Flash Forward is a show about possible (and not so possible) future scenarios. What would the warranty on a sex robot look like? How would diplomacy work if we couldn’t lie? Could there ever be a fecal transplant black market? (Complicated, it wouldn’t, and yes, respectively, in case you’re curious.) Hosted and produced by award winning science journalist Rose Eveleth, each episode combines audio drama and journalism to go deep on potential tomorrows, and uncovers what those futures might re ...
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All About Change
1 Jay Ruderman - How to Find Your Fight & Drive Social Change 32:17
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LikedJay is more than just the host of All About Change podcast. He is a lawyer and international activist, who has focused his life’s work on seeking social justice by advocating for the rights of people with disabilities worldwide. On the special episode of All About Change, Mijon Zulu, the managing producer of the "All About Change" podcast, is taking over hosting duties to interview Jay Ruderman about his new book, his activist journey, and why activism is even more important today. Episode Chapters (0:00) intro (02:38) How does one choose a cause to go after? (03:33) Jay’s path to activism (07:50) Practical steps a new activist can take (09:24) Confrontation vs trolling (17:36) Learning from activists operating in different sectors (19:20) Resilience in activism (22:24) Reflections on Find Your Fight and goodbye For video episodes, watch on www.youtube.com/@therudermanfamilyfoundation Stay in touch: X: @JayRuderman | @RudermanFdn LinkedIn: Jay Ruderman | Ruderman Family Foundation Instagram: All About Change Podcast | Ruderman Family Foundation To learn more about the podcast, visit https://allaboutchangepodcast.com/ Looking for more insights into the world of activism? Be sure to check out Jay’s brand new book, Find Your Fight , in which Jay teaches the next generation of activists and advocates how to step up and bring about lasting change. You can find Find Your Fight wherever you buy your books, and you can learn more about it at www.jayruderman.com .…
MEP Pernille Weiss – Rapporteur of the EU GPL
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Content provided by Vital Health Podcast. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Vital Health Podcast or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this Vital Health Podcast, Duane Schulthess speaks to Pernille Weiss, a former Member of the European Parliament and the Rapporteur of the European Parliament’s revision of the EU's General Pharmaceutical Legislation (GPL). The GPL proposes many profound changes to the regulatory structures of the EU’s pharmaceutical sector, and MEP Weiss sat at the centre of the European Parliament’s revision which rolled-back many of the European Commissions’ suggested cuts to regulatory data protection.
Pernille Weiss is a qualified Nurse, and the CEO of the healthcare consultancy Archimed. Vital Transformation’s analysis of the EU GPL's impact on the pharmaceutical ecosystem can be accessed here.
See omnystudio.com/listener for privacy information.
102 episodes
ShareManage episode 438173854 series 2401268
Content provided by Vital Health Podcast. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Vital Health Podcast or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this Vital Health Podcast, Duane Schulthess speaks to Pernille Weiss, a former Member of the European Parliament and the Rapporteur of the European Parliament’s revision of the EU's General Pharmaceutical Legislation (GPL). The GPL proposes many profound changes to the regulatory structures of the EU’s pharmaceutical sector, and MEP Weiss sat at the centre of the European Parliament’s revision which rolled-back many of the European Commissions’ suggested cuts to regulatory data protection.
Pernille Weiss is a qualified Nurse, and the CEO of the healthcare consultancy Archimed. Vital Transformation’s analysis of the EU GPL's impact on the pharmaceutical ecosystem can be accessed here.
See omnystudio.com/listener for privacy information.
