Vital Health Podcast
Vital Health Podcast
Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast. Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.
Expanding Oncology Treatments: PRIME-ROSE and the Future of Drug Repurposing
In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two key voices driving the PRIME-ROSE initiative: Gro Live Fagereng, Project Manager of the EU-project PRIME-ROSE and Coordinator of Precision Cancer Medicine at Oslo University Hospital, and Henk van der Pol, Ph.D. Candidate at Leiden University Medical Center. They explain the DRUP (Drug Rediscovery Protocol) trial approach, which repurposes existing oncology drugs for new off-label uses, and discuss how this can wi
Feb 21, • 26:55
Breaking Barriers: The Prime Rose Project and Off-Label Drug Innovations
Join host Duane Schulthess on the Vital Health Podcast as he explores the groundbreaking Prime Rose Project, an initiative redefining the use of off-label drugs in oncology. Featuring insights from Dr. Hans Gelderblom, Chair of Medical Oncology at Leiden University Medical Center, and Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, a member of the Dutch National Payers Evaluation Committee, this episode delves into the challenges and opportunities of drug rediscovery protocols. Learn how this
Dec 18, 2024 • 29:15
Impact of the Inflation Reduction Act on Venture Capital in Life Sciences
In this Vital Health Podcast, John Stanford, Executive Director of Incubate, discusses the impact of the Inflation Reduction Act (IRA) on venture capital investments in life sciences. Stanford emphasizes that the IRA's price control mechanisms have led to significant shifts in funding, particularly away from small-molecule drug development, creating what is described as the "small molecule penalty." Key points include: Venture Capital's Role and Challenges: Venture capital is critical in trans
Dec 11, 2024 • 36:11
Investing in Health: Pathways to a Well-being Economy and Smarter Healthcare Budgets
In this insightful episode of the Vital Health Podcast, we dive deep into the economic and societal benefits of investing in healthcare. Our esteemed guests, Professor Herwig Ostermann, Executive Director, Austrian National Public Health Institute, Professor Dennis A. Ostwald, CEO, WifOR Institute and Professor at Steinbeis School of International Business and Entrepreneurship (SIBE), and Massimo Bordignon, Professor of Public Economics at the Catholic University of Milan and member of the Europ
Nov 20, 2024 • 35:30
Addressing Europe's Health Challenges: Innovation, Prevention, and Policy
Join us at the Gastein Health Conference for an insightful conversation on Europe's healthcare challenges and innovations! Host Duane Schulthess sits down with experts like Josep Figueras, the Founder and Director of the European Observatory on Health Systems and Policy, Francesca Colombo, the Head of the OECD Health Division, and Annemiek Verkamman, the Managing Director of HollandBIO, to tackle the EU's pressing healthcare issues. From aging populations and non-communicable diseases to data-dr
Nov 6, 2024 • 38:30
The Future of Biotech: Steve Potts on Innovation, Policy, and the Impact of the IRA
In this episode of the Vital Health podcast, host Duane Schulthess sits down with Steve Potts, a seasoned entrepreneur and CEO of SLAM BioTherapeutics. They dive deep into the challenges and opportunities in biotech, exploring how recent legislative changes, like the IRA, are reshaping the industry. Steve shares insights on the shift from small molecules to biologics, the funding landscape, and the critical role of American innovation in drug development. Tune in to hear about the state of biote
Oct 7, 2024 • 24:58
Revolutionizing Healthcare with Real-World Data
In the latest episode of the Vital Health podcast, we delve into the future of healthcare with Blythe Adamson from Flatiron Health. Learn how Flatiron is at the forefront of transforming drug discovery through real-world data—using insights from everyday clinical practices to drive innovation and improve patient outcomes.Blythe shares fascinating insights on the role of AI in healthcare, stating, "The integration of AI into our data processes isn't just about speed; it's about uncovering pattern
Sep 25, 2024 • 27:13
Exploring the Intersection of Intellectual Property and Biotech Innovation
In the latest episode of the Vital Health podcast, we engage in a thought-provoking discussion with Hans Sauer, Deputy General Counsel for Intellectual Property at the Biotechnology Innovation Organization (BIO), and Gwen O'Loughlin, a seasoned health data researcher. Together, they unpack the complexities of intellectual property (IP) in the rapidly evolving biotech landscape. Hans and Gwen share insights into the current challenges facing the industry, particularly in the wake of new patent el
Sep 18, 2024 • 56:52
Unlocking the Power of Genomic Data: NashBIO's Role in Healthcare Innovation
In this episode of the Vital Health podcast, we dive deep into the world of genomic data and its transformative impact on healthcare. Join host Duane Schulthess as he sits down with Judsen Schneider, CTO of Nashville Biosciences, and Curt Allen, VP of Sales, to explore the origins and growth of Nashville Biosciences. Discover how this pioneering company, in collaboration with Vanderbilt University, is leveraging vast amounts of clinical data to drive innovation in drug development and treatment
Sep 13, 2024 • 19:00
MEP Pernille Weiss – Rapporteur of the EU GPL
In this Vital Health Podcast, Duane Schulthess speaks to Pernille Weiss, a former Member of the European Parliament and the Rapporteur of the European Parliament’s revision of the EU's General Pharmaceutical Legislation (GPL). The GPL proposes many profound changes to the regulatory structures of the EU’s pharmaceutical sector, and MEP Weiss sat at the centre of the European Parliament’s revision which rolled-back many of the European Commissions’ suggested cuts to regulatory data protection. Pe
Sep 4, 2024 • 47:33
Transforming Health Communications: Insights from Virginia Amann
Join us at the International 2024 BIO conference as host Duane Schulthess sits down with Virginia Amann, CEO of the Entente Network. Discover how Virginia has led her firm to become a global leader in strategic communications, crisis management, and behavior science. They discussed the firm's mission to secure positive outcomes for clients, the importance of social capital, and the evolving landscape of health communications. Learn about the latest industry challenges, the impact of COVID-19 on
Aug 22, 2024 • 26:51
Joe Panetta – Policy Impacts on California Biopharma
With the continuing pressure placed upon the US biopharma sector from Washington DC, how is the California biopharma ecosystem, arguably the leading hub for innovative biotech worldwide, responding? In this Vital Health Podcast, we speak with Joseph Panetta to discuss this issue. Joe is the President & CEO of Biocom California, an organization representing over 1,800 members working in California's life sciences sector to break down barriers to doing business and advocate for innovation.
