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. 

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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.

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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. 

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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 [email protected].

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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. 

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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. 

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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.

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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). 

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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. 

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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.

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