A Global Discussion on ISSCR Initiatives
Strategic Initiatives on the Horizon
The ISSCR Launches Consortium to Support Adoption of Stem Cell-Derived Disease Models for Drug Discovery and Development
Advances in human stem cell-derived disease models have the potential to augment our predictive power for the efficacy and safety of new drugs. This technology, which complements existing approaches, is poised to reduce R&D costs and accelerate the development of new therapies for patients.
The International Society for Stem Cell Research (ISSCR) has assembled an international consortium of cross-sector thought leaders from industry, academia, and regulatory science to enable the widespread, responsible adoption.
This ISSCR initiative is aligned with recent announcements and efforts by the Food and Drug Administration (FDA), National Institutes of Health (NIH), and the European Commission. Together, these efforts mark a continuing commitment to enhance patient-centered approaches in biomedical research and drug development and stand to impact the efficiency and speed with which the new therapies are delivered.
Organizations and individuals interested in joining or participating in the consortium may contact isscr@isscr.org.
ISSCR Staff Contact: Chris Barry, Director of Strategic Partnerships | cbarry@isscr.org
Embryo Models Working Group
As research with stem cell-based embryo models advances rapidly, there is a growing need for updated guidance to accommodate scientific progress. To address this need, the ISSCR created the Embryo Models Working Group, tasking it with developing a white paper that summarizes the state of the science, categorizes different types of embryo models, and proposes updates to the 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation. Working group co-chairs Amander Clark and Janet Rossant will present the group's findings and recommendations to the ISSCR Board of Directors, detailing how these updates will be incorporated into a forthcoming revision of the ISSCR Guidelines.
ISSCR Staff Contact: Tyler Lamb, Director of Policy | tlamb@isscr.org
Continuing Education Initiative
The International Society for Stem Cell Research (ISSCR) announces the launch of a new online continuing education course, Stem Cell Medicine: From Scientific Research to Patient Care. The comprehensive course comes at a pivotal moment, addressing the growing demand for evidence-based, expert-led education amid the proliferation of unproven and potentially harmful stem cell interventions that threaten patient safety around the world. The activity, jointly provided by Harvard Medical School and the ISSCR, is open-access, available on demand, and offered at no cost to clinicians, nurses, medical students, scientists, and the public. It is also available in five languages. This initiative is led by the ISSCR Education Committee.
ISSCR Staff Contact: Kendra Prutton, Science Communications and Education Manager l kprutton@isscr.org
Reference Materials
Standards and Best Practices Initiative
Standards for Human Stem Cell Use in Research
The International Society for Stem Cell Research developed a set of recommendations, including reporting criteria, for scientists in basic research laboratories. These criteria are designed to be technically and financially feasible and, when implemented, enhance the reproducibility and rigor of stem cell research. The document was published in June 2023 and efforts are currently ongoing for the adoption and implementation of the Standards including:
Adoption by Journals
The ISSCR is actively working with journals to implement the use of the Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells, The Checklist, for all their relevant publications. An editor from one of the leading journals call this resource a “game changer resource for reporting in stem cell research.”
Stem Cell Reports is concluding its trial run using the checklist and will soon implement it in the formal review process.
Education and Awareness
The ISSCR is collaborating with STEMCELL Technologies to create a series of learning modules that will cover critical aspects of the Standards.
Best Practices for the Translation of Pluripotent Stem Cell-Derived Therapies
The initiative is designed to leverage the ISSCR’s strength in basic stem cell biology and apply it to pluripotent stem cell (PSC)-derived therapeutic approaches. The goal of this phase of the initiative is to assist academics and biotechnology companies by providing a visual, process-based, high-level roadmap for translating PSC-derived therapies regardless of regulatory jurisdictions while providing detailed guidance at key product development pain points.
Currently, subject matter experts within each of seven working groups are actively working on their respective sections which include: starting materials, banking, ancillary materials and devices, regulatory, drug substance and drug product, preclinical, clinical.
ISSCR Staff Contact: Jack Mosher, Scientific Director l jmosher@isscr.org
Reference Materials
Standards for Human Stem Cell Use in Research
Best Practices for the Translation of Pluripotent Stem Cell-Derived Therapies
Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies Webinar (April 2025)
This webinar is available as an ISSCR member benefit in the on-demand library. Learn more about joining ISSCR.
Public Policy & Regulatory Policy
The ISSCR Public Policy Committee supports and defends stem cell research and funding, advocates for scientific integrity and ethical research practices, works to prevent the premature marketing of unproven stem cell-based interventions, and facilitates scientifically informed regulatory decision-making. The committee and staff monitor global issues and ensures the society and its membership have a voice in policy decisions that impact the field. The Lawrence Goldstein Science Policy Fellowship Program contributes to the department’s objectives by training the next generation of aspiring policy advocates to become leaders in the field. In May, members advocated for robust and predictable funding for biomedical research and to stress the need for Congress to exercise its oversight authority of the Food and Drug Administration and the Federal Trade Commission related to any efforts to deregulate stem cell “treatments,” that have not undergone safety or efficacy tests, sold in for-profit clinics preying on the desperation of patients and families.
