Show Notes
For a variety of reasons, early stage clinical trials have been moving out of the United States more and more over the past few years, as companies pursue savings and lighter regulatory burden in places like China and Australia. The industry has long urged the US government to take some action to make it more attractive to bring these trials back to the States. That's the broad idea behind Operation TRIALBLAZER, a campaign launched this summer by HHS and the FDA. On today's podcast, host Jonah Comstock is joined by Dr Harpreet Singh, currently chief medical officer at Precision for Medicine. That's her first private sector job after nearly nine years at the FDA, so she's able to bring both an insider and outsider perspective in discussing this initiative. In addition to sharing some details about her time at the FDA and how the organisation has changed, Dr Singh discusses the situation in clinical research that's led to the US' leadership in clinical trials slipping away, what's in the Trialblazer plans, and whether she thinks it will be enough to turn the tide. They also talk a little bit about radiotherapeutics regulation and discuss why having clinical trials in the United States is important not just for the economy, but also for patients who are missing out on opportunities for cutting-edge care. Tune in for a fascinating primer on a major new US government clinical trials initiative.
More from pharmaphorum Podcast
*This episode of the pharmaphorum podcast is brought to you in association with Klick Health* By 2030, 1.2 billion women worldwide will be menopausal or post-menopausal - many at the peak of their working lives. Yet, menopause remains largely absent from health system planning, despite growing evidence linking unmanaged symptoms to reduced productivity, absenteeism, and women leaving the workforce altogether. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Dr Cecilia Caetano, vice president, global medical affairs and evidence generation lead in women’s health at Bayer, for a conversation on this overlooked, but increasingly urgent global health issue. Caetano discusses the lack of innovation in women’s health and, critically, the lack of understanding of menopausal needs. She also explores the European landscape for menopause in comparison to the UK, as well as describing what ‘health system readiness’ looks like. You can listen to episode 281 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from. *This episode of the pharmaphorum podcast is brought to you in association with Klick Health*
Even the most promising innovation still depends on strong governance, resilient operations, and confidence in sensitive data. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Robbie Tyrie, founder and managing director of Torridon Cyber, for a conversation on cybersecurity when it comes to pharma companies and health systems more widely. Tyrie shares his insights and explains how to ensure cybersecurity acts as a business enabler, as opposed to a barrier to growth. You can listen to episode 280 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.
Industry is using AI to surface hidden patterns and accelerate decision-making in high-pressure launch environments. In a new pharmaphorum podcast, host Nicole Raleigh speaks with Jason Smith, CTO of AI and analytics at Within3, for a conversation on data-fuelled agile launches and smarter decision-making. Smith discusses alignment of cross-functional teams and fostering real collaboration and efficiency, how pharma teams can use real-time data to shape more precise and effective launch strategies, and the importance in all this of maintaining a deep focus on patient needs and healthcare provider challenges. You can listen to episode 279 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.
Bioconvergence is a multidisciplinary research and development approach that merges technologies from biology, engineering, and computation, providing solutions in medicine, food, agriculture, manufacturing, climate, and more. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Shai Melcer, head of the national bioconvergence programme at Israel Innovation Authority, for a conversation exploring bioconvergence broadly. Melcer discusses the foundations, goes into detail about companies currently working in the bioconvergence space, and what it could – all together – mean for the future of human health. You can listen to episode 278 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.
Artificial intelligence is dramatically transforming the landscape for every part of pharma. One area where AI is both essential to implement and important to get right is pharmacovigilance, the group concerned with monitoring and maintaining patient safety.