Assay Development, Clinical Development and Licensing

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Assay Development

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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

JANUARY 4, 2023

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. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

Therapies

Therapies Engineering Production FDA

The hidden risks of over-reliance on healthy donor material

Drug Target Review

OCTOBER 10, 2024

Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinical development and escalate costs. In conclusion, over-reliance on healthy donor material in cell therapy development creates a precarious foundation for clinical translation.

Therapies

Therapies Immune Response Clinical Trials Disease

Drug Discovery Digest

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

The hidden risks of over-reliance on healthy donor material

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