Aug 1, 2024 • 27:30
Niklas Blomberg, Executive Director, EU Innovative Health Initiative
In this Vital Health Podcast, recorded live at the 2024 Bio International Conference, host Duane Schulthess sits down with Niklas Blomberg, the Executive Director of the EU Innovative Health Initiative (IHI). Together, they delve into the transformative journey from the Innovative Medicines Initiative to the broader, more inclusive Innovative Health Initiative. Niklas shares his perspectives on fostering collaboration between pharmaceuticals, medical technologies, and diagnostics while elaborati
Jul 3, 2024 • 19:58
Congressman Michael Burgess – IRA and March-in Rights
Congressman Michael Burgess is the Chair of the House Rules Committee and one of only 20 M.D.s currently serving in Congress. Before his election to the House of Representatives in 2002 for the 26th District in Texas, Congressman Burgess was a practicing physician in obstetrics and gynecology. In this Vital Health podcast, Congressman Burgess outlines the historical background of the need for the Medicare prescription drug benefit passed in 2003, the risks posed to seniors and U.S. healthcare mo
Jun 19, 2024 • 28:55
Kim Hawkins - Project Co-Lead of IMI’s Trials@Home
Trials@Home is a €39 million, pan-European public private partnership of the EU’s Innovative Medicines Initiative, focused on defining the best practices to conduct decentralised clinical trials (DCTs). In this Vital Health Podcast, Duane Schulthess speaks with Kim Hawkins, Global Head of Clinical Project Operations at Sanofi, and the Co-Project Lead of the Trials@Home consortium. Kim outlines how Trials@Home is applying new innovative approaches to DCTs to evaluate different operational models
May 22, 2024 • 32:51
Douglas Holtz-Eakin, “Indications are going to be deeply affected by the IRA”
Douglas Holtz-Eakin was formerly a professor of economics at Syracuse University and served as the director of the Congressional Budget Office from 2003 – 2005. He was the chief economic policy adviser to Senator John McCain's 2008 presidential campaign and is currently president of the American Action Forum, a highly respected think tank in Washington, DC. While heading the CBO, Douglas played a pivotal role in designing and implementing the Medicare Prescription Drug, Improvement, and Moderniz
May 1, 2024 • 54:59
John LaMattina – Drug Price Controls and IP Attacks Get Real
John LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices. He is also a senior partner at PureTech Health and a contributor to Forbes. Last year, when John was a guest on the Vital Health Podcast, the potential impacts of the Inflation Reduction Act (IRA) were still theoretical. B
Mar 27, 2024 • 32:43
Kate Hudson & Joseph P. Allen – The Fact Free Attacks on IP
This podcast features Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities, and Joseph P. Allen, the Executive Director of the Bayh-Dole Coalition. They discuss the unintended consequences that the Biden Administration’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act is having on small companies and VCs inside and outside of the biopharmaceutical sector. As well, they detail how we
Mar 21, 2024 • 35:41
VT’s Grumpy Old Men – The Administration’s Threats to use March-In Rights
On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&D. Vital Transformation released our report, March-in rights under the Bayh-Dole Act & NIH contributions to pharmaceutical patents one week before the Biden Administration released its guidance. We fou
Mar 14, 2024 • 53:48
PRIME-ROSE: The EU’s DRUP Trial Champion
With a six million EUR funding grant from the European Commission, the PRIME-ROSE project will implement, across Europe, a series of prospective, non-randomized clinical trials known as DRUP trials. DRUP trials started in the Netherlands and have successfully increased inclusion rates to offer additional lines of treatment to patients.On this Vital Health Podcast, Duane Schulthess speaks to PRIME-ROSE’s Project Coordinator, Kjetil Tasken of the University of Oslo’s Institute for Cancer, and PRIM
Feb 7, 2024 • 25:44
Peter Kolchinsky - "IRA's 9 Years Is Too Short"
In this Vital Health Podcast, Duane Schulthess speaks with Peter Kolchinsky, Managing Partner at RA Capital Management. Peter has authored several critically acclaimed books, including The Great American Drug Deal and The Entrepreneur’s Guide to a Biotech Startup. Peter also serves as the Director of No Patient Left Behind, a non-profit organization. Peter outlines that not only are IRA’s provisions negotiating small molecules after 9 years a huge challenge, but the continuation of ratcheting up
Jan 17, 2024 • 56:37
Christian Schneider, CMO Biopharma Excellence
Christian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK’s MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe’s Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights bo
Nov 8, 2023 • 49:05
Bettina Ryll at the 2023 ESMO Conference
On this Vital Health Podcast, Duane Schulthess has a conversation with Bettina Ryll, the founder of the Melanoma Patient Network Europe. Bettina is regarded as one of the world’s leading Patient Advocates, who dedicated herself to advocacy after the death of her husband from cancer. While most patient representatives don’t have a medical background, Bettina has a Ph.D. in Biomedical Sciences from University College London. From 2015 – 2018, Bettina chaired the ESMO Patient Advocates Working Grou
Nov 1, 2023 • 40:37
Dan Leonard, Executive Director, We Work For Health
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 • 36:18
Cancer Drug Developer Dr. Steve Potts' Congressional Testimony on the IRA
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 • 41:06
Amy Miller and the PhRMA Foundation Push the R&D Envelope
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 • 38:15
VT’s Grumpy Old Men on Price Controls and IP Attacks
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 • 54:23
Taking the Helm Mid Drug Pricing Maelstrom
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 work
Sep 6, 2023 • 32:14
Best-of Edition: Looking back on the COVID-19 outbreak part 2
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 • 39:22
Best-of Edition: Looking back on the COVID-19 outbreak
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 • 47:30
CMS' Restrictions on Alzheimer's Drugs
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 1, 2023 • 40:53
Biocom California Grapples with Regulatory Assaults on all Fronts
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 • 42:54