102 episodes
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Vital Health Podcast
1 Expanding Oncology Treatments: PRIME-ROSE and the Future of Drug Repurposing 26:55
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Play Later Play Later Lists Like LikedIn this episode of the Vital Health Podcast, host Duane Schulthess speaks with two key voices driving the PRIME-ROSE initiative: Gro Live Fagereng, Project Manager of the EU-project PRIME-ROSE and Coordinator of Precision Cancer Medicine at Oslo University Hospital, and Henk van der Pol, Ph.D. Candidate at Leiden University Medical Center. They explain the DRUP (Drug Rediscovery Protocol) trial approach, which repurposes existing oncology drugs for new off-label uses, and discuss how this can widen treatment options for patients with rare or underserved tumor types. They also describe the complexities of consolidating small patient cohorts across multiple sites and countries, shedding light on how data models like OMOP help standardize clinical information. Listeners will learn about the unique challenges of data harmonization and the importance of building robust evidence in real-world settings. Gro Live and Henk share how PRIME-ROSE is helping healthcare systems coordinate more efficiently, reduce barriers to cutting-edge treatments, and ultimately improve patient outcomes. Tune in for a closer look at how forward-thinking collaborations and adaptive trial designs are reshaping the landscape of precision oncology in Europe. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Breaking Barriers: The Prime Rose Project and Off-Label Drug Innovations 29:15
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Play Later Play Later Lists Like LikedJoin host Duane Schulthess on the Vital Health Podcast as he explores the groundbreaking Prime Rose Project, an initiative redefining the use of off-label drugs in oncology. Featuring insights from Dr. Hans Gelderblom, Chair of Medical Oncology at Leiden University Medical Center, and Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, a member of the Dutch National Payers Evaluation Committee, this episode delves into the challenges and opportunities of drug rediscovery protocols. Learn how this innovative approach balances accessibility, affordability, and evidence-based treatments, transforming the landscape of personalized medicine across Europe. See omnystudio.com/listener for privacy information.…
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1 Impact of the Inflation Reduction Act on Venture Capital in Life Sciences 36:11
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Play Later Play Later Lists Like LikedIn this Vital Health Podcast, John Stanford, Executive Director of Incubate, discusses the impact of the Inflation Reduction Act (IRA) on venture capital investments in life sciences. Stanford emphasizes that the IRA's price control mechanisms have led to significant shifts in funding, particularly away from small-molecule drug development, creating what is described as the "small molecule penalty." Key points include: Venture Capital's Role and Challenges : Venture capital is critical in translating basic research into medicines. The Inflation Reduction Act has disrupted this ecosystem, discouraging investment in certain drugs due to anticipated lower returns under price control regimes. Data from the Life Science Tracker : Stanford highlights the Life Science Tracker findings, showing 36 research programs and 21 specific drug developments discontinued since the IRA's passage. Notably, investments are markedly shifted from small molecules to biologics. Economic and Patient Impact : The IRA has led to reduced innovation in critical areas like oncology and rare diseases. Treatments for diseases like ovarian cancer and blindness have been deprioritized. Stanford argues that the act inadvertently penalizes older patients, the demographic it was designed to benefit, by disincentivizing drugs for age-related diseases. Proposed Solutions : The EPIC Act, a bipartisan effort supported by Incubate, aims to address the disparities by giving small molecules the same 13-year exclusivity period as biologics. Fixing the incentives for drug development, including addressing multiple indication penalties, is crucial to fostering innovation. Critique of Government Assessments : Stanford critiques the Congressional Budget Office (CBO) for its reliance on limited data sources and narrow time horizons, which fail to capture the long-term impacts of the IRA. In conclusion, Stanford stresses the need for legislative adjustments to mitigate the IRA's unintended consequences on drug innovation and patient care. For more insights, listeners are directed to the Life Science Tracker at lifesciencetracker.com . See omnystudio.com/listener for privacy information.…
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1 Investing in Health: Pathways to a Well-being Economy and Smarter Healthcare Budgets 35:30
