Vital Health Podcast

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 t...

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 biot...

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....

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,...

On October 7th, Health and Human Services Secretary Xavier Becerra said that the use of March-In Rights to control the pricing of medicines was not, “Off the Table”. This comment lit a firestorm in the US biopharma sector. In this Vital Health podcast, Duane Schulthess speaks to Patrick Kilbride, the Director of the US Chamber of Commerce’s Global Innovation Policy Center about March-in rights, an...

John LaMattina is the author of several highly respected books showcasing a deep insider's perspective of the biopharma industry. His latest book, "Pharma and Profits Balancing Innovation, Medicine, and Drug Prices", maps out a robust defense of the biopharma sector. John LaMattina was the President of Pfizer Global Research and Development where he managed more than 13,000 scientists and professi...

With the passage of the Inflation Reduction Act (IRA), the US Government has fully embraced the idea of mandating price controls for therapies paid for by Medicare. However, the IRA handles large molecules and small molecules differently, as the government negotiates prices at year 9 for small molecules, but year 13 for large molecules. Practically, this means that small molecules will be disincen...

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

With the US Inflation Reduction Act now law, many in Washington DC are saying that it’s provisions reducing pricing by $80 billion dollars annually in Medicare for drugs near the end of their patent life will not have any negative impacts on the US biopharma ecosystem.  Enter Amitabh Chandra, the director of health policy research at the Harvard Kennedy School of Government, and a professor of bus...

On this Vital Health Podcast, Duane Schulthess speaks with Devin Rosenthal, Vice President at NovaQuest Capital Management, who is responsible for the firm’s deal structuring and due diligence. Devin sits at ground zero of the long-term impacts of the Inflation Reduction Act. The Inflation Reduction Act (IRA) segments government pricing negotiations at 9 years for small molecules, but 13 years for...

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

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

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

What do you do when you’ve been an entrepreneur, and have successfully built and sold two healthcare start-ups to 3M and Aetna? If you’re John Dwyer, you advise The Global CEO Initiative on Alzheimer’s Disease to help find a cure. And given John’s track record of success, this sounds like a fantastic idea. The Global CEO Initiative on Alzheimer’s Disease (or CEOi), is an organization of private-se...

With the passage of the Inflation Reduction Act by the US Senate, the US is now on the cusp of implementing very aggressive drug pricing controls within Medicare. Richard Evans is the general manager of SSR Health, which he founded in 2009 to address the complexity of US drug pricing. Before founding SSR, Richard was a senior analyst at Sanford C. Bernstein, and during his tenure, he was ranked fi...

Michele Oshman is Vice President of External Affairs of BIO, and the Executive Director of BIO’s Council of State Bioscience Associations (CSBA), advancing public policies that support the bioscience industry in partnership with their state-based member associations. Before joining BIO in 2020, Michele had a successful 18-year career at Eli Lilly and Company, where she led their federal advocacy....

John Michael O'Brien was recently appointed as the president and Chief Executive Officer of the National Pharmaceutical Council (NPC), one of the key thought-leading organizations in Washington, DC championing biopharmaceutical innovation. Prior to joining NPC, Dr. O’Brien was a senior advisor to U.S. Secretary of Health and Human Services' Alex Azar. He has held senior positions at CareFirst Blue...

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

 It seems every week we hear of another new proposal out of Washington DC to ‘fix’ drug pricing, and many of the companies that would be impacted by these proposals are in California, arguably, the globe’s leading biotech hub, and where the sector was born. Joe Panetta is President & CEO of Biocom California, the association representing the life science industry in California. With offices in...

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

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

One of the brightest minds in DC, Tom Dilenge recently joined Flagship Pioneering, the highly respected bio platforms innovation company behind such groundbreaking startups as Moderna. Tom leads Flagship’s public policy, regulatory, and governmental affairs. Vital Transformation has worked closely with Tom in his previous role as President of the Biotechnology Innovation Organization (BIO),...

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

When the Centers for Medicare and Medicaid Services (CMS) published its draft determination requiring further clinical trials in Alzheimer’s disease treatments, Sue Peschin was one of the first to state her opposition to the policy. Sue is the President and CEO at the Alliance for Aging Research, the US’ leading non-profit organization dedicated to improving healthy aging for all.&nbsp...

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