The ISSCR Manufacturing, Clinical Translation, and Regulatory Committee and staff help members navigate the regulatory landscape and facilitates the development of stem cell-based interventions and other applications (from tissue transplants to drug screening). The Society shares input about scientific findings and considerations to help global regulators make scientifically informed recommendations for the development of stem cell therapies. In November, the Manufacturing, Clinical Translation, and Regulation (MCTR) Committee held a regulatory meeting with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and South Korea’s Ministry of Food and Drug Safety (MFDS) to discuss topics including the manufacture of pluripotent stem cell (PSC) banks as starting materials for allogeneic, PSC-based therapies; the genetic assessment of human pluripotent stem cells; and jurisdictional differences in guidelines for biological ancillary materials. A summary of the meeting is being finalized and will be published on the ISSCR website once approved by both agencies.
The Committee is currently assembling a global list of cell therapy manufacturers for use by ISSCR members working to develop cell therapies. A working group of MCTR Committee members developed a detailed questionnaire for manufacturers to outline their capabilities and are creating a dedicated space on the ISSCR website for members to access this information. A supplemental document will also be created to support members in conducting risk assessments and due diligence when selecting a manufacturer.
ISSCR Staff Contacts: Tyler Lamb, Director of Policy l tlamb@isscr.org, Denise de Villa, Policy Manager l ddevilla@isscr.org, and Andrew Bremer, Policy Manager | abremer@isscr.org
Reference Materials
ISSCR Signals Concerns about HHS Cuts in Trump FY 26 Budget
ISSCR Statement on the Scientific and Therapeutic Value of Human Embryonic Stem Cell Research
The ISSCR Signs on to Coalition Letter in Support of NIH
ISSCR Encourages Japanese Policymakers to Increase Oversight of Regenerative Medicine Interventions
The ISSCR Announces New Lawrence Goldstein Science Policy Fellows
Additional Committee Initiatives
Early Career Advisory Committee
The committee hosted their first webinar on 11 March, Communicating Science: Simplifying the Complex, focusing on science communication skills for early career scientists, from communicating your science at your poster to exploring careers in science communications. Planning is underway for the next webinar on 2 December, Unlocking Your Career Potential: Insider Strategies for Landing a Job in Academia or Industry. The committee organized the annual Career Panel on Friday, 13 June, Communicating, Connecting, and Leading through Your Science Degree, highlighting the multifaceted opportunities available in stem cell science.
ISSCR Staff Contacts: Liza Boscow, Senior Member Experience Coordinator | lboscow@isscr.org and Glori Rosenson, Director of Outreach l grosenson@isscr.org
Ethics Committee
Under the leadership of Erica Jonlin and Insoo Hyun, the Ethics Committee recently published a white paper in Stem Cell Reports addressing what constitutes “adequate and appropriate scientific justification” for research involving human pluripotent stem cells, embryos, and related areas.
The committee is now focused on enhancing ethics-related content across ISSCR websites. Going forward, the committee will address gaps identified through its thorough review of ethics-related content by developing new or supplemental materials as needed.
ISSCR Staff Contacts: Tyler Lamb, Director of Policy l tlamb@isscr.org and Denise de Villa, Policy Manager | ddevilla@isscr.org
Membership and International Outreach Committee
The committee focuses on strategies for enhancing the membership’s sense of community, promoting awareness of the many benefits of membership, and expanding membership in underrepresented areas to increase diversity and global engagement worldwide. With the goal of growing membership across the international community, the committee works with ISSCR staff to seek volunteers to translate all guidelines, patient guide, standards, and reference materials into various languages. Additionally, the committee works with ISSCR staff to ensure that the ISSCR Travel Awards that support attendance for students and post docs to attend the ISSCR Annual Meeting, encompasses a well-rounded group of awardees that reflects the scientific excellence, gender equity, and global diversity of the community.
ISSCR Staff Contacts: Liza Boscow, Senior Member Experience Coordinator | lboscow@isscr.org, Megan Koch, Senior Marketing Manager l mkoch@isscr.org, Glori Rosenson, Director of Outreach l grosenson@isscr.org
Scientific Programs Committee
The Scientific Programs Committee has been recently focused on the restructuring and revising the composition of the Stem Cell Reports Editorial Board. Over the course of the past year, they have selected the next cohort of Early Career Editorial Board (ECEB) members. First launched in 2022, the ECEB is an opportunity to mentor new group leaders in the review process, journal operations, and as a vital contributor to journal activities. The Committee has also established an Honorary Editorial Board for those who have served as advisors to the journal for 10 years or more.
Resources: Stem Cell Reports
ISSCR Staff Contact: Jack Mosher, Scientific Director l jmosher@isscr.org
Reference Materials: