, and more than half the patients don't need to go on to have a full surgery and don't need adjuvant therapy. And from what we could tell of a very, very low risk of every heavy recurrence of melanoma. Of course, there's the other half of patients where we still need to do better, but these are just fantastic results and I think highly meaningful for patients.   In the context of ongoing clinical trials, another abstract that was presented during the meeting was the update to the individualized neoantigen therapy, or V940 with pembrolizumab or against pembrolizumab alone. That's the KEYNOTE-942 study. In that study, they presented updated data at two and a half years for relapse free survival, noting a 75% rate without relapse. So those results are also highly intriguing. And these are in a similar population of very high risk patients. And so I think most of us believe that neoadjuvant therapy with this study in NADINA is now confirmed as the priority approach for patients who present with high-risk stage 3 disease. So that would be bulky disease picked up on a scan or palpable in a clinic. I think essentially all of us now believe patients should get preoperative immunotherapy. We can debate which approach to take, and it may vary by an individual patient's ability to tolerate toxicity, because, of course, multi agent immunotherapy does have increased toxicity relative to anti PD-1 alone. But we'll have to wait now for the full phase 3 results from the V940 individualized neoantigen therapy. And if those come forward, that will be an extremely attractive approach to think about for patients who did not achieve a major pathological response to neoadjuvant therapy, as well as of course to the other populations of patients with melanoma where we otherwise currently give adjuvant therapy stage 2B all the way through stage 4 resected. It's an amazing time to think about perioperative therapy in melanoma. Dr. Diwakar Davar: So this is clearly outstanding data, outstanding news. Congratulations to the investigators for really doing what is an investigative initiated trial conducted across multiple continents with a huge sample size. So this clearly appears to be, at this point in time at least, a de facto standard. But is this going to be FDA-approved, guideline-approved, or is it possible in your mind? Dr. Jason Luke: Well, that's an interesting question. This study was not designed with the intent to necessarily try to register this treatment regimen with the FDA. One would have to take a step back and say, with how powerful these data appear, it sort of seemed like it would be too bad if that doesn't happen. But all the same, I think the community and those of us who participate in guideline recommendations are fully supportive of this. So, I think we will see this move into compendium listings that support insurance approval, I think, very, very quickly. So, whether or not this actually becomes formally FDA approved or is in the guidelines, I think this should become the standard approach that is considered for patients, again presenting with high-risk stage 3 disease.  Dr. Diwakar Davar: Fantastic. So now we're going to go in and talk about a slightly different drug, but also from the melanoma context, and that is the safety and efficacy of RP1 with nivolumab in the context of patients with melanoma who are PD-1 failures. So, this is Abstract 9517. And in this abstract, our academic colleagues essentially talked about these data, and we'll start by describing what RP1 is. RP1 essentially is a HSV-1 based oncolytic immunotherapy. And RP1 expresses GM-CSF as well as a fusogenic protein, GALV-GP-R-. And in this abstract, Dr. Michael Wong from MD Anderson and colleagues are reporting the results of IGNYTE, which is a phase I trial of intratumoral RP1 co-administered with systemic nivolumab in patients with advanced metastatic treatment refractory cutaneous melanoma. And the data presented in this abstract represents data from a registration directed, abbreviated as RD, registration directed cohort of RP1 plus nivolumab in PD-1 refractory melanoma. So, let's start with the description of the cohort.  Dr. Jason Luke: Right. So, in this study, there were a total of 156 patients who were presented, and that included an initial safety and dose finding group of 16, as well as the RD cohort, as you noted, of 140 patients. And it's important to point out that this was a cohort that was selected for a very strict definition of progression on anti PD-1, or a combination immunotherapy as their immediately prior treatment. So, all of the patients in the cohort had exposure to anti PD-1, and 46% of them had anti PD-1 plus anti CTLA4, nivolumab and ipilimumab as their immediately prior therapy. This was also a group of relatively high-risk patients when one considers stage. So, within the stage 4 population, the entry here included 51% who had stage M1B, C, and D melanoma. And that is worth pointing out because this is an injectable therapy. So, trials like this in the past have tended to be biased towards earlier stage, unresectable or metastatic melanoma, meaning stage 3B, 3C, 3D and then stage 4m1a. Again, to emphasize the point here, these were pretreated patients who had a strict definition of anti PD-1 resistance, and over half of them, in fact, had high-risk visceral metastatic disease.  In that context, it's very interesting to observe that the overall response rate was described in the total population, as 31%, and that included 12% who achieved complete response. And so, again, to make sure it's clear, we're talking about a treatment where the oncolytic virus is injected into one or multiple sites of recurrent disease, and then the patients administer nivolumab as per standard. And so, I think these data are quite intriguing. Again, such a high- risk population and their maturity now, with a follow-up of over a year, I think, makes this look to be a very interesting treatment option.  Dr. Diwakar Davar: I guess on that topic of mature follow-up, it probably would be important for us to inform our audience that the top line data for the primary analysis was actually just released, I think, earlier today, and wherein the central confirmed objective response rate was 34% by modified RECIST and 33% by RECIST, clearly indicating that these responses, as you noted, very treatment refractory patient population, these responses were clearly very durable. So, you mentioned that there were responses seen in uninjected visceral lesions, responses seen in both PD-1 and PD-1 CTLA-4 refractory patients. Can you talk a little bit about the response rate in these high-risk subgroups, the uninjected visceral lesions, the patients who had both combination checkpoint and epidural refractory response rate by primary PD-1 resistance.  Dr. Jason Luke: Sure. You know, I think, again, to emphasize this point in the study, we saw that there were responses in the non-injected lesions, and I think it's really important to emphasize that. Some have referred to this as a putative abscopal like effect, similar to what is described in radiation. But it implies that local treatment with the oncolytic virus is triggering a systemic immune response. In the higher risk patient population, we'll note that whereas the overall response rate in PD-1 refractory patients was 34%, in the combination of PD-1 and CTLA-4 refractory patients, the response rate was 26%. So, [this is] still very good. And when we looked at that split by stage, as I alluded to before, in the population of patients that had, what you might call earlier unresectable diseases, so 3B through 4A, the response rate was 38%, and in the stage 4 M1b through M1d, it was 25%. So slightly lower, but still very good. And that would be as expected, because, of course, the patients with visceral metastatic disease have more advanced disease, but those response rates look quite good. Again, looking at the combination refractory population as well as the more high-risk disease. Dr. Diwakar Davar: So, clearly, these are very promising data and exciting times for multiple investigators in the field and the company, Replimune, as well. So, what are the next steps? I believe that a registration trial is planned, essentially, looking at this with the goal of trying to get this combination registered. Can you tell us a little bit about IGNYTE-3, the trial design, the control arm, and what you foresee this trial doing over the next couple of years?  Dr. Jason Luke: So, as this agent has been maturing, it's worth pointing out that the company that makes this molecule, called RP1, but I guess now we'll have to get used to this name vusolimogene oderparepvec as the actual scientific term, they have been having ongoing discussions with the FDA, and there is the potential that this agent could come forward on an accelerated path prior to the results being released from a phase 3 trial. That being said, the phase 3 confirmatory study, which is called the IGNYTE-3 study, is in the process of being launched now. And that's a study investigating this molecule in combination with nivolumab, as was alluded to earlier, and a randomized phase 3 design, where that combination is compared with a physician's choice, essentially a chemotherapy-based option.   In that study, it will be 400 patients with stage 3B through stage 4; patients will have progressed on anti PD-1, either as a combination or in sequence, and then come on the study to be randomized to either vusolimogene oderparepvec plus nivolumab versus that physician's choice. And the physician's choice includes chemotherapy agents, but also nivolumab plus relatlimab as another option, or an anti PD-1 monotherapy, if that's deemed to be a reasonable option by the treating investigator. And the primary endpoint of that study is overall survival. And unfortunately, in this highly refractory patient population, that's something that may not take long to identify with key secondary endpoints of progression free survival, as well as overall response rate. I'm quite enthusiastic about this study, given these data, which have now been centrally confirmed as you alluded to before. I think this is a very exciting area of investigation and really crossing my fingers that this may be perhaps the first locally administered therapy which does appear to have a systemic impact that can hold up in phase 3. Dr. Diwakar Davar: Very, very, very exciting results. And I guess it's worthwhile pointing out that this company also has got, I think, multiple studies planned with both RP1 and cutaneous squamous cell carcinoma in a solid organ transplant patient population where single agent activity has already been reported by Dr. Migden at prior meetings, as well as a novel trial of potentially RP2 metastatic uveal melanoma. So we'll now pivot to Abstract 6014. So, 6014 is a drug by a company known as Merus. Essentially, it's a very novel agent. Merus essentially is a company that is specialized in making bicyclics and tricyclics. And these are not bicycles or tricycles, but rather drugs that essentially are bispecific antibodies. And Merus essentially has come up with petosemtamab. I think we're going to have to figure out better names for all of these drugs at some point. But petosemtamab, or MCLA-158, essentially is a bicyclic, targeting both EGFR as well as LGR-5. So EGR-5, of course, is a known oncogenic driver in multiple tumor types, squamous, including non small cell lung cancer, cutaneous squamous cell carcinoma, but also head and neck squamous cell carcinoma. And LGR-5 essentially is leucine-rich repeat-containing G-protein coupled receptor 5, but it's a receptor in cancer stem cells and certainly highly expressed in head neck squam. And MCLA-158, or petosemtamab is a IgG one bispecific with ADCC-activity because of IgG1 backbone co-targeting EGFR and LGR5. Merus had earlier results that evaluated petosemtamab monotherapy. They defined the RP2D and second- and third-line head and neck blastoma patients with a respectable response rate of 37% investigator-assessed ORR with six months median DoR, and this was published by Ezra Cohen about a year or so ago.  In this abstract, Dr. Fayette and colleagues report on the results of the MCLA-158-CL01 trial, which is a trial of pembrolizumab plus petosemtamab in one front line head and neck squamous cell population. So maybe let's start with the description of the cohort. And it is a small trial, but we'll be able, I think, to dig into a little bit about why this might be exciting. Dr. Jason Luke: Yes. So, as alluded to, it's not the biggest trial as yet, but there were 26 patients with anti PD-1 treatment naive head and neck squamous cell carcinoma. And all the patients in the study did receive, as you alluded to, pembrolizumab plus petosemtamab. Based on the label for pembrolizumab, all the patients in this study were PDL-1 positive. So that's one point that it's worth pointing out to make sure that that's understood. This is the population of patients who would be expected to benefit from pembrolizumab in the first place. Now, in the abstract, they reported out only 10 response evaluable patients, but they updated that in the actual slides of presentation at the meeting. So among 24 patients that were alluded to, 67% were described as having had a response, although some of those were yet to be confirmed responses. And when it was evaluated by PDL-1 status, there didn't seem to be a clear enrichment of response in the PD-1 positive more than 20% group, as compared to the 1-19% group. That isn't especially surprising because that was a trend that one would see, presumably with pembrolizumab alone. But overall, I think these data are pretty exciting in terms of a preliminary study. Dr. Diwakar Davar: You know, you mentioned that the objective response rate was high, almost 60-something%. The prognosis of these patients is generally poor. The OS is typically thought of as between 6-15 months. And based on KEYNOTE-048, which was led by Dr. Burtness and colleagues, the standard of care in the setting is pembrolizumab +/- platinum based chemotherapy regimens. Allowing for the fact that we only have 10 patients here, how do you think these results stack up against KEYNOTE-048? And you made a very important point earlier, which was, by definition, pembro is on label only for the CPS. So PDL-1 score, at least in head and neck squamous cell carcinoma CPS and not TPS. But in the CPS 1% or greater patient population, where pembro is on label, how do these results stack up against the KEYNOTE-048 results. Dr. Jason Luke: Right. KEYNOTE-048 is considered the seminal study that dictates frontline treatment in head and neck cancer. And before we dive into this too far, we do want to acknowledge that here we're comparing 26 patients versus a phase 3 trial. So, we're not trying to get too far ahead of ourselves, but this is just a preliminary comparison. But in KEYNOTE-048, as you alluded to, two regimens were superior to chemotherapy. One was the pembrolizumab monotherapy, as well as pembrolizumab plus chemotherapy. So again, the study overall survival, of course, was much higher, the PDL-1 positive subgroup, which is what dictated the unlabeled use of this. But response to pembro monotherapy in that population of patients is still modest. We're talking about upwards of 20-30%. So, if you compare that to, again, preliminary evidence here from this trial of only 24 patients, that response rate of 60% seems extremely high. And so even if that were to come down somewhat in a larger data series of patients, that still looks to be quite promising as a treatment regimen, that might eventually even be chemotherapy sparing for this population of patients. I think this raises a lot of eyebrows that perhaps this dual targeting approach, EGFR and LDR-5, may bring something really important to the field that evolves it. Dr. Diwakar Davar: So, what are the next steps for petosemtamab? You mentioned that the activity was interesting. Are we going to see a larger trial? Any thoughts on where things are going to go?  Dr. Jason Luke: Well, based on the phase 2 data of petosemtamab alone, even without pembrolizumab, the molecule had already been given fast track designation by FDA, which means allowing for greater communication between the drug sponsor in the FDA and designing a seminal study design. One would assume that this trial will be rapidly expanded quite greatly, perhaps to 100 or 200 patients, to try to flush out what the real response rate is in a more meaningful number of patients. But I think these data will probably also trigger the design and probably near-term evaluation or expedited acceleration of a phase III clinical trial design that would potentially validate this against the current standard of care. So, I'm pretty excited. I think we'll see a lot more about this agent in the relatively near future. Dr. Diwakar Davar: So, finally, we'll pivot to the last abstract that we're going to talk about, which is Abstract 2504. It's a relatively interesting target, CCR8 monoclonal antibody. But this is the efficacy and safety of LM-108, and LM-108 is an anti CCR8 monoclonal antibody that is being developed by LaNova Medicine. And the results that are described, actually a pool set of results of combinations of LM-108 with anti PD-1, two separate anti PD-1, in patients with gastric cancer, mostly done ex-U.S., which is interesting because of this patient population, and it's a pool result of several, 3 phase 1 and 2 studies.  LM-108 is an Fc-optimized anti CCR8 monoclonal antibody that selectively depletes tumor infiltrating Tregs. The abstract reported a pooled analysis of three phase 1, 2 trials with 3 different NCT numbers that all evaluated the efficacy of LM-108 and anti PD-1 in patients with gastric cancer. So, let's start with the description of the cohort. Maybe, Jason, you can tell us a little bit about before you start, as you describe the cohort, sort of what we know, editorially speaking, about the difficulty with which Tregs depletion has been tried and obviously failed up until now in the tumor microenvironment. Dr. Jason Luke: Right. I think that's a really interesting comment. And so, for decades, in fact, targeting regulatory T-cell to alleviate immune exclusion in the tumor microenvironment has been of interest in immuno-oncology. And in preclinical mouse models, it seems quite clear that such an approach can deliver therapeutic efficacy. However, by contrast, in human clinical trials, various different Treg depleting strategies have been attempted, and there's really little to no evidence that depleting Tregs from human tumors actually can deliver therapeutic responses. And by that we're referring to CD-25 antibodies. The drug ipilimumab, the CTLA-4 antibody, was punitively described as a Tregs depleter preclinically, but that doesn't seem to be the case in patients. And so, in that background, this is quite an eye raiser that an anti CCR8 antibody could be driving this effect. Now, before we talk about the results of this trial, I will point out, however, that given the Fc-optimization, it's entirely possible that the Tregs are being depleted by this mechanism, but that more could also be going on. Because Fc gamma RII binding by this antibody that could be nonspecific also has the potential to trigger immune responses in the tumor microenvironment, probably mediated by myeloid cells. So I think more to come on this. If this turns out to be the first meaningful Tregs depletor that leads to therapeutic efficacy, that would be very interesting. But it's also possible this drug could have multiple mechanisms.  So, having said all of that, in the clinical trial, which was a pooled analysis, like you mentioned, of LM-108 in combination with anti PD-1 of a couple different flavors, there were 48 patients treated either with LM-108, with pembrolizumab, or with toripalimab, which is another anti PD-1 antibody. On the drug combination was, generally speaking, pretty well tolerated, noting grade 3 treatment related adverse events in the range of 38%, which is somewhat expected given combination immunotherapy. We talked about nivolumab and ipilimumab before, which, of course, gives even higher rates of immune-related adverse events, with the most common toxicities being anemia, lipase elevations, rash, ALC decrease; albeit, quite manageable. Dr. Diwakar Davar: So, what about the objective response rate? Can you contextualize the efficacy? And as you do that, maybe we'll think about what you'd expect in the context of, say, gastric cancer, especially in patients who've never really had a prior checkpoint inhibitor before. What do you think about the ORR? What do you think about the relative efficacy of this combination? Dr. Jason Luke: Well, so, in the study, they described overall response rate in the 36 patients as 36% and described immediate progression for survival of about 6.5 months. And so that was among patients who were treatment naive. And in second-line patients, they actually described an even higher response rate, although it was only 11 patients, but they're at 64%. And so, I think those data look to be somewhat interesting. When I was actually scrutinizing the actual data presented, it was of some interest to note that the quality of responses seemed to be about as good on the lower dose of LM-108, so 3 milligrams per kilogram as compared to 10 milligrams per kilogram. I think there's definitely more to learn here to try to optimize the dose and to fully understand what the overall efficacy of this treatment combination would be.  I would emphasize that in this disease, I think novel treatment strategies are certainly warranted. While anti PD-1 with chemotherapy has moved the needle in terms of standard of care treatment, it's really only a minor subset of patients who derive durable long-term benefit like we normally associate with immune checkpoint blockade. I think these are preliminary data. They're very intriguing.   You alluded to earlier that this population of patients was an Asian data set, and it is well known that the efficacy of chemotherapy and immunotherapy does appear to be somewhat enhanced in Asian populations, and that goes to distributions of metastasis and tumor microenvironment effects, etc. Very difficult to try to tease any of that out in this abstract, other than to look at these data and suggest that this is pretty interesting, both from a novel therapeutic approach, we talked about the Tregs consideration, but also straight up on the efficacy because I think if these data could hold up in a larger number of patients, and particularly in a western population of patients, I think it would be very intriguing. Dr. Diwakar Davar: Certainly, ASCO 2024 had a lot of interesting data, including data from targeted agents, the LAURA trial, ADCs. But just focusing on the immune therapy subset, we certainly saw a lot of great advances in patients who were treated with neoadjuvant as well as relapse refractory disease in the context of RP1 and then a couple of newer agents such as this petosemtamab as well as LM-108. And of course, we cannot forget to highlight the extended DMFS data from the pembro vaccine study from KEYNOTE-942.  Jason, as always, thank you for taking a little bit of time out of your extremely busy schedule to come and give us insights as to how these agents are impacting the landscape. We really value your input and so thank you very much.  Dr. Jason Luke: Thank you for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for your time today. You will find the links to all the abstracts that we discussed in the transcript of this episode. And finally, if you value the insights that you hear on this podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. So, thank you.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Follow today's speakers:   Dr. Diwakar Davar   @diwakardavar   Dr. Jason Luke   @jasonlukemd      Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:       Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy       Dr. Jason Luke:    Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX    Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine    Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure    Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)    Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