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Play Later Play Later Lists Like LikedIn this insightful episode of the Vital Health Podcast, we dive deep into the economic and societal benefits of investing in healthcare. Our esteemed guests, Professor Herwig Ostermann, Executive Director, Austrian National Public Health Institute, Professor Dennis A. Ostwald, CEO, WifOR Institute and Professor at Steinbeis School of International Business and Entrepreneurship (SIBE), and Massimo Bordignon, Professor of Public Economics at the Catholic University of Milan and member of the European Fiscal Board, EU Commission, share their expertise on how improved budgeting models and investment metrics can lead to healthier societies and economic growth. Join us as we explore how smart investments in healthcare can drive economic growth and create healthier, more productive societies. Don’t miss this episode packed with valuable insights and practical recommendations. Listen now and be part of the conversation on building a well-being economy through strategic health investments. Key Highlights: Well-being Economy : Professor Ostwald emphasizes the concept of a well-being economy, where health investments are seen not as costs but as crucial investments in the prosperity of countries. He highlights that 12% of Germany’s GDP is related to health investments, showcasing the significant economic impact. Budget Allocation : Professor Ostermann discusses the complexities of health budget allocation in Austria, stressing the need for a holistic approach that integrates various policy areas to maximize the benefits of health investments. EU Perspective : Professor Bordignon talks about the European Union’s new economic framework, which allows for multi-year budgeting, enabling more strategic investments in healthcare. He underscores the importance of seeing health spending as an investment rather than a cost. Prevention and Long-term Planning : The speakers agree on the necessity of shifting from a reactive to a proactive approach in healthcare. Investing in prevention and early diagnostics, particularly for diseases like cardiovascular conditions, can yield substantial long-term benefits. European Health Union : The discussion also touches on the potential of a European Health Union to streamline healthcare investments and policies across member states, enhancing overall efficiency and effectiveness. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Addressing Europe's Health Challenges: Innovation, Prevention, and Policy 38:30
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Play Later Play Later Lists Like LikedJoin us at the Gastein Health Conference for an insightful conversation on Europe's healthcare challenges and innovations! Host Duane Schulthess sits down with experts like Josep Figueras, the Founder and Director of the European Observatory on Health Systems and Policy, Francesca Colombo, the Head of the OECD Health Division, and Annemiek Verkamman, the Managing Director of HollandBIO, to tackle the EU's pressing healthcare issues. From aging populations and non-communicable diseases to data-driven health innovations, they explore how policy, technology, and cross-border collaboration can enhance Europe's healthcare resilience. Tune in for a deep dive into the future of health in Europe! See omnystudio.com/listener for privacy information.…
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1 The Future of Biotech: Steve Potts on Innovation, Policy, and the Impact of the IRA 24:58
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Play Later Play Later Lists Like LikedIn this episode of the Vital Health podcast, host Duane Schulthess sits down with Steve Potts, a seasoned entrepreneur and CEO of SLAM BioTherapeutics. They dive deep into the challenges and opportunities in biotech, exploring how recent legislative changes, like the IRA, are reshaping the industry. Steve shares insights on the shift from small molecules to biologics, the funding landscape, and the critical role of American innovation in drug development. Tune in to hear about the state of biotech in the U.S., the future of drug discovery, and what it takes to succeed in this evolving field. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Revolutionizing Healthcare with Real-World Data 27:13
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Play Later Play Later Lists Like LikedIn the latest episode of the Vital Health podcast, we delve into the future of healthcare with Blythe Adamson from Flatiron Health. Learn how Flatiron is at the forefront of transforming drug discovery through real-world data—using insights from everyday clinical practices to drive innovation and improve patient outcomes.Blythe shares fascinating insights on the role of AI in healthcare, stating, "The integration of AI into our data processes isn't just about speed; it's about uncovering patterns and insights that were previously invisible." She also discusses the unique challenges of navigating health data regulations across different countries and how Flatiron is overcoming these hurdles to make a global impact. This episode is packed with valuable perspectives for anyone interested in biotech, data science, or the evolving landscape of healthcare. See omnystudio.com/listener for privacy information.…
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1 Exploring the Intersection of Intellectual Property and Biotech Innovation 56:52
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Play Later Play Later Lists Like LikedIn the latest episode of the Vital Health podcast, we engage in a thought-provoking discussion with Hans Sauer, Deputy General Counsel for Intellectual Property at the Biotechnology Innovation Organization (BIO), and Gwen O'Loughlin, a seasoned health data researcher. Together, they unpack the complexities of intellectual property (IP) in the rapidly evolving biotech landscape. Hans and Gwen share insights into the current challenges facing the industry, particularly in the wake of new patent eligibility standards. "The crux of innovation in biotech is not just discovery, but ensuring those discoveries are protected and can reach the market," says Sauer, emphasizing the critical role of IP in fostering continued advancement. The conversation also touches on the impact of recent court rulings on biotech patents and what these changes mean for future innovation. Gwen adds, "Understanding these legal nuances is key for anyone in biotech—it’s about protecting your work and driving the industry forward." This episode is a must-listen for anyone involved in biotech, law, or IP management, offering a deep dive into how legal frameworks shape the future of biotechnology. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Unlocking the Power of Genomic Data: NashBIO's Role in Healthcare Innovation 19:00