Amitabh Chandra - IRA’s potential impact on the US biopharma ecosystem
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 compare
Jul 12, 2023 • 39:23
NJ’s Biopharma Sector in a Price Controlled World
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 6, 2023 • 17:24
IRA’s Impact on Orphan Therapies – David Meeker
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 • 35:37
Nick Shipley - IRA’s Impact on the Biopharma Ecosystem
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 • 39:53
Nikolai Brun - Improving Europe's Biopharma Legislation
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 fa
May 31, 2023 • 1:01:59
EU Cost Effectiveness Models Threaten Vulnerable U.S. Patients
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 Europe
May 17, 2023 • 34:49
Andrew Roddam, CEO of Our Future Health
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 • 52:32
Attacks on Bayh-Dole Put University Research at Risk
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 4, 2023 • 32:38
California Life Sciences’ Response to the Inflation Reduction Act
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 Podcas
Mar 16, 2023 • 29:25
"Bayh–Dole Cannot be Used for Controlling Prices"
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 2, 2023 • 51:05
Price Controls put US Biopharma at Risk
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 • 47:16
Patrick Kilbride - The Dangers of March-In Rights
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 2, 2023 • 34:41
John LaMattina, Defending Pharma & Profits
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 acquisi
Jan 25, 2023 • 59:15
Small Molecules Get Short Shrift, Jeff Jonker and the IRA
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 Vi
Dec 22, 2022 • 43:46
The Accelerated Approval Pathway is Vital for Rare Diseases
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 8, 2022 • 35:55
IRA's Impact on Biopharma Innovation with Amitabh Chandra
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 unint
Dec 2, 2022 • 40:33
NovaQuest’s Devin Rosenthal on BioPharma Investing in a Post IRA World
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 valuatio
Nov 11, 2022 • 47:45
Hans Sauer is Sour on the WTO’s Waivers of mRNA IP
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 • 57:41
NIH’s Impact on FDA Approvals is Statistically Zero, with Vital Transformation's Grumpy Old Men
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 Me
Sep 30, 2022 • 48:43
Paul Neureiter on European Innovation, US Legislation, and China’s Biopharmaceutical Growth
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 • 34:52
CEOi’s John Dwyer on accelerated approvals, CMS, and Alzheimer’s Disease
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 8, 2022 • 40:39
SSR Health’s Richard Evans on Medicare Price Controls
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 first by both Institutional Investor and Bloomberg Markets and was also rated as one of the top 20 sto
Aug 10, 2022 • 55:07
Michele Oshman – Driving Innovation for the US’ Biotech State Associations
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. She is a neuroscience researcher working both in clinical development and corporate leadership roles.
Aug 4, 2022 • 29:32
John M. O'Brien’s Hot Takes on March-in, Co-Pays, PBMs, CMS, and Patient Access
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 BlueCross BlueShield, the Centers for Medicare & Medicaid Services (CMS) and in the U.S. Senate as a
Jul 16, 2022 • 35:18
Rutgers’ Gary Branning Untangles a PBM Web of Complexity
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 Management and President of MMR, a health care consulting company that specializes in the reimbursement of
Jul 8, 2022 • 43:15
Joe Panetta Steers Biocom California’s Members Through Increasingly Stormy Seas
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 San Diego, Los Angeles, Sacramento, and the Bay Area, Biocom California advocates for more than 1,6
Jul 1, 2022 • 28:52
Accelerated Approval Study Release - A Vital Pathway for Patients
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 to market, and the vital role played by small innovative biotech firms in that process. As well, wi
Jun 22, 2022 • 42:48
Danny Seiden leads Arizona’s push against march-in rights
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 Seiden, CEO of the Arizona Chamber of Commerce, recently published an article for Real Clear Policy
Jun 15, 2022 • 27:39
Flagship Pioneering’s Tom Dilenge On Accelerated Approvals
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), where he was directly responsible for all their policy, advocacy, communications, legal affairs, and
Apr 21, 2022 • 46:28
George Vradenburg, USAgainstAlzheimer's, and CMS' NCD
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 Broadcasting Company. The podcast discusses the current state of Alzheimer's research and the potential imp
Apr 8, 2022 • 34:58
Sue Peschin - “CMS is in an untenable position” on Alzheimer’s disease
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. In addition, Sue has also had senior roles at the Alzheimer’s Foundation of America and has
Mar 10, 2022 • 27:08
VT analyzed CMS' Alzheimer's disease draft guidance - it's REALLY bad
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 Transformation (VT) CEO Duane Schulthess is joined by VT’s US Business Director, Dr. Joseph H
Feb 25, 2022 • 35:45
All Things Plasma Matter, Amy Efantis - CEO, Plasma Protein Therapeutics Association
Most people think of the plasma sector as just another arm of biotechnology, but nothing could be further from the truth. Relying primarily upon individual donations from the United States to supply global plasma, the sector’s raw material costs mean it has more in common with precision manufacturing and does so under strict scientific controls. The impact of COVID-19 on the willingness and ability of people to donate plasma, and a recent ruling by the U.S. Customs and Border P
Feb 14, 2022 • 31:02
Joan Koerber-Walker and AZBio, Will Drug Pricing Kill a Rising Phoenix?
Joan Koerber-Walker is President and CEO of the Arizona Bioindustry Association (AZBio), supporting one of the top emerging biotech clusters in the United States. Trained as an economist and a biotech investor herself, Joan is no stranger to pricing discussions. As the Build Back Better debate reached a fever pitch, all eyes turned to Arizona given the bill’s focus on drug pricing and Senator Kyrsten Sinema’s known support of the Arizona Biotech Sector. While Build Back Better
Feb 10, 2022 • 41:05
John Murphy, is Build Back Better Bad for Biotech?
