Vital Health Podcast

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Michael Penn, US Head of Reimbursement and Public Policy at Sanofi, to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness.

Key Topics:

IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection.
Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons.
Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development.
Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology.
U.S. Competitiveness: MFN proposals, global R&D incentives, comparisons with China and Europe.

Our new preprint on the IRA’s impact on late-stage R&D is available on our website and examines declines in small-molecule oncology research and orphan oncology studies.

See omnystudio.com/listener for privacy information.

View Details

Across Europe and around the world, demographic change is reshaping our societies. Longer life expectancy, aging populations, and evolving workforce dynamics are creating both new opportunities and growing pressure on healthcare systems, economies, and public policy.

Against this backdrop, health and innovation play an increasingly important role in building resilient societies and supporting healthier, more productive lives. Investing in prevention, early intervention, innovative healthcare solutions, and forward-looking health policies is becoming essential to meeting these challenges.

In this Early Bird edition of the Vital Health Podcast, Duane Schulthess sits with Mike Hodin (Global Coalition on Aging - GCOA; CEO) and Francesca Colombo (Organisation for Economic Co-operation and Development - OECD; Head, Health Division) to explore how strategic investment in health and innovation can help address demographic change and contribute to sustainable social and economic outcomes. They highlight the value of prevention, including adult vaccination, the importance of cardiovascular health, and the critical role of early detection, diagnosis, and timely treatment in cancer care.

Opinions expressed are those of the speakers. Recorded on 6/17/26. This podcast was made with the support of Merck Sharp & Dohme. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Bill Smith (Senior Fellow and Director, Life Sciences Initiative at The Pioneer Institute) to discuss how the 340B program has evolved from a safety net drug discount program into a major source of hospital revenue, what new research suggests about charity care and Medicaid access, and why transparency, hospital consolidation, and broader drug pricing policy are reshaping incentives across oncology and biopharma.

Key Topics:

340B Origins: Medicaid best price, safety net intent, clinic and hospital eligibility.
Hospital Arbitrage: Buy-low sell-high incentives, affluent satellite sites, oncology drug spreads.
Charity Care: Lower reported charity care, Medicaid access concerns, variation across hospital systems.
Transparency Reforms: State reporting laws, separate audited accounts, minimum charity care requirements.
Policy Collisions: Inflation Reduction Act (IRA) price controls, Most-Favored-Nation (MFN) pressure, oncology consolidation, biopharma investment risks.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Steve Potts, CEO of Breakthru Medicine, to discuss how biotech financing, drug pricing policy, scientific infrastructure, and public trust are reshaping oncology innovation and U.S. biopharma leadership.

Key Topics:

Biotech Financing: Series A funding, early-stage platform headwinds, clinical asset momentum, academic funding strain.
Small Molecule Shift: IRA incentives, NDA versus BLA timelines, oncology pipeline pullbacks, antibody drug conjugates.
Orphan Cures and EPIC Acts: Orphan Cures Act, EPIC Act, patent life concerns, investor return requirements.
Most Favored Nation (MFN) Pricing Risk: OECD reference pricing, European access delays, launch sequencing, global cost-sharing tensions.
Science Policy Threats: NIH grant oversight, peer review risks, vaccine backlash, U.S. biopharma leadership.

If biotech CEOs (or an executive delegate from the CEO) are interested in taking the first step toward being a policy voice on one topic in our ecosystem, contact Steve Potts on LinkedIn.

The May 29 Office of Management and Budget sweeping regulatory change, which would shift grant funding decisions from scientists to politicians, is catastrophic for science, patients, and the biotech industry. Please read about what this proposal would do, and if you agree that it would forever tie political views to winning federal funding (and it will cut both ways), please sign this petition or others and speak out: https://fight2win.standupforscience.net/

See omnystudio.com/listener for privacy information.

View Details

In this best-of edition of the Vital Health Podcast, we revisit two conversations Duane Schulthess has with experts on the future of generic medicines, drug shortages, and supply chain risk in the United States.

Patrick Kelly: Chief Advocacy Officer, Healthcare Distribution Alliance
John Murphy: President and CEO, Association for Accessible Medicines

Across these conversations, they discuss how low prices, thin margins, supply chain disruption, reshoring pressure, biosimilar market dynamics, insurance design, and federal pricing policy shape access to generic and biosimilar medicines.

Key Topics:

Generic Economics: Low prices, thin margins, purchaser pressure, manufacturer exits.
Shortage Drivers: Demand spikes, facility shutdowns, sterile injectables, chemotherapy disruptions.
Tariffs and Reshoring: Domestic production costs, national security concerns, tariff pass-through, contract constraints.
Biosimilar Competition: Private-label programs, vertical integration, investment uncertainty, patient access.
Policy and Insurance: IRA redesign, MFN pricing, direct-to-consumer pathways, prescription benefit reform.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Christopher Locher, Chief Executive Officer at Versatope Therapeutics, about the current landscape for vaccine manufacturers and innovators. Their conversation covers vaccine platform development, financing challenges for infectious disease companies, policy and regulatory uncertainty, the public health implications of changes to childhood immunization schedules, and the steps needed to rebuild trust in vaccination.

Key Topics:

Vaccine Platform Innovation: Nanoparticle technology, universal influenza vaccine development, multispecific targeting, infectious disease, and oncology applications.
Financing Challenges: Venture capital headwinds, NIH support, clinical development costs, grant cancellations, and startup survival pressures.
Policy Uncertainty: Changes to childhood immunization schedules, liability debates, academic licensing concerns, royalty proposals, and the biotech investment climate.
Public Health Risks: Vaccine access, childhood disease vulnerability, antimicrobial resistance, influenza complications, and consequences of fragmented immunization policy.
Trust Rebuilding: COVID backlash, transparency concerns, anti-science sentiment, provider-patient communication, rebuilding confidence in vaccines.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Melanie Whittington, Managing Director and Head of the Leerink Center for Pharmacoeconomics and Senior Fellow at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.

They examine how health economic modeling can more accurately reflect real-world market dynamics, the rising pressure behind IRA and MFN drug pricing, the risks to oncology innovation, the limits of conventional cost-effectiveness frameworks, plus the role of transparency and clearer communication of long-term value in sustaining a healthy innovation ecosystem.

Key Topics

Market Modeling: Hypothetical models versus real-world pricing dynamics, patent cliffs.
Pricing Policy: IRA, MFN, market-based pricing scrutiny, communicating why prices are "worth it".
Innovation Incentives: Private capital risk, oncology small molecules, policy-driven pipeline shifts.
Value Framework Limits: QALY concerns, rule-versus-tool debates, GRACE, broader treatment impacts.
Transparency and Outlook: Net price opacity, PBM negotiations, generics and biosimilars, the next innovation cycle.

Opinions expressed are those of the speakers. The Leerink Center for Pharmacoeconomics is a division of MEDACorp.

See omnystudio.com/listener for privacy information.

View Details

Read our MFN preprint: https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two Vital Transformation colleagues on biopharma pricing policy, market access, and innovation risk:

Gwen O'Loughlin: Research Partner at Vital Transformation
Harry Bowen: Consulting Economist at Vital Transformation

They discuss what our new MFN pricing modeling suggests about drug viability, how IRA incentives appear to be reshaping oncology and orphan drug development, why Medicare Advantage and commercial coverage can create administrative friction and delays compared with traditional Medicare, how 340B opacity and consolidation affect the value chain, and what these pressures could mean for insurance premiums, investment, and future innovation.

Key Topics:

MFN Modeling: Net present value analysis, benchmark-country pricing, launch viability, and market uncertainty.
Effects of IRA on Trials: Oncology pullback, small-molecule exposure, orphan drug pressure, and suspended trials.
Coverage Friction: Medicare Advantage burden, prior authorization delays, formulary shifts, and referral slowdowns.
340B Transparency: Vertical integration, hospital consolidation, opaque pricing flows, and revenue pressure.
Innovation Outlook: Premium increases, global competition, intellectual property risk, and future access concerns.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Tim Scott, President & CEO of Biocom California, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California’s life sciences ecosystem became a global innovation engine, why the state’s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China.

Key Topics:

Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California.
Innovation Network: University and research density, regional clusters, talent, and collaboration effects.
Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity.
MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback.
Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today’s political rhetoric about “government-developed drugs” often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from:

Mark Rohrbaugh: Former Director of Technology Transfer and Innovation Policy at the National Institutes of Health (NIH), IP Consultant at Vital Transformation
Gwen O’Loughlin: Research Partner at Vital Transformation

They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug’s origins, why “march-in rights” were designed as a development backstop rather than a pricing tool, and how proposals to redirect royalties or restrict NIH-industry collaboration could disrupt the pipeline that turns early science into real-world therapies.

Key Topics:

NIH’s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why “NIH developed all drugs” is a misleading simplification.
Government Interest Statements: What the statement signals, why it is inconsistently surfaced across patents, and what large-scale reviews suggest about how often it appears in drug-related patent portfolios.
March-In Rights and Policy Misuse: The original purpose (anti-shelving and public health needs), how petitions are evaluated in practice, and why pricing-based efforts have not succeeded.
Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools.
Forward Outlook: How royalty diversion or restricting partnerships could weaken incentives and capacity, and why the guests anticipate near-term disruption with longer-term consequences.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:

Oriana Ciani: Associate Professor of Practice at SDA Bocconi School of Management
Denis Lacombe: Director General at EORTC

They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.

Key Topics:

Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.
Rare Trial Design: Small populations, randomization feasibility, comparator constraints.
Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.
HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.
Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland:

Anja Schiel: Senior Advisor, Norwegian Medical Products Agency
Niklas Hedberg: Chief Pharmacist at The Dental and Pharmaceutical Benefits Agency (TLV)

They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment.

Key Topics:

Trial Generalizability: Selection in trials, real-world populations, and health system variation.
Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges.
Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk.
Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints.
Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with three experts on accelerated patient access to cancer medicines at ISPOR Europe 2025 in Glasgow, Scotland:

Martina Garau: Director at Office of Health Economics
Bettina Ryll: Founder at MPNEurope
Kathleen Grieve: Director - European Public Policy, Access, Pricing and Affordability Lead at MSD Europe

They explore why accelerated access matters when evidence is still emerging, how the APACE framework proposes a structured path from eligibility through reassessment, what it could take to reduce fragmentation across national HTA and reimbursement processes, and why pragmatic pilots and agreed data expectations are central to learning while treating.

Key Topics:

Accelerated Access: Urgency in life-threatening cancer, uneven uptake across countries, and patient time sensitivity.
APACE Framework: Eligibility screening, initial assessment, temporary reimbursement, reassessment, and exit decisions.
National Alignment: EU-level assessment versus country decisions, shared principles, local implementation limits.
Evidence Uncertainty: Early evidence tradeoffs, real-world data needs, and affordability pressure under uncertainty.
Getting Started: Pilot use cases, coalition of the willing, dynamic evidence expectations over time.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

See omnystudio.com/listener for privacy information.

View Details

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.

Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations:

Donna Cryer: Advocacy, Drug Incentives & Research Crisis
Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA
Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks

Key Topics:

Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.
Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.
Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.
PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.
Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.
Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on Most Favored Nation (MFN) drug pricing and its knock-on effects for jobs, state budgets, and the generic supply chain. Over the past year, proposals to link U.S. prices to those in other countries have collided with inflation pressures, tariff debates, and reshoring efforts, creating new uncertainty for manufacturers, payers, and policymakers. In an environment where expectations about future returns are shifting, and the rules of the game are still being defined, this episode is designed as a year-end guide to what MFN-style policies could mean in practice and how to think about the tradeoffs.

Throughout 2025, we our research on MFN-style reference pricing with a series of podcast episodes where host Duane Schulthess sat down with leaders across the generic, distribution, and policy landscape. In this highlights episode, we revisit several of those conversations:

Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks
Patrick Kelly: Inside the Generic Supply Chain Squeeze
John Murphy: Generics, Biosimilars, and U.S. Policy
VT’s Grumpies (Harry Bowen, Joe Hammang) Talk MFN

Key Topics:

MFN Mechanics Explained: How tying U.S. prices to the lowest GDP-adjusted price in a reference basket translates into steep cuts for top-spend medicines in Medicare Parts B and D and shapes expectations across commercial and Medicaid contracts.
Jobs, Earnings, & State Budgets: What our modeling suggests about potential impacts on employment, earnings, and tax revenue under MFN-style reference pricing, and how those effects concentrate in R&D-intensive regions and manufacturing hubs.
Spillovers Into Medicaid, 340B, & ASP: Why MFN in Medicare does not stay in Medicare, how Medicaid best price and 340B ceilings pull discounts across programs, and what lower ASP add-ons could mean for hospital and community oncology margins.
Generics, Shortages, & Tariffs: How razor-thin margins for sterile injectables and generic manufacturers interact with purchaser consolidation, tariff shocks, and price referencing, raising the risk of exits, inventory write-downs, and persistent shortages.
Global Competition & Offshoring: How aggressive reference pricing can accelerate shifts in trials, licensing, and high-value manufacturing to countries that offer more predictable returns, and what that implies for long-run U.S. competitiveness.
Alternatives To MFN: Ideas from our guests on value-based approaches, targeted incentives, and other tools that can improve affordability without hollowing out domestic capacity, innovation, and resilience in the generic and biosimilar supply chain.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

Douglas Holtz-Eakin: “Indications are going to be deeply affected by the IRA”
Steve Usdin: Tariffs, Price Controls, & Inflation Reduction Act (IRA)
VT’s Grumpies Talk IRA with Virginia Acha

Key Topics:

Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.
Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.
Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.
PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.
Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.
Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines:

Steffen Thirstrup: Chief Medical Officer at European Medicines Agency.
Richard Bergstrom: Head of Policy at IQVIA.

They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.

Key Topics

Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments.
Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing.
Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance.
Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons.
Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem.

Key Topics:

Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment.
Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints.
Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe.
HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states.
Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with two Vital Transformation colleagues to explore key trends in drug pricing and macroeconomic policy:

Joe Hammang: US Business Director at Vital Transformation.
Harry Bowen: Consulting Economist at Vital Transformation.

They unpack the Trump administration’s “Most Favored Nation” approach as applied to Medicaid, contrast it with past Medicare proposals, and discuss modeled employment, tax, and GDP impacts. The conversation explores why effects would differ by company and therapy area, the EU’s move toward streamlined compulsory licensing, the knock-on risks for premiums and investment, the fragility of the generics market, and how global competition - including China’s growing clinical footprint - could reshape innovation incentives.

Key Topics:

MFN Basics: What is MFN?, Medicaid focus versus Medicare, price-leveling concept.
Modeled Impacts: Jobs and GDP effects, tax revenue losses, insurance premium pressure.
Uneven Company Effects: Medicaid-heavy portfolios, orphan and rare disease exposure, negotiation dynamics.
EU Signals: Compulsory licensing push, UK pricing realities, risks of spillover to U.S. policy.
Innovation and Competition: Biologics cost structure, generic market fragility, and China’s rising clinical pipeline.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with three leaders advancing precision cancer medicine implementation in Europe:

Bettina Ryll: Stockholm School of Economics, Institute for Research; Founder, Melanoma Patient Network Europe.
Kjetil Taskén: Head of the Institute for Cancer Research, Oslo University Hospital; Professor, University of Oslo; Coordinator, PRIME-ROSE.
Anni Lepland: Head of Personalized Medicine in Oncology, Estonian Cancer Network.

