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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.

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.

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 Sciences at J&J. Back in 2008, Dr. McMurry-Heath was a member of the Obama-Biden transition team, which tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies. President Obama then named her Associate Science Director of the FDA’s Center for Devices and Radiological Health under Commissioner Margaret Hamburg.Michelle McMurry-Heath takes command of BIO during a tumultuous time and amidst unprecedented challenges. In this podcast we discuss BIO´s role supporting companies now producing mRNA vaccines against COVID-19, as well as how US-based biotech, particularly in California and Massachusetts, has been the key player driving the global growth of the biopharmaceutical industry over the last several decades. Repeated technological triumphs notwithstanding, we also highlight the mounting regulatory challenges regarding pricing and access at a time when science is targeting ever smaller populations and more personalized treatments, which require innovative approaches that under current regulatory structures are not always appropriately supported. Lastly, Michelle McMurry-Heath also outlines what priorities are key to ensuring the viability of the biotech sector at the state level.See omnystudio.com/listener for privacy information.

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 Medicine. According to the New York Times, Prof Larson says that, “dispelling vaccine hesitancy means building trust — and avoiding the term “anti-vaxxer.”In this podcast we discuss how skepticism of vaccine safety often mirrors anti-government populism. Prof Larson also outlines how the first conscientious objectors were not against war, but against the smallpox vaccine in Europe in the 1850s. We also investigate the role that social media plays in consolidating opinions today. This podcast touches on the French and Italian governments' recent use of legislation requiring vaccination and how that impacted the debate around vaccine acceptance. Prof Larson also outlines the appropriate strategy for governments to improve the public’s trust in large-scale vaccination programmes.See omnystudio.com/listener for privacy information.

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 evolve, and Leo is now the Chief Energizer at Hack Belgium Labs. We’re speaking to him today, along with Thomas Vande Casteele, the CEO of the promising EU health Tec company, Awell Health. You can register for this year’s addition of Hack Healthcare on the 2nd and 3rd of March, 2021, at HackBelgiumLabs.be In this podcast we discuss the challenges of COVID-19 on the tech innovation culture, and the opportunities that are presented by bottom-up innovation driving adoptions. As well, we highlight the need for the greater use of real world data for healthcare improvement, in ways not often implemented by governments, BioPharma companies, or practitioners.See omnystudio.com/listener for privacy information.

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, joining the company through the acquisition of Celgene. Given Matt’s deep understanding of the need for analytical rigour in healthcare, in this podcast we discuss the current gulf that exists in medical practice between doctors and quants, and how this situation can be solved in the future. We also the many challenges to harnessing observational data are not, in fact, technical, but political. EHDEN can serve as a test-bed to demonstrate the value of RWE to help remove the barriers that current exist to access health records and apply effectiveness in decision making. The podcast also outlines many of the core issues to be discussed in a webinar series as part of EHDEN’s annual General Assembly and Road Show. Matt Wiener has a PhD in mathematics from the University of Chicago, and an undergraduate degree from MIT. He’s applied mathematical modelling and analytics to different phases of drug development, from early research to manufacturing. Before moving into healthcare, he worked in various fields of mathematical modelling, including for the health effects of air pollution. He also, for a time, was engaged in Postdoctoral research at the NIH’s Institute of Mental Health.See omnystudio.com/listener for privacy information.

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 error. Once the pandemic was in full swing, official statistics in most European countries underreported coronavirus-related deaths. More recently, the retraction of two separate clinical studies for hydroxychloroquine published in two top medical journals due to unreliable primary data collection and meta-analysis demonstrated the importance of data quality for assessing vitally needed medicines. In this podcast we discuss how EHDEN was able to produce a high-quality hydroxychloroquine peer review study in only 4 days, and how the platform will be able to assist with European healthcare decision making in the future. It also outlines many of the core issues to be discussed in a webinar series as part of EHDEN’s annual General Assembly and Road Show. Kees studied Computer Science and Bioinformatics, for which he did his research project on lipoprotein metabolism at TNO Quality of Life in The Netherlands and the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston. Through his many years of experience in open source software and standards development in bioinformatics, Kees has a deep understanding of all aspects of open source development.See omnystudio.com/listener for privacy information.

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 outline several issues to be discussed in a multi-stakeholder webinar to be held on October 22nd. Jacoline is the Senior Scientific Adviser for Science Policy and Research at the National Institute for Health and Care Excellence (NICE), based in London. Jacoline is a Dutch health economist specialising in the interface between marketing authorisation and health technology assessment (HTA) of drugs. She’s been involved in several pan-European IMI projects: ADAPT-SMART, ROADMAP, Neuronet and EHDEN.See omnystudio.com/listener for privacy information.

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 analytical skills to the Covid-19 pandemic, serving on the CDC´s working group to evaluate the safety of any future Covid-19 vaccine. He has also been a strong advocate for age-specific approaches to managing the spread of the disease, both in major newspapers in his native Sweden and in Spiked magazine. In this podcast we discuss the ‘anti-herders’ who view herd immunity as a misguided strategy rather than a scientifically proven phenomenon that can prevent unnecessary deaths, and Dr Kulldorff’s firm belief that the approach taken by Sweden is the correct one. Additionally, we point out recent data showing that suicides are more frequent than Covid-19 deaths as a consequence of lockdowns, and allowing those under 50 to practice safe social distancing while protecting the elderly is society’s best option. Martin Kulldorff also outlines how our approach to dealing with the pandemic is putting a heavy burden on the working classes, who are ultimately bearing the largest burden of the Covid-19 policies.See omnystudio.com/listener for privacy information.

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 for Health Outcomes Measurement (ICHOM) on the collection, analysis, and publishing of patient-reported outcomes for international comparison. In this podcast, we discuss the specific challenges of setting the correct health policy for Covid-19 given the high rate of asymptomatic cases and the disproportionate impact of the disease on those over 70 years of age with comorbidities. We also discuss the need for greater global cooperation in the development of a vaccine, risk sharing for manufacturing, and more streamlined data collection. Prior to her 20 years at the OECD, Francesca was the acting head of the Planning Unit at the Ministry of Health and Labour of Guyana. She holds a M.Sc. in development studies from the London School of Economics and Political Science and a B.Sc. in economics and management from Bocconi University.See omnystudio.com/listener for privacy information.

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 2019. Since January 2018, he has also been a member of the Board of the European Health Forum Gastein (EHFG).In this podcast, we discuss pricing and access to new medicines under the challenges of COVID-19, as well as balancing the potential impacts of compulsory licenses to address the pandemic with the need to maintain a viable EU investment market. We also touch on topics such as Europe's competitiveness in global biotech, the hospital exemption of oncology products such as CAR-T, the recent marked decline in authorisations of EU orphan products, and the recent NGO report on the Innovative Medicines Initiative.Yannis is a founding member of the European Alliance for Responsible R&D and Affordable Medicines and represents the public health voice on the following groups: High Level Group (HLG) to the Round Table meetings for European Health Ministers and Heads of Europe of pharmaceutical companies; Health Technology Assessment (HTA) Network Stakeholder Pool of the European Commission.See omnystudio.com/listener for privacy information.