John Murphy is the Vice President of the Biotechnology Innovation Organization (BIO), the largest trade association in the world representing biotechnology companies. John’s role encompasses all legal issues impacting healthcare biotechnology and is an expert on topical issues such as intellectual property, drug pricing, and legislation in the biopharma sector. In this podcast we discuss the drug pricing proposals included in President Biden’s signature legislation, Build Back Better. While many
Dec 16, 2021 • 1:00:22
Miriam Sturkenboom & VAC4EU: Timing is everything
Call it serendipity, ‘luck’, or being at the right place at the right time, but Miriam Sturkenboom led the IMI’s project Advance, which built a pan-European safety monitoring network for vaccines. You can’t make it up, but the project ended in March of 2019. Six months later, the world was thrown into chaos with the Wuhan virus, and ADVANCE, rebranded VAC4EU, now finds itself at the centre of a tsunami of vaccine roll-outs and safety studies in Europe. In this podcast we discuss how VAC4EU is c
Oct 22, 2021 • 25:35
NCATS’ Chris Austin - R&D from NIH, to Industry, through Approval
After nearly two decades at the NIH and almost 10 years as founding director of the National Center for Advancing Translational Sciences (NCATS), Christopher Austin is crossing over to the ‘dark side’, joining Boston-based Flagship Pioneering, the highly respected bioplatforms innovation company. He’s one of Biopharma’s true visionaries, with an expert’s knowledge at the highest levels of government funded NIH research, translational innovation, and industry commercialization. In this podcast, w
Jul 20, 2021 • 1:06:20
About the NIH, Industry, and the R&D Ecosystem, with Richard Moscicki, PhRMA
Richard Moscicki is the Executive Vice President for Science and Regulatory Advocacy and the Chief Medical Officer at Pharmaceutical Research and Manufacturers of America (PhRMA). Previously he was the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and the Chief Medical Officer at Genzyme Corporation.In this podcast, we discuss the U.S. R&D ecosystem and the vital roles that NIH and the private sector
Jul 8, 2021 • 27:20
Jack Scannell on Big Pharma’s Big Drug Discovery Problem
Jack Scannell is one of the world’s leading pharmaceutical industry analysts, as well as one of its most visionary. Jack caused a case of global pharmaceutical R&D indigestion when, a decade ago, he identified in a groundbreaking Nature publication that, unlike in the semi-conductor industry, which had seen the doubling of its productivity every 10 years, the exact opposite was true for the biopharmaceutical sector, where productivity had instead halved in each successive decade.Jack Scannell in
Jun 17, 2021 • 48:56
Is U.S. reference pricing a fatal shot for biotech?
Drug pricing is becoming a hot political issue in Washington DC, with polls showing widespread bipartisan support for congressional action to control the cost of new medicines broadly. While this is political red meat for the base, the reality is that price ceilings on medicines as they are proposed in US House Bill H.R. 3. will weigh heavily on the U.S. biotech sector and particularly on California, which has dominated the development of new cutting-edge medicines over the last decade. Californ
May 5, 2021 • 44:01
KU Leuven Launches Health Innovation Fellowship
While not featured in Hollywood blockbuster films like some universities from the UK, Boston, or California, Belgium’s KU Leuven University has topped the Reuters ranking as Europe’s most innovative university for four of the last six years. This Belgian innovation engine boasts more than 135 spin-off companies and has a dominant focus on healthcare innovation. In this podcast we discuss the role that KU Leuven plays in Flanders with Professors Maarten De Vos and Inge De Prins, who introduce the
Mar 11, 2021 • 17:38
Ivermectin, Dr Pierre Kory’s magic bullet to fight COVID-19
Over the course of the summer, there was a vital discovery that severe, late stage COVID-19 which had been considered a near fatal condition could be successfully treated with dexamethasone, a corticosteroid. One of the key clinicians behind that discovery was Dr Pierre Kory, the President of the Front-Line COVID-19 Critical Care Alliance (FLCCC). Today, corticosteroid is part of the standard COVID-19 pathway, in no small part due to the efforts of the FLCCC. Last month, Dr Kory again lit up the
Mar 2, 2021 • 31:05
Ivor Cummins, “The Fat Emperor” Takes on COVID-19 Lockdowns
If you’ve ever found yourself researching COVID-19 on YouTube, it’s likely you’ve stumbled onto a well-spoken Irishman named Ivor Cummins dissecting the impact of the pandemic with detailed graphs and analysis. Before the COVID-19 era, Ivor, a biochemical engineer, had a large following as a presenter on facts about cardiovascular disease, diabetes, and obesity on his very popular website ‘The Fat Emperor.’ However, since the outbreak of SARS-CoV-2, he has trained his eye on the pandemic with a
Feb 5, 2021 • 57:01
PharmaCCX, a tech savvy solution for pricing EU cancer drugs
The cost of new, highly targeted cancer therapies is becoming a serious political issue in the US, as it has been in Europe for many years. Europeans feel that drug prices are too high, which explains why trying to use a combination of such drugs, which is increasingly recommended as the best approach from a clinical standpoint, is often both politically and economically untenable.That’s the problem my two guests today are trying to solve. Nathan Sigworth and Richard Bergström founded the innova
Jan 28, 2021 • 53:39
BIO’s New CEO Michelle McMurry-Heath, Taking Charge Amidst Chaos
Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third CEO to lead BIO, the world’s largest biotechnology advocacy group, since its founding in 1993.She previously served as Global Head of Evidence Generation for Medical Device Companies, Vice President of Global External Innovation, and Global Leader for Regulatory Scie
Dec 11, 2020 • 26:16
Heidi Larson – Dispelling Vaccine Myths in the COVID-19 Era
With the recent announcement of Pfizer’s completion of clinical trials for a COVID-19 vaccine, the next challenge is ensuring that the general public is willing to be vaccinated. With mounting distrust, how will this be possible? Prof Heidi Larson is one of the world’s leading authorities on why people don’t take vaccines, and how rumors about their safety become part of public opinion. She is the founder of the Vaccine Confidence Project, based at London’s School of Hygiene and Tropical Medicin
Nov 19, 2020 • 26:35
Hack Healthcare’s Leo Exter and Awell Health’s Thomas Vande Casteele
What do you get when you have over 1000 technology developers, healthcare professionals, and medical practitioners working together on a specific problem in the same room? You get what’s called a health-care hackathon. One of the world’s first movers in the pantheon of hackathon, is Leo Exter, the creative force behind Hack Belgium, a massive EU Open Innovation Festival, and one the most ambitious event of its kind for the last decade. With the impact of COVID-19, hackathons have needed to evolv