They explore how Europe’s new Joint Action can accelerate equitable precision oncology, what PRIME-ROSE has learned from aggregating data across national pragmatic trials, and why a distributed, bottom-up model with strong patient involvement and industry collaboration is key to scaling access and evidence generation across member states.

Key Topics:

EU Joint Action: Governmental collaboration, precision prevention, diagnosis, and treatment, precision follow-up.
PRIME-ROSE Collaboration: Data sharing agreements, aggregated cohorts, common biomarker definitions, and monthly alignment.
Patient Need First: Options after standard care, access to molecular profiling, pragmatic protocols, and learning from each case.
Widening Country Gaps: Workforce shortages, national coordination, digital tools, and equitable access to innovative drugs.
Industry and Access: Single point of entry for drugs, managed entry agreements, off-label registries, and scaling trials across Europe.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with John Murphy, President and CEO of the Association for Accessible Medicines (AAM), to discuss how U.S. purchasing dynamics and thin margins drive shortages, the evolving biosimilar landscape amid insurer vertical integration, the Inflation Reduction Act (IRA)’s ripple effects on plan risk and rebates, Most Favored Nation (MFN) policy proposals, and what it will take to reshore capacity while preserving competition and patient access.

Key Topics:

Generic Pricing Pressures: Purchaser consolidation, sterile injectables, margin squeeze, and exits.
Drug Shortage Economics: Quality investments, underpriced redundancy, lessons from saline disruptions.
Biosimilar Market Dynamics: Private-label payer programs, rebate tactics, chilling pipeline investment.
Inflation Reduction Act (IRA) and Coverage: Part D risk shift to plans, negotiation uncertainty, and Medicare access delays.
Tariffs and Reshoring: API onshoring realities, carve-outs to avoid shortages, resilient capacity building.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Patrick Kelly, Chief Advocacy Officer at the Healthcare Distribution Alliance, to discuss why generic markets face razor-thin margins and concentration risk, what is driving recent drug shortages, how tariffs and reshoring could affect costs, potential ripple effects from Most Favored Nation pricing, and the rise of direct-to-consumer pathways and traceability across the supply chain.

Key Topics:

Generic Market Pressures: Race-to-the-bottom pricing, manufacturer exits, concentration risks.
Shortage Drivers: Telemedicine demand spikes for controlled substances, facility shutdowns, and sterile injectable constraints.
Tariffs and Reshoring: Section 232 outlook, potential India duties, pass-through pressures to patients.
MFN Pricing Impacts: Inventory devaluation risk, price-depreciation clauses, manufacturer responses.
DTC and Traceability: Direct-to-consumer models, pharmacy and provider roles, DSCSA unit-level safety.

Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this Vital Health Podcast, host Duane Schulthess speaks with two leading European voices on oncology and health economics:

Andreas Charalambous: Chair of Nursing at Cyprus University and Executive Board Member at MASCC, former President of the European Cancer Organization, Director of the Research Center for Oncology and Palliative Care at eOncoRise
Lieven Annemans: Professor of Health Economics at Ghent University, past President of ISPOR

Together, they unpack why the EU’s Beating Cancer Plan and Cancer Mission remain only partially implemented and what it will take to turn commitments into action.

Key Topics

Centralized vs. National Action: Why Europe still needs coordinated cancer strategies alongside national execution, and how fragmentation drives inertia.
Costs, Rarity, and Value: The economics of small patient populations, return on investment, and why rare cancers demand inclusion in national plans.
Prevention & Early Detection: How shifting budgets from treatment to prevention and screening offers long-term impact but little short-term political payoff.
Equity & Access: Unequal survival rates between and within EU member states, limited medicine availability in countries like Greece, and the role of patient engagement.
Data & Accountability: Calls for plan-do-check-act cycles, stronger measurement, and better digital health training for Europe’s cancer workforce.
Financing & Long-Term Policy: Whether EU-level financing instruments should support health infrastructure, and why tackling social and commercial determinants could reshape outcomes over decades.

This episode offers a candid look at the complexity of cancer policy in Europe, exploring prevention, financing, innovation, and political realities that will define cancer care over the next decade.

Opinions expressed are those of the speakers, not the institutions listed. Podcast created with the support of Merck Sharp & Dohme. Recorded July 2025.

See omnystudio.com/listener for privacy information.

View Details

Kirsten Axelsen is an economist specializing in Medicare reimbursement, payer negotiations, and innovative reimbursement contracts. She’s a fellow of the Aspen Institute and a visiting scholar with the American Enterprise Institute. She joins host Duane Schulthess to unpack bipartisan pressure on drug prices, the Part D redesign’s rapid shift of catastrophic costs to plans, and the resulting premium versus coverage tradeoffs and PDP exits.

Axelson explains why forecasting IRA impacts is uncertain, how nine versus thirteen-year timelines tilt incentives toward biologics, and why price controls can weaken both generic entry and biosimilar uptake. The discussion explores MFN-style ideas and trade uncertainties, vertical integration around biosimilars, and practical fixes from EPIC-like timelines to building a faster, more connected U.S. clinical-trial ecosystem with better participant support.

Politics & Incentives: Trump MFN attempts, bipartisan pressure on high drug prices, and insurer dynamics versus the pace of biomedical innovation.
Part D Redesign: The rapid shift of catastrophic costs to plans, premium versus coverage tradeoffs, PDP exits, and access challenges in rural areas.
Modeling & Consequences: Limits of CBO forecasts, uncertainty bands, design choices around price controls, and risks to post-market and follow-on research.
Competition Levers: Small molecule disincentives, low biosimilar uptake on formularies, generic entry pressures under price controls, and plan behavior.
Policy Paths: EPIC-style timeline fixes, negotiation mechanics, MFN and trade uncertainties, and making U.S. clinical trials faster, more connected, and participant-friendly.

Recorded on July 28, 2025. Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this "Best-of" edition of the Vital Health Podcast, Duane Schulthess revisits two listener favorites on the future of medicines in Europe. First, former MEP Pernille Weiss explains how the European Parliament reshaped the EU’s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), outlines how Europe’s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints.

Key Topics

Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states.
Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions.
EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences.
From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints.
Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies.
SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care.

Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this Vital Health Podcast, host Duane Schulthess - joined by Joe Hammang, Vital Transformation's US Business Director - speaks with Henry Skinner (CEO, AMR Action Fund), about the escalating threat of antimicrobial resistance (AMR) and what it will take to rebuild a viable antibiotics pipeline.

The conversation follows the full story - from bedside to boardroom - covering why short-course, stewardship-constrained antibiotics are undervalued, how cancer patients shoulder disproportionate risk, and which practical incentives can bring capital and talent back into the field. Henry Skinner also details how the AMR Action Fund is investing roughly $1B in clinical-stage biotech while emphasizing that policy, diagnostics, and prevention must move in lockstep.

Key Topics

The Antibiotics Market Problem: Short treatment durations, "break-glass" stewardship, and decade-long, high-cost development create a public-goods gap that markets alone will not solve.
Oncology & Sepsis Under AMR: Cancer patients face higher rates of infection and drug-resistant infection, undermining gains from modern cancer care.
Diagnostics Economics: Cultures and advanced molecular tests are underused due to cost and turnaround time, even though delays drive longer ICU stays and higher system costs.
Rebuilding R&D: Big-pharma retreat, brain drain, and investor opportunity costs demand durable pull incentives to attract capital and expertise back to antibiotics.
Prevention: Vaccination and prudent antibiotic use can reduce morbidity, resistance, and cost when the system properly values these tools.

Recorded July 1, 2025. Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this “Best of” edition, host Duane Schulthess revisits two landmark conversations on the long-term impact of the Inflation Reduction Act (IRA) on the biopharmaceutical industry. First, Peter Kolchinsky (Managing Partner, RA Capital Management; Steering Committee Member, No Patient Left Behind), explains why nine-year negotiation timelines for small molecules undermine early-stage R&D and how extending biologics to 13 years still falls short of the “social contract” Congress originally intended. Then, John LaMattina (former President of Pfizer Global R&D Senior Partner, PureTech Health) discusses how real-world IRA pricing is reshaping pipelines, discovery priorities, and venture capital strategies.

Key Topics:

IRA negotiation timelines and their effect on R&D decisions
Differential price-setting mechanisms: nine years for small molecules vs. 13 years for biologics
Patient access challenges under out-of-pocket caps and the case for insurance reform
The march-in rights debate and its (limited) practical impact
Shifts in VC focus and logical portfolio rebalancing

Read our research on the impacts of the IRA: https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/

Originally broadcast Jan 17, 2024 and Mar 27, 2024. Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

See omnystudio.com/listener for privacy information.

View Details

In this episode of the Vital Health Podcast, host Duane Schulthess convenes three leading voices from the 2025 BIO International Convention - prominent physicians, innovators, and advocates shaping the future of drug development in the wake of the Inflation Reduction Act (IRA). Throughout this conversation, they examine policy impacts, clinical ramifications, and patient access challenges:

Barbara McAneny: Former American Medical Association President; Co‑Chair, ONCare Alliance; CEO, New Mexico Oncology Hematology Consultants, Ltd.
Rafael Fonseca: Chief Innovation Officer & Getz Family Professor of Cancer, Mayo Clinic in Arizona
Steve Potts: Chair, Drug Development Council, ICAN (International Cancer Advocacy Network)

Key Topics:

Pipeline Modality Shifts: Early‑stage developers are retooling small molecule programs into biologics, or abandoning follow‑on indications altogether to sidestep the IRA’s nine‑year exclusivity pill penalty.
Clinical Trial Ecosystem: Independent and academic centers alike are seeing fewer small molecule trials, threatening orphan drug expansions and revenue streams that underwrite care.
Oncology Practice Economics: Cuts to drug margins will jeopardize community practices, forcing difficult choices between patient treatment and financial survival.
Patient Affordability & Copays: The cap on out‑of‑pocket oral drug costs versus the hidden burden of high copays and co‑insurance - and why eliminating them could raise premiums only modestly.
PBM & Insurer Vertical Integration: Payers acquiring manufacturers and ownership of formularies are steering patients toward the highest‑rebate products at the expense of clinical judgment.
Broader Systemic Ripples: From congested ERs due to unmanaged side effects to rural access collapse, plus the missed opportunity to cut PBM take‑rates instead of hampering innovation.
Policy Fix Imperatives: Proposals include recalibrating exclusivity durations (extend small molecule to 13 years), automating rebate flows to CMS, and overhauling PBM incentives.

This discussion covers the interplay between drug-pricing reform and the future of care, highlighting unintended consequences and pragmatic solutions. It’s essential listening for policymakers, payers, industry leaders, patient advocates, and every stakeholder invested in sustaining medical innovation and ensuring equitable patient access.

Opinions expressed are those of the speakers, not the companies listed. Recorded on June 16, 2025.

See omnystudio.com/listener for privacy information.

View Details

In this episode, Duane Schulthess is joined by Sam Rasty, Chief Business Officer at Sensorium Therapeutics, Steve Potts, Chair of the Drug Development Council at the International Cancer Advocacy Network, and Joe Hammang, neuroscientist and US Business Director at Vital Transformation, to discuss how U.S. health policy is reshaping neuroscience innovation, investment priorities, and patient access.

Key Topics:
- Investment and R&D Strategy Shifts: Explore how the Inflation Reduction Act’s pricing controls and Medicare negotiations change venture capital allocation and steer neuroscience pipelines.
- Patient Advocacy and Access Barriers: Guests discuss how formulary rules, generic-first requirements, and uneven advocacy across diseases affect drug adoption and innovation incentives.
- Neuroscience Development Hurdles: The discussion highlights how social stigma around psychiatric conditions, fragmented orphan-disease incentives, and small-molecule exclusivity gaps slow CNS drug progress.
- Legislative Fix Imperatives: Contributors outline proposed solutions such as the EPIC Act and expanded orphan-designation policies aimed at restoring balanced incentives for novel therapies.
- Ecosystem Collaboration: The conversation covers the essential partnership between NIH funding, biotech startups, and pharmaceutical companies in advancing drugs from discovery to patients.

This episode examines the policy, economic, and social factors influencing neuroscience drug discovery and the importance of communicating biotech’s value. It also highlights the need to improve the biotech narrative so that policymakers and the public understand its contributions. It is essential listening for industry leaders, investors, policymakers, and patient advocates seeking insight into innovation challenges and solutions.

See omnystudio.com/listener for privacy information.

View Details

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 Strategy: A look at how economic modeling and real-world data underpin policy recommendations for biopharma legislation and health policy.
IRA Drug-Pricing Mechanisms: Exploration of CPI-U–based inflationary rebates, the Part D overhaul with a $2,000 out-of-pocket cap, and the phased rollout of Medicare negotiations in 2026.
Forecasts Versus Impact: Examination of the CBO’s initial estimate of two drugs every ten years compared to later indications of a far greater effect on individual companies.
R&D Incentive Shifts: Analysis of the nine-year exclusivity for small molecules versus thirteen years for biologics and its influence on venture capital flows.
Trade, Tariffs, and Regulation: Discussion of EPIC Act prospects, most favored nation pricing proposals, tariff implementation challenges, China’s expanding trial footprint, and the call for clearer FDA and NIH guidance.

This episode illuminates how the IRA, economic forecasts, and global policy dynamics are influencing drug pricing, innovation incentives, and supply chains. It’s essential listening for policymakers, industry leaders, investors, and anyone invested in the future of healthcare economics and biopharma strategy.

See omnystudio.com/listener for privacy information.

View Details

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 Topics:
- Pill Penalty Explained: How nine-year data exclusivity for small molecules versus 13 years for biologics discourages investment in affordable therapies for older adults.
- EPIC Act Solutions: A bipartisan proposal to extend small-molecule exclusivity to 13 years and rebalance research and development incentives.
- Orphan Drug Incentives: Proposed reforms that would allow multiple exclusivity periods per drug to drive rare disease innovation.
- Patient Advocacy Role: Strategies for empowering patients and disease foundations to influence policy and protect future therapies.
- Biotech Ecosystem Impact: The effect of policy shifts on venture capital flows, lab space demand, and the health of regional innovation hubs.

This episode highlights the critical link between policy design and the pace of medical innovation and why targeted legislative adjustments are essential to sustain future cures. It is a must-listen for policymakers, industry leaders, patient advocates, and anyone interested in the intersection of health policy and drug development.

Recorded on May 30th, 2025.

See omnystudio.com/listener for privacy information.

View Details

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 in biosimilars, and looming tariff threats - all through the lens of innovation, patient access, and economic resilience.

Key Topics

PBM Consolidation Concerns: Three PBMs now control 80% of U.S. prescriptions, raising red flags over patient steering, inflated costs, and limited access.
IRA's Small-Molecule Penalty: The Inflation Reduction Act's nine-year price-setting for pills versus thirteen for biologics is shrinking investment in elderly-targeted therapies.
Vertical Integration in Biosimilars: Insurers and PBMs are now owning biosimilars and pharmacies, limiting patient options and delaying uptake of lower-cost treatments.
Tariff Risks and U.S. Manufacturing: Proposed pharmaceutical tariffs could undermine domestic production despite the sector’s significant economic footprint and current exemptions.
Rebuilding Innovation Incentives: From the EPIC Act to patient-first rebate reform, industry stakeholders are pushing for legislative fixes that sustain R&D and reduce care disparities.

