Parexel International Corp.
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Latest From Parexel International Corp.
Some 50 experts and executives in the biopharma sector shared their views on the major trends they expect to see driving change in the clinical trials arena in 2024. Artificial intelligence applied to clinical development, greater use of remote monitoring and increased patient diversity in trials were key themes.
CTMC CEO Jason Bock talked to Scrip about the venture between MD Anderson and National Resilience, which provides manufacturing, process development and regulatory support for small cell therapy developers’ preclinical and clinical proof-of-concept studies. Meanwhile, Verge Genomics initiated a Phase Ib study of its AI-discovered drug for ALS; EyePoint and Aviceda dosed patients in their Phase II DME trials; Parexel teamed up with a non-profit cancer research group in Japan; and BARDA selected PPD to run its Phase II platform trial for ARDS.
Eisai and Lilly were the biggest winners at the 19th Annual Scrip Awards in a glittering ceremony at the Dorchester in London’s Mayfair, hosted by the actor and comedian Jon Culshaw.
Cell/Gene Therapies: US FDA Wants ‘Quantitative Correlation' Between Surrogate And Clinical Outcome, Former Reviewer Says
When weighing accelerated approval, the FDA wants to see that ‘X change in the surrogate translates into Y change in the clinically meaningful outcome,’ Parexel’s Steve Winitsky says. CBER Director Peter Marks opines on the types of therapeutic settings where accelerated approval is best suited, and what happens when a confirmatory trial disappoints.
- Contract Research Organization-CRO
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