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 min
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 04, 2022•30 min
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 min
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 08, 2022•43 min
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 1,60...
Jul 01, 2022•29 min
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, wit...
Jun 22, 2022•43 min
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 . I...
Jun 15, 2022•28 min
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...
Apr 21, 2022•46 min
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...
Apr 08, 2022•35 min
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 man...
Mar 10, 2022•27 min
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 C...
Feb 25, 2022•36 min
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...
Feb 14, 2022•31 min
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 dr...
Feb 10, 2022•41 min
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 hr
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 cu...
Oct 22, 2021•26 min
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 hr 6 min
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 s...
Jul 08, 2021•27 min
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 Scanne...
Jun 17, 2021•49 min
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 05, 2021•44 min
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•18 min
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 02, 2021•31 min
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 05, 2021•57 min
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 innov...
Jan 28, 2021•54 min
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 Sci...
Dec 11, 2020•26 min
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•27 min
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 min
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•31 min
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•32 min
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 05, 2020•29 min
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•29 min
