FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.

R&D heads of Takeda, Amgen, Lilly and Novartis discuss some of the tectonic forces shaping the biopharma sector and the unintended consequences of the IRA on small molecule innovation. Advances in the neurodegenerative diseases segment amid impressive data from donanemab was another key talking point.

Senior Parexel executives tell Scrip that disruptions resulting from the Ukraine war and constraints in the US given the backlog in clinical care there could channel more trials to the Asia-Pacific region. They also discuss how things are moving in China, a market where the CRO has long-standing experience, the "conducive" ecosystem in India and issues around trial diversity.