The Drug Information Association, in cooperation with the American Society of Gene & Cell Therapy (ASGCT), will host Clinical Development of Stem Cell
Therapies: Scientific, Regulatory, and Ethical Considerations from April 12-13 in North Bethesda, MD.
Representatives from academia, industry, and regulatory agencies will come together to analyze the transitional process from discovery and regulatory approval to the therapeutic use of stem cell products. Topics will include:
• Case studies related to the preclinical, CMC, and clinical stages of development for stem cell products
• FDA and European Medicines Agency experience with stem cell clinical development
• NIH guidelines
• Examples of stem cells in preclinical and clinical development
• Immunosuppression strategies
• Analysis of CMC issues around reagents, devices, and potency
“Experts will present specific examples of, and solutions for, issues related to the preclinical, CMC, and clinical stages of development for stem cell products,” says Program Co-chair Joy Cavagnaro, PhD, DABT, RAC, Fellow ATS, RAPS Fellow, President, Access BIO.
Register for Clinical Development of Stem Cell Therapies.
ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
ABOUT THE AMERICAN SOCIETY OF GENE AND CELL THERAPY
The American Society of Gene & Cell Therapy (ASGCT) is a professional nonprofit medical and scientific organization dedicated to the understanding, development and application of genetic and cellular therapies and the promotion of professional and public education in the field. ASGCT includes researchers, clinicians, and other professionals from around the world dedicated to discovering and developing new genetic and cellular therapies.
Contact: Joe Krasowski