Vital Health Podcast

Latest Episodes:

Patrick Kilbride - The Dangers of March-In Rights Feb 02, 2023

Show notes

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.

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John LaMattina, Defending Pharma & Profits Jan 25, 2023

Show notes

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.

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Small Molecules Get Short Shrift, Jeff Jonker and the IRA Dec 22, 2022

Show notes

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.

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The Accelerated Approval Pathway is Vital for Rare Diseases Dec 08, 2022

Show notes

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.

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IRA's Impact on Biopharma Innovation with Amitabh Chandra Dec 02, 2022

Show notes

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.

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NovaQuest’s Devin Rosenthal on BioPharma Investing in a Post IRA World Nov 11, 2022

Show notes

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.

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Hans Sauer is Sour on the WTO’s Waivers of mRNA IP Oct 28, 2022

Show notes

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 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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NIH’s Impact on FDA Approvals is Statistically Zero, with Vital Transformation's Grumpy Old Men Sep 30, 2022

Show notes

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 impacts the creation of new drugs approved by the FDA to treat patients.

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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Paul Neureiter on European Innovation, US Legislation, and China’s Biopharmaceutical Growth Sep 15, 2022

Show notes

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 Representative (USTR) and was part of the U.S. Foreign Service from 1987 to 2001.

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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CEOi’s John Dwyer on accelerated approvals, CMS, and Alzheimer’s Disease Sep 08, 2022

Show notes

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-sector executives who have joined together to provide business leadership in the fight against Alzheimer’s. John Dwyer is playing a key role within this organization.

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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