Vital Health Podcast

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.

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. Reilly has recently turned his focus to the response to COVID-19, writing an article on April 28th for SPIKED online called, “There is no empirical evidence for these lockdowns.” Needless to say, his analysis lit a firestorm of debate on the internet, similar to whacking a hornet’s nest with a broom handle. He recently updated this article on May 8th with fresh data and the title, “The lockdowns still aren’t working”, also published in SPIKED online.Reilly, who is African American, has appeared or been quoted in television, radio and print media outlets, claiming that many or most recent high-profile hate crimes (i.e. Jussie Smollett, Yasmin Seweid, Air Force Academy, Eastern Michigan, Hopewell Baptist) have turned out to be hoaxes. Reilly's recent book Hate Crime Hoax: How the Left is Selling a Fake Race War, was published by Regnery Publishing in February 2019. For the book, Reilly assembled a data set of 409 allegedly false or dubious hate crime allegations (concentrated during the past five years), which he describes as hoaxes on the basis of reports in mainstream national or regional news sources. This data set is available to anyone who requests it. He is also the author of Taboo: 10 Facts You Can’t Talk About, also published by Regnery.See omnystudio.com/listener for privacy information.