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Play Later Play Later Lists Like LikedIn this episode of the Vital Health podcast, we dive deep into the world of genomic data and its transformative impact on healthcare. Join host Duane Schulthess as he sits down with Judsen Schneider, CTO of Nashville Biosciences, and Curt Allen, VP of Sales, to explore the origins and growth of Nashville Biosciences. Discover how this pioneering company, in collaboration with Vanderbilt University, is leveraging vast amounts of clinical data to drive innovation in drug development and treatment strategies. Learn about the unique healthcare ecosystem in Nashville, the challenges of coastal bias, and the significant role of data diversity in their success. The discussion also touches on the evolving landscape of AI in healthcare, the global reach of their data, and what the future holds for genomic discovery. Whether you're a healthcare professional, biotech enthusiast, or just curious about the future of medicine, this episode is packed with insights you won't want to miss! Don't forget to like, comment, and subscribe for more episodes of the Vital Health podcast! See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 MEP Pernille Weiss – Rapporteur of the EU GPL 47:33
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Play Later Play Later Lists Like LikedIn this Vital Health Podcast, Duane Schulthess speaks to Pernille Weiss, a former Member of the European Parliament and the Rapporteur of the European Parliament’s revision of the EU's General Pharmaceutical Legislation (GPL). The GPL proposes many profound changes to the regulatory structures of the EU’s pharmaceutical sector, and MEP Weiss sat at the centre of the European Parliament’s revision which rolled-back many of the European Commissions’ suggested cuts to regulatory data protection. Pernille Weiss is a qualified Nurse, and the CEO of the healthcare consultancy Archimed. Vital Transformation’s analysis of the EU GPL's impact on the pharmaceutical ecosystem can be accessed here . See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Transforming Health Communications: Insights from Virginia Amann 26:51
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Play Later Play Later Lists Like LikedJoin us at the International 2024 BIO conference as host Duane Schulthess sits down with Virginia Amann, CEO of the Entente Network. Discover how Virginia has led her firm to become a global leader in strategic communications, crisis management, and behavior science. They discussed the firm's mission to secure positive outcomes for clients, the importance of social capital, and the evolving landscape of health communications. Learn about the latest industry challenges, the impact of COVID-19 on public trust, and innovative strategies for effective advocacy and engagement. Don't miss this in-depth conversation filled with valuable insights for anyone interested in the biotech and life sciences sectors! See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Joe Panetta – Policy Impacts on California Biopharma 27:30
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Play Later Play Later Lists Like LikedWith the continuing pressure placed upon the US biopharma sector from Washington DC, how is the California biopharma ecosystem, arguably the leading hub for innovative biotech worldwide, responding? In this Vital Health Podcast, we speak with Joseph Panetta to discuss this issue. Joe is the President & CEO of Biocom California, an organization representing over 1,800 members working in California's life sciences sector to break down barriers to doing business and advocate for innovation. As the head of Biocom California since 1999, Joe is regarded as a thought leader in biotech and life sciences globally. See omnystudio.com/listener for privacy information.…
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1 Niklas Blomberg, Executive Director, EU Innovative Health Initiative 19:58
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Play Later Play Later Lists Like LikedIn this Vital Health Podcast, recorded live at the 2024 Bio International Conference, host Duane Schulthess sits down with Niklas Blomberg, the Executive Director of the EU Innovative Health Initiative (IHI). Together, they delve into the transformative journey from the Innovative Medicines Initiative to the broader, more inclusive Innovative Health Initiative. Niklas shares his perspectives on fostering collaboration between pharmaceuticals, medical technologies, and diagnostics while elaborating on the challenges and strategies for integrating diverse sectors in healthcare research. Discover how IHI is breaking down silos and creating a collaborative platform that brings together regulators, industry players, and patient organizations. Nicholas also touches on the importance of comprehensive public healthcare systems, the role of SMEs in innovation, and the exciting projects on the horizon, including those addressing regulatory science and digital health. Whether you are interested in public-private partnerships, healthcare innovation, or the future of medical research in Europe, this episode will provide valuable insights and forward-thinking ideas. It’s an engaging discussion with one of the leading voices in global health research. See omnystudio.com/listener for privacy information.…
