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The ISSCR Responds to FDA’s Draft Guidance on Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
On 1 September, the ISSCR submitted comments to the Food and Drug Administration’s draft guidance for Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.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.
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.
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