Vital Health Podcast

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.

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 play in bringing new therapies to patients. Richard was previously at Massachusetts General Hospital (MGH) and Harvard Medical School, and this strong academic background combined with his industry knowledge gives him a unique perspective on both sides of public and industrial R&D, as well as how NIH developed intellectual property moves from the ‘Eureka’ phase to becoming an actual medicine.Our conversation includes President Biden’s new $6.5 billion proposal called ARPA-H, modeled on DARPA, specifically for drug discovery, and where those efforts would be best directed to facilitate needed medicines to address unmet medical needs. We also touch on how the rapid evaluation and approval of vaccines for COVID-19 could serve as an improved regulatory blueprint for accelerated evidence driven access to patients.See omnystudio.com/listener for privacy information.

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 investigates R&D productivity from both an economic and a scientific perspective, with a focus on the fact that the cost of scientific inputs has dropped exponentially, yet, the drug and biotech industries have seen a huge long-term decline in innovative output efficiency. He works as an independent consultant to drug and biotech firms, financial institutions, and the public sector. He was head of Discovery Research at e-Therapeutics, an Oxford-based biotechnology firm. He’s also worked for the Boston Consulting Group.See omnystudio.com/listener for privacy information.

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. California and has been responsible for nearly 25% of new drug discoveries in that period, but with many state politicians supporting the bill, it is at risk of seeing industry revenues cut by nearly 40%, which will severely impact its biotech sector.In this podcast, we speak with Keith Murphy, CEO and Founder of Viscient Biosciences and a board member of the California Life Science Association (CLSA), and Oliver Rocroi, Vice President of CLSA. We discuss the looming challenges that one-size-fits-all pricing models such as reference pricing place upon the global biotech ecosystem and try to answer the question “How did we get here?” We also highlight possible solutions that the successful accelerated development of COVID-19 vaccines foreshadow and reflect on how Europe is struggling to vaccinate its population after putting in hard price ceilings in its vaccine procurement negotiations, which are now limiting supply and access for the EU public at large. This podcast further outlines in depth how the entirety of the funding landscape responds to financial incentives and how the risk-reward calculations for VCs would be impacted by radical reductions in revenue. We highlight the areas of research, such as rare diseases and neurological disorders (e.g. Alzheimer’s, Parkinson’s), that are likely to be cut first if H.R. 3 becomes law. Lastly, we challenge the system to better respond by focusing on value and not on price, and call out industry bad actors who use intellectual property to block generic access.See omnystudio.com/listener for privacy information.

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 latest effort to broaden the EU’s innovation capacity through their new initiative focused on health innovation fellowships. Named The Institute for Biodesign, it will open its doors this spring in collaboration with TU Delft and Erasmus University Medical Center in the Netherlands. The institute’s Health Fellowship Network will be further supported by the European Institute of Technology (EIT), whose input in ensuring that KU Leuven’s new project comes to fruition is also discussed in the podcast. Lastly, the podcast details how interested researchers, healthcare professionals, and industry partners can join the new Institute for Biodesign and offers some insights into what the programme will deliver in the future. We touch on the broad macroeconomic competitive challenges that the EU currently faces and how the fellowship network hopes to overcome these to keep breakthrough technologies and the value they create within Europe.See omnystudio.com/listener for privacy information.

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 internet, giving a forceful testimony in front of the US Senate Homeland Security Committee, describing the “miraculous impact” of the antiparasitic agent ivermectin in the treatment and prevention of COVID-19. Could it be possible that Dr Kory and the team at the FLCCC have twice found successful treatments in the fight against COVID-19? Can lightning strike twice? In this podcast, we discuss the evidence behind the FLCCC’s use of ivermectin for both in the prevention and treatment of COVID-19. We outline why this team of internists at the FLCCC have succeeded in potentially finding two significant treatments for COVID-19 when the majority of the world’s public health establishment have been mired in indecision and a lack of innovation. Dr Kory discusses the challenges he’s met changing set opinions once many clinicians have put treatment paradigms into practice. He also touches upon the toxic environment that exists for those practitioners on the front lines trying to promote improved treatment protocols in an increasingly politicized medical landscape where prevailing opinions are often dictated by dogma, orthodoxy and bureaucracy, rather than by following the clear path created by evidence-based medicine. This podcast is made possible with the support of PharmaCCXSee omnystudio.com/listener for privacy information.

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 series of in-depth YouTube videos commenting on the response of public health experts and calling into question many government policies as well as conventional wisdom. In this podcast, Ivor provides historical background which explains why, in line with the WHO’s 2019 guidance for dealing with a potential pandemic, lockdowns and isolation were actually not recommended. Yet, due to presumed pressure exerted by the Chinese government https://youtu.be/978zLJJLo-I, these recommendations, based on decades of empirical research, were simply ignored or changed without the backing of hard new clinical evidence. Ivor highlights similar changes in recommendations for mask wearing, which were also not seen as a useful approach to mitigating the impact of a pandemic, yet were suddenly recommended over the summer, contradicting research hosted on both the CDC and WHO websites that stated that masks were ineffective. Ivor’s podcast touches on topics such as the Diamond Princess Cruise Line, the Great Barrington Declaration, Occam’s and Hanlon’s Razors, and even the conspiracy around ‘The Great Reset.’ It’s a wide-ranging conversation that raises many questions as to why the EU and the US have adopted strategies to combat COVID-19 despite indications that the chosen paths are not based on evidence. This podcast is made possible with the support of:Pharma CCXSee omnystudio.com/listener for privacy information.

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 innovative startup PharmaCCX, an independent, third-party technology platform focused on improving patient outcomes by helping both sides of the negotiation reach access agreements more efficiently. Their goal is ambitious: to improve overall deal management by reshaping the way pricing and access agreements in the biopharma sector are made and sustained, so that patients can get the complex therapies - including combination oncology - they need to survive.In this podcast, we discuss how PharmaCCX was formed, bringing together the unique skills of Nathan, who approaches the drug pricing problem by leveraging proven financial technologies used by Wall Street, and Richard, former Director General of EFPIA with years of regulatory policy experience in the pharma sector.We also highlight the current market access challenges for effective cancer therapies and what it takes to find a consensus on drug pricing. As oncology treatments are becoming more targeted, their prices goes up due to the ever smaller pool of patients they treat. This becomes particularly challenging when clinical advice is to use several such therapies in combination, yet governments feel the price of a single one of them is already unacceptably high.See omnystudio.com/listener for privacy information.