Nov 10, 2020 • 37:02
Matt Wiener - EHDEN’s SME Marketplace and Harnessing Informatics
Matt Wiener co-leads the development of EHDEN’s SME Marketplace, training and certifying the project’s growing international network of SMEs that are leveraging observational data locally. The SME network is the EHDEN project’s engine, supplying the local knowledge required to convert the observational data available in many unique EU databases into a common data model so they are usable within a federated network. Matt is a Director of Informatics and Predictive Sciences at Bristol-Myers Squibb
Oct 20, 2020 • 30:39
Kees van Bochove, A Hyve in EHDEN
Kees van Bochove founded The Hyve, based in Utrecht, to facilitate open source software development, enable open science by developing and FAIRifying data in life sciences. Their platform and expertise are a driving force behind the success of the EHDEN project. The Covid-19 pandemic underscores the need for high-quality health data that is readily deployed. Europe’s early epidemiological assessments at the start of the pandemic projected infection and mortality rates by orders of magnitude in e
Oct 12, 2020 • 31:30
NICE’s Jacoline Bouvy – Using EHDEN to Determine Value for Patients
IMI’s EHDEN is developing a federated data network at scale across Europe, to reduce the time to provide key answers to health research in the real world. The challenge is how can a federated data model help HTAs determine value for patients and healthcare systems? In this podcast we discuss these challenges with Jacoline Bouvy, who co-leads EHDEN’s work package 2, focused on outcome driven healthcare. It will outline many of the core challenges that HTA’s face harnessing federated datasets, and
Oct 5, 2020 • 29:10
Martin Kulldorff: "Herd immunity is a scientific fact"
Martin Kulldorff, PhD, is a world-renowned biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School. His research centers on developing new statistical methods for disease surveillance, including methods for disease cluster evaluation and the early detection of disease outbreaks. His methods are used by the Centers for Disease Control and Prevention (CDC) in the US and almost every country in the world. Recently, he has turned his prodigious analyti
Jun 19, 2020 • 28:54
OECD´s Francesca Colombo, At the Centre of the Covid-19 Storm
Francesca Colombo, M.Sc., is Head of the Health Division at the Organisation for Economic Co-operation and Development (OECD). She is responsible for providing internationally comparable data on health systems and applying economic analysis to health policies, as well as advising policy makers and other stakeholders on how to respond to citizen demands for more and better health care. In this capacity, Francesca has also been involved with the OECD’s partnership with the International Consortium
Jun 10, 2020 • 34:48
Yannis Natsis, Pricing and Advocacy under Covid-19
Yannis Natsis leads the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA). Before joining EPHA in January 2016, he worked at the European Parliament, the Greek Ministry of Foreign Affairs, the UN and the private sector in Brussels and Athens. In May 2019, Yannis was appointed to the Management Board of the European Medicines Agency (EMA) by EU Member States. He is one of the two patient representatives on the Board with a 3-year mandate starting in June 2
Jun 3, 2020 • 44:31
Wilfred Reilly: "There is no empirical evidence for these lockdowns."
Dr Wilfred Reilly is a political muckraker and data-driven contrarian par excellence. He is currently an Associate Professor of Political Science at Kentucky State University, a historically Black college in Frankfort, Kentucky. He holds a PhD in Political Science from Southern Illinois University and a law degree from the University of Illinois. Reilly's research focuses on empirical testing of political claims which are often very influential but rarely well-supported by scientific data. Dr. R
May 22, 2020 • 47:32
Robert Madelin - Innovation and Leadership During a Pandemic
Robert Madelin is the Chairman and Chief Strategist at FIPRA International Ltd. Robert is a rare politician with hands-on experience guiding pan-European policy for IT and healthcare. From 2004-2016 he was the Director General for Communications Networks, Content and Technology (CONNECT) and Director General for Health and Consumer Policy (SANCO). Robert Madelin was also a negotiator for both EU and UK international trade and investment, and served in the Cabinet of European Commission Vice-Pres
May 15, 2020 • 37:15
Dimitrios Athanasiou, a Duchenne Patient Advocate in the COVID-19 Era
Working at the sharp edge of finance by restructuring companies, Dimitrios Athanasiou was a very successful business consultant and executive with more than 25 years’ experience on international projects. Then, his life changed when his son was diagnosed with Duchenne Muscular Dystrophy. He has since put his business career aside, becoming a fulltime international patient advocate in Duchenne and in rare diseases. In this podcast we discuss the impact of COVID-19 on both the access to regular ca
May 12, 2020 • 30:29
Adrian van den Hoven, Providing Europe’s COVID-19 Medicine Arsenal
Adrian van den Hoven, Director General of Medicines for Europe, sits at the center of the industry body tasked with supplying the majority of the medicines required to fight COVID-19 in Europe. With the record high demands for antiseptics, unprecedented challenges to global supply chains, and the current rush to repurpose and test many generic compounds to fight the WuHan Virus, Medicines for Europe sits in the crosshairs of Europe’s COVID-19 public health challenges. Adrian’s members need to su
Apr 17, 2020 • 27:33
BIO CEO Jim Greenwood, An Innovation Led Assault on COVID19
Jim Greenwood is President and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C., representing over 1,000 biotechnology companies and academic institutions in more than 30 countries worldwide. In this podcast, we discuss how BIO is at the front lines of the battle to find treatments and cures for COVID19, by harnessing the many technological breakthroughs of the last two decades. As well, we discuss the political fallout to the U.S. biopharma sector being caused by high
Apr 8, 2020 • 38:34
Rick Grobbee - Trials@Home & Tribulations with COVID19
One of the world’s leading Epidemiologists, Rick Grobbee has been at the centre multiple ground breaking projects of the Innovative Medicine’s Initiative that have focused on harnessing health data in new and unique ways. IMI’s GetReal, Big Data for Better Outcomes, and Big Data@Heart have all focused on improving research, but now, Rick Grobbee is leading the newly launched Trials@Home, that will move clinical trials from the hospital to the home, fundamentally changing the way clinical researc
