Policy & Advocacy

Maria Santaella, PhD (c), MSN, RN-BC, CPHON serves as the Vice President of Research for the National Bleeding Disorders Foundation. During the workshop she spoke on clinical trial enrollment by sharing strategies to address barriers in recruiting.

Inclusive Trial Design Amplifies Patient Voices and Drives Meaningful Outcomes

Samuel Hughes, MBA, St. Jude Children's Research Hospital | June 18, 2024

Overcoming recruitment, endpoint, and resource challenges in rare disease trials was the focus of the workshop organized by the Patient Outreach Committee at the ASGCT 27th Annual Meeting.

Annual Meeting 2024  |  Outreach  |  Patient Perspectives  |  Policy & Advocacy
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Patient Advocates Connect at the Annual Meeting

Ali Kujawski, Senior Patient Outreach Manager | June 12, 2024

Patient advocates connected, learned from researchers, and shared experiences at ASGCT's 2nd Annual Patient Advocate Connection Luncheon, hosted at the ASGCT Annual Meeting, highlighting the Society's commitment to engaging the patient community.

Annual Meeting 2024  |  Policy & Advocacy
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FDA's Dr. Nicole Verdun and Julie Tierney to Speak at ASGCT's 2024 Policy Summit

Register today to hear from these influential FDA officials Sept. 23-24. | May 29, 2024

Register today to hear from these influential FDA officials Sept. 23-24.

Policy & Advocacy  |  Policy Summit
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ASGCT Urges Congress to Address Gene Therapy Access Hurdles

Margarita Valdez Martínez | May 24, 2024

ASGCT advocates for policies to ensure patient access to transformative cell and gene therapies, which can face coverage barriers in employer-sponsored insurance plans. Key issues include transparency around coverage decisions and flexibility to explore innovative payment models.

Policy & Advocacy
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FDA Hosts Third Installment of CGT Science Series on CMC Guidance

Watch now! | April 11, 2024

Watch this virtual event, as well as past installments of this series, on our YouTube channel.

Policy & Advocacy
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Society Responds to FDA’s Potency Assurance for Cellular and Gene Therapy Products

Margarita L. Valdez Martínez  | April 11, 2024

Potency assays are a key part of product development. ASGCT believes that addressing the overarching concerns with FDA’s outlined potency assurance strategy through these comments will enhance the value of the final guidance document to assist CGT product developers as they address product potency. 

Policy & Advocacy
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ASGCT Responds to FDA’s Advanced Manufacturing Technologies Designation Program Draft Guidance

Margarita L. Valdez Martínez | March 11, 2024

Given the Society's mission, ASGCT expressed concerns about the limited scope of the proposed program and its ability to be a catalyst for innovation in CGT manufacturing. 

Policy & Advocacy
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ASGCT Members Share Regulatory Recommendations During FDA Liaison Meeting

Christina Mayer, MPA | March 07, 2024

View presentations and read a recap of the sixth annual FDA liaison meeting last month with CBER's Office of Therapeutic Products.

ASGCT-FDA Liaison Meeting   |  Policy & Advocacy
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Dr. Terence Flotte Calls for CGT Investment and Collaboration During Congressional Testimony

Read Dr. Flotte's testimony + watch the hearing | February 29, 2024

Read Dr. Flotte's full testimony and watch a recording of the hearing.

ASGCT News  |  Policy & Advocacy
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Final FDA Guidances on Gene Editing + CAR T-Cell Products Include Society Recommendations

Christina Mayer, MPA | February 28, 2024

ASGCT is happy to see FDA incorporate our recommendations into two guidances released last month.

Policy & Advocacy
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Biden-Harris Administration Announces New CGT Payment Model

Margarita Valdez Martínez | February 01, 2024

On Tuesday, January 30, the Biden-Harris Administration announced the cell and gene therapy (CGT) access model. This model will enable the Centers for Medicare and Medicaid Services (CMS) to negotiate outcomes-based agreements with manufacturers. The CGT model is expected to launch in January 2025, and enrollment for states and select territories will be on a rolling basis. This multi-year model will be voluntary for both states and manufacturers. 

Policy & Advocacy
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Looking Back at 2023's Policy and Advocacy Highlights

Margarita Valdez Martínez | January 18, 2024

Learn about last year's successes and highlights from ASGCT's Policy and Advocacy team.

Policy & Advocacy
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Apply for the Congressional Policy Fellowship to Share Your CGT Expertise with Policymakers

Apply through Jan. 15, 2024 | November 07, 2023

We'll place you in a congressional office where you'll share your CGT knowledge with legislators in Washington, D.C. Apply through Jan. 15, 2024!

Policy & Advocacy
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Medicaid Paper Offers Policy Solutions for Equitable CGT Access 

Rayne Rouce, MD | June 23, 2023

A group of experts published a review that sheds light on the challenges of equitable patient access within the Medicaid system.

Policy & Advocacy
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The Federal Budget Process and Its Impact on Your Research Program

Christina Mayer, MPA | April 04, 2023

ASGCT is a strong supporter of robust funding to federal regulatory and research agencies. Find out how the Congressional budget process has a direct impact on the gene and cell therapy field.

Policy & Advocacy
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Learn How ASGCT Impacted FDA Guidance for CGT

Chiagbanwe (ChiChi) Enwere, MPH | March 14, 2023

FDA acknowledged Society comments in recent guidance documents.

Policy & Advocacy
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2024

Register for the ASGCT Policy Summit

September 23-24, 2024 | Washington, D.C.

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