Vital Health Podcast

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.

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.

In 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.

Christian 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.

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.

Dan 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.

In 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.

In 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.

The 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.

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. See omnystudio.com/listener for privacy information.

In 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.

In 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.

In this Vital Health Podcast, Duane Schulthess speaks with John Dwyer. John is a serial entrepreneur, having successfully built and sold two healthcare start-ups to 3M and Aetna. He’s now a key player in The Global CEO Initiative on Alzheimer’s Disease, and also serves an active role in the patient advocacy organization U.S. Against Alzheimer’s. John outlines the continued controversy surrounding the Center for Medicare and Medicaid Services' intransigence regarding its coverage decision on the next generation treatments for Alzheimer's disease, despite the recent FDA approval for the drug Leqembi, which includes clinical data showing a significant positive impact on patient outcomes. We also outline how the Inflation Reduction Act is changing the investment decisions for new orphan medicines, and the potential fate of recent Senate proposals such as the Smart Pricing Act. See omnystudio.com/listener for privacy information.

With the Inflation Reduction Act now law, there are mounting concerns that its drug pricing revisions will have a huge negative impact on the California Biotech ecosystem, arguably, the globe’s leading hub for innovative biotech. Joseph Panetta is President & CEO of Biocom, the San Diego, California organization leading 1200 companies, service sector firms, universities and research institutes working in the biotechnology sector. Joe’s been the head of Biocom since 1999 and is universally regarded as one of the world’s biotech thought leaders. In this Vital Health Podcast, Joe Panetta and Duane Schulthess discuss the IRA, the Smart Pricing Act, PBM reform, march-in rights, WTO’s waiver of COVID-19 MRA intellectual property, and the seemingly never-ending federal challenges being foisted upon the innovative biopharma sector in California. In this wide-ranging discussion, Joe and Duane even manage to find time to discuss San Diego’s weather. See omnystudio.com/listener for privacy information.

Amitabh Chandra is the director of health policy research at the Harvard Kennedy School of Government, and a professor of business administration at Harvard Business School. Dr Chandra is a rare voice sounding an alarm about the unintended consequences of the drug pricing provisions of the inflation reduction act. In this Vital Health Podcast, Amitabh highlights the enormous disincentives for small molecules created by the IRA, as companies will receive four fewer years of revenue when compared to large molecules. As well, we touch on the challenges of PBM rebates due to their lack of transparency, and how this is creating political issues for the biopharma sector. See omnystudio.com/listener for privacy information.

In this Vital Health Podcast, we speak with Debbie Hart, President & CEO of BioNJ about the direct impacts of the Inflation Reduction Act upon her members. Under Debbie’s leadership, BioNJ has earned the reputation as the trusted voice of the life sciences industry in New Jersey. Most recently, she was named by Governor Murphy as the new Chair of the New Jersey Commission on Science, Innovation and Technology which supports innovation with grants and other programs. According to the trade journal BioSpace, “New Jersey is one of the most important states in the U.S. pharmaceutical industry. The state is home to 14 of the 20 largest pharmaceutical companies in the U.S., and the New Jersey pharmaceutical industry generates over $120.9 billion in revenue each year, with 63,415 jobs directly linked to the industry.” See omnystudio.com/listener for privacy information.

A Boston Success story, Rhythm Pharmaceuticals brought to market an innovative orphan therapy treating an extremely rare genetic disorder which causes hyperphagia, a pathological hunger that leads to abnormal food-seeking behaviors, and severe obesity. In this Vital Health Podcast, we have a conversation with Dr. Meeker, the Chairman, President & CEO of Rhythm Pharmaceuticals, who was also formerly the President and CEO of Genzyme. David is one of the world’s leading experts in the successful development of therapies for ultra-rare diseases. David gives his vital insights on the risks posed by the Inflation Reduction Act on the development of orphan therapies, as well as the many uncertainties it creates for biopharmaceuticals investors. We also discuss the problems caused by CMS’ continued encroachment into roles normally managed by the FDA, and the implications of Medicare being run like a European-style HTA in the future. As well, we highlight the growing innovative capacity of China in developing next generation therapies, and how this contrasts with the current regulatory pressures being place upon the innovative U.S. biopharma ecosystem. See omnystudio.com/listener for privacy information.