Vital Health Podcast

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.

Join 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.

With 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.

In 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.

Congressman 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.

Trials@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.

Douglas 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.

John 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.

This 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.

On 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.