ISSCR News
The ISSCR Forms Embryo Models Working Group
Since the ISSCR released its May 2021 update to the Guidelines for Stem Cell Research and Clinical Translation, research with stem cell-based embryo models has evolved rapidly. During the extensive conversations leading up to the 2021 guidelines update, many of the embryo models that are being used today did not exist. The speed of embryo model research has resulted in new challenges for oversight committees, policymakers, funders, and journal editors grappling with how to assess the unique aspects of the science and the associated ethical and regulatory issues.
ISSCR Holds First Academia Briefing Meeting with the European Medicines Agency
On 10 April 2024, the ISSCR held its first Academia Briefing Meeting with the European Medicines Agency (EMA). The meeting was organized by ISSCR’s Manufacturing, Clinical Translation, and Regulatory (MCTR) Committee and included invitees to present to the agency on two topics: recommendations for the manufacturing of PSC banks as starting materials for allogeneic PSC-based therapies and genetic characterization of human PSCs. Following the meeting, both parties confirmed the importance of regular meetings to ensure a bi-directional sharing of knowledge to advance the development of cellular therapies.
ISSCR Members Hold First Scientific Advice Meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency
The International Society for Stem Cell Research (ISSCR) held its first Broader Scope Scientific Advice meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on May 15, 2023. ISSCR’s regulatory advocacy aims to give its members a voice to help educate policymakers about scientific findings and considerations that will help regulators make scientifically informed policy decisions and facilitate the development of advanced stem cell-based therapies and applications.
The ISSCR Advocates for Stem Cell Research on Capitol Hill
On a beautiful spring day in Washington, D.C., leaders from the ISSCR walked the halls of the U.S. Congress to inform legislators and their health policy staff about the progress and potential of stem cell research during the annual ISSCR Congressional Advocacy Day.
The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products
On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products. ISSCR appreciates FDA’s commitment to assuring the potency of human CGT products at all stages of the product lifecycle. This guidance from the FDA will help our members, who are at the forefront of research and innovation, in their work.
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