pharmaphorum Podcast

Earlier this year, the FDA released draft guidance endorsing Bayesian methods and simulation-based evidence in clinical trials in a significant shift in how regulators think about predictive medicine. 

In a new pharmaphorum podcast, Dr Irina Babina, CEO of oncology R&D platform Concr, discusses how current regulatory frameworks were built for static, one-test-one-answer diagnostics, as well as the potential of digital twins, and how, if regulators keep approving AI medical tools the way they approve blood tests, the most promising predictive technologies will never reach patients.

You can listen to episode 276 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*

Europe continues to offer major life sciences advantages: deep scientific talent, strong clinical expertise, mature research infrastructure, and significant manufacturing capability. Indeed, biotech companies continue to invest in Europe as a long-term hub for scientific innovation, clinical research, and economic growth.

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Giancarlo Benelli, SVP & Head of Europe at BeOne Medicines, for a conversation on what Europe must do, however, in order to remain globally competitive.

Benelli discusses EFPIA’s latest reports on Europe’s competitiveness as a location for the life sciences industry, as well as exploring why it is at the same time losing ground to the US and to China. Additionally, Benelli comments on the importance of regulatory stability looking forward.

You can listen to episode 275 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*

*This episode of the pharmaphorum podcast is brought to you in association with Klick Health*

When it comes to digital innovation and AI, consideration of using and implementing such responsibly and ethically ever more becomes forefront. But how can pharma lead the way in ethical AI and trust-driven innovation?

In a new pharmaphorum podcast, Erik Janssen, head of digital care transformation at UCB, joins web editor Nicole Raleigh for a conversation on responsible digital innovation and ethical AI.

Janssen discusses how pharma can lead in responsible experimentation by focusing digital innovation on enhancing (not replacing) human care. He also speaks about co‑creating solutions with clinicians and patients, as well as the role of evidence‑based technology across the innovation framework.

You can listen to episode 274 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*

Public demand for prevention is surging, with 33.6 million people now using the NHS App, yet, NHS leaders say the digital infrastructure required to deliver prevention at scale isn’t in place.

In a new episode of the podcast, pharmaphorum spoke with James Davis, a healthcare expert at PA Consulting, for a conversation on the digital foundations needed to unlock a prevention first NHS.

Davis also discusses the initiatives with the biggest near term impact, what NHS leaders are worried about, and issues of trust and inequality.

You can listen to episode 273 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.

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.