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Listicle: Maximising outsourcing models beyond time and cost

Drug Discovery World

This white paper expands on three key factors – cost, time, and innovation – and illustrates how integrating these factors will minimise the challenges and ensure success in outsourcing drug discovery. Three common questions regarding the challenges when considering outsourcing partners for drug discovery.

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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

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.


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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.

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Brochure: Dynabeads manual and automated SARS-CoV-2 enrichment

The Pharma Data

A schematic of domain and functional organization of two of the major structural proteins of SARS-CoV-2, Nucleocapsid protein as a target viral antigen for assay development. Based on our discovery experiments, we decided upon nucleocapsid protein as our target antigen for assay development.

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