Mar 24, 2020 • 29:00
Better Science, Better Health: Sarah Garner, Managing Europe’s Innovation for the WHO
Sarah Garner is the Acting Programme Manager of Health Products and Pharmaceuticals of the WHO Euro, and is the former Associate Director for Scientific Policy and Research at the UK’s National Institute for Health and Care Excellence. She is a visionary seeking new approaches to improve innovation, access, and outcomes in healthcare, and has a nuanced view of the financial realities of R&D and the challenges of our national healthcare systems.In this podcast, Sarah discusses the need to support
Jan 10, 2020 • 23:17
Biocom’s Joseph Panetta Discusses the Impact of IPI on the California Biotech Ecosystem
California leads the world in biotech productivity and innovation, and Joseph Panetta, President & CEO of Biocom, has been at the center of the growth of the San Diego biotech ecosystem since 1989. In this podcast, we discuss the various international pricing proposals being discussed in Washington DC, and their potential negative impact on the California biopharma ecosystem. Biocom is an association that advocates for 1200 companies, service sector firms, universities and research institutes wo
Dec 20, 2019 • 37:37
CLSA Challenges the U.S. Congress’ H.R. 3 in Support of California Biotech, Patients, and Innovation
The California Life Sciences Association (CLSA) has been very active in the current discussions on Medicare Pricing Reform, and finds itself at the center of the debate with the US congress regarding the announced plans to introduce international reference pricing for medicines. CLSA is a 1000-member trade association representing California’s life sciences industry and was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. We’
Dec 2, 2019 • 32:40
Who Killed Healthcare? Dr Regina Herzlinger Knows Who’s Guilty
In 2007, Dr. Regina Herzlinger, the Nancy R. McPherson Professor of Business Administration at the Harvard Business School, wrote a book called “Who Killed Health Care”, making a strong case for a healthcare system based on consumer choice and pricing transparency. More than a decade later, America is now struggling to make the Affordable Care Act, or ‘Obama-care’, solvent, and most countries in Europe are facing exponentially increasing healthcare costs and the rationing of government services.
Nov 26, 2019 • 27:26
John LaMattina, former President Pfizer Global Research, on Medicare International Reference Pricing
John LaMattina is a contributor to Forbes Magazine where is he one of the world’s thought-leaders in healthcare journalism. John was the president of Pfizer Global Research and Development from 2007 where he managed more than 13,000 scientists and professionals in the United States, Europe, and Asia for a decade. He is the author of "Drug Truths: Dispelling The Myths Of R&D" and the recently published “Devalued And Distrusted: Can The Pharmaceutical Industry Restore Its Broken Image?" John LaMat
Oct 30, 2019 • 33:05
Eduardo Bravo on Medicare Pricing Reform, Orphan Designations, and the EU Biotech Sector
Called one of the 50 most influential people in Regenerative Medicine, Eduardo Bravo is currently the CEO of Nordic Nanovector, a company focused on a unique combo therapy combining a monoclonal antibody with a radiation therapy. He successfully steered the stem cell company TiGenix through a rejected FDA application and re-emerge with a new product portfolio to be successfully acquired in 2018 by Takeda in an all cash deal valued over $600 mil. Eduardo is also the former president of the trade
Oct 22, 2019 • 33:10
Richard Barker, Famed U.K. Thought-Leader Discusses Precision Health, Pricing, and Brexit
For thirty years, Richard Barker has been one of the U.K.’s healthcare thought leaders. He is the Founder of New Medicine Partners and the Founding Director of the Centre for the Advancement of Sustainable Medical Innovation (CASMI), where he championed the concept of adaptive licensing. With the current U.S. focus on international reference pricing for Medicare Part D & B, Richard’s work in Adaptive Reimbursement is gaining traction as a potential solution to pricing debates that are currently
Sep 30, 2019 • 28:39
The Alliance for Aging Research’s Sue Peschin Talks About Medicare Reform
Recorded in July of 2019, this podcast features Sue Peschin, the President and CEO of the Alliance for Aging Research in Washington DC, which is an organisation currently at the centre of the current Medicare Part B and Part D debates. Sue has more than 20 years of experience in health policy roles and has led Alliance since 2012. She has driven efforts in adult immunization, NIH Alzheimer’s funding, cardiovascular disease, and co-organized the first-ever NIH geriatric medicine summit. She parti
Sep 11, 2019 • 22:51
Susan Cantrell’s AMCP Is Driving the Adoption of effective RWE in America
Susan Cantrell is the CEO of the Academy of Managed Care Pharmacy (AMCP), the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians, nurses, and professionals in life sciences and biopharmaceutical companies leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effec
Sep 3, 2019 • 29:17
Pfizer’s John Doyle Champions Value-based Healthcare
John Doyle leads the Patient Health & Impact Global Healthcare Innovation Center at Pfizer. His team designs new models for value-based contracting and innovative financing and forges new partnerships across the healthcare sector to facilitate value-based healthcare. Prior to joining Pfizer, John led the Global Enterprise Solutions team at IQVIA, providing technology-enabled real world evidence platforms and research networks to healthcare systems worldwide. John also led the Global Value & Outc
Jul 12, 2019 • 21:47
EUnetHTA’s Board Chair, Niklas Hedberg, Discusses OMPs and the EU HTA Review
With the future of the EU HTA Regulation in question, Niklas Hedberg, Chair of the EUnetHTA Executive Board, discusses what’s needed to get the HTA Proposal back on track. Recorded at the HTAi conference in Köln, Niklas also expresses his opinions on the state of the OMP legislation from the standpoint of both EUnetHTA and his home HTA in Sweden, and does so incorporating the discussions around the orphan legislation at the conference. Niklas Hedberg is the Chief Pharmacist of the Swedish Pharma
Jul 5, 2019 • 22:27
Anne Pariser of NCATS Discusses the Future of Rare Disease Research
In this podcast we discuss the evolution of science that is driving the increasing focus on rare indications with Anne Pariser, the Director of the Office of Rare Diseases Research at the National Center for Advancing Translational Sciences (NCATS). Anne is a noted international expert or rare diseases, and has been involved in numerous collaborations within the FDA, as well as with drug developers, governmental agencies, patient groups and other stakeholders in the development of treatments for