The Office of the National Coordinator for Health IT has its sights set on advancing health equity through “Health Equity By Design” and U.S. Core Data Interoperability standards to ensure that everyone has fair and equal access to the highest quality of health care regardless of race, gender, disability, location and a host of other factors. Artificial intelligence is also playing a pivotal role in helping agencies achieve national health goals. Recently appointed acting chief AI officer of the Department of Health and Human Services, Tripathi said AI is helping to close health equity gaps when it comes to analytics, determining patient demographics and informing decision-making for treating patients. Tripathi also highlighted ONC's collaborative efforts with the Centers for Disease and Control and Prevention (CDC) and other agencies that are improving interoperability and the integration of public health data.

Commemorating the 20th anniversary of the Office of the National Coordinator for Health Information Technology (ONC). The episode revisits key milestones and initiatives from the ONC's inception in 2004 by executive order of President George W. Bush to its recent accomplishments. Topics include the High Tech Act, the evolution of health IT infrastructure, the significance of electronic health records, and the challenges faced in achieving interoperability. Bill reflects on what worked, what didn't, and the lessons learned for the future, particularly in the context of AI and healthcare technology. The episode also highlights various strategic plans and legislation, such as the 21st Century Cures Act, which have shaped the healthcare IT landscape.00:00 Introduction and Overview00:59 The Birth of ONC03:03 Early Challenges and Investments04:01 The High-Tech Act and Its Impact05:28 Advancements and Unintended Consequences10:48 Strategic Plans and Final Rules12:11 Recent Developments and Future Directions13:14 Conclusion and Reflections

