ASGCT News

ASGCT to Host 2025 Policy Summit on Sept. 25-26 in Washington, D.C.

September 02, 2025

Cell and gene therapies are transforming healthcare, but their full potential depends on a supportive policy landscape. Join policymakers, industry leaders, and science stakeholders to explore new regulatory policy developments, payment systems, and key therapeutic bottlenecks.

Policy & Advocacy

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FDA Approves First Gene Therapy for Recurrent Respiratory Papillomatosis

Terry Flotte, MD | August 21, 2025

This new therapy not only transforms the treatment landscape for RRP but also demonstrates the continued evolution of CGTs in addressing rare diseases. 

Cell & Gene Therapy Approval

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Patients Are the Center with Kimberly Haugstad, MBA

Listen + subscribe on the ASGCT Podcast Network! | August 19, 2025

"Rare disease can be really isolating at times, but there is so much hope right now just in us working together as a combined community."

Annual Meeting 2025  |  Podcasts

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ASGCT Supports Further Alignment of Regulations with Scientific Advancement in CGT

Andrew Liermann and Alexis Starosta | August 15, 2025

The American Society of Gene & Cell Therapy (ASGCT) recently submitted two comment letters to federal agencies on regulatory issues affecting cell and gene therapy (CGT) development and approval. The submissions address how regulatory frameworks can better accommodate the unique characteristics of CGTs while maintaining safety standards.

Policy & Advocacy

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25 Years of Molecular Therapy with Drs. Rayne Rouce and Joseph Glorioso

Listen + subscribe wherever you get your podcasts! | August 08, 2025

Listen to this episode of the Molecular Therapy Podcast on the ASGCT Podcast Network!

Molecular Therapy  |  Podcasts

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Access to a Cure: Ensuring Equitable Access to Cell and Gene Therapies for Children with Sickle Cell Disease

ASGCT Partners with Children’s Hospital Association on Sickle Cell Disease Access

Christina Mayer | August 04, 2025

Achieving equitable access to gene therapies requires coordinated action across clinical care delivery, healthcare administration, and payment policy. By tackling the issues raised at the briefing, we can help ensure the next generation of SCD therapies reach patients, wherever they are.

Policy & Advocacy

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Building a Vision with Dr. Mimi Lee

Listen + subscribe on the ASGCT Podcast Network! | August 04, 2025

Listen to Dr. Mimi Lee talk about her vision to prevent and treat diseases for every unique individual at the genetic level.

Annual Meeting 2025  |  Podcasts

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Read the ASGCT-Citeline 2025 Q2 Landscape Analysis Field Report

Read + download the report | August 01, 2025

In Q2, three new therapeutics were approved and the number of gene therapy programs continued to climb.

Publications

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Behind the Breakthroughs: What Every Caregiver Should Know About Clinical Trial Design

Ali Kujawski, MPH, Senior Patient Outreach Manager | July 23, 2025

For families facing rare diseases, clinical trials often represent more than just a research protocol—they represent hope. But what actually goes into designing those trials?

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A Vaccine for Cocaine Addiction with Dr. Stephen Kaminsky

Listen + subscribe | July 22, 2025

During the 2025 Annual Meeting, Dr. Kaminsky presented results from a phase 1 clinical trial describing a vaccine for cocaine addiction.

Annual Meeting 2025  |  Podcasts

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Gene and Cell Therapy in Africa: Reflections on My ASGCT Journey

Irene Honam Tsey, PhD | July 16, 2025

Irene Honam Tsey, a research fellow at the University of Health and Allied Sciences (UHAS) in Ghana, attended the 2025 ASGCT Annual Meeting in New Orleans in May.

Annual Meeting 2025

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25 Years of Molecular Therapy with Drs. Beverly Davidson and Jeff Chamberlain

Listen + subscribe to the ASGCT Podcast Network | July 16, 2025

Listen to this episode of the Molecular Therapy Podcast on the ASGCT Podcast Network!

Podcasts

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Takeaways from the 7th Annual FDA Liaison Meeting

Andrew Liermann | July 15, 2025

The meeting featured two ASGCT-led presentations addressing challenges and opportunities in regulatory policy for CGT development.

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Developing Therapeutic Platforms with Dr. P.J. Brooks

Listen + subscribe to the ASGCT Podcast Network | July 09, 2025

"I think what we're really seeing as a therapeutic platform emerging is particularly genome editing with the idea that...we're looking at an editor and a delivery system and applying that to more than one disease."

Annual Meeting 2025  |  Podcasts

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Navigating Funding and Development Challenges for Transformative Therapies

Caitlin McCombs, MBA | July 09, 2025

CGT development stands at a critical juncture as the field addresses unique challenges distinct from traditional pharmaceutical development pathways.

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Lessons from the Frontlines of CGT Trials

Lexi Starosta | July 08, 2025

“The assumption is that we’ll do anything to save our child...But we also know how to say no when the risk doesn’t match the reward.”

Outreach

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