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1 Congressman Michael Burgess – IRA and March-in Rights 28:55
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Play Later Play Later Lists Like LikedCongressman Michael Burgess is the Chair of the House Rules Committee and one of only 20 M.D.s currently serving in Congress. Before his election to the House of Representatives in 2002 for the 26th District in Texas, Congressman Burgess was a practicing physician in obstetrics and gynecology. In this Vital Health podcast, Congressman Burgess outlines the historical background of the need for the Medicare prescription drug benefit passed in 2003, the risks posed to seniors and U.S. healthcare more broadly due to the Inflation Reduction Act, and the Government’s potential use of march-in rights. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Kim Hawkins - Project Co-Lead of IMI’s Trials@Home 32:51
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Play Later Play Later Lists Like LikedTrials@Home is a €39 million, pan-European public private partnership of the EU’s Innovative Medicines Initiative, focused on defining the best practices to conduct decentralised clinical trials (DCTs). In this Vital Health Podcast, Duane Schulthess speaks with Kim Hawkins, Global Head of Clinical Project Operations at Sanofi, and the Co-Project Lead of the Trials@Home consortium. Kim outlines how Trials@Home is applying new innovative approaches to DCTs to evaluate different operational models of DCTs in RADIAL, the project’s pan-European proof of concept study. As well, Kim Hawkins describes how one core mission of the project is placing patient choices and opinions at the centre of decision making and implementation. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Douglas Holtz-Eakin, “Indications are going to be deeply affected by the IRA” 54:59
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Play Later Play Later Lists Like LikedDouglas Holtz-Eakin was formerly a professor of economics at Syracuse University and served as the director of the Congressional Budget Office from 2003 – 2005. He was the chief economic policy adviser to Senator John McCain's 2008 presidential campaign and is currently president of the American Action Forum, a highly respected think tank in Washington, DC. While heading the CBO, Douglas played a pivotal role in designing and implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, aka the Medicare Part D prescription drug benefit. Given his experience, in this podcast, we reflect upon how that legislation led to the rapid expansion of the U.S. innovative biopharma sector and the material risks posed by the Inflation Reduction Act. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 John LaMattina – Drug Price Controls and IP Attacks Get Real 32:43
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Play Later Play Later Lists Like LikedJohn LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices . He is also a senior partner at PureTech Health and a contributor to Forbes. Last year, when John was a guest on the Vital Health Podcast, the potential impacts of the Inflation Reduction Act (IRA) were still theoretical. But one year on, the Centers for Medicare and Medicaid Services (CMS) released their prices for drug negotiations, and the impacts of the IRA have now become real. John discusses how the IRA will impact the development of critically needed new therapies and provides his insights into the Biden Administration’s recent threats to use march-in rights to confiscate intellectual property as a way to control the price of drugs. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Kate Hudson & Joseph P. Allen – The Fact Free Attacks on IP 35:41
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Play Later Play Later Lists Like LikedThis podcast features Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities, and Joseph P. Allen, the Executive Director of the Bayh-Dole Coalition. They discuss the unintended consequences that the Biden Administration’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act is having on small companies and VCs inside and outside of the biopharmaceutical sector. As well, they detail how well-funded advocacy groups had promoted the use of march-in rights as an effective tool for price controls, and were mistaken in this belief. Kate and Joe also describe a new strategy being pressure tested in DC, promoting the expansion of the application of march-in rights to IP created by the private sector. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 VT’s Grumpy Old Men – The Administration’s Threats to use March-In Rights 53:48
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Play Later Play Later Lists Like LikedOn December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&D. Vital Transformation released our report, March-in rights under the Bayh-Dole Act & NIH contributions to pharmaceutical patents one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements. See omnystudio.com/listener for privacy information.…
