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.

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.

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.

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• 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.

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• 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.

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• 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.

• 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.

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.

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.

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:

• 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.

• 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.

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.

• 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.

• 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.

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.

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.

• 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.

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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.

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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.

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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.

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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.

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• 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.

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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.

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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.

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.

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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.

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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.

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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.

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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/

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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.

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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.

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• 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.

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1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

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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.

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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!

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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.

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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.

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Kim outlines how Trials@Home is applying new innovative approaches to DCTs to evaluate different operational models of DCTs in RADIAL, the project’s pan-European proof of concept study. As well, Kim Hawkins describes how one core mission of the project is placing patient choices and opinions at the centre of decision making and implementation.

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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.

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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. 

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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. 

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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. 

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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. 

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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. 

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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.

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• 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.

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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.

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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.

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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.

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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.

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In this Vital Health Podcast, Amitabh highlights the enormous disincentives for small molecules created by the IRA, as companies will receive four fewer years of revenue when compared to large molecules. As well, we touch on the challenges of PBM rebates due to their lack of transparency, and how this is creating political issues for the biopharma sector.

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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.”

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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.

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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.

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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.

This podcast was made possible with the support of EFPIA - The European Federation of Pharmaceutical Industries and Associations. 

00:00:41 - EU Pharmaceutical Legislation Proposal: AMR and EMA Review Timelines
00:03:46 - Europe's Loss of Competitiveness: Regulatory Sandbox and Real-World Data
00:07:34 - Regulatory Data Protection Linked to Access to All 27 Member States
00:12:03 - Development of COVID-19 Vaccines: The Regulatory Challenges
00:15:45 - AMR Incentives
00:20:45 - Europe Losing Ground vis-à-vis the USA
00:24:42 - Global Share of Clinical Trials
00:31:37 - Regulatory Sandbox
00:35:21 - Forced Access to All 27 Member States and Incentives  
00:41:40 - Regulators’ Skills Gap
00:48:19 - Europe and Value-Based Healthcare
00:49:50 - Unmet Medical Needs and Accelerated Procedures
00:55:57 - The Best Place to Start to Improve the European System
00:58:36 - Advanced Therapies Development: The Case of China 

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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.

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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.

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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).

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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.

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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. 

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https://bit.ly/3S8G8KW

https://bit.ly/3lF0U8O

https://bit.ly/3KcWqQM

https://www.the-scientist.com/infographics/cell-and-gene-therapy-tracker-64450

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In this Vital Health podcast, Duane Schulthess speaks 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.

They 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 and what this means for US Universities as well as for patients in the long-term. Patrick also provides 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.

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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.

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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. 

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• 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.

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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.

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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 

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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.

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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.

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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.  

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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.

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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.

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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 

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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.

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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.

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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.

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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.

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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.

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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. 

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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.

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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.

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