This episode unpacks how policy shifts are reshaping biopharma’s incentive structures, investment flows, and ultimately, patient outcomes. Essential listening for policymakers, investors, and health economists seeking clarity on U.S. pharmaceutical policy and its global ripple effects.

See omnystudio.com/listener for privacy information.

View Details

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:
- National Strategy Spotlight: Sweden’s comprehensive life sciences strategy underscores government priorities and creates cross‑ministerial governance for innovation.
- Regional Autonomy Dynamics: Balancing national directives with regional healthcare mandates enables tailored implementation and closer patient engagement.
- Funding as Investment: Reframing healthcare budgets as long‑term investments is illustrated by Sweden’s hepatitis C program and emerging prevention initiatives.
- Governance and Collaboration: The Office for Life Sciences and public‑private partnerships align industry, academia, and policymakers for cohesive action.
- EU Policy Intersection: Navigating Europe’s complex regulatory landscape - from data protection periods to strategic autonomy - reveals opportunities to accelerate R&D and access.

This episode uncovers the strategic mechanisms behind Sweden’s success in life sciences and offers a roadmap for harmonizing national and EU policies to boost innovation and patient access. It’s essential listening for policymakers, industry leaders, and healthcare stakeholders seeking practical guidance on aligning governance, funding, and regulation for sustainable pharmaceutical advancements.

See omnystudio.com/listener for privacy information.

View Details

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 Advocacy Evolution: Donna reflects on her transition from DOJ prosecutor to founding the Global Liver Institute and amplifying patient voices in healthcare policy.
- Rare Disease Incentive Gaps: An examination of the orphan drug exclusivity landscape and its impact on treatment pipelines for ultra‑rare conditions.
- Inflation Reduction Act Fallout: Insights into how Medicare price controls under the IRA are reshaping research priorities and patient access for older and rare disease populations.
- mRNA Platform Politics: A discussion on the politicization of mRNA vaccines and the threat this poses to future cancer and therapeutic innovations.
- NIH Funding Emergency: A look at the dramatic NIH budget cuts, stalled clinical trials, and the broader implications for biomedical research.

Throughout this episode, Donna Cryer and Duane Schulthess unpack the challenges and potential solutions shaping patient‑driven policy, drug innovation, and research funding – insights critical for anyone invested in the future of healthcare. Patient advocates, healthcare policymakers, and industry leaders will find this discussion indispensable for navigating the complexities of innovation incentives and research ecosystems.

See omnystudio.com/listener for privacy information.

View Details

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: How the 9-year small-molecule vs 13-year biologic exclusivity gap reshapes R&D incentives
Investor Exodus: The flight of early-stage venture capital and its implications for future cures
Access vs Cost: Why poorly designed price controls can restrict, not expand, patient access
Policy Fixes: From the EPIC Act to prize-based innovation rewards, proposed solutions to realign incentives
Global Threats: Tariff talk, reference pricing pitfalls, and reshoring risks for manufacturing and supply security

This episode is essential for policymakers, industry leaders, and anyone invested in the future of medicine. Download our free IRA impact report at the link below: https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/

See omnystudio.com/listener for privacy information.

View Details

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 surge in clinical filings, and what these policy shifts mean for innovation, patient access and America’s competitive edge.

Recorded April 8th, 2025

Key Topics:

Tariffs & Trade Policy: Section 232 investigations threaten pharma-specific levies that drive up interest rates, deter capital raises, and expose domestic and allied supply chains to greater disruption.
Inflation Reduction Act (IRA) Impacts: A nine-year exclusivity window for small molecules versus thirteen for biologics creates a “pill penalty,” chilling R&D in age-related and chronic disease; debates around the EPIC Act and expanded orphan-drug carve-outs aim to recalibrate incentives.
Regulatory Uncertainty: Arbitrary NIH and FDA budget cuts, coupled with an HHS leadership shake-up, are stalling translational science, jeopardizing advanced biomanufacturing efforts, and eroding long-term policy stability.
Science & Public Trust: COVID-era vaccine mandates and missteps have fueled anti-science sentiment and mRNA platform skepticism, complicating future therapeutic innovation and public-health communication.
Global Competition & Talent: China’s record number of IND filings, restrictive H-1B visa policies, and repatriation of PhD talent threaten U.S. biotech preeminence unless immigration and research-funding policies pivot to attract and retain innovators.

See omnystudio.com/listener for privacy information.

View Details

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 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.

View Details

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 innovative approach balances accessibility, affordability, and evidence-based treatments, transforming the landscape of personalized medicine across Europe.

See omnystudio.com/listener for privacy information.

View Details

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 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.

View Details

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 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.

View Details

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-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.

View Details

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 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.

View Details

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 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.

View Details

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 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.

View Details

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 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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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 pilot. 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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

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.

View Details

In this Best-Of edition of the Vital Health Podcast, we’re looking back on the outbreak of the COVID-19 pandemic and discussions I 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.

View Details

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.

View Details

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.

View Details

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.

View Details

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 challenges for the biopharma sector.

See omnystudio.com/listener for privacy information.

View Details

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.

View Details

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.

View Details

This Vital Health Podcast was recorded at the BIO international Conference on the afternoon of the release of Vital Transformation’s research study outlining the impacts of the Inflation Reduction Act on U.S. biopharma innovation. It features Duane Schulthess, Nick Shipley, the Executive Vice President of BIO, and Joe Hammang, Vital Transformation’s US business Director.

The podcast provides an overview of the IRA’s chilling effect on R&D in orphan oncology, and how mandated negotiations at year 9 for small molecules will create an exodus of research funding in neurological disorders, a therapeutic area of high unmet medical need. The discussion also touches on Merck’s lawsuit challenging the legality of the IRA in Federal court, as well as the potential changes that need to be made to the law in the near term to minimize the IRA’s many negative unintended consequences for patients.

See omnystudio.com/listener for privacy information.

View Details

Nikolai Brun is a rare regulator who has rolled up his sleeves and successfully helped bring a therapy to market. He was part of a team at Genmab that discovered one of the first monoclonal antibodies for treating cancer. Nikolai was previously the Chief Medical Officer (CMO) of the Danish Medicines Agency, and has recently gone back into industry, as the CMO of the Swedish biotech company, Affibody.

In this Vital Health Podcast, Nikolai Brun outlines why Europe’s biopharmaceutical sector is falling behind the rest of the world's and how the proposed EU pharmaceutical legislation, while containing many good ideas, may harm the sector instead. The podcast also highlights how the continuing decline in clinical trials in the EU should be setting off alarm bells in Brussels, even if the reaction of many bureaucrats implies that they don’t see this as a concern or a priority.

See omnystudio.com/listener for privacy information.

View Details

The Quality Adjusted Life Year, or QALY, was invented at the UK’s University of York by Prof Alan Williams in the 1970s. Some currently engaged in the bitter trench warfare of America’s drug pricing debate think it’s high time for another British invasion, and the US should fully embrace the UK’s use of QALYs.

In this Vital Health Podcast, we have a discussion with William Smith, a Senior Fellow at the Pioneer Institute, about his recently published book, “Rationing Medicine: Threats from European Cost-Effectiveness Models to America’s Seniors and other Vulnerable Populations.” William makes a strong case that the use of QALY for cost-effectiveness assessments within Medicare and Medicaid would violate several key provisions of the Americans with Disabilities Act.

See omnystudio.com/listener for privacy information.

View Details

Andrew Roddam is the CEO of Our Future Health, the UK’s largest ever health research programme. The objective of Our Future Health is to bring together up to five million people linking healthcare and genomic information to develop new ways to prevent, detect and treat diseases.

Andrew Roddam is an internationally renowned epidemiologist. He started his career at University of Oxford and found his way to GSK, where he was, until recently, Vice President of Data Strategy. In this Vital Health podcast, we discuss both the challenges and opportunities for UK research and public health post Brexit.

See omnystudio.com/listener for privacy information.

View Details

For the last several years in DC, a debate has raged as to the appropriate roles of industry, academia, and the NIH for R&D in the biopharma sector. With the Biden Administration committed to organizing a multi-agency review of the Bayh-Dole Act, many top-tier U.S. research universities are sounding alarm bells over the potential risks this could pose to the American innovation ecosystem.

In this Vital Health Podcast, Duane Schulthess speaks with Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities (AAU), regarding the risks of fundamental changes to the Bayh-Dole Act. Kate’s role at the AAU includes intellectual property, technology transfer, public access, data privacy, and copyright issues. She has also served as a senior advisor in the legislative and executive branches, most recently with the U.S. Government Accountability Office (GAO).

See omnystudio.com/listener for privacy information.

View Details

Known for sunshine, Hollywood Movies, Mikey Mouse, and Silicon Valley, California has been at the center of global biotech for nearly half a century. The 1976 founding of Genentech in South San Francisco is considered the birth of the modern biotechnology industry.

However, the US Congress’ recent passage of the Inflation Reduction Act is now understood to pose serious risks to the California biotech sector, potentially starving it of badly needed investment capital.

On this Vital Health Podcast, Duane Schulthess speaks with Mike Guerra, the President & CEO of California Life Sciences (CLS), regarding the many mounting challenges to maintaining California’s global biopharma leadership.

For 30 years, CLS has supported early-stage innovators and startups, as well as established players in biotechnology, pharmaceuticals, and medical technology. Mike has been leading CLS since 2019. Last year, he was named CEO of the Year by the San Diego Business Journal and has more than a decade of experience in the life sciences.

See omnystudio.com/listener for privacy information.

View Details

On this Vital Health Podcast, we speak to Joseph Allen, the Executive Director of the Bayh-Dole Coalition. Joe served as a Senior Staff Member of former Senator Birch Bayh and was instrumental in working behind the scenes to ensure the passage of the historic Bayh-Dole Act.

The Wall Street Journal has stated that The Bayh-Dole Act is one of the three greatest policies that helped create U.S. Jobs. Passed in 1980 with the bipartisan sponsorship of Senators Birch Bayh and Bob Dole, the act allowed for university researchers that had received government funding to license important discoveries commercially.

However, recent comments by members of the U.S. Senate and Biden Administration are threatening to upend the Bayh-Dole act, with increasingly bellicose demands for the government to ‘march-in’ and take back patents licensed under Bayh-Dole. Joe Allen provides many historical insights into the passage of the Bayh-Dole act, and outlines how this would be a disaster for U.S. patients and biopharma innovation.

See omnystudio.com/listener for privacy information.

View Details

Vital Transformation’s Grumpy Old Men discuss their recently published research which found that 60% of FDA approved medicines from 2011- 2020 originated in the United States. Their study, “The US Ecosystem for Medicines - How new drug innovations get to patients”, shows a profound shift in global innovation and highlights the success of U.S. biopharma in creating new medicines.

Duane Schulthess, CEO of Vital Transformation, joins Dr Joseph Hammang, VT’s US Business Director, and Dr Harry Bowen, VT’s consulting economist in a discussion about the U.S. drug development ecosystem and its unique ability to adapt to the market demands of both orphan indications and potential blockbuster therapies to help patients with unmet medical needs.

VT’s Grumpy Old Men also highlight the many unintended consequences of the legislative proposals being made in Washington, DC to control the price of drugs, and the slippery slope that Europe is already traveling down due to similar policies.

Sources Quoted in this Podcast:
https://healtheconomicsreview.biomedcentral.com/articles/10.1186/s13561-014-0023-5
https://www.hbs.edu/ris/Publication%20Files/09-118.pdf
https://twitter.com/podeuropa/status/1610551097671962624?cxt=HHwWgMDS1Zbs6dksAAAA

See omnystudio.com/listener for privacy information.

View Details

On October 7th, Health and Human Services Secretary Xavier Becerra said that the use of March-In Rights to control the pricing of medicines was not, “Off the Table”. This comment lit a firestorm in the US biopharma sector.

In this Vital Health podcast, we speak to Patrick Kilbride, the Director of the US Chamber of Commerce’s Global Innovation Policy Center about March-in rights, and the role of high-value intellectual property to the US biopharma ecosystem.

We discuss the implications of Senator Elizabeth Warren’s April of 2022 public letter to Secretary Becerra advocating the use of March-in rights for price controls, what this means for US Universities and for patients in the long-term. As well, we give an overview of the continuing attacks on IP caused by the WTO’s nearly insatiable demands for the use of TRIPS waivers targeting all COVID-19 therapeutics and diagnostics.

See omnystudio.com/listener for privacy information.

View Details

John LaMattina is the author of several highly respected books showcasing a deep insider's perspective of the biopharma industry. His latest book, "Pharma and Profits Balancing Innovation, Medicine, and Drug Prices", maps out a robust defense of the biopharma sector.

John LaMattina was the President of Pfizer Global Research and Development where he managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. He headed Pfizer's R&D programs through the acquisition and development of many blockbuster treatments such as Lipitor and Viagra, and is currently a senior partner at PureTech Health, as well as a contributor to Forbes.

In this Vital Health Podcast, we discuss the increasing regulatory challenges facing the industry from the Biden Administration, including their June 2022 surrender of mRNA patent protections within the WTO TRIPS framework. We highlight HHS Secretary Becerra's willingness to use March-In Rights on patented medicines developed in partnership with the NIH, and the passage of the Inflation Reduction Act which mandates negotiated price controls within Medicare.

These many regulatory changes have profound implications for the U.S. biopharma sector, and their ability to continue to provide new medicines for patients with unmet medical needs.

See omnystudio.com/listener for privacy information.

View Details

With the passage of the Inflation Reduction Act (IRA), the US Government has fully embraced the idea of mandating price controls for therapies paid for by Medicare. However, the IRA handles large molecules and small molecules differently, as the government negotiates prices at year 9 for small molecules, but year 13 for large molecules. Practically, this means that small molecules will be disincentivized by the U.S. government, losing four years of revenue when compared to biologics.
On this Vital Health Podcast, Jeff Jonker, the CEO of Belharra Therapeutics, discusses the implications of the IRA for his early-stage private biotech company focused on the discovery of the next generation of small molecule-based medicines. Belharra Therapeutics is one of the many platform companies to emerge from California trying to find new approaches to drug discovery.
While the backbone of the California biotech sector has traditionally been ‘large molecule’ biologics, there has been a resurgence of R&D focused on traditional medicinal chemistry and small molecules like those being pursued by Belharra Therapeutics. The IRA puts funding pressures both on an already challenging R&D environment for small molecules, and the U.S. biopharma ecosystem writ large.

See omnystudio.com/listener for privacy information.

View Details

Proposed federal and state policies to restrict coverage and access to biomedical innovations approved through the FDA’s accelerated approval pathway are setting off alarms among rare disease advocates. That's because accelerated approvals are a vitally important pathway for faster, reliable drug development to meet the unmet needs of people with rare diseases.

Vital Transformation completed a comprehensive impact assessment of these proposed changes and what they could mean for patients currently lacking treatments and future innovations. In this Vital Health Podcast, Duane Schulthess takes a deep dive into those findings, joined by Amanda Malakoff, the Executive Director of the Rare Disease Company Coalition and Lisa Feng, the Senior Director of Policy at Alexion, AstraZeneca Rare Disease.

Topics of discussion include the detrimental impacts of radical changes to the use of surrogate endpoints, and the virtually nonexistent impacts of accelerated approved medicines on state Medicaid budgets.

See omnystudio.com/listener for privacy information.

