AI-enabled pharmacovigilance, with Updesh Dosanjh

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.   In today's pharmaphorum podcast, sponsored by IQVIA Safety Solutions, host Jonah Comstock speaks with Updesh Dosanjh, IQVIA commercialisation lead for safety technology, about how and why the role of AI in pharmacovigilance is changing, as well as tips for implementing these new tools safely and reliably.   Dosanjh discusses why AI in pharmacovigilance is moving beyond document extraction and case processing, how regulatory expectations are shifting from basic compliance to meaningful patient outcomes, and why governance and monitoring matter more than technology alone.   Then, in the second half of the conversation, he covers how organisations can build trust and adoption across their teams, what patient-level safety monitoring could look like in the era of personalised medicine, and, finally, why starting with a meaningful, high-value use case is critical to AI success.   Check out the full podcast below, and then download the White Paper to learn even more.

Earlier this year, the FDA released draft guidance endorsing Bayesian methods and simulation-based evidence in clinical trials in a significant shift in how regulators think about predictive medicine.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

Chronic liver disease affects around 1.5 billion people globally. As understanding of liver disease improves, outcomes are increasingly determined by how early patients are identified, not just what therapies are available. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Lee Lehman Becker, Roche’s global head of healthcare insights at Roche Information Solutions (RIS), for a discussion of the liver disease epidemic that is being diagnosed too late and driving a growing health system crisis globally. The conversation also explores scalable diagnostic innovation and the role of this in addressing health system burden – metabolic liver disease projected to affect some 1.8 billion people by 2050, with global costs expected to exceed $2.3 trillion. You can listen to episode 271 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.

The drug price negotiation provisions in the Inflation Reduction Act were designed to continue evolving with each passing year. As CMS prepares for 2028 and 2029, the agency has put out new draft guidance codifying and, in some cases, modifying the fine print of the controversial law. They’ve also recently issued additional draft guidance on how they’ll handle the imminent introduction of Part B drugs into the programme. Hogan Lovells partner Alice Valder Curran returned to join pharmaphorum editor-in-chief Jonah Comstock to elucidate some of the finer points of this latest communication from CMS – and to urge the industry to take advantage of the public comment periods associated with it. Curran and Comstock discuss small, but impactful, changes in CMS’s policies around deemed biologics, vaccines, and the special provisions that protect small biotechs. And Curran gives a rundown of what’s in – as well as what’s not in – the new MFP effectuation guidance, laying out how the differences in how Part D and Part B drugs are paid for leave some big question marks hanging over the programme. Tune in for an easy-to-understand deep dive into some complicated subject matter, and for a more comprehensive rundown don’t forget to check out Hogan Lovells’ policy briefs on the new draft rules and the MFP effectuation guidance.

SYNGAP1-related disorder negatively impacts synaptic signalling during critical periods of brain development, leading to a range of cognitive, epileptic, behavioural, and motor symptoms. In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh spoke with Kelly Gold, CFO of CAMP4 Therapeutics, about antisense oligonucleotides (or ASOs) - medicines designed to selectively restore natural protein production in diseases caused by gene under expression. Gold discusses the space and CAMP4’s CMP-002 study, targeting the regRNA associated SYNGAP1 gene. You can listen to episode 269 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.

The M&A market has been rebounding in the US, driven by factors like patent cliffs and improved balance sheets – but the question is whether this will play out in Europe and how the wave could differ. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Andrea Carta Mantiglia, partner and lead of the Healthcare & Life Sciences Focus Team at Italian law firm BonelliErede, about whether the current US biotech M&A surge will indeed extend into Europe. The conversation touches upon the appetite for cross-border dealmaking, the growing role of private equity in European pharma and medtech, generational exits among family-owned pharma groups in Italy, and the role of digitalisation in all this. You can listen to episode 268 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.