Working together to innovate on pragmatic clinical trials, with Rob DiCicco

Process innovation in the pharmaceutical industry is never easy, but its best chance of success comes when companies come together to work on big problems – especially when they bring in regulators and other stakeholders.   In today’s episode of the pharmaphorum podcast, host Jonah Comstock speaks with Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, a membership organisation where big pharma companies work together to innovate around the discovery, development, and manufacturing of new drugs.   DiCicco gives an update on TransCelerate’s work with pragmatic trials and the group’s meetings last year with the FDA. He discusses what pragmatic trials are and how they can improve the efficiency of clinical research, as well as describing the work that was done at the meeting last year and the report that’s come out of it.   He also gets into next steps, how the new administration has and hasn’t affected the work TransCelerate is doing with the FDA, and the role TransCelerate plays in taking these recommendation and putting them into practice.   Tune in to learn how the pharma industry is working together to change the way clinical trials are done.

At the end of September, President Trump invited Pfizer CEO Albert Bourla to the Oval Office to announce that the company and the administration had reached a "deal" on most-favoured nations drug pricing. This was followed by similar announcements from AstraZeneca and Merck. But are these deals substantive policy or PR sleight of hand? In today’s episode of the pharmaphorum podcast, host Jonah Comstock invites Hogan Lovells Partner Alice Valder Curran back to the show to help get to the bottom of that question, as well as to talk a little about TrumpRx. And this time she's brought along her colleague Elizabeth Jungman who gives us the skinny on the FDA's new priority voucher system and what exactly the government shutdown means for the pharma industry. Despite the many press releases, oval office announcements, and guidance documents, there’s still a lot we don’t know about all these topics. But Curran and Jungman help clarify what we do know so far and provide context and analysis to fill in the gaps. For the rest, we’ll have to wait and see what US policymakers have in store. Tune in for the whole illuminating conversation.

Amid historic advances in cell-based therapies and precision medicine, biotech’s biggest challenge isn’t scientific, it’s political. In a new pharmaphorum podcast, James Roosevelt Jr, a longtime healthcare leader, former associate commissioner of social security for retirement policy, and grandson of FDR, as well as Advisory Board Member for Pluri Inc, discusses regulatory bottlenecks and their stalling effect on cell-based therapies, as well as the real dynamics behind FDA reform, and why biotech CEOs must become more fluent in policymaking now. You can listen to episode 215 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.

Radiation has for over a century been considered one of the most powerful methods of destroying cancer. But, even now, ways to deliver significant doses to a tumour without damaging normal surrounding tissue are few. And this is where targeted radiotherapeutics come in. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Dr Marc Hedrick, president and CEO of Plus Therapeutics, a clinical stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today and for the future. You can listen to episode 214 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.

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Ilya Burkov, global head of healthcare & life sciences at Nebius, a company building one of the world’s leading AI infrastructure companies. Burkov discusses the deployment of AI and cloud-native infrastructure for improving the speed and indeed quality of drug development, as well as why access to compute not enough and how GenAI is helping pharma teams integrate real-world evidence into the pipeline. You can listen to episode 213 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.

Bayer and Veeva have partnered for several years across commercial, R&D, and quality functions. But recently Bayer migrated to Veeva’s Vault CRM, taking that relationship, and Bayer’s connected platform journey, to the next level. In order to discuss this migration further, pharmaphorum spoke with Alexander Alex, head of Veeva Platform at Bayer, and Florian Schnappauf, vice president of enterprise commercial strategy at Veeva. Alex and Schnappauf explain how Vault CRM is a step-change for companies like Bayer, and discuss the benefits of being able to reflect the whole customer journey on a single platform, as well as the importance of collaboration. You can listen to episode 212 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.

As pharmaphorum reported during ESMO 2025, fresh from a return to oncology with the FDA approval of zongertinib as a treatment for HER2-positive non-small cell lung cancer (NSCLC), tumour shrinkage observed by investigator review - Boehringer Ingelheim is racing to expand its label. As the company reported new data at the Congress from the phase 1b Beamion LUNG-1 study, underpinning the approval of zongertinib (Hernexeos) as a second-line therapy, web editor Nicole Raleigh spoke with Lykke Hinsch Gylvin, chief medical officer of Boehringer Ingelheim, and Itziar Canamasas, Boehringer's head of oncology, offsite in Berlin. Discussing also Boehringer’s novel T-cell engager obrixtamig in combination with standard of care chemoimmunotherapy for patients with extensive-stage small cell lung carcinoma, Gylvin and Canamasas make clear Boehringer’s oncology foothold and commitment to making an unprecedented impact on the lives of those affected by cancer through innovative research. Certainly, patient engagement, patient quality of life, and patient trial co-creation are core Boehringer Ingelheim concerns. This and other reportage from ESMO 2025 can be found here. You can listen to episode 211 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.

Back in June, pharmaphorum spoke with Entity Risk’s CEO and co-founder, Neal Masia, a leading health economist, about the unknowns unfolding in the US following the commencement of the second Trump administration this year. Tune into today’s podcast for an exploration of the potential scenarios Masia mused might arise, as well as his insights on the 340B Program, PBMs, and risk-based contracts. You can listen to episode 210 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.

In the final episode of our special Frontiers Health limited series of the pharmaphorum podcast, web editor Nicole Raleigh speaks with the Chairman of Frontiers Health, Robert Ascione. Ascione - a serial entrepreneur & thought leader in health innovation and digital health, global executive, CEO and founder of Healthware Group, and President of Health Innovation at EVERSANA – talks about his favourite memory from Frontiers Health, as well as how his work outside of the conference both informs and is informed by it. Finally, he contemplates what will define the future of health. Listen to this and other episodes from the Frontiers Health limited series here.

As Gain Therapeutics announces positive Phase 1b results for its lead compound, GT-02287, pharmaphorum looks back to a conversation with the company’s CEO Gene Mack earlier in the year, discussing allosteric small molecule therapies in the Parkinson’s disease space. Mack discusses the company’s progress in this field, and explores where next in terms of the unmet needs of Parkinson’s disease and the potential of this specific area of R&D in the future. You can listen to episode 209a 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.