View Details

With the US Inflation Reduction Act now law, many in Washington DC are saying that it’s provisions reducing pricing by $80 billion dollars annually in Medicare for drugs near the end of their patent life will not have any negative impacts on the US biopharma ecosystem.

Enter Amitabh Chandra, 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 has been sounding the alarm of the unintended consequences of the many pricing bills that have been emerging from both the Trump and Biden Administrations, as well as the US Congress.

In this Vital Health Podcast, Duane Schulthess and Amitabh Chandra discuss the pricing provisions of the inflation reduction act (IRA), particularly price controls for Medicare therapies with the highest amount of spending at two different time points, 9 years for small molecules and 13 years for large molecules. Amitabh discusses the ramifications of this decision from the perspective of venture capitalists, who are vital for their willingness to take early-stage risks in developing new medicines.

As well, we discuss the concept of the US Government acting as a price negotiator and offer potential market-based solutions in contrast to what will surely be price-setting by the largest buyer on the planet. These solutions, however, require fixing the many perverse incentives baked into the US pharmaceutical benefit manager (PBM) system, as people who are the sickest currently subsidize the 95% of healthy Medicare beneficiaries through pricing rebates.

See omnystudio.com/listener for privacy information.

View Details

On this Vital Health Podcast, Duane Schulthess speaks with Devin Rosenthal, Vice President at NovaQuest Capital Management, who is responsible for the firm’s deal structuring and due diligence. Devin sits at ground zero of the long-term impacts of the Inflation Reduction Act.

The Inflation Reduction Act (IRA) segments government pricing negotiations at 9 years for small molecules, but 13 years for large molecules, and Devin outlines the potential distortions this could create in future valuations and investment decisions. The discussion also touches on the potential ramifications of the IRA on the development of orphan drugs as well as existing pediatric incentives.
As PBMs have previously shown a lack of flexibility in adjusting their rebate demands when there are large shifts in prices, this podcast also highlights the unintended consequences of IRA price reductions on PBM demanded rebates. This has been overlooked in the IRA legislation and could have large impacts upon the future development of needed new therapies.

See omnystudio.com/listener for privacy information.

View Details

On June 17th, a Rubicon of sorts was crossed in Geneva as The World Trade Organization (WTO) agreed to the compulsory licensing for COVID-19 vaccines. In plain English, world leaders, including representatives from the US Trade Representative, agreed to allow countries to access core mRNA intellectual property without requiring permission from the patent holders.

The Wall Street Journal Editorial Board said the agreement is “a vehicle to raid U.S. innovation…that will benefit China and set a precedent that erodes intellectual property protection.”

In this podcast, Duane Schulthess speaks with Hans Sauer, the Deputy General Counsel for Intellectual Property for the Biotechnology Innovation Organization (BIO) and a Professor at Georgetown Law School, about the enormous potential negative consequences of the Biden Administration allowing the WTO to waive IP rights of mRNA technology, potentially creating huge negative consequences for U.S. innovation. Hans attended the WTO meeting and is considered one of the world’s leading patent attorneys in the biopharma sector.

See omnystudio.com/listener for privacy information.

View Details

Our podcast features Vital Transformation’s Grumpy Old Men (Harry Bowen, Joseph Hammang, and Duane Schulthess) and their recently published peer review study. The study, “The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals” investigates 8,000 NIH-funded patents invented from over 23,000 NIH grants to determine how much an NIH-funded discovery impacts the creation of new drugs approved by the FDA to treat patients.

Additionally, the Grumpy Old Men discuss the many profound implications of the recently approved Medicare price control provisions in the Inflation Reduction Act, the World Trade Organization’s decision to exercise IP ‘TRIPS’ waivers on the core intellectual property of the mRNA technologies used by Pfizer and Moderna in the COVID-19 vaccines, and the continued attack on IP with the hypothetical use of ‘march-in rights’ for NIH-derived patents in commercially available medicines.

Our per review study, “The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals” is available via open access. https://bit.ly/3LyD4Eu

See omnystudio.com/listener for privacy information.

View Details

The covid pandemic has brought into sharp focus the benefits as well as the challenges posed by the global supply chain related to the development of innovative new drugs. Paul Neureiter is the Executive Director for International Government Affairs & Trade Policy at Amgen. Before taking a role in ‘big pharma’, Paul was the Senior Director for China Affairs for the Office of the U.S. Trade Representative (USTR) and was part of the U.S. Foreign Service from 1987 to 2001.

In this podcast we discuss how price controls for therapies can be a Faustian bargain, creating short term gain for long term losses, where patients are ultimately those who suffer the most. We also touch on the WTO and US Trade’s decision to use TRIPs waivers to potentially pry open intellectual property rights for the mRNA technologies, and the broader implications of those decisions.

As well, we highlight how the EU’s approach to viewing biopharmaceutical innovation as a cost, and not as an investment, has had a demonstrably negative impact on their development of new, small, and innovative biotechnology firms like those driving US innovation and helping meet unmet medical needs for patients. Finally, we touch upon how Build Back Better can cause similar damage to the US innovation ecosystem as price controls have in the EU, and how China is quickly gaining on American biopharma innovation, and what that portends if the wrong political decisions are taken in the US Congress.

See omnystudio.com/listener for privacy information.

View Details

What do you do when you’ve been an entrepreneur, and have successfully built and sold two healthcare start-ups to 3M and Aetna? If you’re John Dwyer, you advise The Global CEO Initiative on Alzheimer’s Disease to help find a cure. And given John’s track record of success, this sounds like a fantastic idea. The Global CEO Initiative on Alzheimer’s Disease (or CEOi), is an organization of private-sector executives who have joined together to provide business leadership in the fight against Alzheimer’s. John Dwyer is playing a key role within this organization.

In this podcast, John Dwyer discusses research presented by Vital Transformation at the BIO conference which shows the potential results of the Center for Medicare and Medicaid Services’ (CMS’) decision to limit access to a new therapy for Alzheimer’s disease and any future therapy with the same mechanism of action. For the first time, CMS denied coverage for an FDA approved on-label treatment, as they called into question the evidence base of an accelerated approval pathway.

We discuss the implications of two government agencies, CMS and FDA, not agreeing on the evidence requirements for coverage under Medicare, as well as the unintended consequences this will have on the future development of new therapies. We also highlight the impact of this regulatory impasse on patients in desperate need of effective new treatments.

See omnystudio.com/listener for privacy information.

View Details

With the passage of the Inflation Reduction Act by the US Senate, the US is now on the cusp of implementing very aggressive drug pricing controls within Medicare. Richard Evans is the general manager of SSR Health, which he founded in 2009 to address the complexity of US drug pricing. Before founding SSR, Richard was a senior analyst at Sanford C. Bernstein, and during his tenure, he was ranked first by both Institutional Investor and Bloomberg Markets and was also rated as one of the top 20 stock-pickers globally across all large-cap industries.

Ironically, one of the most challenging questions to answer in US drug pricing is“How much does it cost?” Is it the cost of the drug out of pocket? Perhaps the cost to the insurer, to the PBM, to the hospital, or the total that finally ends up on the company balance sheet as revenue? To each of these value chain actors, the answer will be markedly different and Richard’s knowledge of the interplay of their various competing interests is without peer.

In this podcast, Richard explains the role of PBMs in market access and drug pricing, the perverse incentives that are baked into the US and EU systems, and how all of the actors are simply behaving logically within the odd construct of the current healthcare ecosystems. Often, these outcomes are not aligned to the best interests of patients at the point of sale. As well, we discuss the enormous revenue reductions that are likely to occur within the US biopharma ecosystem if the Inflation Reduction Act is signed into law in its current form, and the ominous implications this has for patients with unmet medical needs requiring cures.

See omnystudio.com/listener for privacy information.

View Details

Michele Oshman is Vice President of External Affairs of BIO, and the Executive Director of BIO’s Council of State Bioscience Associations (CSBA), advancing public policies that support the bioscience industry in partnership with their state-based member associations.
Before joining BIO in 2020, Michele had a successful 18-year career at Eli Lilly and Company, where she led their federal advocacy. She is a neuroscience researcher working both in clinical development and corporate leadership roles. Uncommon for people working in public policy, Michele earned a Six Sigma Black Belt in statistics in 2005 and is a closeted quant!
This podcast discusses the multitude of challenges facing the US biopharma sector, including proposed changes to the accelerated approval pathway and the broader issues of affordability related to out of pocket costs in Medicare Part D. Michele Oshman outlines the vital role state associations play in both advancing medical innovations and relationships with local and state governments to ensure that patients have access to needed new medicines.

See omnystudio.com/listener for privacy information.

View Details

John Michael O'Brien was recently appointed as the president and Chief Executive Officer of the National Pharmaceutical Council (NPC), one of the key thought-leading organizations in Washington, DC championing biopharmaceutical innovation.

Prior to joining NPC, Dr. O’Brien was a senior advisor to U.S. Secretary of Health and Human Services' Alex Azar. He has held senior positions at CareFirst BlueCross BlueShield, the Centers for Medicare & Medicaid Services (CMS) and in the U.S. Senate as a policy fellow – he has worn just about every hat in DC related to healthcare that can be worn.

In this podcast, John O’Brien and Duane discuss the multiple and varied assaults currently being lobbed at the US innovative biopharmaceutical sector. It outlines how the ecosystem, which successfully created highly effective and innovative medicines for patients, could be rendered inert by the many and various ill-conceived pricing proposals currently emanating from Washington, DC.

See omnystudio.com/listener for privacy information.

View Details

On May 5th of this year, a very strange thing happened. For the first time in memory, the Pharmaceutical Benefit Managers, or PBMs, who act as the go-between for patients, insurers, and the biopharma industry, were given a good old fashioned grilling in the US Senate. This will come as no surprise to Gary Branning.

Gary is a Professor at Rutgers Graduate School of Business in Pharmaceutical Management and President of MMR, a health care consulting company that specializes in the reimbursement of medicines in the US healthcare system. With 30 plus years’ expertise in healthcare, Gary is known for his innovative approaches to access and policy issues related to the infinitely complex US healthcare system and the access to new medicines.

In this podcast, Gary unpacks the complex web of how drugs are actually paid for, and outlines the role played by PBMs in keeping money following and controlling the cost of premiums. However, he also outlines how the system of ‘rebates’ driven by beneficiaries and managed by the PBMs is creating confusion and controversy in the delivery of new specialty pharmaceutical products to patients.

See omnystudio.com/listener for privacy information.

View Details

It seems every week we hear of another new proposal out of Washington DC to ‘fix’ drug pricing, and many of the companies that would be impacted by these proposals are in California, arguably, the globe’s leading biotech hub, and where the sector was born. Joe Panetta is President & CEO of Biocom California, the association representing the life science industry in California. With offices in San Diego, Los Angeles, Sacramento, and the Bay Area, Biocom California advocates for more than 1,600 companies, service sector firms, universities, and research institutes working across the state in the biotechnology sector. Joe’s been the head of Biocom California since 1999 and is universally regarded as one of the world’s thought leaders in innovative biopharma.

In this podcast, Joe provides insightful comments about the birth of the biotechnology industry, the current business climate, and what continues to make California such an attractive and vibrant life science cluster, in spite of the turbulent equity markets and near double digit inflation. He’ll also discuss the ever-increasing challenges and storm waves being hurled at innovative biotech companies by Congress, including proposals to change the criteria of the accelerated approval pathway, CMS’ ability to limit access to treatments by requesting more evidence, proposed pricing negotiations resurrected from Build Back Better, and the recent statements by Senator Elizabeth Warren (D-Mass) to use march-in rights to lower the price of therapies

See omnystudio.com/listener for privacy information.

View Details

Recorded live at the 2022 BIO International Conference in San Diego, this podcast discusses the results of Vital Transformation's latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role played by small innovative biotech firms in that process.

As well, with the use of the US Government's 'march-in rights' for NIH funded research being discussed as an option to influence pricing and patient access, this podcast also touches on the relative role that private and public R&D serves in the creation of needed new therapies via groundbreaking intellectual property. The podcast features contributions by Nick Shipley, the Executive Vice President of BIO, John Murphy, BIO's Chief Policy Officer & Deputy Counsel, and Joseph Hammang Ph.D., Vital Transformation's US Business Director.

This research was made possible with the support of BIO, Rare Disease Company Coalition (RDCC), Global CEO Initiative on Alzheimer's Disease (CEOi), Sarepta, Travere, Gilead, Alexion and Bristol Meyers Squibb.

See omnystudio.com/listener for privacy information.

View Details

With the Center for Medicare and Medicaid Services’ recent decision to limit access to Biogen’s Alzheimer’s treatment, and with drug pricing sure to be one of the central issues of the looming mid-term elections, Arizona Senator Kyrsten Sinema’s support of the biopharma sector places her state at ground zero of the drug pricing debate.

Stepping directly into the fray, Danny Seiden, CEO of the Arizona Chamber of Commerce, recently published an article for Real Clear Policy titled Bye-bye Bayh. In it, Danny argues that the recent threats by members of the US Senate to exercise little-known and rarely used legal provisions called march-in rights contained in the Bayh-Dole legislation would, “crush American innovation, creating a new avenue for government to punish companies for bringing products – including lifesaving treatments – successfully to market.”

Phoenix is one of the fastest growing biopharma regions in America, and this is in no small part due to Danny Seiden and the Arizona Chamber of Commerce working with their state and federal representatives to ensure that their economy balances the needs of business and the public. Danny makes a compelling case that the current discussions on drug pricing are rarely based on evidence, and to address rising healthcare costs there is a critical need for market driven solutions which also promote scientific innovation.

See omnystudio.com/listener for privacy information.

View Details

One of the brightest minds in DC, Tom Dilenge recently joined Flagship Pioneering, the highly respected bio platforms innovation company behind such groundbreaking startups as Moderna. Tom leads Flagship’s public policy, regulatory, and governmental affairs.

Vital Transformation has worked closely with Tom in his previous role as President of the Biotechnology Innovation Organization (BIO), where he was directly responsible for all their policy, advocacy, communications, legal affairs, and Board governance operations – he had the largest desk plaque in DC.

In this podcast, we discuss several DC proposals trying to change the way accelerated approvals are managed by the FDA, and Vital Transformation’s recently released research and analysis of the impact of CMS’ guidance related to Alzheimer’s disease, which was commissioned and funded by Biogen. The podcast highlights the mounting attacks on the accelerated approval pathway, and the negative unintended consequences that would impact the US R&D ecosystem if it were to be regulated out of existence.

This Vital Health Podcast was recorded on April 1st, 2022, before CMS had finalized its National Coverage Determination of Amyloid treatments for Alzheimer’s Disease. However, the now final CMS policy continues what the podcast participants feel is an unfavorable approach towards amyloid products and accelerated approvals. The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, Tom Dilenge. While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.

See omnystudio.com/listener for privacy information.

View Details

George Vradenburg is the co-founder and chairman of USAgainstAlzheimer's, a patient advocacy organization founded in 2010, which has successfully worked to increase funding for Alzheimer’s and dementia research. Along with his philanthropic activities, George Vradenburg is also a very successful corporate lawyer and has been the Executive Vice President of AOL Time Warner and the Fox Broadcasting Company.

The podcast discusses the current state of Alzheimer's research and the potential impact of CMS guidance requiring confirming clinical trials for new treatments targeting Amyloid plaques in its prevention. We also highlight a growing consensus of concern surrounding CMS' current guidance as unintended consequences will likely be detrimental to future therapy developments in high unmet medical need areas. The FDA's accelerated approval pathway itself is now also at risk as therapies developed for high unmet medical needs have historically utilized this FDA-approved pathway.

