Media Summary: Hear from Dr. Andrew Byrnes during the third installment of the BIO-ASGCT CGT Science Series. In this keynote from the 2023 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's Center for ... Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most ...

Recent Cmc Guidance For Cellular - Detailed Analysis & Overview

Hear from Dr. Andrew Byrnes during the third installment of the BIO-ASGCT CGT Science Series. In this keynote from the 2023 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's Center for ... Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most ... In this episode of the DES Pharma Podcast, we sit down to unpack the FDA's January 11th ... This presentation highlighted key clinical regulatory issues encountered during early-phase development of This presentation addressed CBER's Chemistry, Manufacturing, and Control considerations for early phase studies of

In this in-depth keynote from the 2024 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's ... Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA) Learn why regulatory and chemistry, manufacturing and controls ( In this BioProcess Buzz episode from BioProcess International Week in Boston, Alvin sits down with Rene from LumaCyte. September 26, 2025 Yale's Review of Advances in Oncology from the 2025 ASCO Annual Meeting Presenters: Michael Hurwitz, ...

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Recent CMC Guidance for Cellular and Gene Therapies: BIO-ASGCT CGT Science Series
FDA Guidance for Cell and Gene Therapy: Insights from Peter Marks at CGT Summit 2023
Beyond Purity: Addressing the FDA’s CMC Expectations for gRNA
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FDA’s 2024 Vision for Cell & Gene Therapy Innovation
Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy
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Navigate the complexities of cell and gene therapies with regulatory and CMC expertise
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Recent CMC Guidance for Cellular and Gene Therapies: BIO-ASGCT CGT Science Series

Recent CMC Guidance for Cellular and Gene Therapies: BIO-ASGCT CGT Science Series

Hear from Dr. Andrew Byrnes during the third installment of the BIO-ASGCT CGT Science Series.

FDA Guidance for Cell and Gene Therapy: Insights from Peter Marks at CGT Summit 2023

FDA Guidance for Cell and Gene Therapy: Insights from Peter Marks at CGT Summit 2023

In this keynote from the 2023 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's Center for ...

Beyond Purity: Addressing the FDA’s CMC Expectations for gRNA

Beyond Purity: Addressing the FDA’s CMC Expectations for gRNA

Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most ...

FDA’s Flexible Requirements for Cell and Gene Therapy: CMC & Supply Chain Impact (Episode 1)

FDA’s Flexible Requirements for Cell and Gene Therapy: CMC & Supply Chain Impact (Episode 1)

https://despharmaconsulting.com/ In this episode of the DES Pharma Podcast, we sit down to unpack the FDA's January 11th ...

FDA-NIH 2024 | D1S12 - Early Development of Cellular and Gene Therapy in Oncology -Clinical...

FDA-NIH 2024 | D1S12 - Early Development of Cellular and Gene Therapy in Oncology -Clinical...

This presentation highlighted key clinical regulatory issues encountered during early-phase development of

FDA-NIH 2024 | D1S10 - CBER’s CMC Considerations for Early Phase Studies of Cell and Gene Therapy...

FDA-NIH 2024 | D1S10 - CBER’s CMC Considerations for Early Phase Studies of Cell and Gene Therapy...

This presentation addressed CBER's Chemistry, Manufacturing, and Control considerations for early phase studies of

FDA’s 2024 Vision for Cell & Gene Therapy Innovation

FDA’s 2024 Vision for Cell & Gene Therapy Innovation

In this in-depth keynote from the 2024 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's ...

Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy

Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)

What's New Doc? End-of-the-Year Updates on CAR T-cell Therapy in Multiple Myeloma

What's New Doc? End-of-the-Year Updates on CAR T-cell Therapy in Multiple Myeloma

CAR T-

Navigate the complexities of cell and gene therapies with regulatory and CMC expertise

Navigate the complexities of cell and gene therapies with regulatory and CMC expertise

Learn why regulatory and chemistry, manufacturing and controls (

FDA CMC Guidance, AI, and Analytics for Advanced Therapies | BPI Boston 2025

FDA CMC Guidance, AI, and Analytics for Advanced Therapies | BPI Boston 2025

In this BioProcess Buzz episode from BioProcess International Week in Boston, Alvin sits down with Rene from LumaCyte.

FDA-NIH 2024 | D1S11 - Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support....

FDA-NIH 2024 | D1S11 - Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support....

This presentation provided

Cellular Therapies: Present Challenges and Future Directions

Cellular Therapies: Present Challenges and Future Directions

September 26, 2025 | Yale's Review of Advances in Oncology from the 2025 ASCO Annual Meeting Presenters: Michael Hurwitz, ...