Dr. Diwakar Davar and Dr. Jason Luke discuss key abstracts from the 2024 ASCO Annual Meeting that explore triplet therapy in advanced melanoma, TIL cell therapy in immune checkpoint inhibitor–naive patients, and other novel approaches that could shape the future of immunotherapy in melanoma and beyond.  TRANSCRIPT Dr. Diwakar Davar: Hello and welcome to the ASCO Daily News Podcast. I am your guest host, Dr. Diwakar Davar. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. I'm delighted to have my friend and colleague, Dr. Jason Luke, on the podcast today to discuss key abstracts in melanoma and immunotherapy that will be featured and highlighted at the 2024 ASCO Annual Meeting. Dr. Luke is an associate professor of medicine, the director of the Cancer Immunotherapeutic Center, as well as the associate director for clinical research at the University of Pittsburgh's Hillman Cancer Center.  You will find our full disclosures in the transcript of this episode.  Jason, as always, it's a pleasure to have you on this podcast to hear your key insights on trials in the immunotherapy space and melanoma development paradigm, and to have you back on this podcast to highlight some of this work.  Dr. Jason Luke: Thanks so much for the opportunity to participate. I always enjoy this heading into ASCO.  Dr. Diwakar Davar: We're going to go ahead and talk about three abstracts in the melanoma space, and we will be starting with Abstract 9504. Abstract 9504 essentially is the RELATIVITY-048 study. It describes the efficacy and safety of the triplet nivolumab, relatlimab, and ipilimumab regimen in advanced PD-1 naive melanoma. So in this abstract highlighted by Dr. Ascierto and colleagues, they report on the results of this phase 2 trial in this setting. By way of background, PD-1 inhibitors and immune checkpoint inhibitors starting in PD-1 and CTLA-4, as well as PD-1 and LAG-3, are all FDA-approved on the basis of several pivotal phase 3 trials, including KEYNOTE-006, CheckMate-066, CheckMate-067, and most recently, RELATIVITY-047. Jason, can you briefly summarize for this audience what we know about each of these drugs, at least the two combinations that we have at this time?  Dr. Jason Luke: For sure. And of course, these anti PD-1 agents, became a backbone in oncology and in melanoma dating back to more than 10 years ago now, that response rates in the treatment-naive setting to anti PD-1 with either pembrolizumab or nivolumab are roughly in the range of mid-30s to high-40s. And we've seen clinical trials adding on second agents. You alluded to them with the seminal study being CheckMate-067, where we combined a PD-1 antibody and CTLA-4 antibody or nivo + ipi. And there the response rate was increased to approximately 56%. And more recently, we have data combining PD-1 inhibitors with anti-LAG-3. So that's nivolumab and relatlimab. Now, in that trial, RELATIVITY-047, the overall response rate was described as 43%. And so that sounds, on a first pass, like a lower number, of course, than what we heard for nivolumab and ipilimumab. We have to be cautious, however, that the cross-trial comparison between those studies is somewhat fraught due to different patient populations and different study design. So I think most of us think that the response rate or the long-term outcomes between PD-1, CTLA-4, and PD-1 LAG-3 are probably roughly similar, albeit that, of course, we have much better or much longer follow up for the nivo + ipi combo.  The one other caveat to this, of course then, is that the side effect profile of these two combinations is distinct, where the incidence of high-grade immune-related adverse events is going to be roughly half with nivolumab and relatlimab, a combination of what you would see with the nivolumab and ipilimumab. So that has caused a lot of us to try to think about where we would use these different combinations. But we do see that all of these treatments can land a durable long-term response in the subset of patients that do have an initial treatment benefit. The landmark, I think, for the field has been the 7-and-a-half-year median overall survival that we've seen with PD-1 plus CTLA-4, nivo + ipi; of course, we don't have such long-term follow up for PD-1 and LAG-3. But I think that's the setting for thinking about the rationale for combining a triplet regimen of PD-1, CTLA-4, and LAG-3. Dr. Diwakar Davar: So, Jason, in your mind, given the difference in the disparity and durability of the responses for the 067 regimen of nivo-ipi, and the RELATIVITY-047 regiment of nivo-rela, what is the standard of care in the U.S., and how does it change in the rest of the world, knowing that nivo-rela is not necessarily approved in all jurisdictions? Dr. Jason Luke: So this is a major complication in our field, is that there is perhaps not complete agreement across the world in terms of what the frontline standard of care should be. I think most United States investigators, or those of us that really treat melanoma most of the time, would suggest that a combination regimen, given the enhanced response rate and longer-term outcomes, should be the consideration for the majority of patients. In fact, in my practice, it's hard to think of who I would treat with a monotherapy PD-1 approach in the PD-1 naive setting. So either nivo + ipi or nivo + rela. As you alluded to however, in other regulatory settings throughout the world, combinations might not actually even be approved at this point. So PD-1 monotherapy would be the backbone of that setting. It does set up some complications when you think about a comparator arm; say you were going to look at various combinations, probably PD-1 monotherapy would be the worldwide comparator. You have to understand though, in the United States, I think that that's a less attractive option. Dr. Diwakar Davar: So in RELATIVITY-047, Dr. Ascierto and his colleagues are looking at generating a triplet. And in this case, they looked at this in the context of frontline metastatic melanoma, 46 patients. Very interestingly, the dose of ipilimumab studied here was 1 mg/kg through 8 weeks, not the 3 mg/kg every three weeks times four doses using 067, or even the low dose ipilimumab regimen that you studied in the second line setting, which was 1 mg/kg every 3 weeks for 4 doses. So let's talk about the results and specifically the implications of potentially studying lower doses of ipi. Dr. Jason Luke: I appreciate you raising that point. I think it's really important as we think about this dataset because this triplet regimen is not by any means the only version of a triplet that could be developed using these agents. So just to give the high-level numbers from the abstract, we see from these data that the overall response rate is described as 59% and 78%, a disease control rate with patients having an unreached link. So duration of response of unreached, and then the progression-free survival at about 5 months. So those are really interesting data. But as was alluded to, it's not totally clear to me that that's the best that we could do with this regimen.   Now, you alluded to this low-dose ipilimumab schedule at 1 mg/kg every 8 weeks, and it's really important to note that we have no benchmark for that regimen in melanoma oncology. And in fact, the one study that used that regimen, which was the adjuvant study of nivolumab and ipilimumab, known as CheckMate915, is in fact the only immune checkpoint inhibitor study in melanoma oncology that was actually negative. That study noted no benefit to adding ipilimumab at 1 mg/kg every 8 weeks on top of nivolumab, again, the adjuvant setting. So it's a little bit curious to then understand what it means in this study to have that amount of ipilimumab added to the rela-nivo backbone. And that manifests in a few different ways. We see the response rate here at 59%. Again, if you compare that just against the standard nivo + ipi dosing schedule, it's about the same. So is that really an advantage to having the triplet as compared to just doing standard nivo + ipi?   We do see that it manifests in a slightly lower rate of grade 3/4 immune-related adverse events, at 39%. That's a little bit lower than what we'd expect for standard nivo + ipi. But again, I think that that emphasizes to me the possibility that some efficacy was left on the table by using this very low dose ipilimumab regimen. I think that's really a concern. It's not clear to me that these triplet data really differentiate from what we'd expect with the already approved regimen of nivo + ipi. Therefore, it makes it difficult to think about how would we really want to move this regimen forward, or should there be more work done about dose and schedule to optimize how we might want to do this?  Dr. Diwakar Davar: As far as triplet therapy in the context of frontline metastatic melanoma, meaning triplet immune therapy, because there are at least several targeted therapy triplets that are FDA-approved, [but] not necessarily widely utilized. How would you summarize the future for triplet therapy? Do you think it's potentially attractive? Do you think it's very attractive with some caveats? Dr. Jason Luke: Well, I think it's attractive, and we have 3 independently active agents. And so I do think it's a priority for the field to try to figure out how we could optimize the therapy. We've had such a revolution in melanoma oncology, talking about 7.5-year median survival from CheckMate-067, but that still implies that 7.5 years, half the patients have passed away. There's more to do here. And so I do think it should be a priority to sort this out. I guess I would be cautious, though, about advancing this regimen directly to a phase 3 trial because it doesn't seem clear to me that this is optimized in terms of what the outcome could be. If we're willing to tolerate higher rates of toxicity from other dose schedules of nivo-ipi alone, then I think we should do a little bit more here to potentially explore the space that might be possible to increase that overall response rate a little more without getting into a completely exaggerated toxicity profile that would be unacceptable. So, I do think it's exciting, but there's possibly more to do before really think about going big time with this. Dr. Diwakar Davar: Great. So now we'll switch gears and move from frontline metastatic melanoma to the second line and beyond looking at a new agent and contextualizing the effects of that actually in the frontline settings. So Abstract 9505 describes the efficacy and safety of lifileucel, which is essentially autologous tumor-infiltrating lymphocyte cell therapies, also known as TIL, in combination with pembrolizumab in patients with ICI naive, so not necessarily pretreated, but ICI naive metastatic or unresectable melanoma. This is data from the IOV-COM-202 Cohort 1A oral abstract presented by Dr. Thomas and colleagues. In this abstract, Dr. Thomas and colleagues are presenting data from the 1A cohort, which is the phase 2 portion of the frontline trial that is evaluating autologous TIL with pembro in checkpoint inhibited naive metastatic melanoma.  