The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, George Vradenburg. While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.

See omnystudio.com/listener for privacy information.

View Details

When the Centers for Medicare and Medicaid Services (CMS) published its draft determination requiring further clinical trials in Alzheimer’s disease treatments, Sue Peschin was one of the first to state her opposition to the policy. Sue is the President and CEO at the Alliance for Aging Research, the US’ leading non-profit organization dedicated to improving healthy aging for all. In addition, Sue has also had senior roles at the Alzheimer’s Foundation of America and has been critical of the many efforts to implement one-size-fits-all cost controls under Medicare.

In this Vital Health Podcast, Sue digs into the broader implications of Vital Transformation’s research and analysis of the CMS guidance, which was commissioned and funded by Biogen, and its potential impacts on her Alliance members. We also discuss the many potential unintended consequences of the proposal, including risks to the accelerated approval pathway, and to the development of new treatments in areas of high unmet needs such as neurological disorders.

Sue highlights that CMS’ guidance positions them as a de facto health technology assessment agency and spells out the implications for Medicare program participants. Additionally, we discuss existing case law in America which has previously decided that using QALY (quality adjusted life years) for reimbursement is age discriminatory, further bringing into question the viability of CMS’ Alzheimer’s disease guidance.

See omnystudio.com/listener for privacy information.

View Details

The Centers for Medicare & Medicaid Services (CMS) recently released draft guidance that, in the future, proposes to only reimburse FDA approved treatments for Alzheimer’s disease in a CMS authorized randomized controlled trial. To the outside world, this likely doesn’t seem like a problem. However, this CMS proposal has ignited a firestorm across the US healthcare ecosystem.

Vital Transformation (VT) CEO Duane Schulthess is joined by VT’s US Business Director, Dr. Joseph Hammang, and VT’s Consulting Economist, Dr. Harry Bowen to discuss the core findings of their recent research and analysis which was commissioned and funded by Biogen, Inc. The VT team found that, if implemented, CMS’ plan would have devastating impacts on the development of new treatments for Alzheimer’s disease, neurological disorders, and new therapies using accelerated approvals.

Additionally discussed are the enormous challenges and high failure rates associated with clinical developments in neurology since reaching their peak in 2009. VT’s research finds the current failure rate for clinical developments in Alzheimer’s disease is 99.5%, meaning that if the proposed CMS guidance is implemented, it would likely drive down the number of new therapies developed for Alzheimer’s disease to nearly zero.

See omnystudio.com/listener for privacy information.

View Details

Most people think of the plasma sector as just another arm of biotechnology, but nothing could be further from the truth. Relying primarily upon individual donations from the United States to supply global plasma, the sector’s raw material costs mean it has more in common with precision manufacturing and does so under strict scientific controls. The impact of COVID-19 on the willingness and ability of people to donate plasma, and a recent ruling by the U.S. Customs and Border Protection on cross-border donations has put the global sector under serious pressure and the supply chain under tremendous stress.

To discuss all things plasma, I’m joined by Amy Efantis, the CEO of the Plasma Protein Therapeutics Association. In this podcast, we highlight how the cost of collecting plasma has skyrocketed, and how this has had a hugely negative impact on the global supply of vitally needed products such as immunoglobulin and albumen. As well, we talk about how the contradictory border policies of the Biden administration have many within the plasma sector scratching their heads, trying to solve the seemingly arbitrary enforcement of U.S. laws and its impact on plasma collections.

See omnystudio.com/listener for privacy information.

View Details

Joan Koerber-Walker is President and CEO of the Arizona Bioindustry Association (AZBio), supporting one of the top emerging biotech clusters in the United States. Trained as an economist and a biotech investor herself, Joan is no stranger to pricing discussions. As the Build Back Better debate reached a fever pitch, all eyes turned to Arizona given the bill’s focus on drug pricing and Senator Kyrsten Sinema’s known support of the Arizona Biotech Sector. While Build Back Better is no more, the drug pricing debate is not going away anytime soon.

In this podcast we discuss how the drug pricing debate threatens to derail innovation, as does aggressive tax policy positions being taken by many leaders in traditionally pro-biotech states like California and Massachusetts. The biotech sector in Arizona has been a direct beneficiary of many of these decisions.

As well, we discuss how institutions like the Mayo Clinic, which have a large footprint in Arizona, are making big investments developing a commercial R&D hub called the Discovery Oasis. Joan highlights how the Mayo Clinic fertilizes innovation across Arizona’s Health Innovation Ecosystem, and how that lays the groundwork for product development locally.

See omnystudio.com/listener for privacy information.

View Details

John Murphy is the Vice President of the Biotechnology Innovation Organization (BIO), the largest trade association in the world representing biotechnology companies. John’s role encompasses all legal issues impacting healthcare biotechnology and is an expert on topical issues such as intellectual property, drug pricing, and legislation in the biopharma sector.

In this podcast we discuss the drug pricing proposals included in President Biden’s signature legislation, Build Back Better. While many in the general public feel that it’s only fair that Medicare start to negotiate drug pricing similar to what is done in the EU to control the out of pocket costs of medicines, John Murphy highlights what this would mean practically for the biotech sector, highlighting that even if drug price controls appear reasonable on the surface, there are inevitable trade-offs. Build Back Better will likely place severe constraints on the global innovation ecosystem in the development of needed therapies for orphan conditions as well as for diseases like oncology and Alzheimer’s disease.

The discussion also highlights the need for a robust private sector to take-on the risks of development, and how many proposals such as the new $3 bil innovation public private partnership called ARPA-H are not likely to lead to meaningful leaps in innovation. Further, we discuss the implications of ‘Operation Warp Speed’, and how the possibility to rapidly deliver needed mRNA vaccines to market in only 9 months could serve as a blueprint for addressing seemingly intractable issues such as antimicrobial resistance.

See omnystudio.com/listener for privacy information.

View Details

Call it serendipity, ‘luck’, or being at the right place at the right time, but Miriam Sturkenboom led the IMI’s project Advance, which built a pan-European safety monitoring network for vaccines. You can’t make it up, but the project ended in March of 2019. Six months later, the world was thrown into chaos with the Wuhan virus, and ADVANCE, rebranded VAC4EU, now finds itself at the centre of a tsunami of vaccine roll-outs and safety studies in Europe.

In this podcast we discuss how VAC4EU is currently active in the study and development of vaccines in the fight against COVID-19. We look back of the history of the project’s development out of the IMI, and the role it’s currently playing in the EU evaluating the performance, safety, and efficacy of the vaccines currently in use or being developed in Europe and internationally.

Miriam is the head of the Department of Data Science and Biostatistics at the University Medical Center Utrecht in the Netherlands. She’s a PhD of Mathematics and Physics, and the past president of the International Society for Pharmacoepidemiology, serving as an expert to the EMA, FDA, WHO and many other organizations.

See omnystudio.com/listener for privacy information.

View Details

After nearly two decades at the NIH and almost 10 years as founding director of the National Center for Advancing Translational Sciences (NCATS), Christopher Austin is crossing over to the ‘dark side’, joining Boston-based Flagship Pioneering, the highly respected bioplatforms innovation company. He’s one of Biopharma’s true visionaries, with an expert’s knowledge at the highest levels of government funded NIH research, translational innovation, and industry commercialization.

In this podcast, we touch on the litany of proposals emanating from the US congress including international reference pricing and APRA-H, the proposed DARPA of healthcare. Chris Austin approaches the increasingly caustic debates around discovery, R&D, and pricing with a nuance and subtle understanding that is truly unique in its depth and wisdom, articulating why the U.S. ecosystem from the NIH through to commercial Biopharma has been both successful and effective.

Chris provides a background to many R&D breakthroughs with which he’s been personally involved, whilst explaining in detail how the US innovation engine works, and what makes it tick. We also outline how well-intentioned proposals such as price controls and IP waivers put the US ecosystem, and the future of drug discovery, at risk. Chris Austin graduated with a degree in biology from Princeton in 1982, and received his MD at Harvard Medical School. He completed his clinical training in internal medicine and neurology at Massachusetts General Hospital.

See omnystudio.com/listener for privacy information.

View Details

Richard Moscicki is the Executive Vice President for Science and Regulatory Advocacy and the Chief Medical Officer at Pharmaceutical Research and Manufacturers of America (PhRMA). Previously he was the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and the Chief Medical Officer at Genzyme Corporation.

In this podcast, we discuss the U.S. R&D ecosystem and the vital roles that NIH and the private sector play in bringing new therapies to patients. Richard was previously at Massachusetts General Hospital (MGH) and Harvard Medical School, and this strong academic background combined with his industry knowledge gives him a unique perspective on both sides of public and industrial R&D, as well as how NIH developed intellectual property moves from the ‘Eureka’ phase to becoming an actual medicine.

Our conversation includes President Biden’s new $6.5 billion proposal called ARPA-H, modeled on DARPA, specifically for drug discovery, and where those efforts would be best directed to facilitate needed medicines to address unmet medical needs. We also touch on how the rapid evaluation and approval of vaccines for COVID-19 could serve as an improved regulatory blueprint for accelerated evidence driven access to patients.

See omnystudio.com/listener for privacy information.

View Details

Jack Scannell is one of the world’s leading pharmaceutical industry analysts, as well as one of its most visionary. Jack caused a case of global pharmaceutical R&D indigestion when, a decade ago, he identified in a groundbreaking Nature publication that, unlike in the semi-conductor industry, which had seen the doubling of its productivity every 10 years, the exact opposite was true for the biopharmaceutical sector, where productivity had instead halved in each successive decade. Jack Scannell investigates R&D productivity from both an economic and a scientific perspective, with a focus on the fact that the cost of scientific inputs has dropped exponentially, yet, the drug and biotech industries have seen a huge long-term decline in innovative output efficiency. He works as an independent consultant to drug and biotech firms, financial institutions, and the public sector. He was head of Discovery Research at e-Therapeutics, an Oxford-based biotechnology firm. He’s also worked for the Boston Consulting Group.

See omnystudio.com/listener for privacy information.

View Details

Drug pricing is becoming a hot political issue in Washington DC, with polls showing widespread bipartisan support for congressional action to control the cost of new medicines broadly. While this is political red meat for the base, the reality is that price ceilings on medicines as they are proposed in US House Bill H.R. 3. will weigh heavily on the U.S. biotech sector and particularly on California, which has dominated the development of new cutting-edge medicines over the last decade. California and has been responsible for nearly 25% of new drug discoveries in that period, but with many state politicians supporting the bill, it is at risk of seeing industry revenues cut by nearly 40%, which will severely impact its biotech sector.

In this podcast, we speak with Keith Murphy, CEO and Founder of Viscient Biosciences and a board member of the California Life Science Association (CLSA), and Oliver Rocroi, Vice President of CLSA. We discuss the looming challenges that one-size-fits-all pricing models such as reference pricing place upon the global biotech ecosystem and try to answer the question “How did we get here?” We also highlight possible solutions that the successful accelerated development of COVID-19 vaccines foreshadow and reflect on how Europe is struggling to vaccinate its population after putting in hard price ceilings in its vaccine procurement negotiations, which are now limiting supply and access for the EU public at large.

This podcast further outlines in depth how the entirety of the funding landscape responds to financial incentives and how the risk-reward calculations for VCs would be impacted by radical reductions in revenue. We highlight the areas of research, such as rare diseases and neurological disorders (e.g. Alzheimer’s, Parkinson’s), that are likely to be cut first if H.R. 3 becomes law. Lastly, we challenge the system to better respond by focusing on value and not on price, and call out industry bad actors who use intellectual property to block generic access.

See omnystudio.com/listener for privacy information.

View Details

While not featured in Hollywood blockbuster films like some universities from the UK, Boston, or California, Belgium’s KU Leuven University has topped the Reuters ranking as Europe’s most innovative university for four of the last six years. This Belgian innovation engine boasts more than 135 spin-off companies and has a dominant focus on healthcare innovation.

In this podcast we discuss the role that KU Leuven plays in Flanders with Professors Maarten De Vos and Inge De Prins, who introduce the latest effort to broaden the EU’s innovation capacity through their new initiative focused on health innovation fellowships. Named The Institute for Biodesign, it will open its doors this spring in collaboration with TU Delft and Erasmus University Medical Center in the Netherlands. The institute’s Health Fellowship Network will be further supported by the European Institute of Technology (EIT), whose input in ensuring that KU Leuven’s new project comes to fruition is also discussed in the podcast.

Lastly, the podcast details how interested researchers, healthcare professionals, and industry partners can join the new Institute for Biodesign and offers some insights into what the programme will deliver in the future. We touch on the broad macroeconomic competitive challenges that the EU currently faces and how the fellowship network hopes to overcome these to keep breakthrough technologies and the value they create within Europe.

See omnystudio.com/listener for privacy information.

View Details

Over the course of the summer, there was a vital discovery that severe, late stage COVID-19 which had been considered a near fatal condition could be successfully treated with dexamethasone, a corticosteroid. One of the key clinicians behind that discovery was Dr Pierre Kory, the President of the Front-Line COVID-19 Critical Care Alliance (FLCCC). Today, corticosteroid is part of the standard COVID-19 pathway, in no small part due to the efforts of the FLCCC.

Last month, Dr Kory again lit up the internet, giving a forceful testimony in front of the US Senate Homeland Security Committee, describing the “miraculous impact” of the antiparasitic agent ivermectin in the treatment and prevention of COVID-19. Could it be possible that Dr Kory and the team at the FLCCC have twice found successful treatments in the fight against COVID-19?

Can lightning strike twice?

In this podcast, we discuss the evidence behind the FLCCC’s use of ivermectin for both in the prevention and treatment of COVID-19. We outline why this team of internists at the FLCCC have succeeded in potentially finding two significant treatments for COVID-19 when the majority of the world’s public health establishment have been mired in indecision and a lack of innovation.

Dr Kory discusses the challenges he’s met changing set opinions once many clinicians have put treatment paradigms into practice. He also touches upon the toxic environment that exists for those practitioners on the front lines trying to promote improved treatment protocols in an increasingly politicized medical landscape where prevailing opinions are often dictated by dogma, orthodoxy and bureaucracy, rather than by following the clear path created by evidence-based medicine.

This podcast is made possible with the support of PharmaCCX

See omnystudio.com/listener for privacy information.

View Details

If you’ve ever found yourself researching COVID-19 on YouTube, it’s likely you’ve stumbled onto a well-spoken Irishman named Ivor Cummins dissecting the impact of the pandemic with detailed graphs and analysis. Before the COVID-19 era, Ivor, a biochemical engineer, had a large following as a presenter on facts about cardiovascular disease, diabetes, and obesity on his very popular website ‘The Fat Emperor.’ However, since the outbreak of SARS-CoV-2, he has trained his eye on the pandemic with a series of in-depth YouTube videos commenting on the response of public health experts and calling into question many government policies as well as conventional wisdom.

In this podcast, Ivor provides historical background which explains why, in line with the WHO’s 2019 guidance for dealing with a potential pandemic, lockdowns and isolation were actually not recommended. Yet, due to presumed pressure exerted by the Chinese government https://youtu.be/978zLJJLo-I, these recommendations, based on decades of empirical research, were simply ignored or changed without the backing of hard new clinical evidence. Ivor highlights similar changes in recommendations for mask wearing, which were also not seen as a useful approach to mitigating the impact of a pandemic, yet were suddenly recommended over the summer, contradicting research hosted on both the CDC and WHO websites that stated that masks were ineffective.

