Cell + Gene Therapy Science Series

An ASGCT collaboration with BIO and FDA


The Cell and Gene Therapy (CGT) Science Series is a quarterly seminar series focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), ASGCT, and Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area.  Topics in the series may include, but are not limited to, nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle. 

Past Events

Recent CMC Guidance for Cellular and Gene Therapies

March 2024

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

Gene-Editing Technologies: Powerful Tools Rewriting the Code of Life

July 14, 2023

The second CGT Science Series seminar was presented by Jing Liao, PhD, Director of Vector Development and Operations at Alexion Pharmaceuticals:

Dr. Liao’s focus is on novel gene therapy and gene editing technologies for patients. She has 15+ years of experience in genome editing using conventional homologous recombination or TALENs, CRISPR/Cas9 technology, with extensive experience with cassettes optimization and capsid engineering to improve AAV manufacturability and enhancing the potency of the AAV vectors. 

Short and Long Read Sequencing for AAV Characterization

March 30, 2023

The inaugural CGT Science Series seminar focused on NGS characterization of AAV and was presented by Dr. Lauriel Earley. 

Dr. Earley is a Senior Scientist with Shape Therapeutics who has been studying the basic biology of adeno-associated virus for over decade. During her graduate studies at Oregon Health & Science University, she examined the role of assembly-activating protein under the mentorship of Dr. Hiroyuki Nakai. After receiving her PhD, she joined Dr. Jude Samulski's laboratory at the University of North Carolina, Chapel Hill and took on a project to characterize the intrinsic promoter ability of the inverted terminal repeat sequences from various AAV serotypes. Dr. Earley joined Shape Therapeutics in 2019 and is currently leading their vector platform development team. In addition, Dr. Earley has been an active member of ASGCT since 2012 and is currently serving on the Patient Outreach Committee.

2025

Class Considerations on Immunogenicity for AAV GT Products

January 22-23, 2025 | Virtual

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