Vital Health Podcast

Latest Episodes:

NJ’s Biopharma Sector in a Price Controlled World Jul 06, 2023

Show notes

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.”

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IRA’s Impact on Orphan Therapies – David Meeker Jun 29, 2023

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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.

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Nick Shipley - IRA’s Impact on the Biopharma Ecosystem Jun 23, 2023

Show notes

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 U.S. 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.

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Nikolai Brun - Improving Europe's Biopharma Legislation May 31, 2023

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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.

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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EU Cost Effectiveness Models Threaten Vulnerable U.S. Patients May 17, 2023

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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.

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Andrew Roddam, CEO of Our Future Health May 11, 2023

Show notes

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.

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Attacks on Bayh-Dole Put University Research at Risk May 04, 2023

Show notes

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).

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California Life Sciences’ Response to the Inflation Reduction Act Mar 16, 2023

Show notes

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.

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"Bayh–Dole Cannot be Used for Controlling Prices" Mar 02, 2023

Show notes

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.

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Price Controls put US Biopharma at Risk Feb 16, 2023

Show notes

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://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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