Jun 28, 2019 • 12:46
Better Science, Better Health: VC Peter Young on Trump’s International Reference Pricing Plan
Peter Young is a Venture Partner at Pappas Capital, and brings to his investment approach thirty-five years of experience in the biopharma sector. The former Vice President and Therapy Head at Glaxo Wellcome in the mid-1990s, Peter led the global introduction of combination HIV therapies that revolutionized HIV treatment, quintupled Glaxo’s HIV sales, and maintained leadership on global treatment access. Peter has since served as CEO of two private start-ups, a vaccine company that raised over $
Jun 21, 2019 • 32:30
Better Science, Better Health: EURORDIS’ Simone Boselli on the OMP Review and EU Access to Medicines
EURORDIS, a portmanteau of European Rare Disease, is a non-governmental alliance of organisations representing 860 rare disease patient organisations in 70 countries, and the 30 million people affected by rare diseases throughout Europe. CEO Yann Le Cam in 1997, one of the founders of EURORDIS, who's eldest of three daughters is living with cystic fibrosis.With the upcoming European Commission Conference on Rare Diseases occurring on June 17th coupled with the ongoing inquiry around the OMP regu
Jun 17, 2019 • 25:43
Better Science, Better Health: Erik Tambuyzer Negotiated the First EU Orphan Drug Legislation
Erik Tambuyzer is one of the world’s thought leaders in orphan drugs and rare disease indications. While he was Genzyme’s EU and International Senior Vice-President for Corporate Affairs, he was also the industry’s negotiation lead with the European Commission and Parliament on the Orphan Medicinal Products Regulation, introduced in the year 2000, working together with patients’ organisations and academics. As an entrepreneur in 1985, he had co-founded and managed the biotech company Innogenetic
May 24, 2019 • 27:59
Nigel Hughes, on a quest to find big data's garden of EHDEN.
Nigel Hughes is the Scientific Director of Real World Evidence at Janssen Clinical Innovation. He collaborates with the EFPIA Digital Strategic Governing Group, and he is also co-lead of Big Data for Better Outcome’s €30 million flagship consortium, the European Health Data & Evidence Network, or EHDEN. Janssen and Nigel have long been at the forefront of developing the needed tools and infrastructure to harness health data, both through their involvement with previous IMI projects such as EMIF
May 14, 2019 • 35:22
Dr. Clemens Martin Auer, the vision of Austria’s nominee for WHO Regional Director for Europe
Dr. Clemens Martin Auer is currently Special Envoy for Health at the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection and formerly longstanding Director General of the same institution. In this podcast, we discuss his leadership for implementation of better tools to evaluate healthcare efficiency and outcomes as the co-chair of the European eHealth Network to establish cross-border eHealth applications. In 2017, he was elected President of the European Health F
May 7, 2019 • 31:38
IMI’s RWE Vaccines Platform ADVANCE Relaunched as VAC4EU.org
Vaccines are one of the most effective public health measures available, saving some two to three million lives worldwide every year. However, in Europe where vaccine preventable disease almost disappeared, the public is now worried about the safety of the vaccine, limiting their use, resulting in outbreaks of preventable diseases like Measles. IMI’s Advance project, which concluded in March of 2019, brought together a large cross-section of European stakeholders to create a system and network t
Apr 23, 2019 • 23:02
Better Science, Better Health: Peter Pitts Discusses the International Pricing Index (IPI)
Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest, Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He is the editor of the new book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting. In this podcast, we discuss the
Apr 15, 2019 • 23:23
Better Science, Better Health: BIO's Joe Damond discusses pricing and access in Europe and the US
Joe Damond is the Executive Vice President for International Affairs at the Biotechnology Innovation Organization (BIO), the largest service organisation for biotech companies in the world. In this podcast we discuss the continuing attacks on Intellectual Property in Europe and the US, as well as how the International Pricing Index (IPI) of the Trump administration will impact biotech investment and innovation. Joe spent 12 years as a trade negotiator at the Office of the United States Trade Rep
Apr 8, 2019 • 24:12
Better Science,Better Health: Mark McClellan, Director of the Duke-Margolis Center for Health Policy
Vital Transformation launches its new series of Better Science, Better Health podcasts focused on the challenges and opportunities of new medicines. With the increasing focus on drug pricing in the US Congress and Senate, and with the Trump Administration's proposals for international reference pricing on therapies covered under Medicare Part B, Vital Transformation shares the insights of Dr. Mark McClellan, one of the world's most important thought leaders in value-based healthcare. Mark McClel
Mar 21, 2019 • 30:44
Deputy Director General for Health Martin Seychell and Europe's New Horizons for Vaccines
Martin Seychell, Deputy Director General for Health, Food and Safety of the European Commission, outlines how Europe must use a combination of social media communications and new real-time tools for safety monitoring to regain the public’s trust in vaccinations. Our Vital Health Podcast was recorded at the final event of the Innovative Medicine’s Initiative’s ADVANCE project, which promotes the use of distributed health databases to facilitate vaccine safety studies in Europe.See omnystudio.com/
Mar 8, 2019 • 22:11
Anja Schiel - Norway’s HTA is Pushing the Evidence Envelope
The Norwegian Medicine Agency’s Anja Schiel is one of Europe’s leading proponents of new methodologies to harness Real World Evidence in the comparative analysis of new medicines. She’s the agency’s senior statistician and works at the forefront of developing new methodologies to improve the way we understand how therapies actually work in practice.See omnystudio.com/listener for privacy information.
Mar 1, 2019 • 38:43
Schneeweiss, Harvard's World Leader in Analytic Effectiveness Methods
Sebastian Schneeweiss is Professor of Medicine and Epidemiology at Harvard Medical School and is one of the world’s leaders in analytic methods to understand the effectiveness of newly marketed medical products using healthcare databases. His research has been funded by NIH, PCORI, and FDA grants, and he’s also the co-founder of Aetion, a healthcare technology company that delivers the real-world evidence for value-based care.See omnystudio.com/listener for privacy information.
