ISSCR News
ISSCR Joins Coalition Effort to Support Advocacy for NIH Funding
The ISSCR is proud to join a broad coalition of scientific societies in affirming the essential role of the National Institutes of Health in advancing biomedical discovery and sustaining a robust research enterprise. As part of this effort, ISSCR members in the targeted states of Kansas, North Carolina, Pennsylvania, and Utah have been invited to share stories that illustrate the vital importance of research investment. Additional opportunities for members in all states will be available in September. This campaign is led by our alliance partner, Research!America.
The ISSCR Calls for Science Serving the Public Good to be of the Highest Quality and Integrity
“The ISSCR joined more than 90 scientific, academic, and professional organizations to emphasize that science serving the public good should be of the highest quality, integrity, and utility. In a letter sent to White House Office of Science and Technology Policy Director Michael Kratsios, signatories urged policymakers to recognize that any efforts to strengthen scientific integrity, including those outlined in the recent Executive Order “Restoring Gold Standard Science”, must build upon, rather than undermine, the existing foundational pillars of gold standard science that have driven decades of scientific and technological progress. These principles, including empirical rigor, objectivity, peer review, and reproducibility have been central to the advancement of stem cell science and the development of cell-based therapies.
The ISSCR Responds to ICH’s Q1 Guideline on Stability Testing of Drug Substances and Drug Products
On 28 July, the ISSCR submitted a response to the International Council for Harmonisation’s (ICH) guideline on stability testing of drug substances and drug products. The ISSCR recommends adding specific examples to clarify appropriate applications of certain studies and incorporating considerations for diverse manufacturing models, particularly decentralized manufacturing, where products are administered immediately after production. The ISSCR also advises including guidance on pluripotent stem cell bank stability testing, referencing Tissue Engineered Products (TEP), and clarifying whether ATMP combined products are covered under the term “combination of a drug product with a medical device.”
To request the comments or learn more, contact Denise de Villa.
The ISSCR Responds to EMA’s Concept Paper on the Revision of Part IV Guidelines on GMP Specific to ATMPs
On 8 July 2025, the ISSCR submitted comments on the European Medicines Agency's concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. ISSCR supports the proposal to update t Part IV of the Guidelines to address inconsistencies, clarify ambiguities, and to include guidance on the use of new manufacturing technologies.
The ISSCR recommends incorporating these updates into the main body of EudraLex Volume 4, rather than maintaining them as a separate document. This approach would offer more consistent and clear guidance to ATMP developers.
To request the comments or learn more, contact Denise de Villa.
The ISSCR Signals Concerns About Dangerous and Devastating Cuts to HHS in President Trump’s Draft FY 2026 Budget
The ISSCR joined with more than 500 health and research coalitions and organizations to express concern regarding the Administration’s draft (now proposed) Fiscal Year 2026 budget for the U.S. Department of Health and Human Services (HHS) that proposes a nearly 40% cut to the National Institutes of Health.
In a letter sent to the Chairs and Ranking Members of the Senate and House Appropriations Subcommittees for Labor, Health and Human Services, and Related Agencies, signatories stressed that the proposed FY 2026 budget would cut about one-third of the agency’s discretionary spending and effectively devastate the nation’s research, scientific, and public health infrastructure. Characterized as dangerous and devastating, the budget proposal would put the nation’s health and security at risk.
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