By way of background, TIL is FDA approved on the basis of several cohorts from a phase 2 trial. The data has been presented multiple times now by Drs. Sarli, Chesney, and multiple colleagues of ours. And essentially autologous TIL, which is generated from a surgical procedure in which a patient undergoes a surgery to extract a tumor from which T cells are then grown after ex vivo expansion and rapid expansion protocol. The entire procedure was essentially pioneered by several colleagues at the NCI, primarily Dr. Steve Rosenberg, and this approach produces objective response rates of approximately 31% to 36%. And the most recent publication demonstrated that at median follow up of approximately 2 years, the median duration of response was not reached. The median OS was about 14 months and PFS was about 4 months or so. So, can you contextualize the results of the abstract in the frontline setting? And then we'll talk a little bit about where we think this is going to go. Dr. Jason Luke: So I think this is a timely study given the recent approval. And in the abstract presented here, we see an early data cut from the PD-1 naive study, as you alluded to. So here we had 22 patients and distributed across various states of advanced melanoma. Ten out of the 22 had M1C, but there also were smatterings of earlier M1A and M1B at 18.2% and 9.1%. So this is important, as we think who the treatment population is that's going to be optimized with a TIL procedure. The median sum of diameters, meaning how much tumor burden the patients have, was about 5.5cm, and I'll note that that's a relatively modest amount of tumor burden, albeit not that unusual for an early-stage trial. So of the patients that participated, 8 had BRAF mutations so that's 36%. That's not that high, but it's reasonable. And I think the important overlying number, the response rate so far in the study, with about 17 months of follow up, was 63.6%, and that includes 22% or 23% having complete response. So those are interesting data.  And another point that was made in the abstract, which we've all seen, is that responses to TIL, all of immunotherapy but especially TIL, do seem to mature over time, meaning they deepen over time. So it's possible the response rate could go up some extent as we watch this study advance. So I think these are exciting data on some level. Also, a 63.6% response rate sounds pretty impressive, but we do have to put that in the context of a double checkpoint blockade, which we just got done discussing, gives you almost a 60% response rate, 59% response rate. So then the question really is: Is it worth the amount of effort that we could go into generating a TIL product in a treatment naive patient, and put them through the lymphodepletion that is associated with TIL and the high dose interleukin 2 treatment that accompanies the reinfusion of the TIL, if you're going to get a response rate that's roughly the same as what you would get if you gave them off the shelf nivo plus ipilimumab?  At this point it's a little bit hard to know the answer to that question. I think it could be possible that the answer is yes, because we don't know exactly which populations or patients are most likely to benefit from each of these therapies. And if it could be teased out who's not going to benefit to nivo + ipi from the get-go, then of course, we would want to offer them a therapy that has that frontline potential, durable, long-term response. But I have to say, on a one-to-one with TIL therapy, you get a lot of toxicity initially with the treatment; with nivo + ipi on the back end, you get a fair amount of toxicity with the treatment. How are we going to judge those two things? And I think we probably need a larger dataset to really have a good handle on that.  So these are interesting early data, but it's not totally clear to me that even if this holds up all the way through the trial, and we're going to talk about the design of the registration trial here in a second, a 60% response rate on its own without further biomarker stratification is a little bit hard for me to see in clinical practice why we would want to do that, given we can already just go off the shelf and give checkpoint inhibitors. Dr. Diwakar Davar: So that brings us to TILVANCE-301. So TILVANCE is a phase 3 trial. It's a registration intent trial by our Iovance colleagues evaluating the pembro-TIL regimen versus pembrolizumab alone. So in this phase 3 trial, approximately 670 patients will be randomized to either arm A, which is lifileucel + pembro. And in this arm A, patients are going to be getting lifileucel with the tumor resection, non-myeloablative lymphoid depletion, the lifileucel and abbreviated course of high-dose IL-2, and thereafter, continued pembro for the study mandated duration versus arm B, where patients will be getting just pembrolizumab monotherapy per label. Arm B patients, per the design, may cross over to receive TIL monotherapy at the time of central-blinded, radiology-confirmed disease progression.   The study design otherwise is fairly routine and, per most of our registration trials these days, patients have actually been permitted to receive neoadjuvant and adjuvant therapy, including checkpoint inhibitors, as long as the receipt of the therapy was more than 6 months prior to the inclusion of the patient in that registration trial. The dual primary efficacy endpoints as stated are BICR-assessed objective response rate as well as PFS, and the key secondary endpoint is overall survival.   So Jason, what are your thoughts on the study design and potentially the regulatory implications, particularly given, one, the control arm of pembro monotherapy, and two, the role of TIL crossover to receive TIL monotherapy at the time of BICR mandated progression for arm B? Dr. Jason Luke: So this goes to a few points that we've touched on already in the discussion here. When we think about the primary endpoints for this study, with one of them being overall response rate, one has to assume that that's a given that they would get that. I feel like that's a low bar. And we go back to that cross-trial comparison. If their results end up being that the response rates are about 60%, I don't know that that differentiates necessarily from what's already available in the field with combination immune checkpoint blockade. For the purposes of the study that would mean it's a positive study, so I think that would probably be good. But again, the comparator to pembrolizumab monotherapy, I think some of us would argue, isn't really consistent with what we would do with a patient in our clinic. So it's not that it's bad per se, but I think there's going to be a whole lot of cross-trial comparison. So if the study is positive, that would be good for getting the drug available. It's still a bit hard though, based on the preliminary data that I've seen, to imagine how this would have uptake in terms of utilization as a frontline therapy.  You alluded to the crossover, and I think there, the assumption is that patients who get TIL therapy as a second line perhaps would have an attenuated benefit. But I'm not sure that's really true. It certainly looks from the data that we have, like the patients who benefit most from TIL are going to be those who didn't respond to anti PD-1 in the front line. So I'm not sure how much difference there's going to be between first- and second-line TIL therapy, but those data will kind of wait to be seen. So I think it's an important study. Of course, the accelerated approval of TIL as a later line therapy is dependent on this trial being positive. So there is some risk that if this trial ended up not being positive, that that could have regulatory implications on the utility or availability of TILs, a subsequent line therapy. But all of these, I guess we'll have to wait to see the results. We do hope for a positive trial here, although I think it'll be nuanced to sort of interpret those data given that pembrolizumab monotherapy control arm.  Dr. Diwakar Davar: Fantastic. So we've learned a lot about TIL, both its use in the second-line setting and this very exciting but potentially risky frontline trial that is ongoing at some centers in the United States and certainly a lot of ex-U.S. enrollment.   So we'll now pivot to a related product which actually belongs to a much larger class of agents that are antigen specific T-cell therapies in a variety of different formats. And that is Abstract 9507, which is the “Phase 1 safety and efficacy of IMC-F106C, a PRAME × CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma (CM).” Now, in this abstract, Dr. Omid Hamid and colleagues reported the results of this phase 1 trial. As a disclosure, I'm an investigator and the last author on this manuscript. Jason, it would be important for our audience, for us to maybe firstly, outline the PRAME as a target, and then the ImmTAC as a platform prior to discussing these results. So let's start with the target PRAME, which I think is a target that you know well. So why don't you start with the target and we'll talk a little bit about that and then the platform? Dr. Jason Luke: Yeah, so I think for the audience, being aware of PRAME, or the Preferentially Expressed Antigen in Melanoma, is going to be quite important moving into the future. So PRAME as a therapeutic target is a cancer testis antigen that's overexpressed in tumor tissues. And of course the name has melanoma in it, but it's not uniquely present in melanoma. So the expression patterns of PRAME as a target are very high in melanoma. So in cutaneous disease, this is upwards of almost 100%, somewhere between 95% and 100%, in metastatic melanoma tissues. And PRAME has several different roles on a molecular level, although I don't think for our purposes here, it's so much important to be aware of them, but rather that this is a very highly expressed target, which then can make it attractive for using T cell receptor-based therapies. And so in the case we're talking about here on the ImmTAC platform, that's a CD3 PRAME×CD3 bispecific approach. But of course there are other approaches that can also be taken, such as TCR T cells that directly go after PRAME itself. Dr. Diwakar Davar: Let's now talk about the platform and how it differs from some of the other antigen targeting platforms that you have just alluded to. I think the Immtac platform is basically a fusion protein comprising engineered TCRs with a CD3 specific short chain variable fragment. And then the engineered TCR therefore binds antigens in an HLA dependent fashion. But you know quite a lot about some of these alternative platforms, and I think it'll be important to contextualize for the audience the difference between ImmTAC, which is a prototype drug that is already approved in the context of tebentafusp. But how does this differ from some of the other more nuanced platforms, such as the Immatics TCR or TCR platform and TScan TCRT nanoplasmonic platform.  Dr. Jason Luke: Right. So the ImmTAC platform as alluded to is already approved on the market with tebentafusp, which is the gp100-CD3 bispecific molecule. And the advantage of that approach is infusion off the shelf of a drug. The downside of it is that it is a weekly dosing strategy as it stands now. And there are some complicated disease kinetics associated with treatment response, which we'll come back to in the context of the PRAME bispecific. Those are, in contrast with T-cell receptor-transduced T cells, as an alternative strategy, which is a form of adopted cell transfer. So we just got done talking about TIL therapy, which of course, is trying to take lymphocytes out of the tumor and grow them up and then give them back. Here with TCR-transduced T cells, we're talking about taking leukopak from the blood and then using different transfection approaches to try to insert into the lymphocytes of the patient a T cell receptor that recognizes to a certain cancer antigen, in this case, PRAME.  So you alluded to a couple of different companies that have different platforms to do this. Immatics has a molecule called IMA 203, for which there have been data disclosed in the past year, again showing some very interesting responses in patients who have highly refractory melanoma. That process, though, again, does require lymphodepletion before you reinfuse the cells. Again, in contrast, the ImmTAC, which is an off the shelf revenue administer, there you have to make the product and then bring the patient back, lymphodeplete, and give the cells back. Immatics platform uses a viral transfection vector. The T scan approach that you alluded to before uses an approach of a mixed system on multiple HLA backgrounds to try to get past HLA-A*02:01 only, and in this case, uses a plasmid-based transfection syndrome that perhaps can be more broadly utilized given the lack of a lentiviral vector.   