Feb 20, 2019 • 25:17
Tomas Salmonson – Looking Back on a Job Well Done and Forward to Meet New Challenges
For five years, Tomas Salmonson was the chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency at a time of unprecedented innovation and challenge. Stepping down as the senior scientific advisor at the Swedish Medical Products Agency, Tomas has an open and frank discussion about how Europe must evolve to address the accelerating demands of innovation.See omnystudio.com/listener for privacy information.
Feb 12, 2019 • 34:53
Marc Berger, the Godfather of Real World Data
If there is a Godfather of Real World Data, it would be Marc Berger. Currently the chair of the ISPOR Real-World Data Task Force, Marc has developed many of the models and techniques we use today to put RWE into practice. Marc was the Senior Scientist at OptumInsight, now part of United Health Group. He was also was the VP of Global Health Outcomes at Eli Lilly and Company, and for five years was the VP of RWD at Pfizer. He is now an advisor to SHYFT Analytics.See omnystudio.com/listener for pri
Feb 4, 2019 • 34:49
Ain Aaviksoo, A Success Story of Estonia's E-Health Platform
The 2017 Presidency of Estonia is roundly seen as one of the EU's most successful, with a long-lasting impact on Europe's health strategy. Ain Aaviksoo was the Deputy Minister of Health and oversaw the ground-breaking implementation of Estonia’s E-Health platform. It is a showcase of what can be accomplished by a government, while, at the same time, respecting the confidentiality and wishes of citizens. Ain is now the Chief Medical Officer of the blockchain company Guardtime.See omnystudio.com/l
Jan 28, 2019 • 26:47
Pierre Meulien Guides the IMI on a Direct Course for the Future
The Innovative Medicines Initiative (IMI) is the world’s largest public private partnership with a €5 Billion budget. For three years, Pierre Meulien has been the IMI’s Executive Director, bringing with him a wealth of international experience including a stint as the head of Genome Canada and founding Molecular Medicine Ireland. In this podcast we discuss the challenges of European healthcare, the evolution of the IMI since his appointment, and the role the IMI should play in Horizon Europe wit
Jan 18, 2019 • 29:56
Better Science, Better Health: EUCOPE Sits at Ground Zero in the IP and Orphan Drug Debates
EUCOPE is Europe’s principal trade body for small to medium-sized biotechnology companies working in areas often targeting orphan diseases. In this podcast we're joined by Alexander Natz, EUCOPE’s Secretary General, and Delphine Roulland, Senior Manager Public Affairs, to discuss the impact on their members of proposed EU policy changes related to intellectual property, as well as the EU's ongoing review of the orphan drug legislation.See omnystudio.com/listener for privacy information.
Dec 20, 2018 • 36:27
Real world data, pay for performance or blockchain, Richard Bergström is always ahead of the curve
In Big Data for Better Outcomes, BigData@Heart, DO->IT, EHDN, the EU data Consortia, and yes, even concepts like pay for performance, Richard Bergström has had a hand in their creation. The former Director General of EFPIA, and now the head of health both at SICPA and their joint venture blockchain company Guardtime, Richard is always ahead of the curve. In fact, he's usually the one who makes the curve in the first place.See omnystudio.com/listener for privacy information.
Dec 10, 2018 • 42:29
Better Science, Better Health: ZIN’s Amr Makady wrote the book, LITERALLY, on using RWE for HTA
Many HTAs in Europe are seen as conservative and even reactionary when it comes to innovating or changing their processes. However, Amr's PhD thesis is a 300+ page ‘how to’ manual highlighting RWE best practices and has put him at the forefront of the next generation of EU officials who are trying to move healthcare forward in Europe.See omnystudio.com/listener for privacy information.
Nov 30, 2018 • 24:43
Bettina Ryll: Razor-sharp intellect, scientific expertise, and a conviction to patient access
One of Europe’s most articulate and forceful patient advocates, Bettina Ryll is a cyclone of energy, persistence and vision driven by her own family tragedy dealing with cancer. With a PhD in Biomedical Sciences from University College London, she possesses technical insights in drug development that few European patient representatives have. As well, Bettina cuts through the noise to best represent her members in the Melanoma Patient Network Europe, which she founded.See omnystudio.com/listener
Nov 26, 2018 • 33:22
Better Science, Better Health: BIA’s CEO is the hardest working man in biotech since Brexit
In this podcast, Steve Bates, UK BioIndustry Association's CEO, discusses both the challenges and opportunities of Brexit on the UK’s biotechnology sector, and the need for strong, vital IP supported by private investment. Steve was an advisor to Tony Blair’s government and a founding member of United Life Sciences, a strategic partnership representing over 1000 life science and healthcare member companies internationally. He also sits on the Science, Industry and Translation Committee of The Ro
Nov 16, 2018 • 26:53
Pamela Tenaerts - Discussing global research, Belgian endives, and everything in between
Founded in 2007 by the FDA and Duke University, the Clinical Trials Transformation Initiative (CTTI) has as its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Pamela Tenaerts, CTTI's Executive Director, has a broad international perspective given her previous life running large international clinical research at KU Leuven, and we were fortunate to catch up with her at the IMI Stakeholder Workshop in Brussels to discuss how
Nov 9, 2018 • 24:30
Better Science, Better Health: The US Chamber's Patrick Kilbride on the Rapidly Changing IP World
Patrick Kilbride is vice president of international intellectual property for the Global Innovation Policy Center (GIPC) at the U.S. Chamber of Commerce. Over the last several years, there has been a growing chorus of voices internationally that have begun to question the role of IP in drug development. In this podcast, we separate fact from fiction around the role of IP in developing new biotech products, the changing global landscape for innovation, and what we need to do to ensure that we don
Oct 26, 2018 • 24:46
Better Science, Better Health - Stirring the IP Pot
Emil Pot was one of the founders of ActoGeniX, which was successfully acquired in 2015 by Intrexon. Emil outlines the ingredients Europe needs to build a company from scratch, and leverage home-grown Intellectual Property.See omnystudio.com/listener for privacy information.
Oct 19, 2018 • 18:59
