India Clinical Trials Scenario: Leaders From Novartis, IQVIA, PwC Signal Winds Of Change
Executive Summary
Leaders from Novartis, IQVIA and PwC discuss the ground situation for trials in India as regulatory reforms, improved infrastructure and clinical expertise provide opportunities. Potential in areas like orphan diseases and tips for peer Amgen on getting trials going in India were among other highlights.
You may also be interested in...
AI/ML Efforts, Quick Approvals, Regulator Digitalization: What India Is Doing For Drug Discovery
AI initiatives in a country known for its software prowess, along with startup support, clinical trial rule changes, crunched approval timelines, unified digital regulatory interfaces and a R&D policy laying out $600m in funds, are all meant to build something greater than the sum of its parts. In a bottom-up approach, India is building an innovation ecosystem
FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
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.
Big Pharma R&D Chiefs On IRA’s Unintended Casualty, Product Life Cycle Compression
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.