ISSCR News
The ISSCR Introduces CDMO Directory, a Screening Tool to Support Researchers Advancing Toward Clinical Translation
The International Society for Stem Cell Research (ISSCR) is developing a new CDMO Directory, a web-based resource designed to help Society members identify contract development and manufacturing organizations (CDMOs) with capabilities relevant to their research and clinical translation needs.
Led by the ISSCR Manufacturing, Clinical Translation, and Regulatory (MCTR) Committee, the directory is intended to help bridge the gap between researchers and manufacturers by consolidating key information about participating CDMOs in one centralized resource. The directory will be available to the ISSCR’s nearly 5,000 members across the world staring on 19 October.
CDMOs may participate in the directory by completing a questionnaire developed to capture information researchers consider important when selecting a manufacturing partner. Responses are used to populate each organization’s profile. Through the CDMO Directory, the ISSCR is providing researchers moving toward clinical translation with a practical resource for exploring manufacturing capabilities and beginning conversations with potential partners.
The ISSCR Responds to FDA’s Draft Guidance on Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
On 1 September, the ISSCR submitted comments to the Food and Drug Administration’s draft guidance for Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing. ISSCR supports FDA’s desire to share the Agency’s current thinking on the type of prior knowledge (i.e., public and platform knowledge) that may be scientifically appropriate to leverage to advance product development.
ISSCR Submits Comments Opposing Proposed U.S. Regulations that would Harm Merit-Based Science and International Collaborations
The ISSCR submitted comments on proposed regulations from the U.S. Office of Management and Budget (OMB) that would reshape how the U.S. federal government funds scientific research. Among other changes, the proposed regulations would de-emphasize merit-based review of scientific grant applications and instead establish a political review process, enable mid-stream grant cancellations without cause, and place restrictions or significant bureaucratic burdens on international research collaborations. As outlined in the comment letter, these proposed changes would have harmful impacts to the progress of stem cell research and its translation to the clinic. Given this, the ISSCR respectfully urged OMB to withdraw the proposed regulations.
Take Action to Preserve Merit-Based Science and International Collaborations
The White House Office of Management and Budget (OMB) has proposed a new rule titled “Regulation for Federal Financial Assistance” that will significantly reshape how the U.S. government funds and manages scientific research, including international collaborations, through the National Institutes of Health (NIH) and other agencies. All ISSCR members, regardless of whether you are U.S.-based or not, are eligible to provide comment on the proposed policy.
Though the rule is extensive and applies to all federal grantmaking, there are several areas where input from our community is critical.
The ISSCR Joins Coalition Letter in Support of the National Institutes of Health (NIH)
The ISSCR joined more than 110 organizations in the cell and gene therapy sector to urge congressional appropriators to provide at least $51.303 billion for the National Institutes of Health (NIH) for fiscal year 2027. This funding level would represent a robust investment in important biomedical research and a meaningful increase over enacted fiscal year 2026 levels. NIH funding remains foundational to the continued advancement of stem cell research. Strong support for NIH will ensure the continued translation of stem cell research into the clinic and to the lives of patients. In addition to the funding request, the letter urges the timely distribution of NIH funding to ensure biomedical research can continue without disruption.
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