Vital Health Podcast

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 titled Bye-bye Bayh. In it, Danny argues that the recent threats by members of the US Senate to exercise little-known and rarely used legal provisions called march-in rights contained in the Bayh-Dole legislation would, “crush American innovation, creating a new avenue for government to punish companies for bringing products – including lifesaving treatments – successfully to market.”   Phoenix is one of the fastest growing biopharma regions in America, and this is in no small part due to Danny Seiden and the Arizona Chamber of Commerce working with their state and federal representatives to ensure that their economy balances the needs of business and the public. Danny makes a compelling case that the current discussions on drug pricing are rarely based on evidence, and to address rising healthcare costs there is a critical need for market driven solutions which also promote scientific innovation.See omnystudio.com/listener for privacy information.

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 Board governance operations – he had the largest desk plaque in DC. In this podcast, we discuss several DC proposals trying to change the way accelerated approvals are managed by the FDA, and Vital Transformation’s recently released research and analysis of the impact of CMS’ guidance related to Alzheimer’s disease, which was commissioned and funded by Biogen. The podcast highlights the mounting attacks on the accelerated approval pathway, and the negative unintended consequences that would impact the US R&D ecosystem if it were to be regulated out of existence. This Vital Health Podcast was recorded on April 1st, 2022, before CMS had finalized its National Coverage Determination of Amyloid treatments for Alzheimer’s Disease. However, the now final CMS policy continues what the podcast participants feel is an unfavorable approach towards amyloid products and accelerated approvals.  The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, Tom Dilenge.  While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.See omnystudio.com/listener for privacy information.

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 impact of CMS guidance requiring confirming clinical trials for new treatments targeting Amyloid plaques in its prevention. We also highlight a growing consensus of concern surrounding CMS' current guidance as unintended consequences will likely be detrimental to future therapy developments in high unmet medical need areas.  The FDA's accelerated approval pathway itself is now also at risk as therapies developed for high unmet medical needs have historically utilized this FDA-approved pathway. The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, George Vradenburg.  While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.See omnystudio.com/listener for privacy information.

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 been critical of the many efforts to implement one-size-fits-all cost controls under Medicare. In this Vital Health Podcast, Sue digs into the broader implications of Vital Transformation’s research and analysis of the CMS guidance, which was commissioned and funded by Biogen, and its potential impacts on her Alliance members. We also discuss the many potential unintended consequences of the proposal, including risks to the accelerated approval pathway, and to the development of new treatments in areas of high unmet needs such as neurological disorders. Sue highlights that CMS’ guidance positions them as a de facto health technology assessment agency and spells out the implications for Medicare program participants. Additionally, we discuss existing case law in America which has previously decided that using QALY (quality adjusted life years) for reimbursement is age discriminatory, further bringing into question the viability of CMS’ Alzheimer’s disease guidance.See omnystudio.com/listener for privacy information.

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 Hammang, and VT’s Consulting Economist, Dr. Harry Bowen to discuss the core findings of their recent research and analysis which was commissioned and funded by Biogen, Inc.  The VT team found that, if implemented, CMS’ plan would have devastating impacts on the development of new treatments for Alzheimer’s disease, neurological disorders, and new therapies using accelerated approvals. Additionally discussed are the enormous challenges and high failure rates associated with clinical developments in neurology since reaching their peak in 2009.  VT’s research finds the current failure rate for clinical developments in Alzheimer’s disease is 99.5%, meaning that if the proposed CMS guidance is implemented, it would likely drive down the number of new therapies developed for Alzheimer’s disease to nearly zero. See omnystudio.com/listener for privacy information.

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 Protection on cross-border donations has put the global sector under serious pressure and the supply chain under tremendous stress.  To discuss all things plasma, I’m joined by Amy Efantis, the CEO of the Plasma Protein Therapeutics Association.  In this podcast, we highlight how the cost of collecting plasma has skyrocketed, and how this has had a hugely negative impact on the global supply of vitally needed products such as immunoglobulin and albumen. As well, we talk about how the contradictory border policies of the Biden administration have many within the plasma sector scratching their heads, trying to solve the seemingly arbitrary enforcement of U.S. laws and its impact on plasma collections.See omnystudio.com/listener for privacy information.

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 is no more, the drug pricing debate is not going away anytime soon. In this podcast we discuss how the drug pricing debate threatens to derail innovation, as does aggressive tax policy positions being taken by many leaders in traditionally pro-biotech states like California and Massachusetts. The biotech sector in Arizona has been a direct beneficiary of many of these decisions. As well, we discuss how institutions like the Mayo Clinic, which have a large footprint in Arizona, are making big investments developing a commercial R&D hub called the Discovery Oasis. Joan highlights how the Mayo Clinic fertilizes innovation across Arizona’s Health Innovation Ecosystem, and how that lays the groundwork for product development locally. See omnystudio.com/listener for privacy information.

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 in the general public feel that it’s only fair that Medicare start to negotiate drug pricing similar to what is done in the EU to control the out of pocket costs of medicines, John Murphy highlights what this would mean practically for the biotech sector, highlighting that even if drug price controls appear reasonable on the surface, there are inevitable trade-offs. Build Back Better will likely place severe constraints on the global innovation ecosystem in the development of needed therapies for orphan conditions as well as for diseases like oncology and Alzheimer’s disease. The discussion also highlights the need for a robust private sector to take-on the risks of development, and how many proposals such as the new $3 bil innovation public private partnership called ARPA-H are not likely to lead to meaningful leaps in innovation. Further, we discuss the implications of ‘Operation Warp Speed’, and how the possibility to rapidly deliver needed mRNA vaccines to market in only 9 months could serve as a blueprint for addressing seemingly intractable issues such as antimicrobial resistance.See omnystudio.com/listener for privacy information.

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 currently active in the study and development of vaccines in the fight against COVID-19. We look back of the history of the project’s development out of the IMI, and the role it’s currently playing in the EU evaluating the performance, safety, and efficacy of the vaccines currently in use or being developed in Europe and internationally. Miriam is the head of the Department of Data Science and Biostatistics at the University Medical Center Utrecht in the Netherlands. She’s a PhD of Mathematics and Physics, and the past president of the International Society for Pharmacoepidemiology, serving as an expert to the EMA, FDA, WHO and many other organizations.See omnystudio.com/listener for privacy information.

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, we touch on the litany of proposals emanating from the US congress including international reference pricing and APRA-H, the proposed DARPA of healthcare. Chris Austin approaches the increasingly caustic debates around discovery, R&D, and pricing with a nuance and subtle understanding that is truly unique in its depth and wisdom, articulating why the U.S. ecosystem from the NIH through to commercial Biopharma has been both successful and effective. Chris provides a background to many R&D breakthroughs with which he’s been personally involved, whilst explaining in detail how the US innovation engine works, and what makes it tick. We also outline how well-intentioned proposals such as price controls and IP waivers put the US ecosystem, and the future of drug discovery, at risk. Chris Austin graduated with a degree in biology from Princeton in 1982, and received his MD at Harvard Medical School. He completed his clinical training in internal medicine and neurology at Massachusetts General Hospital.See omnystudio.com/listener for privacy information.