Policy Summit

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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Register Now for the 2020 Policy Summit!

ASGCT Staff | August 12, 2020

Your registration for the virtual event covers the full 2.5 days of programming Sept. 23-25.

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Sen. Tim Scott Will Give a Keynote Address at the Policy Summit

ASGCT Staff | July 30, 2020

Scott's keynote address will kick off the last day of the Policy Summit on Sept. 25.

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The 2020 Policy Summit is Going Virtual

ASGCT Staff | July 02, 2020

From the comfort and safety of your home, you can virtually participate in discussions on regulatory, government relations, market access, and ethical issues related to gene and cell therapy.

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Policy Summit Slides Are Now Available

ASGCT Staff | December 18, 2019

We're excited to offer presentation slides to all of our members from the 2019 ASGCT Policy Summit last month in Washington, D.C.

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States Innovating on Gene Therapy Medicaid Reimbursement

ASGCT Staff | November 12, 2019

During the November 5 program at the ASGCT Policy Summit in Washington, D.C., state Medicaid experts shared their perspectives on developing coverage for these innovative new treatments.

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Government Innovation is Key to Creating Regulatory Convergence

ASGCT Staff | November 11, 2019

During the Policy Summit’s Nov. 4 session, Developments in Gene Therapy Policy Landscape, speakers emphasized the importance of balancing predictability with flexibility as they discussed ways to align regulatory frameworks for gene and cell therapies.

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NIH’s Collins Calls for Germline Gene Editing Moratorium at Policy Summit

ASGCT Staff | November 06, 2019

NIH Director Francis Collins, M.D., Ph.D. called for a worldwide moratorium on clinical uses of human germline gene editing, while defending ongoing and future applications of therapeutic somatic gene editing, on the third day of the ASGCT Policy Summit on November 6. 

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