Ivor’s podcast touches on topics such as the Diamond Princess Cruise Line, the Great Barrington Declaration, Occam’s and Hanlon’s Razors, and even the conspiracy around ‘The Great Reset.’ It’s a wide-ranging conversation that raises many questions as to why the EU and the US have adopted strategies to combat COVID-19 despite indications that the chosen paths are not based on evidence.

This podcast is made possible with the support of: Pharma CCX

See omnystudio.com/listener for privacy information.

View Details

The cost of new, highly targeted cancer therapies is becoming a serious political issue in the US, as it has been in Europe for many years. Europeans feel that drug prices are too high, which explains why trying to use a combination of such drugs, which is increasingly recommended as the best approach from a clinical standpoint, is often both politically and economically untenable.

That’s the problem my two guests today are trying to solve. Nathan Sigworth and Richard Bergström founded the innovative startup PharmaCCX, an independent, third-party technology platform focused on improving patient outcomes by helping both sides of the negotiation reach access agreements more efficiently. Their goal is ambitious: to improve overall deal management by reshaping the way pricing and access agreements in the biopharma sector are made and sustained, so that patients can get the complex therapies - including combination oncology - they need to survive.

In this podcast, we discuss how PharmaCCX was formed, bringing together the unique skills of Nathan, who approaches the drug pricing problem by leveraging proven financial technologies used by Wall Street, and Richard, former Director General of EFPIA with years of regulatory policy experience in the pharma sector.

We also highlight the current market access challenges for effective cancer therapies and what it takes to find a consensus on drug pricing. As oncology treatments are becoming more targeted, their prices goes up due to the ever smaller pool of patients they treat. This becomes particularly challenging when clinical advice is to use several such therapies in combination, yet governments feel the price of a single one of them is already unacceptably high.

See omnystudio.com/listener for privacy information.

View Details

Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third CEO to lead BIO, the world’s largest biotechnology advocacy group, since its founding in 1993.

She previously served as Global Head of Evidence Generation for Medical Device Companies, Vice President of Global External Innovation, and Global Leader for Regulatory Sciences at J&J. Back in 2008, Dr. McMurry-Heath was a member of the Obama-Biden transition team, which tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies. President Obama then named her Associate Science Director of the FDA’s Center for Devices and Radiological Health under Commissioner Margaret Hamburg.

Michelle McMurry-Heath takes command of BIO during a tumultuous time and amidst unprecedented challenges. In this podcast we discuss BIO´s role supporting companies now producing mRNA vaccines against COVID-19, as well as how US-based biotech, particularly in California and Massachusetts, has been the key player driving the global growth of the biopharmaceutical industry over the last several decades. Repeated technological triumphs notwithstanding, we also highlight the mounting regulatory challenges regarding pricing and access at a time when science is targeting ever smaller populations and more personalized treatments, which require innovative approaches that under current regulatory structures are not always appropriately supported. Lastly, Michelle McMurry-Heath also outlines what priorities are key to ensuring the viability of the biotech sector at the state level.

See omnystudio.com/listener for privacy information.

View Details

With the recent announcement of Pfizer’s completion of clinical trials for a COVID-19 vaccine, the next challenge is ensuring that the general public is willing to be vaccinated. With mounting distrust, how will this be possible?

Prof Heidi Larson is one of the world’s leading authorities on why people don’t take vaccines, and how rumors about their safety become part of public opinion. She is the founder of the Vaccine Confidence Project, based at London’s School of Hygiene and Tropical Medicine. According to the New York Times, Prof Larson says that, “dispelling vaccine hesitancy means building trust — and avoiding the term “anti-vaxxer.”

In this podcast we discuss how skepticism of vaccine safety often mirrors anti-government populism. Prof Larson also outlines how the first conscientious objectors were not against war, but against the smallpox vaccine in Europe in the 1850s. We also investigate the role that social media plays in consolidating opinions today.

This podcast touches on the French and Italian governments' recent use of legislation requiring vaccination and how that impacted the debate around vaccine acceptance. Prof Larson also outlines the appropriate strategy for governments to improve the public’s trust in large-scale vaccination programmes.

See omnystudio.com/listener for privacy information.

View Details

What do you get when you have over 1000 technology developers, healthcare professionals, and medical practitioners working together on a specific problem in the same room? You get what’s called a health-care hackathon. One of the world’s first movers in the pantheon of hackathon, is Leo Exter, the creative force behind Hack Belgium, a massive EU Open Innovation Festival, and one the most ambitious event of its kind for the last decade. With the impact of COVID-19, hackathons have needed to evolve, and Leo is now the Chief Energizer at Hack Belgium Labs. We’re speaking to him today, along with Thomas Vande Casteele, the CEO of the promising EU health Tec company, Awell Health.

You can register for this year’s addition of Hack Healthcare on the 2nd and 3rd of March, 2021, at HackBelgiumLabs.be

In this podcast we discuss the challenges of COVID-19 on the tech innovation culture, and the opportunities that are presented by bottom-up innovation driving adoptions. As well, we highlight the need for the greater use of real world data for healthcare improvement, in ways not often implemented by governments, BioPharma companies, or practitioners.

See omnystudio.com/listener for privacy information.

View Details

Matt Wiener co-leads the development of EHDEN’s SME Marketplace, training and certifying the project’s growing international network of SMEs that are leveraging observational data locally. The SME network is the EHDEN project’s engine, supplying the local knowledge required to convert the observational data available in many unique EU databases into a common data model so they are usable within a federated network.

Matt is a Director of Informatics and Predictive Sciences at Bristol-Myers Squibb, joining the company through the acquisition of Celgene. Given Matt’s deep understanding of the need for analytical rigour in healthcare, in this podcast we discuss the current gulf that exists in medical practice between doctors and quants, and how this situation can be solved in the future. We also the many challenges to harnessing observational data are not, in fact, technical, but political. EHDEN can serve as a test-bed to demonstrate the value of RWE to help remove the barriers that current exist to access health records and apply effectiveness in decision making.

The podcast also outlines many of the core issues to be discussed in a webinar series as part of EHDEN’s annual General Assembly and Road Show. Matt Wiener has a PhD in mathematics from the University of Chicago, and an undergraduate degree from MIT. He’s applied mathematical modelling and analytics to different phases of drug development, from early research to manufacturing. Before moving into healthcare, he worked in various fields of mathematical modelling, including for the health effects of air pollution. He also, for a time, was engaged in Postdoctoral research at the NIH’s Institute of Mental Health.

See omnystudio.com/listener for privacy information.

View Details

Kees van Bochove founded The Hyve, based in Utrecht, to facilitate open source software development, enable open science by developing and FAIRifying data in life sciences. Their platform and expertise are a driving force behind the success of the EHDEN project.

The Covid-19 pandemic underscores the need for high-quality health data that is readily deployed. Europe’s early epidemiological assessments at the start of the pandemic projected infection and mortality rates by orders of magnitude in error. Once the pandemic was in full swing, official statistics in most European countries underreported coronavirus-related deaths. More recently, the retraction of two separate clinical studies for hydroxychloroquine published in two top medical journals due to unreliable primary data collection and meta-analysis demonstrated the importance of data quality for assessing vitally needed medicines.

In this podcast we discuss how EHDEN was able to produce a high-quality hydroxychloroquine peer review study in only 4 days, and how the platform will be able to assist with European healthcare decision making in the future. It also outlines many of the core issues to be discussed in a webinar series as part of EHDEN’s annual General Assembly and Road Show.

Kees studied Computer Science and Bioinformatics, for which he did his research project on lipoprotein metabolism at TNO Quality of Life in The Netherlands and the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston. Through his many years of experience in open source software and standards development in bioinformatics, Kees has a deep understanding of all aspects of open source development.

See omnystudio.com/listener for privacy information.

View Details

IMI’s EHDEN is developing a federated data network at scale across Europe, to reduce the time to provide key answers to health research in the real world. The challenge is how can a federated data model help HTAs determine value for patients and healthcare systems?

In this podcast we discuss these challenges with Jacoline Bouvy, who co-leads EHDEN’s work package 2, focused on outcome driven healthcare. It will outline many of the core challenges that HTA’s face harnessing federated datasets, and outline several issues to be discussed in a multi-stakeholder webinar to be held on October 22nd.

Jacoline is the Senior Scientific Adviser for Science Policy and Research at the National Institute for Health and Care Excellence (NICE), based in London. Jacoline is a Dutch health economist specialising in the interface between marketing authorisation and health technology assessment (HTA) of drugs. She’s been involved in several pan-European IMI projects: ADAPT-SMART, ROADMAP, Neuronet and EHDEN.

See omnystudio.com/listener for privacy information.

View Details

Martin Kulldorff, PhD, is a world-renowned biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School. His research centers on developing new statistical methods for disease surveillance, including methods for disease cluster evaluation and the early detection of disease outbreaks. His methods are used by the Centers for Disease Control and Prevention (CDC) in the US and almost every country in the world.

Recently, he has turned his prodigious analytical skills to the Covid-19 pandemic, serving on the CDC´s working group to evaluate the safety of any future Covid-19 vaccine. He has also been a strong advocate for age-specific approaches to managing the spread of the disease, both in major newspapers in his native Sweden and in Spiked magazine.

In this podcast we discuss the ‘anti-herders’ who view herd immunity as a misguided strategy rather than a scientifically proven phenomenon that can prevent unnecessary deaths, and Dr Kulldorff’s firm belief that the approach taken by Sweden is the correct one. Additionally, we point out recent data showing that suicides are more frequent than Covid-19 deaths as a consequence of lockdowns, and allowing those under 50 to practice safe social distancing while protecting the elderly is society’s best option. Martin Kulldorff also outlines how our approach to dealing with the pandemic is putting a heavy burden on the working classes, who are ultimately bearing the largest burden of the Covid-19 policies.

See omnystudio.com/listener for privacy information.

View Details

Francesca Colombo, M.Sc., is Head of the Health Division at the Organisation for Economic Co-operation and Development (OECD). She is responsible for providing internationally comparable data on health systems and applying economic analysis to health policies, as well as advising policy makers and other stakeholders on how to respond to citizen demands for more and better health care. In this capacity, Francesca has also been involved with the OECD’s partnership with the International Consortium for Health Outcomes Measurement (ICHOM) on the collection, analysis, and publishing of patient-reported outcomes for international comparison.

In this podcast, we discuss the specific challenges of setting the correct health policy for Covid-19 given the high rate of asymptomatic cases and the disproportionate impact of the disease on those over 70 years of age with comorbidities. We also discuss the need for greater global cooperation in the development of a vaccine, risk sharing for manufacturing, and more streamlined data collection.

Prior to her 20 years at the OECD, Francesca was the acting head of the Planning Unit at the Ministry of Health and Labour of Guyana. She holds a M.Sc. in development studies from the London School of Economics and Political Science and a B.Sc. in economics and management from Bocconi University.

See omnystudio.com/listener for privacy information.

View Details

Yannis Natsis leads the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA). Before joining EPHA in January 2016, he worked at the European Parliament, the Greek Ministry of Foreign Affairs, the UN and the private sector in Brussels and Athens. In May 2019, Yannis was appointed to the Management Board of the European Medicines Agency (EMA) by EU Member States. He is one of the two patient representatives on the Board with a 3-year mandate starting in June 2019. Since January 2018, he has also been a member of the Board of the European Health Forum Gastein (EHFG).

In this podcast, we discuss pricing and access to new medicines under the challenges of COVID-19, as well as balancing the potential impacts of compulsory licenses to address the pandemic with the need to maintain a viable EU investment market. We also touch on topics such as Europe's competitiveness in global biotech, the hospital exemption of oncology products such as CAR-T, the recent marked decline in authorisations of EU orphan products, and the recent NGO report on the Innovative Medicines Initiative.

Yannis is a founding member of the European Alliance for Responsible R&D and Affordable Medicines and represents the public health voice on the following groups: High Level Group (HLG) to the Round Table meetings for European Health Ministers and Heads of Europe of pharmaceutical companies; Health Technology Assessment (HTA) Network Stakeholder Pool of the European Commission.

See omnystudio.com/listener for privacy information.

View Details

Dr Wilfred Reilly is a political muckraker and data-driven contrarian par excellence. He is currently an Associate Professor of Political Science at Kentucky State University, a historically Black college in Frankfort, Kentucky. He holds a PhD in Political Science from Southern Illinois University and a law degree from the University of Illinois. Reilly's research focuses on empirical testing of political claims which are often very influential but rarely well-supported by scientific data.

Dr. Reilly has recently turned his focus to the response to COVID-19, writing an article on April 28th for SPIKED online called, “There is no empirical evidence for these lockdowns.” Needless to say, his analysis lit a firestorm of debate on the internet, similar to whacking a hornet’s nest with a broom handle. He recently updated this article on May 8th with fresh data and the title, “The lockdowns still aren’t working”, also published in SPIKED online.

Reilly, who is African American, has appeared or been quoted in television, radio and print media outlets, claiming that many or most recent high-profile hate crimes (i.e. Jussie Smollett, Yasmin Seweid, Air Force Academy, Eastern Michigan, Hopewell Baptist) have turned out to be hoaxes. Reilly's recent book Hate Crime Hoax: How the Left is Selling a Fake Race War, was published by Regnery Publishing in February 2019. For the book, Reilly assembled a data set of 409 allegedly false or dubious hate crime allegations (concentrated during the past five years), which he describes as hoaxes on the basis of reports in mainstream national or regional news sources. This data set is available to anyone who requests it. He is also the author of Taboo: 10 Facts You Can’t Talk About, also published by Regnery.

See omnystudio.com/listener for privacy information.

View Details

Robert Madelin is the Chairman and Chief Strategist at FIPRA International Ltd. Robert is a rare politician with hands-on experience guiding pan-European policy for IT and healthcare. From 2004-2016 he was the Director General for Communications Networks, Content and Technology (CONNECT) and Director General for Health and Consumer Policy (SANCO). Robert Madelin was also a negotiator for both EU and UK international trade and investment, and served in the Cabinet of European Commission Vice-President Leon Brittan.

His 2016 book, “Opportunity Now: Europe's mission to innovate” outlines how the EU can better manage innovation, which is of particular interest given Europe’s immediate need to find solutions to solving the current lockdowns for Covid-19. In this podcast we discuss practical solutions for addressing Europe’s need for technical leadership, as well as how the EU can adapt to meet the structural challenges exposed by the response to the pandemic. We also discuss several ongoing regulatory reviews related to pharmaceutical incentives including those targeting orphan drugs and medicinal products.

See omnystudio.com/listener for privacy information.

View Details

Working at the sharp edge of finance by restructuring companies, Dimitrios Athanasiou was a very successful business consultant and executive with more than 25 years’ experience on international projects. Then, his life changed when his son was diagnosed with Duchenne Muscular Dystrophy. He has since put his business career aside, becoming a fulltime international patient advocate in Duchenne and in rare diseases.

In this podcast we discuss the impact of COVID-19 on both the access to regular care for patients dealing with a rare disease, and the state of the development of needed new orphan and medicinal products given the impact of global lock downs. Dimitrios also reflects on how we can improve the state of treating orphan conditions in Europe given what we’ve learned from dealing with the pandemic.

