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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development.

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AI At The Frontier: Empowering Early Career Professionals In Drug Discovery

Elrig

My role involved generating and characterizing complex proteins critical for biological assay development, hit discovery, and structural biology. Rising from Research Scientist to Senior Scientist, I supported early-stage DD efforts within their Protein Science group, based in Cambridge, UK.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. after ischemic heart disease and stroke. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. were from cancer.