Advocacy

Advocacy Reflects on Accomplishments and Looks Ahead to Future Efforts

ASGCT Staff | January 20, 2020

Learn about ASGCT's advocacy accomplishments in 2019 and our priorities for 2020.

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ASGCT Holds Second Annual FDA Liaison Meeting

ASGCT Staff | December 11, 2019

ASGCT members presented on three topics to staff of the Office of Tissues and Advanced Therapies (OTAT), providing ASGCT recommendations to the Agency on regulatory topics of mutual interest in the field. Below, Wilson Bryan, MD, director of the FDA OTAT, acknowledges his staff during the discussion about common gene therapy IND deficiences and recommendations for improvement.

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(From left) Michael C. Burgess, MD (R-TX) (with Matthew Porteus, M.D., Ph.D., and Jennelle Stephenson), and Danny K. Davis (D-IL), gave remarks emphasizing the importance of supporting sickle cell disease research.

ASGCT Co-Hosts Second Congressional Briefing on Sickle Cell Disease

ASGCT Staff | November 26, 2019

ASGCT co-hosted a briefing on Capitol Hill to hightlight how policymakers can support sickle cell disease (SCD) screening as well as treatment development and access.

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ASGCT Policy Summit Highlights Patient and Advocate Perspectives

ASGCT Staff | October 14, 2019

ASGCT will have patient, caregiver, and advocate speakers participating in all three days of our upcoming Policy Summit, held at The Westin in Washington, D.C. November 4-6.

Advocacy   |   Policy Summit
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Rhoda Baer acquired from National Cancer Institute

Bridging the Gap Between Scientists And Patients In Gene Therapy Development

David Barrett, J.D. | September 27, 2019

Patients with rare diseases must rely collectively on scientists, physicians, pharmaceutical and biotechnology companies, and rare disease advocates to learn about these disorders, says ASGCT Executive Director David Barrett.

Advocacy   |   Education
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Credit: U.S. Mission Photo by Eric Bridiers, Flickr.com

ASGCT Submits Comments to WHO Advisory Committee

ASGCT Staff | August 22, 2019

ASGCT submitted comments on August 16 to the World Health Organization’s (WHO) Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing regarding guidance to governments, institutions, and researchers on scientific, ethical, social, and legal challenges related to both germline and somatic cell human genome editing.

Advocacy   |   Policy Updates
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ASGCT, NORD Partner for Free Educational Gene Therapy Webinars

ASGCT Staff | August 19, 2019

Have you heard about gene therapy? Do you want to learn about the history of gene therapy, which gene therapies are currently available and what the future may hold? ASGCT and NORD partner to host the first of five educational gene therapy webinars, "Gene Therapy: Yesterday, Today and Tomorrow," on August 29 at noon EST.

Advocacy   |   Education
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Credit: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health

CAR T-Cell Therapy Covered by Medicare, but Still Inadequately Reimbursed

ASGCT Staff | August 14, 2019

An announcement that the Centers for Medicare & Medicaid Services will cover CAR T-cell therapy is welcome news, but ASGCT remains concerned about reimbursement levels for CAR T-cell therapies for Medicare beneficiaries provided in the inpatient setting.

Advocacy   |   CAR T-cell Therapy   |   Medicare   |   Payment Policy
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What is the ASGCT Policy Summit?

Guangping Gao, Ph.D. | July 19, 2019

Registration is now open for the ASGCT Policy Summit as ASGCT heads back to Washington D.C. November 4 – 6. But what is it? All that and more from ASGCT President Guangping Gao, Ph.D.

Advocacy   |   President's Message
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ASGCT Heats Up in Summer 2019

Maritza McIntyre, Ph.D. | June 14, 2019

Up-to-date clinical trials info and a new policy-centered event keep up the post-meeting momentum.

Advocacy   |   ASGCT News
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Scientific Leaders Call For Global Moratorium on Germline Gene Editing

April 24, 2019

In a letter sent to U.S. Department of Health and Human Services Secretary Alex Azar today, a broad collective of 62 individual scientists, bioethicists, and biotechnology executives, including past-presidents and current board of directors members from ASGCT, across industry and academia called for collaboration on a binding global moratorium on human clinical germline experimentation.

Advocacy   |   Policy Updates
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ASGCT Advocacy Annual Plan 2019

ASGCT Staff | January 24, 2019

Emboldened by our success last year, ASGCT is doubling down on our advocacy efforts and plans to establish the Society and its membership as a leading voice for policy decisions by increasing our presence in Washington, D.C.

Advocacy   |   Policy Updates
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ASGCT Debuts Patient Education Program

ASGCT Staff | January 18, 2019

Gene Therapy 101 Collection Now Live on ASGCT.org

Advocacy   |   Education
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ASGCT Submits Comment on FDA Gene Therapy Guidance Documents

ASGCT Staff | December 11, 2018

ASGCT submitted comments to the FDA regarding six draft guidance documents on gene therapy development on Dec. 10. ASGCT welcomes the provisional guidance in the development of gene therapies and submitted 71 individual recommendations and requests for clarification for FDA consideration.

Advocacy   |   Policy Updates
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Full Summary of ASGCT's FDA Liaison Meeting

ASGCT Staff | October 25, 2018

The September 13 liaison meeting between the FDA and ASGCT covered manufacturing, safety, and testing requirements for gene therapies, as well as an FDA update on the new RMAT designation. This deep-dive longread includes the recommendations from those discussions.

Advocacy   |   Policy Updates
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ASGCT Submits Comments to CMS on OPPS Proposal

ASGCT Staff | October 09, 2018

ASGCT indicated its support for removal of patient care services from the CAR T-cell therapy Q codes for tisangenlecleucel and axicabtagene ciloleucel to more accurately report, and to obtain more sufficient reimbursement for, administration of these therapies.

Advocacy   |   Policy Updates
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2020

23rd Annual Meeting

May 12-15 | Boston