So this is a complicated area of technology that starts to get into immune engineering, and I think for the purposes of this discussion, we don't want to belabor it. But both of these technologies, talking about the CD3 bispecific with the off the shelf aspect of it and the adoptive cell transfer, each of these using a T cell receptor-based therapy to try to go after PRAME, I think have very high upsides, and I think we'll initially see it in melanoma over the next year or so. But this is likely to be relevant to multiple tumor types beyond melanoma.  Dr. Diwakar Davar: So let's discuss the results of this phase 1 trial. IMC-F106C, like all other ImmTAC, is administered intravenously and does require step-up dosing. You alluded to the fact that the tebentafusp was approved, and it's one of those drugs that is fortunately otherwise administered weekly, which can be difficult for the patient and requires at least the patient spend the first 3 doses overnight under some kind of monitoring, whether it's in the hospital or extended outpatient monitoring, for at least 23 hours. The efficacy of this agent and this platform appears to be surprising in that you tend to see a relatively low RECIST response rate. We'll have you comment a little bit on why that is the case and what may be the role of ctDNA, as opposed to conventional RECIST in assessing response.   At least in this trial, they mandated pre-testing, but did not require it for study enrollment. And pre-positivity was defined using immunohistochemistry with a relatively low H-score of 1%. And the molecular response definition was a 0.5 log or a 68% ctDNA reduction just prior to the first imaging assessment. So how do you contextualize the results? But maybe before you talk a little bit about the results, the ctDNA aspect, that was a recent publication by Drs. Rich Carvajal, Alex Shoushtari, and I think you are also involved in that.  Dr. Jason Luke: So, I think an interesting observation around tebentafusp has been that ctDNA may be a better predictor of long-term outcomes. And how you define ctDNA response is still something that the field is grappling with, albeit that I think is going to be an important consideration as we think about these novel therapies, these ImmTACs and other CD3 engagers moving into the future. But for the purposes of the abstract here, we see that in the population of patients treated, there were 46 patients with cutaneous melanoma. The majority got monotherapy with IMC-F106C, and that's the PRAME bispecific. So 40 patients that got monotherapy and six who got a combination with checkpoint inhibitor. All these patients had prior treatment with immunotherapy, and most of them had PD-1 and CTLA-4 antibody with a small spanner that also had BRAF inhibitors.  In terms of that PRAME testing that you alluded to, based on the immunohistochemistry H-score greater than 1%, 35 out of 40 patients were positive, so they defined 5 as negative. And we could come back if we have time, but there are other ways to do PRAME testing as well that I think may become unique for different agents, maybe an important biomarker. In the data, 31 out of the 46 patients were RECIST evaluable. The outcomes of those patients were to note that the response rate was 13%, which was four partial responses. But 35% of patients had tumor regression with a disease control rate at 65%. It was clear that there was an enrichment by PRAME positivity for both progression free and overall survival. So those patients who had obvious positivity essentially had a doubling of the PFS and more than the doubling of the OS, 2.1 to 4.1 months for TFS and landmark OS, 40% to 94%. So I think these are quite intriguing data.  It does suggest that for the vast majority of patients, we do see some induction of the antitumor effect, albeit that RECIST might undercall the effect. And so this may become another area where the ctDNA monitoring might be able to help us to understand who is likely to have really long-term benefit from this therapy. And given the number of emerging treatments that we have for melanoma, we might be able to really focus in on that group of patients in terms of optimizing how we would use this drug moving into the future. Dr. Diwakar Davar: So you talked about a response rate, and at first glance, this response rate is a little underwhelming. We're talking about 4 out of 31 RECIST evaluable patients, 13%. So it's in the double digits, but barely. So how enthusiastic are you about the results? How does it contrast with at least the publicly known data from other brain targeting approaches, such as the IMA203 agent, understanding that while they may be all targeting somewhat the same target, they are actually extraordinarily different platforms. One's off the shelf, one's highly customized. How do you contextualize the results? How would it contrast with other cellular approaches?  Dr. Jason Luke: I think it's important, again, to emphasize the point you made, which is that they're very different kinds of treatments. So even though they both target PRAME, they're going to be differently useful, and they could be quite useful for different groups of patients. And so here we see that there is a subfraction of patients who are deriving long-term benefit. And we commonly have an argument in our field about, is overall response rate really a useful monitor that describes a patient-centric outcome? While, of course, patients like to know their tumors are shrinking, what they want the most is for the tumors not to get worse and for them not to pass away from cancer. So I think I'm enthusiastic about these results, but emphasizing the point that we need to better understand who is going to benefit the most from this CD3 bispecific PRAME approach and how we're going to be able to harness that into long term benefit for patients because there's no doubt that an off the shelf therapy has a high degree of value relative to adoptive cell transfer, which sort of requires a big wind up.   So when you say, what does it contrast with? Well, the data for IMA203 has shown more than a 50% response rate in patients with more than 5 lines of therapy for metastatic disease. That really looks quite exciting. And several of those patients are now out for quite an extended period, meaning 2 years or more given only a single dose of IMA203. But again, the caveat being, you have to make the cell product for the patient, and that takes time. You lymphodeplete the patient, not all patients can tolerate that in the refractory disease setting, and then they have to be able to tolerate the reinfusion of the cells. And so this drug, IMC-F106C, looks very promising. Moving into the earlier phase trial that we'll talk about, I think the TCR T cell program has a lot of upsides for patients, especially with refractory disease. And so I think these two different approaches are really on parallel tracks. They both target PRAME, but I don't think they necessarily need to be compared one to one, as if they're going to go head-to-head with each other. Dr. Diwakar Davar: So now we'll talk a little bit about the frontline setting, because on the basis of some of these results, Immunocore is now exploring IMC-F106C frontline melanoma. This trial is actually being presented as a trial in progress at this meeting by Georgina Long and colleagues. Some of us are co-authors in that abstract. And in this study, HLA-A*02:01 positive patients with advanced unresectable melanoma will be randomized one to one to the combination of IMC-F106C, which actually, I think after this meeting will be known as bre-ni in combination with nivolumab versus nivolumab regimens, which will either be nivo or nivo-rela, investigators choice and likely dependent on region. So what do you think of the challenge of this trial? We talked about some of the challenges of the TILVANCE trial earlier. But what is going to be the challenge of this trial and in this setting, particularly given the response rates that we've seen so far? Dr. Jason Luke: Yeah, so, similar to comments we had before, thinking about what the optimal control arm is for a study like this is difficult, and so that'll be important as we think about interpreting the results. One has to assume for the purpose of this conversation that it is a positive trial, and that adding the PRAME bispecific theory does lead to an improvement in progression free survival relative to those in checkpoint alone approaches. And I think the magnitude of that difference is going to be of some relevance. And then I think importantly, also figure out who needs this treatment and who's going to benefit long term are going to be really important considerations.  We alluded to how this drug requires an intensive dosing period at the get go, and so telling patients that they need to come in weekly or bi-weekly initially for some number of weeks before they switch to a longer-term intermittent regimen, that comes with real world considerations for patients, their families, their finances, etc. So the benefit has to be clearly obvious that makes it worthwhile doing that, again, because a default could be giving drugs that we've had for 10 years with the nivolumab and ipilimumab. So there's going to be a lot of cross-trial comparison that is going to necessarily have to take place here to think about what these results really mean in the context of other available therapies.  I think the study is reasonable to do. I think this is a very active agent. There's no doubt there's a subset of patients who seem to benefit a lot from it. And I would just emphasize the point that that's probably going to be the most important thing to really drill down on is under the assumption there's a positive trial, we need to know who those people are so we could optimize giving this kind of a treatment to them. Dr. Diwakar Davar: I guess one important point to underscore what Jason said about potential predictive biomarkers, I think as part of the presentation, Dr. Hamid and colleagues will be talking about a candidate predictive biomarker of this agent, which is potentially class specific and not necessarily agent specific of a T cell signature that potentially could define patients who are more likely to benefit from this agent.  So, Jason, as always, thank you for sharing your expertise and insights with the team today. We certainly look forward to catching up again for our wrap up episode after the annual meeting where we'll talk about some of the data that we could not talk about, particularly the late breaking abstracts and other key advances that will shape the future of, certainly the field of immunotherapy and melanoma, potentially the field of cancer immunotherapy at large. Dr. Jason Luke: Oh, thanks very much for the opportunity. Dr. Diwakar Davar: And thank you to our listeners today. You'll find the links to the abstracts discussed today in the transcript of this episode. And finally, if you value the insights that you hear on this podcast, please take a moment to rate, review, and subscribe wherever you get your podcast. So thank you, and we'll see you soon.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Follow today's speakers:   Dr. Diwakar Davar   @diwakardavar   Dr. Jason Luke   @jasonlukemd      Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:       Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy       Dr. Jason Luke:    Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX    Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine    Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure    Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)    Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio      

