Event
American Society of Gene & Cell Therapy 2025
May 13 - May 17, 2025
New Orleans, Louisiana
The American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting is the premier event for gene and cell therapy professionals. The meeting is the best place for people in the field to learn from the latest scientific research, stay current on new technologies, and make career-advancing connections with peers.
Originally designed as a venue for academic researchers to share their work, the Annual Meeting has grown to serve a wide community encompassing clinicians, bio-industry developers, regulatory agencies, equipment manufacturers, patient advocates, and more. And Parexel will be there!
Parexel has had several posters accepted, and we’re excited to share some details with you. The abstract poster sessions will be held on Tuesday, Wednesday, and Thursday of the event, so be sure to check back soon for the specific timing!
Kausik Maiti
Executive Director, Safety Medical Sciences
Tuesday, May 13 from 6 – 7:30p.m.
Title – Does the Occurrence of ICANS After CAR-T Therapy Increase the Risk of Late Neurological Complications: A Real-World Data Analysis
Poster Hall 12
Chris Learn, Ph.D., P.M.P.
Franchise Head, Cell and Gene Therapy and Early Phase
Tuesday, May 13 from 2–2:30p.m. in room 383-385
30-minute symposia
Title – When Safety Becomes a Value Proposition for CAR-T Trials
The benefit-risk of Chimeric Antigen Receptor T-cell (CAR-T) therapy has been called into question given safety concerns, notably the observation of secondary T-cell malignancies in patients who received FDA-approved autologous CAR-T products. This panel discussion will delve into the critical intersection of safety, regulatory challenges, and the evolving value proposition of CAR-T trials, with a focus on leveraging Real-World Evidence (RWE) to address these pressing issues.
Steve Winitsky, M.D.
Vice President, Technical - Regulatory Strategy
Tuesday, May 13 from 2–2:30p.m. in room 383-385
30-minute symposia
Title – When Safety Becomes a Value Proposition for CAR-T Trials
The benefit-risk of Chimeric Antigen Receptor T-cell (CAR-T) therapy has been called into question given safety concerns, notably the observation of secondary T-cell malignancies in patients who received FDA-approved autologous CAR-T products. This panel discussion will delve into the critical intersection of safety, regulatory challenges, and the evolving value proposition of CAR-T trials, with a focus on leveraging Real-World Evidence (RWE) to address these pressing issues.
Thursday, May 15 from 5:30p.m. – 7p.m.
Title – Deconstructing FDA’s Expedited Program Determinations: Analyzing how the Agency may Set the Bar for RMAT Designation
Poster Hall 12
Nancy Lunney, MA, LPA
HSP Project Director and Program Leader, Cell and Gene Therapy Center of Excellence
Tuesday, May 13 from 2–2:30p.m. in room 383-385
30-minute symposia
Title – When Safety Becomes a Value Proposition for CAR-T Trials
The benefit-risk of Chimeric Antigen Receptor T-cell (CAR-T) therapy has been called into question given safety concerns, notably the observation of secondary T-cell malignancies in patients who received FDA-approved autologous CAR-T products. This panel discussion will delve into the critical intersection of safety, regulatory challenges, and the evolving value proposition of CAR-T trials, with a focus on leveraging Real-World Evidence (RWE) to address these pressing issues.
Tuesday, May 13 from 6 – 7:30p.m.
Title – ICANS and CRS Following Lymphodepletion in CAR-T Therapy: A Real-World Data Analysis
Poster Hall 12
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