In this episode, host Duane Schulthess sits down with Ipsita Smolinski , Founder and Managing Director of Capitol Street and faculty at Georgetown University and Johns Hopkins Carey Business School. They unpack the Inflation Reduction Act’s drug-pricing mechanisms, assess economic projections against emerging industry data, and discuss how changing R&D incentives, trade policy complexities, and regulatory uncertainty are reshaping the biopharmaceutical landscape. Key Topics: Data-Driven Stra...
Jun 26, 2025•27 min
In this Vital Health Podcast episode, host Duane Schulthess sits down with Steve Potts, biopharma entrepreneur and chair of the Drug Development Council (ICAN), and Robert Coughlin, Managing Director of Life Sciences at Jones Lang LaSalle, to explore how recent policy changes are reshaping the future of drug development. They unpack the unintended consequences of exclusivity gaps, discuss legislative fixes, and examine the broader impact on patients, investors, and regional biotech clusters. Key...
Jun 18, 2025•44 min
In this Vital Health Podcast, host Duane Schulthess speaks with Jocelyn Ulrich , Vice President of Policy and Research at PhRMA , to discuss the far-reaching implications of current U.S. drug pricing and reimbursement policies. With a unique journey from opera stages to Senate testimony, Ulrich brings both strategic acumen and firsthand experience in navigating complex policy terrain. The conversation explores PBM consolidation, the fallout from the Inflation Reduction Act, vertical integration ...
Jun 11, 2025•32 min
In this episode of the Vital Health Podcast, host Duane Schulthess sits down with Jenni Nordborg, Director of International Affairs at The Swedish Association of the Pharmaceutical Industry (LIF), to explore how national and European policies intersect to shape life sciences innovation. They discuss Sweden’s holistic governance model, the strategic framing of healthcare spending as an investment, and the challenges of aligning regional autonomy with EU‑wide regulatory frameworks. Key Topics: - N...
May 22, 2025•26 min
In this episode of the Vital Health Podcast, host Duane Schulthess sits down with patient advocate and Global Liver Institute founder Donna Cryer. They trace her journey from Harvard and the DOJ prosecutor’s office to becoming a liver transplant recipient and a leading voice in healthcare policy. Donna shares insights on orphan drug incentives, the Inflation Reduction Act’s impact on research, the politicization of mRNA innovation, and the current crisis in NIH funding. Key Topics: - Patient Adv...
May 12, 2025•49 min
In this special Grumpies episode, host Duane Schulthess, CEO of Vital Transformation, is joined by neuroscientist and US Business Director Joe Hammang, consulting economist Dr. Harry Bowen, and MSD Associate VP of Science and Regulatory Policy Virginia “Ginny” Acha. They examine the IRA and question its promise to lower drug prices for Medicare beneficiaries, revealing how it discourages R&D, reroutes venture capital, and restricts patient access. What You’ll Learn Pill Penalty Breakdown: Ho...
May 06, 2025•59 min
In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended “small-molecule penalty” baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism, and China’s surg...
Apr 23, 2025•57 min
In 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 wi...
Feb 21, 2025•27 min
Join 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...
Dec 18, 2024•29 min
In 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 transl...
Dec 11, 2024•36 min
In 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 Europ...
Nov 20, 2024•36 min
Join 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-dr...
Nov 06, 2024•39 min
In 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 biote...
Oct 07, 2024•25 min
In 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 pattern...
Sep 25, 2024•27 min
In 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 el...
Sep 18, 2024•57 min
In 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 ...
Sep 13, 2024•19 min
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. Pe...
Sep 04, 2024•48 min
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 ...
Aug 22, 2024•27 min
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 ...
Aug 01, 2024•28 min
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 elaborati...
Jul 03, 2024•20 min
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 mo...
Jun 19, 2024•29 min
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 ...
May 22, 2024•33 min
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 Moderniz...
May 01, 2024•55 min
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. ...
Mar 27, 2024•33 min
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 wel...
Mar 21, 2024•36 min
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 fou...
Mar 14, 2024•54 min
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 PRI...
Feb 07, 2024•26 min
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 u...
Jan 17, 2024•57 min
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 bo...
Nov 08, 2023•49 min
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 Grou...
Nov 01, 2023•41 min