The Office of the National Coordinator for Health Information Technology (ONC) aims to recruit a more diverse pool of candidates to work in public health care. ONC Deputy National Coordinator for Operations and Chief Operating Officer Lisa Lewis Person helped create the Diversity Equity Inclusion and Accessibility Council back in 2020. An employee-led committee, the council develops policies and programs that ensure all Americans are represented in ONC's workforce. Person also sponsors the Public Health Informatics and Technology (PHIT) Workforce Program, which gives minority serving institutions the ability to provide certifications as well as degrees in public health. She discusses why diversity in health care matters and how it impacts health IT.

In this episode, Patti Brown, LMFT, Founder of Wellness Within, extends a warm welcome to Sara Stratton, NTP, ONC, an Oncology Nutrition Consultant and breast cancer survivor.  Join us as Sara shares her experience and insights into the vital role of nutrition in cancer wellness. Discover the metabolic approach to cancer and practical tips for supporting your body's resilience. Tune in for practical guidance deeply grounded in purpose and inspiration. Sara also references "The Metabolic Approach to Cancer: Integrating Deep Nutrition, the Ketogenic Diet, and Nontoxic Bio-Individualized Therapies," a book that delves into strategies for cancer care through nutrition.Sara, a lifelong health enthusiast with over 20 years of healthcare experience, faced a breast cancer diagnosis at 37.  She utilizes her certifications from the Nutritional Therapy Association and the Oncology Nutrition Institute to empower others in their health journey. Today, thriving five years post-diagnosis in Northern California, Sara inspires through her holistic approach, backed by her education and dedication to helping others eat, move, and live with purpose. Learn more about Sara at:Remission NutritionPurposely RootedThis podcast is sponsored in part by UC Davis Health, Elizabeth A. Harmon D.D.S., and Columbia Bank. It is offered freely to ensure everyone has access to these practices and conversations offered by Wellness Within Cancer Support Services. If you feel inspired to donate to support Wellness Within offerings, please visit www.wellnesswithin.org/giveSupport the Show.This podcast offers health, wellness, fitness and nutritional information and is designed for educational purposes only. You should not rely on this information as a substitute for, nor does it replace, professional medical advice, diagnosis, or treatment. If you have any concerns or questions about your health, you should always consult with a physician or other health-care professional. Do not disregard, avoid or delay obtaining medical or health related advice from your health-care professional because of something you may have read on this site. The use of any information provided on this podcast is solely at your own risk.

