Policy Summit

Policy Summit Speakers Offer Strategies to Deal With the Challenges of Accelerated Approval

ASGCT Staff | October 06, 2021

FDA's accelerated approval program allows for early approval of drugs and biologics that treat serious conditions with a lack of alternate treatments.

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Engage Patients Early to Ensure Successful Therapeutics

Rachel Salzman, DVM | October 05, 2021

Increasing patient input will contribute to developing and delivering transformative medicines to benefit all of society, says Rachel Salzman, DVM.

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Policy Summit Takeaways Include Advice for Action on Access

ASGCT Staff | September 27, 2021

During sessions on Medicare and Medicaid payment policies, speakers on the first day of the Policy Summit provided potential solutions for stakeholders working toward patient access to gene and cell therapies.

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A Call to Arms: Transparency and Inclusion in Gene and Cell Therapy Development

Emily Walsh Martin, PhD | September 24, 2021

It is more important than ever that the field continues transparent data sharing and collaborative solution finding to meet the challenges we will continue to discover in the clinic, says Emily Walsh Martin, PhD.

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Considering Payors on the Path to Patient Access

Emily Walsh Martin, PhD | September 23, 2021

The sessions on the first day of the Policy Summit will provide you with a deeper understanding of the questions, complexities, and solution options at play for patient access to the therapies you are developing.

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Accessing the 2021 Policy Summit

ASGCT Staff | September 21, 2021

Whether you're attending in person or virtually, here's some information that will help you make the most out of the meeting.

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Why I Attend the ASGCT Policy Summit

Emily Walsh Martin, PhD | August 09, 2021

This year's hybrid Policy Summit promises to deliver with key discussions around Medicaid coverage considerations, AAV insertion risk assessment, patient views on therapy opportunities and challenges, and more.

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Policy Summit’s Sickle Cell Disease Session Emphasizes Patient Access

Emily Nettesheim | October 05, 2020

The Policy Summit session on sickle cell disease focused on patient education and the policy reforms necessary to bring curative gene therapy treatments to the millions of patients suffering from SCD around the world.

Policy & Advocacy   |   Policy Summit

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ASGCT Policy Summit: Peter Marks on Bespoke Gene and Cell Therapies

Emily Walsh Martin, Ph.D. | September 28, 2020

At the ASGCT Policy Summit, FDA CBER Director Peter Marks, M.D., Ph.D., spoke about the unique challenges in developing gene and cell therapies for very rare diseases.

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Policy Summit Speakers Discuss Access to Testing and Treatment

ASGCT Staff | September 25, 2020

In the final half day of the Policy Summit, we heard about real world experiences with gene and cell therapies and newborn screening policies.

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Policy Summit Day Two: Trial Design, Regulatory Challenges, and Health Disparities

ASGCT Staff | September 24, 2020

On the second day of the Policy Summit, attendees began the morning with a keynote address from Peter Marks, M.D., Ph.D.

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Policy Summit’s First Day Focuses on Ethical and Regulatory Issues

ASGCT Staff | September 23, 2020

Here's our recap from the first day of the Policy Summit, which began with a keynote address from George Daley, M.D., Ph.D.

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Here's How to Access The Policy Summit

ASGCT Staff | September 23, 2020

Here's how you can access the full content of ASGCT's 2020 Policy Summit.

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Crucial Patient Access Issues Take Center Stage at the Policy Summit

Max G. Bronstein, M.P.P. | September 17, 2020

ASGCT Government Relations Committee member Max Bronstein provides a preview of some of the issues that speakers will discuss at next week's Policy Summit.

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Peter Marks, M.D., Ph.D., Director of FDA CBER, speaking at the 2019 ASGCT Policy Summit in Washington, D.C.

Another Can’t-Miss Policy Summit Session: Trial Design Considerations for Gene Therapy for Rare Diseases

Emily Walsh Martin, Ph.D. | September 11, 2020

Dr. Marks will be speaking about how CBER plans to leverage new regulatory frameworks to help advance therapies in ultra-rare indications towards authorization.

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Your Guide to a Can’t-Miss Policy Summit Session on CMC and Regulatory Considerations

Emily Walsh Martin, Ph.D. | August 21, 2020

Core to the success of any gene or cell therapy development program is a well-thought-out plan for manufacturing which bridges everything from early discovery selection of a candidate construct to your process validation runs to support a commercial application. 

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