Tag Archives: Policy Summit

AMT Designation Program and CDRP Pilot to Facilitate CMC Development of Products; ASGCT 2023 Policy Summit Analysis (Blast 2/2)

ASGCT 2023 Policy Summit Analysis 2: CMC information plays a fundamental role in the development and regulation of cell and gene therapies (CGTs), which has motivated the generation of new policies to facilitate and expedite its evaluation. Celltelligence is publishing a two-part series discussing the strategies the FDA is following to keep up with innovation in the CGT field and providing insights about their relevance in the cell therapy space. In this second blast, 2 new non-CGT-specific FDA policy initiatives focused on addressing CMC challenges are covered:

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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The Office of Therapeutic Products Bets on Communication; New Cell and Gene Therapy Access Model to Be Tested; ASGCT 2023 Policy Summit Analysis (Blast 1/2)

ASGCT 2023 Policy Summit Analysis 1: Cell and gene therapies (CGTs) have emerged as novel treatment options with unique characteristics that differ from previously approved therapies, which has motivated the generation of new regulatory processes and policies. The ASGCT 2023 Policy Summit delved into some of the strategies the FDA is following to keep up with innovation in the CGT field. Celltelligence will publish a two-part series discussing these new approaches and providing insights about their relevance in the cell therapy space. In this first blast, the following topics are covered:  

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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