Health Affairs' Jeff Byers interviews Jack Hoadley from Georgetown University about the final rule for the Medicare Advantage and Medicare Part D programs for 2025.Read the new Health Policy Brief on digital inclusion.Join us for our ONC 20th anniversary event on May 9.Finish the sentence and win an online journal subscription for a year: You're a health policy wonk if...Become a Health Affairs Insider to read our newsletters on drug pricing, antitrust, and more.Related Links:Differences in Use of Services and Quality of Care in Medicare Advantage and Traditional Medicare, 2010 and 2017 (Health Affairs)Increased Medicare Advantage Penetration is Associated with Lower Postacute Care Use for Traditional Medicare Patients (Health Affairs)DTC Companies Double Down on Medicare Advantage Supplemental Benefits (Health Affairs This Week)

Matt Lowe, MDiv, MSN, APRN, FNP-C, ONC sat down with Dr. Mary O'Connor to discuss the impact that social determinants and individual behavior choices can have on musculoskeletal disparities in our nation. Mary is an orthopaedic surgeon with over 23 years of experience at Mayo Clinic and Yale University School of Medicine and is Co-founder and Chief Medical Officer of Vori Health. As the chair of the board of Directors for Movement is Life, a multidisciplinary coalition with a mission to decrease musculoskeletal health disparities among women and underserved individuals, she shares about the success of their community-based program, Operation Change which focuses on early intervention, education, behavior change and advocacy.

This episode of Enabling Health Value showcases the US National Coordinator for Health IT, Micky Tripathi. He leads the Office of the National Coordinator (or the ONC) – a staff ...

In this episode, our guest is Colin Banas, MD, MSHA, Chief Medical Officer, DrFirst. Colin Banas is an Internal Medicine Hospitalist and the former Chief Medical Information Officer for VCU Health System in Richmond, VA prior to stepping down after 15 fulfilling years to pursue consulting. He is proud to have testified before the U.S. Senate and the Office of the National Coordinator (ONC) on the topic of Health IT and the Meaningful Use Program and is a former Health IT Fellow for the ONC. His interests center the role of big-data and analytics on patient outcomes and on novel forms of Clinical Decision Support, those that are outside of the realm of traditional rules and alerts, and include real-time dashboarding and intuitive usability designs. He also helped spearhead the VCU effort to participate in the Open Notes initiative, where patients have access to their clinical documentation in real time. In 2017 Dr. Banas was humbled to receive the HIMSS-AMDIS award for Physician Executive of the Year from his peers. Pharmacy Interoperability: New Opportunities, Persistent ChallengesTopic Summary: Interoperability has been a buzzword for the healthcare industry for many years, but until now, the conversation has centered around how to get doctors and healthcare systems more accurate, complete patient health data for improved outcomes. In 30 years of e-prescribing, the pharmacy's role – at least where interoperable data sharing is concerned - has been viewed from the narrow lens of fulfillment. Today, there are encouraging signs of change, particularly coming out of the ONC's annual meeting in December 2023. Pharmacy Interoperability: Persistent Challenges….-Technical, economic, structural, and psychological issues that must be addressed-Conflicting concerns/interests of the major players within the industry, including NACDS/NCPA, AMA, HHS, and others-Data standards/lack of available infrastructure and networks to advance and scale interoperability with pharmacists and pharmacies-Competition can impede pharmacy collaboration in data sharing ….New Opportunities-Awareness is growing, more attention and focus from ONC, CMS, and others of the unique technical, economic, and business challenges pharmacies face – and acknowledgment of the critical role pharmacists play as equal members of the patient care team-AI in pharmacy workflow and patient-facing tech solutions are connecting the provider, patient, and pharmacy like never before  -Pharmacy vendors are looking for new and innovative ways to partner within innovative data-sharing business modelsGuest - Dr. Colin BanasHost - Hillary Blackburn, PharmD, MBAwww.hillaryblackburn.com  https://www.linkedin.com/in/hillary-blackburn-67a92421/ @talktoyourpharmacist for Instagram and Facebook@HillBlackburn Twitter/X ★ Support this podcast on Patreon ★

Deputy National Coordinator for Health IT Steven Posnack discusses a few updates to data sharing and interoperability rules for the health IT community, including HTI-1, HTI-2, United States Core Data for Interoperability (USCDI) and Trusted Exchange Framework and Common Agreement (TEFCA). As organizations work to adopt new interoperability standards and policies, artificial intelligence is showing promise for its impact in health IT processes. Posnack highlights how ONC is starting to think about AI and associated ethical concerns.

