Stem cell based clinical research is an exciting new frontier holding promise for patients with medical needs that traditional pharmaceuticals cannot address. Clinical research professionals conducting trials in this area can expect to face new and more complex regulatory and operational challenges. This program will review advances in stem cell science and present related ethical considerations. A general overview of the unique and evolving regulatory landscape around stem cell based therapies will also be presented. Finally, this program will explore the specific ways that stem cell based therapies challenge every stage of a clinical trial, from participant recruitment and informed consent to dosing and long-term follow-up.
Upon completion of this Webinar, attendees should be able to*:
1. Understand the fundamentals of stem cell science and its evolution as a field of study
2. Describe the ethical considerations and unique regulatory landscape of stem call based therapies
3. Identify operational challenges of conducting stem cell clinical trials as they pertain to current and future applications
Speaker Betty Cabrera has worked in academia for over 15 years and her career spans basic, preclinical and clinical research. She has solid theoretical knowledge of scientific investigations given her education in biochemistry (UCSD) and graduate degree in public health (SDSU). As practical experience goes, she was actively engaged in colon cancer research in the laboratory she managed and worked as clinical trial coordinator for rare-disease studies before joining the UC San Diego CIRM Alpha Stem Cell Clinic. She also played a key role in a community-university partnership to develop, maintain and promote an international patient registry for the rare, metabolic disorder cystinosis. Until recently, she was a Project Manager for IND-preparatory cystinosis safety and toxicology studies involving gene modified hematopoietic stem cells. Her career transition from laboratory research to investigational, clinical interventions have allowed to her to develop a keen understanding and appreciation of bench-to-bedside initiatives and regulatory compliance (GLP, GCP, GMP, etc.) that she applies to accelerating stem cell clinical trials at UC San Diego.