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.
--------
29:20
--------
29:20
Policy in Focus: Trump’s MFN deals, FDA vouchers, and the government shutdown
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.
--------
29:46
--------
29:46
Biotech’s biggest challenge isn’t scientific, but political – with James Roosevelt Jr
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.
--------
11:54
--------
11:54
On targeted radiotherapeutics, with Marc Hedrick
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.
--------
34:30
--------
34:30
Towards one, cohesive AI workflow: In conversation with Ilya Burkov
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.
pharmaphorum is one of the leading global channels for insight into the pharma and healthcare industry – and is essentially a group of passionate people who like asking excellent questions. Our podcasts offer a chance to pose some of these questions to the keenest minds in our industry to look at the big issues and opportunities facing pharma, biotech and healthcare today. With interviews and contributions from a host of industry experts and insiders, the pharmaphorum podcast is a must-listen for those who want insight into the future of health and medicine.
Ireland