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 m...
Oct 11, 2023•36 min
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 ...
Sep 27, 2023•41 min
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, transla...
Sep 20, 2023•38 min
The U.S. Congress and Biden Administration’s attacks on IP and Drug Pricing continue unabated as the 2024 election approaches. In this Vital Health Podcast, VT’s Grumpy Old Men (Duane Schulthess, Joe Hammang, and Harry P. Bowen) are particularly grumpy about the current state of affairs and dig into their research findings on the Inflation Reduction Act. They also ruminate on what the continued ratcheting-up of rhetoric and legislation against the industry means for tough-to-treat neurological d...
Sep 13, 2023•54 min
In this Vital Health Podcast, Duane Schulthess speaks with Rachel King, the Interim CEO of the Biotechnology Innovation Organization (BIO), who is steering the organization through the increasingly choppy waters of the DC drug pricing debate. With mounting regulatory pressure from all angles towards the global biopharma sector, Washington DC’s BIO sits at the center of the tempest. Rachel King comes to BIO with a wealth of experience as the former Chair of BIO’s Board of Directors. She has worke...
Sep 06, 2023•32 min
In this Best-Of edition of the Vital Health Podcast, we’re looking back on the outbreak of the COVID-19 pandemic and discussions we had with statistician Miriam Sturkenboom and Ivor Cummings, both of whom, in very different ways, were at the center of COVID-19 as to the appropriate response to the pandemic. Miriam Sturkenboom, who’s vaccine safety monitoring platform VAC4EU, found herself at the center of a tsunami of vaccine rollouts and safety studies in Europe, providing evidence to the Europ...
Aug 24, 2023•39 min
In this Best-Of edition of the Vital Health Podcast, we're looking back on the outbreak of the COVID-19 pandemic, and conversations with Epidemiologist Martin Kulldorff, and Political Scientist Wilfred Reilly. By spring of 2020, there were already serious questions being asked about COVID-19 policies, and both men were expressing skepticism of the political approaches being advocated by governments. Martin Kulldorff is a world renown biostatistician at the Harvard Medical School and a co-author ...
Aug 10, 2023•48 min
In this Vital Health Podcast, Duane Schulthess speaks with John Dwyer. John is a serial entrepreneur, having successfully built and sold two healthcare start-ups to 3M and Aetna. He’s now a key player in The Global CEO Initiative on Alzheimer’s Disease, and also serves an active role in the patient advocacy organization U.S. Against Alzheimer’s. John outlines the continued controversy surrounding the Center for Medicare and Medicaid Services' intransigence regarding its coverage decision on the ...
Aug 01, 2023•41 min
With the Inflation Reduction Act now law, there are mounting concerns that its drug pricing revisions will have a huge negative impact on the California Biotech ecosystem, arguably, the globe’s leading hub for innovative biotech. Joseph Panetta is President & CEO of Biocom, the San Diego, California organization leading 1200 companies, service sector firms, universities and research institutes working in the biotechnology sector. Joe’s been the head of Biocom since 1999 and is universally re...
Jul 20, 2023•43 min
Amitabh Chandra is 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 is a rare voice sounding an alarm about the unintended consequences of the drug pricing provisions of the inflation reduction act. In this Vital Health Podcast, Amitabh highlights the enormous disincentives for small molecules created by the IRA, as companies will receive four fewer years of revenue when compared ...
Jul 12, 2023•39 min
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 jo...
Jul 06, 2023•17 min
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 successfu...
Jun 29, 2023•36 min
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 a...
Jun 23, 2023•40 min
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 fal...
May 31, 2023•1 hr 2 min
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 Europ...
May 17, 2023•35 min
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 pod...
May 11, 2023•53 min
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...
May 04, 2023•33 min
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...
Mar 16, 2023•29 min
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...
Mar 02, 2023•51 min
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...
Feb 16, 2023•47 min
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 impli...
Feb 02, 2023•35 min
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 acquis...
Jan 25, 2023•59 min
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 Vit...
Dec 22, 2022•44 min
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 current...
Dec 08, 2022•36 min
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 uninte...
Dec 02, 2022•41 min
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 valuation...
Nov 11, 2022•48 min
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 pre...
Oct 28, 2022•58 min
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 M...
Sep 30, 2022•49 min
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 di...
Sep 15, 2022•35 min
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 Alzheim...
Sep 08, 2022•41 min
