ISSCR News
The ISSCR Comments on Draft Guidance from FDA - Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
The ISSCR shared comments on draft guidance from the FDA's Center for Biologics Evaluation and Research (CBER) (Docket No. FDA2021-D-1146) Real-World Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products.
The ISSCR Launches Standards Initiative for Pluripotent Stem Cell Research
Universally accepted characterization standards for stem cell research are needed to improve the rigor and reproducibility of stem cell research. Standards set researchers up for success, ensure rigor in preclinical research, and ultimately strengthen the pipeline of therapies for patients. As the foremost international stem cell research society with a reputation for scientific and ethical rigor, the ISSCR is uniquely positioned to develop and propose research standards that can be widely adopted worldwide.
Member Spotlight: Pulin Li, PhD
“The most rewarding aspect of my work is the opportunity to interact with brilliant scientists from diverse fields. This includes collaboration with synthetic biologists, developmental biologists, mechanical engineers, and applied mathematicians”.
Advocating for Regulations that Facilitate Safe and Efficacious Therapies
Last December, nearly 40 professionals with the U.S. Food and Drug Administration (FDA) gathered with ISSCR leaders to discuss advances in the development of stem cell therapies. The attendance of FDA leaders – Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), Celia Witten, Deputy Director, CBER, and Wilson Bryan, Director, Office of Tissues and Advanced Therapies (OTAT) – signals how important it is for the agency to discuss scientifically informed recommendations from the ISSCR as new stem cell-based therapies advance.
Lorenz Studer Receives the 2022 ISSCR Achievement Award
Skokie, IL—The International Society for Stem Cell Research (ISSCR) will award its 2022 Achievement Award to Lorenz Studer, M.D., Memorial Sloan Kettering Cancer Center (MSK), USA. The prize recognizes the transformative body of work of an investigator that has had a major impact on the field of stem cell research or regenerative medicine. Dr. Studer will be recognized and will present his research on 17 June during Plenary V: Disentangling Single Cell Contributions to Organogenesis and Pathology beginning at 5:15 p.m. Pacific Time during ISSCR 2022 San Francisco + Virtual, the world’s leading meeting of global innovators in stem cell science and regenerative medicine.
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