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
Examples of stem cells in preclinical and clinical development
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 DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.
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.