Female Founders Story - Lygeia Ricciardi Founder of AdaRose Making an Impact Balancing Tech and Human Connection for Improved Well-being Host: Megan Antonelli & Janae Sharp Guest: Lygeia Ricciardi Join them for an insightful interview with Lygeia Ricciardi, a trailblazer with over 20 years of experience in digital health. From her roles at the FCC to ONC and Carium, Lygeia has shaped the landscape of holistic well-being and co-founded AdaRose. In this discussion, we delve into her diverse career, AdaRose's response to the changing dynamics of remote work, the concept of holistic wellbeing, challenges in corporate wellness programs, emerging trends, the balance between technology and human connection, addressing mental health, and the future of corporate wellness. Gain valuable insights and advice from a leading voice in healthcare and wellness on making a positive impact in this transformative space. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

In this episode of the Real Health Podcast, Chief Medical Officer Dr. Ron Hunninghake, MD, talks to Jess Higgins Kelley, MNT, ONC and author of “The Metabolic Approach to Cancer”, about the importance of hydration. Many of us underestimate the health risks that stem from dehydration and toxic water sources. Jess Higgins Kelley, aims to enlighten us on this matter while also providing us with tangible solutions for it. Learn more about the hosts:Dr. Ron Hunninghake: https://riordanclinic.org/staff/ron-hunninghake-md/Jess Higgins Kelley, MNT, ONC: https://www.remissionnutrition.com/jess-higgins-kelley Learn more about Riordan Clinic:https://riordanclinic.org/Interested in becoming a Patient:https://riordanclinic.org/request-an-appointment/Disclaimer: The information contained on The Real Health Podcast and the resources mentioned are for educational purposes only. They are not intended as, and shall not be understood or construed as medical or health advice. The information contained on this podcast is not a substitute for medical or health advice from a professional who is aware of the facts and circumstances of your individual situation. Information provided by hosts and guests on The Real Health Podcast or the use of any products or services mentioned does not create a practitioner-patient relationship between you and any person affiliated with this podcast.

"If you want to be exceptional, you can't do what everybody else is doing...I made a shift about maybe eight months ago. I took a Post-It note put it on the bottom of my monitor, and it said, 'How can GPT support me in this?' Because literally, GPT can support you, whether you want it to write for you or you want it to give you ideas, whether you want to proofread or you want to translate, if you want to come up with jokes or quotes or stats, it literally can support you in anything that you're doing, personally or professionally."   On Take the Stage, presented by Haley Marketing, we bring you the BEST speakers, coaches, trainers, and strategic partners from across the staffing and recruiting industry every other week. More than your standard interview, each conversation is built off of a specific session or topic these industry thought leaders bring to conferences and audiences around the country. KEY MOMENTS FROM THIS EPISODE: 0:01:06 Should the staffing and recruiting industry be afraid of AI? 0:01:46 Recruiters using AI will replace those who are not using it. 0:04:10 AI assistants save recruiters time and improve workflow. 0:06:41 Leveraging AI allows recruiters to spend more time on phone calls. 0:08:39 AI provides recruiters with the ability to influence interviews. 0:11:30 AI can help with prospecting and preparing for sales calls. 0:13:04 "Overwhelm HR" technique uses AI to ask difficult questions. 0:14:56 Entry-level ways to use AI for recruiting and prospecting. 0:17:00 GPT can support you in any task, personally or professionally. 0:18:29 The importance of asking the right questions to optimize efficiency. 0:21:26 Differentiating yourself by not doing what everyone else is doing. 0:22:33 Building personalized cadences for individuals instead of generic ones. 0:23:52 Using AI to write candidate presentations for recruiting firms. 0:26:55 Using AI to free up time for more meaningful tasks 0:27:30 Using AI to capture interview notes Rapid Fire Round: One book that changed your life? Onc conversation with anyone living or dead. Who are you sitting down with? One piece of advice for someone just starting in the staffing industry   ABOUT THE SPEAKERS Brad Bialy  (LinkedIn) Brad Bialy has a deep passion for helping staffing and recruiting firms achieve their business objectives through strategic digital marketing. For over a decade, Brad has developed a proven track record of motivating and educating staffing industry professionals at over 100 industry-specific conferences and webinars.    As a visionary leader, Brad has helped guide the comprehensive marketing strategy of more than 300 staffing and recruiting firms. His keen eye for strategy and delivery has resulted in multiple industry award-winning social media campaigns, making him a sought-after expert and speaker in the industry.    Tricia Tamkin (LinkedIn) My recruiting career began in 1993, I started my search firm in 1997 and began coaching and training recruiters in 2009. Over a 30-year career in this industry, I've produced tens of millions in billing, helped recruiters launch over 50 firms, and positively impacted thousands of recruiters' lives through increased billings. I love what I do!

There's growing excitement that artificial intelligence can make health care better by speeding up care, improving diagnoses and easing the burden on a burned out workforce. But there are also concerns that these powerful new tools will perpetuate biases and inequities long baked into our health care system.In Part 2 of our special series on racial bias in health care AI, we dig into what the Biden administration is doing to keep biased algorithms from getting to the bedside.Guests:Emily Sterrett, MD, Associate Professor of Pediatrics, Director of Improvement Science, Duke University School of Medicine Department of PediatricsMark Sendak, MD, MPP, Population Health & Data Science Lead, Duke Institute for Health InnovationMinerva Tantoco, Chief AI Officer, New York University McSilver Institute for Poverty, Policy and ResearchCarmel Shachar, JD, MPH, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law SchoolKathryn Marchesini, JD, Chief Privacy Officer, Office of the National Coordinator for Health Information TechnologyMelanie Fontes Rainer, JD, Director, HHS Office for Civil RightsLearn more and read a full transcript on our website.Dan Gorenstein will moderate three one-on-one discussions featuring industry leaders and top officials from ONC, FDA, and HHS' Office of Civil Rights over two plenary sessions, you can watch them here.Support this type of journalism today, with a gift, which for a limited time will be matched! Hosted on Acast. See acast.com/privacy for more information.

There's growing excitement that artificial intelligence can make health care better by speeding up care, improving diagnoses and easing the burden on a burned out workforce. But there are also concerns that these powerful new tools will perpetuate biases and inequities long baked into our health care system.In the first of two back-to-back episodes on racial bias in health care AI, we explore the challenge of diagnosing bias in AI and what one health system is trying to do about it.Guests:Emily Sterrett, MD, Associate Professor of Pediatrics, Director of Improvement Science, Duke University School of Medicine Department of PediatricsMark Sendak, MD, MPP, Population Health & Data Science Lead, Duke Institute for Health InnovationGanga Moorthy, MD, Global Health Fellow, Duke Pediatric Infectious Disease ProgramPaige Nong, PhD Candidate, University of Michigan School of Public HealthLearn more and read a full transcript on our website.Dan Gorenstein will moderate three one-on-one discussions featuring industry leaders and top officials from ONC, FDA, and HHS' Office of Civil Rights over two plenary sessions, you can watch them here.Support this type of journalism today, with a gift, which for a limited time will be matched!Want more Tradeoffs? Sign up for our free weekly newsletter featuring the latest health policy research and news. Hosted on Acast. See acast.com/privacy for more information.