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

Known for sunshine, Hollywood Movies, Mikey Mouse, and Silicon Valley, California has been at the center of global biotech for nearly half a century. The 1976 founding of Genentech in South San Francisco is considered the birth of the modern biotechnology industry. However, the US Congress’ recent passage of the Inflation Reduction Act is now understood to pose serious risks to the California biotech sector, potentially starving it of badly needed investment capital.  On this Vital Health Podcast, Duane Schulthess speaks with Mike Guerra, the President & CEO of California Life Sciences (CLS), regarding the many mounting challenges to maintaining California’s global biopharma leadership. For 30 years, CLS has supported early-stage innovators and startups, as well as established players in biotechnology, pharmaceuticals, and medical technology. Mike has been leading CLS since 2019. Last year, he was named CEO of the Year by the San Diego Business Journal and has more than a decade of experience in the life sciences.See omnystudio.com/listener for privacy information.

On this Vital Health Podcast, we speak to Joseph Allen, the Executive Director of the Bayh-Dole Coalition. Joe served as a Senior Staff Member of former Senator Birch Bayh and was instrumental in working behind the scenes to ensure the passage of the historic Bayh-Dole Act. The Wall Street Journal has stated that The Bayh-Dole Act is one of the three greatest policies that helped create U.S. Jobs. Passed in 1980 with the bipartisan sponsorship of Senators Birch Bayh and Bob Dole, the act allowed for university researchers that had received government funding to license important discoveries commercially. However, recent comments by members of the U.S. Senate and Biden Administration are threatening to upend the Bayh-Dole act, with increasingly bellicose demands for the government to ‘march-in’ and take back patents licensed under Bayh-Dole. Joe Allen provides many historical insights into the passage of the Bayh-Dole act, and outlines how this would be a disaster for U.S. patients and biopharma innovation. See omnystudio.com/listener for privacy information.

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-64450See omnystudio.com/listener for privacy information.

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, 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.See omnystudio.com/listener for privacy information.

John LaMattina is the author of several highly respected books showcasing a deep insider's perspective of the biopharma industry. His latest book, "Pharma and Profits Balancing Innovation, Medicine, and Drug Prices", maps out a robust defense of the biopharma sector.John LaMattina was the President of Pfizer Global Research and Development where he managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. He headed Pfizer's R&D programs through the acquisition and development of many blockbuster treatments such as Lipitor and Viagra, and is currently a senior partner at PureTech Health, as well as a contributor to Forbes. In this Vital Health Podcast, we discuss the increasing regulatory challenges facing the industry from the Biden Administration, including their June 2022 surrender of mRNA patent protections within the WTO TRIPS framework. We highlight HHS Secretary Becerra's willingness to use March-In Rights on patented medicines developed in partnership with the NIH, and the passage of the Inflation Reduction Act which mandates negotiated price controls within Medicare.These many regulatory changes have profound implications for the U.S. biopharma sector, and their ability to continue to provide new medicines for patients with unmet medical needs.See omnystudio.com/listener for privacy information.

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

Proposed federal and state policies to restrict coverage and access to biomedical innovations approved through the FDA’s accelerated approval pathway are setting off alarms among rare disease advocates. That's because accelerated approvals are a vitally important pathway for faster, reliable drug development to meet the unmet needs of people with rare diseases. Vital Transformation completed a comprehensive impact assessment of these proposed changes and what they could mean for patients currently lacking treatments and future innovations. In this Vital Health Podcast, Duane Schulthess takes a deep dive into those findings, joined by Amanda Malakoff, the Executive Director of the Rare Disease Company Coalition and Lisa Feng, the Senior Director of Policy at Alexion, AstraZeneca Rare Disease. Topics of discussion include the detrimental impacts of radical changes to the use of surrogate endpoints, and the virtually nonexistent impacts of accelerated approved medicines on state Medicaid budgets.See omnystudio.com/listener for privacy information.

With the US Inflation Reduction Act now law, many in Washington DC are saying that it’s provisions reducing pricing by $80 billion dollars annually in Medicare for drugs near the end of their patent life will not have any negative impacts on the US biopharma ecosystem.  Enter Amitabh Chandra, the director of health policy research at the Harvard Kennedy School of Government, and a professor of business administration at Harvard Business School. Dr Chandra has been sounding the alarm of the unintended consequences of the many pricing bills that have been emerging from both the Trump and Biden Administrations, as well as the US Congress.   In this Vital Health Podcast, Duane Schulthess and Amitabh Chandra discuss the pricing provisions of the inflation reduction act (IRA), particularly price controls for Medicare therapies with the highest amount of spending at two different time points, 9 years for small molecules and 13 years for large molecules. Amitabh discusses the ramifications of this decision from the perspective of venture capitalists, who are vital for their willingness to take early-stage risks in developing new medicines.  As well, we discuss the concept of the US Government acting as a price negotiator and offer potential market-based solutions in contrast to what will surely be price-setting by the largest buyer on the planet. These solutions, however, require fixing the many perverse incentives baked into the US pharmaceutical benefit manager (PBM) system, as people who are the sickest currently subsidize the 95% of healthy Medicare beneficiaries through pricing rebates. See omnystudio.com/listener for privacy information.

On this Vital Health Podcast, Duane Schulthess speaks with Devin Rosenthal, Vice President at NovaQuest Capital Management, who is responsible for the firm’s deal structuring and due diligence. Devin sits at ground zero of the long-term impacts of the Inflation Reduction Act. The Inflation Reduction Act (IRA) segments government pricing negotiations at 9 years for small molecules, but 13 years for large molecules, and Devin outlines the potential distortions this could create in future valuations and investment decisions. The discussion also touches on the potential ramifications of the IRA on the development of orphan drugs as well as existing pediatric incentives. As PBMs have previously shown a lack of flexibility in adjusting their rebate demands when there are large shifts in prices, this podcast also highlights the unintended consequences of IRA price reductions on PBM demanded rebates. This has been overlooked in the IRA legislation and could have large impacts upon the future development of needed new therapies. See omnystudio.com/listener for privacy information.