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With a six million EUR funding grant from the European Commission, the PRIME-ROSE project will implement, across Europe, a series of prospective, non-randomized clinical trials known as DRUP trials. DRUP trials started in the Netherlands and have successfully increased inclusion rates to offer additional lines of treatment to patients. On this Vital Health Podcast, Duane Schulthess speaks to PRIME-ROSE’s Project Coordinator, Kjetil Tasken of the University of Oslo’s Institute for Cancer, and PRIME-ROSE’s Work Package Lead of Social Innovation, Bettina Ryll of the Stockholm School of Economics Institute for Research. They outline how the project will develop and build upon the DRUP trial model. For more information about the project, contact PRIME-ROSE via email at kjetil.tasken@medisin.uio.no. See omnystudio.com/listener for privacy information.…
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1 Peter Kolchinsky - "IRA's 9 Years Is Too Short" 56:37
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Play Later Play Later Lists Like LikedIn this Vital Health Podcast, Duane Schulthess speaks with Peter Kolchinsky, Managing Partner at RA Capital Management. Peter has authored several critically acclaimed books, including The Great American Drug Deal and The Entrepreneur’s Guide to a Biotech Startup . Peter also serves as the Director of No Patient Left Behind, a non-profit organization. Peter outlines that not only are IRA’s provisions negotiating small molecules after 9 years a huge challenge, but the continuation of ratcheting up of increasingly hostile regulatory proposals is having a demonstrably negative impact on biopharma investments and innovations. See omnystudio.com/listener for privacy information.…
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1 Christian Schneider, CMO Biopharma Excellence 49:05
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Play Later Play Later Lists Like LikedChristian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK’s MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe’s Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU’s proposed revision of the general pharmaceutical legislation. This podcast was supported by The European Federation of Pharmaceutical Industries and Associations (EFPIA) and has been recorded in collaboration with PharmaLex GmbH. It is not meant to serve as legal advice and may contain certain marketing statements. PharmaLex and its parent, Cencora, Inc. strongly encourage listeners to review all available information and to rely on their own experience and expertise in making decisions with regard to the information discussed today. 00:00:01 Introduction 00:01:05 What's your day like as a regulator? 00:09:48 Patient access to novel and effective treatments and patient engagement with the EMA. 00:11:40 Availability of data and clinical trials. 00:14:12 Clinical Trials Regulation. 00:15:19 Europe's loss of competitiveness and its role as an innovator. 00:16:36 The importance of Scientific Advice. 00:17:28 Revision of the EU Pharmaceutical legislation: Fostering innovation and streamlining the regulatory process. 00:20:32 Europe losing ground vis-à-vis the USA: Regulatory assessment. 00:27:37 The use of drug-device combinations. 00:32:30 Reimbursement and pricing decisions and criteria for (High) Unmet Medical Needs. 00:41:02 Revising EU Pharmaceutical legislation and creating a future-proof framework for clinical trials and R&D investments. 00:44:15 Ability of Member States to access all medicines. 00:46:27 Recommendations to the European Commission and the EMA on the EU Pharmaceutical package. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
On this Vital Health Podcast, Duane Schulthess has a conversation with Bettina Ryll, the founder of the Melanoma Patient Network Europe. Bettina is regarded as one of the world’s leading Patient Advocates, who dedicated herself to advocacy after the death of her husband from cancer. While most patient representatives don’t have a medical background, Bettina has a Ph.D. in Biomedical Sciences from University College London. From 2015 – 2018, Bettina chaired the ESMO Patient Advocates Working Group, which was the first time that position was held by a non-oncologist. See omnystudio.com/listener for privacy information.…
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1 Dan Leonard, Executive Director, We Work For Health 36:18
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Play Later Play Later Lists Like LikedDan is the newly appointed Executive Director of We Work For Health, bringing more than two decades of experience in advocacy, policy, and public affairs to this role. He previously headed the Association for Accessible Medicines (AAM) and the National Pharmaceutical Council (NPC). In this podcast, we discuss the ten drugs selected for negotiation under the IRA and their unintended consequences on the availability and access of generic and biosimilar medicines. We also highlight the desire for many regulators to broaden government negotiations within Medicare under the Smart Pricing Act and the recently introduced bill by Congressman Frank Pallone, Jr. (NJ-06). See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Cancer Drug Developer Dr. Steve Potts' Congressional Testimony on the IRA 41:06
41:06 Play Later Play Later Lists Like Liked41:06