Dimitrios Athanasiou is currently a board member of European Patient Forum (EPF) and the World Duchenne Organization. He represents EURORDIS on the Paediatric Committee of the European Medicines Agency, and is a trainer for the EUPATI Academy, building the next generation of patient advocates.

See omnystudio.com/listener for privacy information.

View Details

Adrian van den Hoven, Director General of Medicines for Europe, sits at the center of the industry body tasked with supplying the majority of the medicines required to fight COVID-19 in Europe. With the record high demands for antiseptics, unprecedented challenges to global supply chains, and the current rush to repurpose and test many generic compounds to fight the WuHan Virus, Medicines for Europe sits in the crosshairs of Europe’s COVID-19 public health challenges. Adrian’s members need to supply the vast majority of the medicines that keep hospitals open and sick people healthy, regardless of the logistical challenges of the pandemic.

In this podcast, we discuss the many barriers to keeping Europe’s supply chains open, whether it’s due to lockdowns, international production shocks, or the old-fashioned hording of goods. Adrian provides his insights as to how Europe can better prepare for future challenges to our healthcare infrastructure and increase the security of needed medical supplies under existing legislation. Adrian took on the role of Director General of Medicines for Europe in 2013, and before that, was the Deputy Director General of Business Europe.

See omnystudio.com/listener for privacy information.

View Details

Jim Greenwood is President and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C., representing over 1,000 biotechnology companies and academic institutions in more than 30 countries worldwide. In this podcast, we discuss how BIO is at the front lines of the battle to find treatments and cures for COVID19, by harnessing the many technological breakthroughs of the last two decades. As well, we discuss the political fallout to the U.S. biopharma sector being caused by high out of pocket expenses, and how best to move forward I order to improve trust between industry, government, and patients.

A former member of congress, Jim Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from 1993 to 2005 when he became BIO’s CEO, and his deep relationships on Capitol Hill and policy expertise have substantially raised BIO’s profile and advocacy work. Under his leadership, he has successfully doubled the size of BIO, as well as grown its international influence on global biotechnology innovation. After a hugely successful tenure as BIO’s CEO, Jim Greenwood announced that he will be stepping down at the end of the 2020 fiscal year.

See omnystudio.com/listener for privacy information.

View Details

One of the world’s leading Epidemiologists, Rick Grobbee has been at the centre multiple ground breaking projects of the Innovative Medicine’s Initiative that have focused on harnessing health data in new and unique ways. IMI’s GetReal, Big Data for Better Outcomes, and Big Data@Heart have all focused on improving research, but now, Rick Grobbee is leading the newly launched Trials@Home, that will move clinical trials from the hospital to the home, fundamentally changing the way clinical research is conducted.

In this podcast, we discuss the challenges posed by COVID19 to European healthcare systems, as well as the opportunity for harnessing Europe’s health data resources for smarter treatment and prevention. Rick is the professor of Clinical Epidemiology at University Medical Centre Utrecht and founder of the Julius Center for Health Sciences, currently employing roughly 500 staff. In 2017 he was knighted by the Dutch King, and given the Knight in the Order of the Dutch Lion.

See omnystudio.com/listener for privacy information.

View Details

Sarah Garner is the Acting Programme Manager of Health Products and Pharmaceuticals of the WHO Euro, and is the former Associate Director for Scientific Policy and Research at the UK’s National Institute for Health and Care Excellence. She is a visionary seeking new approaches to improve innovation, access, and outcomes in healthcare, and has a nuanced view of the financial realities of R&D and the challenges of our national healthcare systems.

In this podcast, Sarah discusses the need to support the evaluation of medicines for countries on the periphery of EMEA, as well as the role science and innovation are playing in personalised medicines, and orphan indications. We also discuss the WHO’s interest in using its convening power to discuss strategies to overcome barriers to access to high value medicines.

See omnystudio.com/listener for privacy information.

View Details

California leads the world in biotech productivity and innovation, and Joseph Panetta, President & CEO of Biocom, has been at the center of the growth of the San Diego biotech ecosystem since 1989. In this podcast, we discuss the various international pricing proposals being discussed in Washington DC, and their potential negative impact on the California biopharma ecosystem.

Biocom is an association that advocates for 1200 companies, service sector firms, universities and research institutes working in the biotechnology sector. As President and CEO since 1999, Mr. Panetta leads programs in capital formation, public policy, workforce education, and member-to-member services. He is a co-founder of the Biocom Political Action Committee, the Biocom Institute for education and workforce development, and the California Biotechnology Foundation, a joint initiative to inform legislators and the media about the life science industry in the state, of which he is Chairman.

Research quoted: https://vitaltransformation.com/2019/11/international-reference-pricing-under-h-r-3-would-devastate-the-emerging-biotechnology-sector-leading-to-56-fewer-new-medicines-coming-to-market-over-10-years/ https://healtheconomicsreview.biomedcentral.com/articles/10.1186/s13561-014-0023-5 https://www.hbs.edu/faculty/Publication%20Files/09-118.pdf

See omnystudio.com/listener for privacy information.

View Details

The California Life Sciences Association (CLSA) has been very active in the current discussions on Medicare Pricing Reform, and finds itself at the center of the debate with the US congress regarding the announced plans to introduce international reference pricing for medicines. CLSA is a 1000-member trade association representing California’s life sciences industry and was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged.

We’re joined in this podcast by two CLSA representatives, Bill Newell, the CEO of Sutro Biopharma and the former CLSA board chair, and Jenny Nieto, CLSA’s Vice President of Federal Government Relations & Alliance Development, who leads the organizations policy activities in DC.

See omnystudio.com/listener for privacy information.

View Details

In 2007, Dr. Regina Herzlinger, the Nancy R. McPherson Professor of Business Administration at the Harvard Business School, wrote a book called “Who Killed Health Care”, making a strong case for a healthcare system based on consumer choice and pricing transparency. More than a decade later, America is now struggling to make the Affordable Care Act, or ‘Obama-care’, solvent, and most countries in Europe are facing exponentially increasing healthcare costs and the rationing of government services. In fact, the US congress is now developing proposals for 1970’s style pricing controls for Medicare Part D.

Dr. Herzlinger’s book was absolutely prescient in predicting the problems we face today funding healthcare and, in this podcast, she offers her unique perspective on how we can fix it.

See omnystudio.com/listener for privacy information.

View Details

John LaMattina is a contributor to Forbes Magazine where is he one of the world’s thought-leaders in healthcare journalism. John was the president of Pfizer Global Research and Development from 2007 where he managed more than 13,000 scientists and professionals in the United States, Europe, and Asia for a decade. He is the author of "Drug Truths: Dispelling The Myths Of R&D" and the recently published “Devalued And Distrusted: Can The Pharmaceutical Industry Restore Its Broken Image?" John LaMattina is also a senior partner at PureTech Health, a leading biotech company investing in businesses that combat serious diseases.

In this podcast, we discuss the potential impact on Bio-pharmaceutical innovation if the US Congress or Trump Administration succeed in passing their various international pricing proposals, which potentially have an impact of up to $70 billion of reduced revenue annually. As well, John LaMattina highlights the challenges of developing products for neurological disorders such as Alzheimer’s disease, and how the current R&D system is producing therapeutic breakthroughs in previously untreatable areas such as oncology and anti-infectives.

See omnystudio.com/listener for privacy information.

View Details

Called one of the 50 most influential people in Regenerative Medicine, Eduardo Bravo is currently the CEO of Nordic Nanovector, a company focused on a unique combo therapy combining a monoclonal antibody with a radiation therapy. He successfully steered the stem cell company TiGenix through a rejected FDA application and re-emerge with a new product portfolio to be successfully acquired in 2018 by Takeda in an all cash deal valued over $600 mil. Eduardo is also the former president of the trade body European Biopharmaceutical Enterprises (EBE), and led several initiatives to help Europe’s competitiveness in the biotech sector. In this podcast we discuss the looming international debates on drug pricing as well as the challenges to commercialisation in Europe.

See omnystudio.com/listener for privacy information.

View Details

For thirty years, Richard Barker has been one of the U.K.’s healthcare thought leaders. He is the Founder of New Medicine Partners and the Founding Director of the Centre for the Advancement of Sustainable Medical Innovation (CASMI), where he championed the concept of adaptive licensing. With the current U.S. focus on international reference pricing for Medicare Part D & B, Richard’s work in Adaptive Reimbursement is gaining traction as a potential solution to pricing debates that are currently reaching a global crescendo.

Dr Barker was the Director General of the Association of the British Pharmaceutical Industry (ABPI) for six years between 2004 and 2011, and intimately understands both NHS budget constraints, as well as the need for a vibrant investment ecosystem to make healthcare innovation a reality. Richard is currently Chairman of the Health Innovation Network of South London, and a member of the Celgene board of Directors. He is the former EU head of McKinsey’s Healthcare practice and was also the General Manager of IBM's healthcare business.

See omnystudio.com/listener for privacy information.

View Details

Recorded in July of 2019, this podcast features Sue Peschin, the President and CEO of the Alliance for Aging Research in Washington DC, which is an organisation currently at the centre of the current Medicare Part B and Part D debates. Sue has more than 20 years of experience in health policy roles and has led Alliance since 2012. She has driven efforts in adult immunization, NIH Alzheimer’s funding, cardiovascular disease, and co-organized the first-ever NIH geriatric medicine summit. She participates in many major industry and policy symposiums around the United States each year and has published many opinion pieces in leading news outlets nationwide.

See omnystudio.com/listener for privacy information.

View Details

Susan Cantrell is the CEO of the Academy of Managed Care Pharmacy (AMCP), the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians, nurses, and professionals in life sciences and biopharmaceutical companies leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effective and safe medications and other drug therapies. AMCP members improve the lives of nearly 300 million Americans served by private and public health plans, pharmacy benefit management firms, and emerging care models.

AMCP advocates at the national and state level for developing and applying evidence-based medication use strategies that improve access to medication, enhance patient and population health outcomes, and safeguard the wise use of health care dollars. Before AMCP, Susan was Senior Vice President and Managing Director, Americas for the Drug Information Association (DIA). She is also a registered pharmacist and former hospital and home care pharmacy administrator.

See omnystudio.com/listener for privacy information.

View Details

John Doyle leads the Patient Health & Impact Global Healthcare Innovation Center at Pfizer. His team designs new models for value-based contracting and innovative financing and forges new partnerships across the healthcare sector to facilitate value-based healthcare. Prior to joining Pfizer, John led the Global Enterprise Solutions team at IQVIA, providing technology-enabled real world evidence platforms and research networks to healthcare systems worldwide. John also led the Global Value & Outcomes Center of Excellence at Quintiles, overseeing pricing and market access, policy analysis, and health economics and outcomes research.

Recorded live at the 2019 BIO international conference in Philadelphia, this podcast includes in-depth discussions on what value-based pricing is and the challenges to its implementation. John also discusses the Administration’s International Reference Pricing Initiative and offers alternatives that focus on bringing better value to US patients without limiting access.

See omnystudio.com/listener for privacy information.

View Details

With the future of the EU HTA Regulation in question, Niklas Hedberg, Chair of the EUnetHTA Executive Board, discusses what’s needed to get the HTA Proposal back on track. Recorded at the HTAi conference in Köln, Niklas also expresses his opinions on the state of the OMP legislation from the standpoint of both EUnetHTA and his home HTA in Sweden, and does so incorporating the discussions around the orphan legislation at the conference.

Niklas Hedberg is the Chief Pharmacist of the Swedish Pharmaceutical Benefits Agency (TLV) and a frequent presenter at leading conferences such as DIA and ISPOR. He is seen as one of Europe’s young visionaries, working to develop new approaches to evaluating medicines in the member states while also improving access for patients.

See omnystudio.com/listener for privacy information.

View Details

In this podcast we discuss the evolution of science that is driving the increasing focus on rare indications with Anne Pariser, the Director of the Office of Rare Diseases Research at the National Center for Advancing Translational Sciences (NCATS). Anne is a noted international expert or rare diseases, and has been involved in numerous collaborations within the FDA, as well as with drug developers, governmental agencies, patient groups and other stakeholders in the development of treatments for rare indications.

Dr Pariser comes to NCATS from the FDA, where she had worked since 2000 on the development of drug and biological products for orphan and rare conditions. Dr Pariser also served as an associate director in the FDA’s Office of Translational Sciences, which is part of the Center for Drug Evaluation and Research (CDER).

See omnystudio.com/listener for privacy information.

View Details

Peter Young is a Venture Partner at Pappas Capital, and brings to his investment approach thirty-five years of experience in the biopharma sector. The former Vice President and Therapy Head at Glaxo Wellcome in the mid-1990s, Peter led the global introduction of combination HIV therapies that revolutionized HIV treatment, quintupled Glaxo’s HIV sales, and maintained leadership on global treatment access. Peter has since served as CEO of two private start-ups, a vaccine company that raised over $80 million in NIH, HIV, and biodefense grants, and a specialty pharmaceutical company he led to a successful exit.

In a podcast recorded at the BIO International conference, Peter discusses the ramifications of the Trump Administration’s proposals for international reference pricing in Medicare Part B, as well as how to balance the higher prices being driven by smaller, targeted indications and the need to support the natural movement of science in rare therapies. We also discuss the ‘hot-button’ issues around the orphan drug legislation and how we can constructively move forward without throwing the orphan baby out with the bathwater.

This podcast is made possible with the support of EUCOPE.

See omnystudio.com/listener for privacy information.

View Details

EURORDIS, a portmanteau of European Rare Disease, is a non-governmental alliance of organisations representing 860 rare disease patient organisations in 70 countries, and the 30 million people affected by rare diseases throughout Europe. CEO Yann Le Cam in 1997, one of the founders of EURORDIS, who's eldest of three daughters is living with cystic fibrosis.

With the upcoming European Commission Conference on Rare Diseases occurring on June 17th coupled with the ongoing inquiry around the OMP regulation, this timely podcast with EURORDIS’ Director of Public Affairs, Simone Boselli, puts the discussions squarely in the context of patient access to needed medicines for rare indications by developing a pan-European value-based evaluation network.

This Better Science, Better Health Podcast is made possible with the support of EUCOPE.

See omnystudio.com/listener for privacy information.

View Details

Erik Tambuyzer is one of the world’s thought leaders in orphan drugs and rare disease indications. While he was Genzyme’s EU and International Senior Vice-President for Corporate Affairs, he was also the industry’s negotiation lead with the European Commission and Parliament on the Orphan Medicinal Products Regulation, introduced in the year 2000, working together with patients’ organisations and academics. As an entrepreneur in 1985, he had co-founded and managed the biotech company Innogenetics, ultimately acquired by Fujirebio. He is the Executive Chairperson and co-founder of the BioPontis Alliance for Rare Diseases, an international philanthropic foundation turning science into medicines.

This Better Science, Better Health Podcast is made possible with the support of EUCOPE.

See omnystudio.com/listener for privacy information.

View Details

Nigel Hughes is the Scientific Director of Real World Evidence at Janssen Clinical Innovation. He collaborates with the EFPIA Digital Strategic Governing Group, and he is also co-lead of Big Data for Better Outcome’s €30 million flagship consortium, the European Health Data & Evidence Network, or EHDEN. Janssen and Nigel have long been at the forefront of developing the needed tools and infrastructure to harness health data, both through their involvement with previous IMI projects such as EMIF and EHR4CR, as well as supporting open source data sharing platforms such as OMOP and OHDSI.

Nigel brings his decades of experience in nursing and directing NGOs in AIDS and Hepatitis C to IMI's EHDEN. His unique perspective on the need for global collaboration to address societal challenges like Alzheimer's disease is well-reasoned and refreshing in today's fractured and divisive political climate.

See omnystudio.com/listener for privacy information.

View Details

Dr. Clemens Martin Auer is currently Special Envoy for Health at the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection and formerly longstanding Director General of the same institution. In this podcast, we discuss his leadership for implementation of better tools to evaluate healthcare efficiency and outcomes as the co-chair of the European eHealth Network to establish cross-border eHealth applications. In 2017, he was elected President of the European Health Forum Gastein, which under his direction has focused on improving the delivery of healthcare in the EU member states. He has been nominated by the Austrian Government to be the next WHO Regional Director for Europe, and we discuss his vision and objectives if he were to be successfully elected to that position.

See omnystudio.com/listener for privacy information.

View Details

Vaccines are one of the most effective public health measures available, saving some two to three million lives worldwide every year. However, in Europe where vaccine preventable disease almost disappeared, the public is now worried about the safety of the vaccine, limiting their use, resulting in outbreaks of preventable diseases like Measles. IMI’s Advance project, which concluded in March of 2019, brought together a large cross-section of European stakeholders to create a system and network to rapidly provide real world evidence on vaccine coverage, safety and effectiveness using existing health data in EU countries.

ADVANCE has built VAC4EU: a non-for profit legal entity that will implement the ADVANCE system and vision, and in this podcast we are joined by two members of the ADVANCE co-ordinating team responsible for its launch and rebranding.

Miriam Sturkenboom, ADVANCE’s Project Coordinator Patrick Mahy, Scientific Institute of Public Health in Belgium

See omnystudio.com/listener for privacy information.

View Details

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest, Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He is the editor of the new book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting.

In this podcast, we discuss the potential impact of the International Pricing Index (IPI) on global innovation, as well as several alternatives which could be put in place that would create less havoc for innovators and patients. As well, we discuss the increasing divergence of the innovative capacity between the US and Europe, and how the current systems of reimbursement are impacting the ability to support and R&D ecosystem.

See omnystudio.com/listener for privacy information.

View Details

Joe Damond is the Executive Vice President for International Affairs at the Biotechnology Innovation Organization (BIO), the largest service organisation for biotech companies in the world. In this podcast we discuss the continuing attacks on Intellectual Property in Europe and the US, as well as how the International Pricing Index (IPI) of the Trump administration will impact biotech investment and innovation.

Joe spent 12 years as a trade negotiator at the Office of the United States Trade Representative for Asia and Pacific/APEC Affairs, and is a well-respected thought-leader helping governments develop sustainable biotech ecosystems. Joe Damond received his master’s degree from Princeton University’s Woodrow Wilson School of Public and International Affairs.

See omnystudio.com/listener for privacy information.

View Details

Vital Transformation launches its new series of Better Science, Better Health podcasts focused on the challenges and opportunities of new medicines. With the increasing focus on drug pricing in the US Congress and Senate, and with the Trump Administration's proposals for international reference pricing on therapies covered under Medicare Part B, Vital Transformation shares the insights of Dr. Mark McClellan, one of the world's most important thought leaders in value-based healthcare.

Mark McClellan is the founding Director of the Duke-Margolis Center for Health Policy at Duke University. He is a world-renowned physician and economist who has researched outcomes-based reimbursement and real-world evidence evaluation models for new therapies. Dr McClellan was both the former administrator of the Centers for Medicare & Medicaid Services and Commissioner of the FDA. He was a Senior Fellow in Economic Studies at the Brookings Institution, where he was the Director of the Health Care Innovation and Value Initiatives.

See omnystudio.com/listener for privacy information.

View Details

Martin Seychell, Deputy Director General for Health, Food and Safety of the European Commission, outlines how Europe must use a combination of social media communications and new real-time tools for safety monitoring to regain the public’s trust in vaccinations. Our Vital Health Podcast was recorded at the final event of the Innovative Medicine’s Initiative’s ADVANCE project, which promotes the use of distributed health databases to facilitate vaccine safety studies in Europe.

See omnystudio.com/listener for privacy information.

View Details

The Norwegian Medicine Agency’s Anja Schiel is one of Europe’s leading proponents of new methodologies to harness Real World Evidence in the comparative analysis of new medicines. She’s the agency’s senior statistician and works at the forefront of developing new methodologies to improve the way we understand how therapies actually work in practice.

See omnystudio.com/listener for privacy information.

View Details

Sebastian Schneeweiss is Professor of Medicine and Epidemiology at Harvard Medical School and is one of the world’s leaders in analytic methods to understand the effectiveness of newly marketed medical products using healthcare databases. His research has been funded by NIH, PCORI, and FDA grants, and he’s also the co-founder of Aetion, a healthcare technology company that delivers the real-world evidence for value-based care.

See omnystudio.com/listener for privacy information.

View Details

For five years, Tomas Salmonson was the chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency at a time of unprecedented innovation and challenge. Stepping down as the senior scientific advisor at the Swedish Medical Products Agency, Tomas has an open and frank discussion about how Europe must evolve to address the accelerating demands of innovation.

See omnystudio.com/listener for privacy information.

View Details

If there is a Godfather of Real World Data, it would be Marc Berger. Currently the chair of the ISPOR Real-World Data Task Force, Marc has developed many of the models and techniques we use today to put RWE into practice. Marc was the Senior Scientist at OptumInsight, now part of United Health Group. He was also was the VP of Global Health Outcomes at Eli Lilly and Company, and for five years was the VP of RWD at Pfizer. He is now an advisor to SHYFT Analytics.

See omnystudio.com/listener for privacy information.

View Details

The 2017 Presidency of Estonia is roundly seen as one of the EU's most successful, with a long-lasting impact on Europe's health strategy. Ain Aaviksoo was the Deputy Minister of Health and oversaw the ground-breaking implementation of Estonia’s E-Health platform. It is a showcase of what can be accomplished by a government, while, at the same time, respecting the confidentiality and wishes of citizens. Ain is now the Chief Medical Officer of the blockchain company Guardtime.

See omnystudio.com/listener for privacy information.

View Details

The Innovative Medicines Initiative (IMI) is the world’s largest public private partnership with a €5 Billion budget. For three years, Pierre Meulien has been the IMI’s Executive Director, bringing with him a wealth of international experience including a stint as the head of Genome Canada and founding Molecular Medicine Ireland. In this podcast we discuss the challenges of European healthcare, the evolution of the IMI since his appointment, and the role the IMI should play in Horizon Europe with the next commission.

See omnystudio.com/listener for privacy information.

View Details

EUCOPE is Europe’s principal trade body for small to medium-sized biotechnology companies working in areas often targeting orphan diseases. In this podcast we're joined by Alexander Natz, EUCOPE’s Secretary General, and Delphine Roulland, Senior Manager Public Affairs, to discuss the impact on their members of proposed EU policy changes related to intellectual property, as well as the EU's ongoing review of the orphan drug legislation.

See omnystudio.com/listener for privacy information.

View Details

In Big Data for Better Outcomes, BigData@Heart, DO->IT, EHDN, the EU data Consortia, and yes, even concepts like pay for performance, Richard Bergström has had a hand in their creation. The former Director General of EFPIA, and now the head of health both at SICPA and their joint venture blockchain company Guardtime, Richard is always ahead of the curve. In fact, he's usually the one who makes the curve in the first place.

See omnystudio.com/listener for privacy information.

View Details

Many HTAs in Europe are seen as conservative and even reactionary when it comes to innovating or changing their processes. However, Amr's PhD thesis is a 300+ page ‘how to’ manual highlighting RWE best practices and has put him at the forefront of the next generation of EU officials who are trying to move healthcare forward in Europe.

See omnystudio.com/listener for privacy information.

View Details

One of Europe’s most articulate and forceful patient advocates, Bettina Ryll is a cyclone of energy, persistence and vision driven by her own family tragedy dealing with cancer. With a PhD in Biomedical Sciences from University College London, she possesses technical insights in drug development that few European patient representatives have. As well, Bettina cuts through the noise to best represent her members in the Melanoma Patient Network Europe, which she founded.

See omnystudio.com/listener for privacy information.

View Details

In this podcast, Steve Bates, UK BioIndustry Association's CEO, discusses both the challenges and opportunities of Brexit on the UK’s biotechnology sector, and the need for strong, vital IP supported by private investment.

Steve was an advisor to Tony Blair’s government and a founding member of United Life Sciences, a strategic partnership representing over 1000 life science and healthcare member companies internationally. He also sits on the Science, Industry and Translation Committee of The Royal Society.

See omnystudio.com/listener for privacy information.

View Details

Founded in 2007 by the FDA and Duke University, the Clinical Trials Transformation Initiative (CTTI) has as its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Pamela Tenaerts, CTTI's Executive Director, has a broad international perspective given her previous life running large international clinical research at KU Leuven, and we were fortunate to catch up with her at the IMI Stakeholder Workshop in Brussels to discuss how to improve clinical research.

See omnystudio.com/listener for privacy information.

View Details

Patrick Kilbride is vice president of international intellectual property for the Global Innovation Policy Center (GIPC) at the U.S. Chamber of Commerce. Over the last several years, there has been a growing chorus of voices internationally that have begun to question the role of IP in drug development.

In this podcast, we separate fact from fiction around the role of IP in developing new biotech products, the changing global landscape for innovation, and what we need to do to ensure that we don’t throw the IP baby out with the rhetorical bath water.

See omnystudio.com/listener for privacy information.

View Details

Emil Pot was one of the founders of ActoGeniX, which was successfully acquired in 2015 by Intrexon. Emil outlines the ingredients Europe needs to build a company from scratch, and leverage home-grown Intellectual Property.

See omnystudio.com/listener for privacy information.

View Details

With a continuing series of educational courses, several functioning web platforms to harness real world evidence, and now, an extension of project funding for two years, GetReal is regarded as one of the Innovative Medicine’s Initiatives true success stories. Duane speaks with Elaine Irving of GSK, who has been Driving the GetReal bus for three years, avoiding potholes, and keeping the wheels turning as the project’s coordinator.

See omnystudio.com/listener for privacy information.

View Details

Luca Pani is one of the global thought leaders on using real world evidence to evaluate medicines. In this podcast, we discuss his latest book, “PHARMACEUTICAL RESILIENCE – How to Govern the Evolution of Treatments” as well as innovative approaches he's developed in partnership with economists Sylvain Chassang and Erik Snowberg to model the value of new medicines with uncertain outcomes.

For 5 years, Luca was the head of the Italian Medicine’s Agency, and successfully implemented the world’s first pay for performance system. He is now the Executive Director for Global Medical Innovation at NeuroCog Trials, and is a Professor at the University of Miami’s Miller School of Medicine.

See omnystudio.com/listener for privacy information.

View Details

Better Science, Better Health: VIB’s Johan Cardoen, An EU Biotech Success Story.

For the first podcast in our series investigating the impact and importance of IP on European biotech and innovation, we have an in-depth discussion with Johan Cardoen of VIB, Gent’s life sciences research institute in Belgium. VIB has been called by Reuters, “part of the success . . . to Belgium’s distinct approach to biotech start-ups.” Given that a VIB spin-out Ablynx was recently acquired by Sanofi for $5 billion dollars, Johan's approach to successful innovation is starting to be noticed in the EU's offices in Brussels, just down the road from Gent, but often a world apart.

Our conversation covers many pressing topics including how VIB has built its well-deserved reputation for creating successful biotech platforms, the brain-drain of maturing biotech companies and strategies to keep them in Europe, the potential impact of IP exemptions like WTO compulsory licenses on biotech companies, why the past GMO debate matters today, and what technologies are currently going to be the next ones to impact the lives of patients.

See omnystudio.com/listener for privacy information.

View Details

Dr. Eichler continues his global efforts at the forefront of promoting new and innovative approaches to both regulatory approvals and science in the face of a torrent of change at the EMA. In this podcast we discuss the impact of Brexit, the movement towards increasing international collaboration to improve the way we evaluate medicines, and how the response complexity of many new indications such as CAR-T is impacting the benefit risk and reimbursement landscape for regulators and payers.

See omnystudio.com/listener for privacy information.

View Details

An adventurer, a child health advocate, a former Female Welsh Rugby side member, a Phd researcher, and now a healthcare entrepreneur, Elin Haf Davies is truly a force of nature. Her health-tech start-up company Aparito was recently written about in a gushingly positive article by Forbes who asked, “Can Aparito's Wearable Tech Solve Big Pharma's Billion-Dollar Crisis”? We try to answer that question, and many more, in this Vital Health Podcast.

See omnystudio.com/listener for privacy information.

View Details

Steve Rosenberg, Senior Vice President and General Manager of Oracle Health Sciences, discusses with Duane Schulthess of Vital Transformation many of the cloud-based solutions for clinical trial management, patient-reported outcomes, and advanced analytics which are industry standards today that Steve has personally had a hand in developing. We also pull out our crystal ball to guess where the industry is headed, and who will be the winners and losers going forward.

See omnystudio.com/listener for privacy information.

View Details

Duane Schulthess of Vital Transformation sits down at the DIA Global conference in Boston, for a one on one discussion with Nikolai Brun, CMO Danish Medicines Agency.

See omnystudio.com/listener for privacy information.

View Details

Duane Schulthess of Vital Transformation sits down at the DIA Global conference in Boston, for a one on one discussion with Jeff Allen, CEO of Friends of Cancer Research from Washington DC.

Washington DC’s Friends of Cancer Research is an advocacy group that has had a profound influence on how we bring new cancer therapies to market. Friends played a key role establishing the FDA’s breakthrough designation, and their president and CEO, Jeff Allen, is now focused on harnessing Real World Evidence to improve the way we evaluate oncology treatment.

See omnystudio.com/listener for privacy information.

View Details

Duane Schulthess of Vital Transformation sits down for a one on one discussion with Luca Pani, the Director General of the Italian Medicines Agency, to discuss his new book “Sustainable Innovation: Medicines and the Challenges for the Future of our National Health Service”.

This 30 minute podcast recording at the AIFA digs into Italy’s very successful outcomes based reimbursement system launched by Prof Pani, as well as the implications and needs of an open data system for improving health and preventing disease. The podcast also investigates the opportunities and challenges presented by next generation therapies such as regenerative medicines, gene therapies and immuno-oncology treatments given the experience of the new class of Hepatitis C drugs.

See omnystudio.com/listener for privacy information.

View Details

Nashville Biosciences and Vital Transformation are collaborating on a ground-breaking project to measure the impact of CAR-T on the total cost of treating cancer by harnessing RWE.

The CEO of Nashville Biosciences, Leeland Ekstrom, sat down with Duane Schulthess in an open discussion on how to use RWE to improve drug development, reduce costs, cut time to market, and have an honest understanding of what is actually happening within our healthcare systems. You can register to attend their collaborative workshop taking place at the DIA 2018 Global conference in Boston on June 24th via http://bettersciencebetterhealth.com/dia-global-2018-value-pricing-bootcamp-crash-course-use-real-world-evidence-better-measure-outcomes-evaluate-new-innovative-therapies.

See omnystudio.com/listener for privacy information.

Vital Health Podcast: Recent Episodes

Vital Health Podcast