Play Later Play Later Lists Like LikedIn this Vital Health Podcast, we’re speaking with Steve Potts before his congressional testimony for the U.S. House Committee on Energy and Commerce. Steve presented evidence regarding the negative impacts of the Inflation Reduction Act on U.S. venture capital investors, the development of small molecules, and the needed therapies that will most likely be lost to patients over the next ten years. Steve is a hugely successful serial entrepreneur in the life sciences, leading several companies to develop new cancer treatments. He is a board member of AZBio and an expert on the development of small molecules for the treatment of cancer. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Amy Miller and the PhRMA Foundation Push the R&D Envelope 38:15
38:15 Play Later Play Later Lists Like Liked38:15
Play Later Play Later Lists Like LikedIn this vital health podcast, we’re speaking with Amy M. Miller, the recently appointed President of the PhRMA Foundation. Amy has held nonprofit leadership roles for nearly 20 years in DC, including President and CEO of the Society for Women’s Health Research and Executive Vice President of the Personalized Medicine Coalition. The PhRMA Foundation catalyzes the careers of promising researchers through competitive peer-reviewed grants and fellowships in the drug delivery, drug discovery, translational medicine, health outcomes research, and value assessment fields. Since its founding in 1965, the Foundation has awarded over $110 million to over 2,700 researchers from diverse backgrounds at more than 300 institutions. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 VT’s Grumpy Old Men on Price Controls and IP Attacks 54:23
54:23 Play Later Play Later Lists Like Liked54:23
Play Later Play Later Lists Like LikedThe U.S. Congress and Biden Administration’s attacks on IP and Drug Pricing continue unabated as the 2024 election approaches. In this Vital Health Podcast, VT’s Grumpy Old Men (Duane Schulthess, Joe Hammang, and Harry P. Bowen) are particularly grumpy about the current state of affairs and dig into their research findings on the Inflation Reduction Act. They also ruminate on what the continued ratcheting-up of rhetoric and legislation against the industry means for tough-to-treat neurological disorders, late-stage cancers, and orphan diseases. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
In this Vital Health Podcast, Duane Schulthess speaks with Rachel King, the Interim CEO of the Biotechnology Innovation Organization (BIO), who is steering the organization through the increasingly choppy waters of the DC drug pricing debate. With mounting regulatory pressure from all angles towards the global biopharma sector, Washington DC’s BIO sits at the center of the tempest. Rachel King comes to BIO with a wealth of experience as the former Chair of BIO’s Board of Directors. She has worked as a VC, and was both the co-founder and CEO of GlycoMimetics. She was also a senior VP at Novartis. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Best-of Edition: Looking back on the COVID-19 outbreak part 2 39:22
39:22 Play Later Play Later Lists Like Liked39:22
Play Later Play Later Lists Like LikedIn this Best-Of edition of the Vital Health Podcast, we’re looking back on the outbreak of the COVID-19 pandemic and discussions we had with statistician Miriam Sturkenboom and Ivor Cummings, both of whom, in very different ways, were at the center of COVID-19 as to the appropriate response to the pandemic. Miriam Sturkenboom, who’s vaccine safety monitoring platform VAC4EU, found herself at the center of a tsunami of vaccine rollouts and safety studies in Europe, providing evidence to the European Medicines Agency and other public health bodies. This podcast was first broadcast in October of 2021. Now an internet and social media legend, it’s likely you’ve stumbled onto Ivor Cummins dissecting the impact of the response to the pandemic with detailed graphs and analysis on YouTube or X (f/k/a Twitter). Before the COVID-19 era, Ivor was a biochemical engineer and had a large following as a presenter on cardiovascular disease, diabetes, and obesity on his popular website, ‘The Fat Emperor.’ The interview with Ivor was first broadcast in February of 2021. See omnystudio.com/listener for privacy information.…
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Vital Health Podcast
1 Best-of Edition: Looking back on the COVID-19 outbreak 47:30
47:30 Play Later Play Later Lists Like Liked47:30
Play Later Play Later Lists Like LikedIn this Best-Of edition of the Vital Health Podcast, we're looking back on the outbreak of the COVID-19 pandemic, and conversations with Epidemiologist Martin Kulldorff, and Political Scientist Wilfred Reilly. By spring of 2020, there were already serious questions being asked about COVID-19 policies, and both men were expressing skepticism of the political approaches being advocated by governments. Martin Kulldorff is a world renown biostatistician at the Harvard Medical School and a co-author of the Great Barrington Declaration . Martin was one of the co-defendants in the recent Federal 1st Amendment case, State of Missouri v. Joseph R. Biden, Jr., et al, which found that he and his colleagues' rights were violated when his opinions regarding COVID-19 were censored on social media by the Biden Administration. This interview was first broadcast on June 19th, 2020. Political scientist Wilfred Reilly is a well-known contrarian on twitter, aka X. He is an Associate Professor of Political Science at Kentucky State University and was an outspoken critic of lockdowns on the basis of his research which found no evidence of their effectiveness. He is the author of several best-selling books on race, politics, and culture in America. This interview was first broadcast on May 22, 2020. See omnystudio.com/listener for privacy information.…
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