For anyone wanting to know more about how the research scientists move their work forward, here are some new video presentations that give insight into the depth of the challenges and how they streamline their work before going to the FDA with their therapy.
Stem Cell Clinical Trials: Staying on the Critical Path Workshop | Intro by Ellen Feigal, CIRM
The mission of California’s Stem Cell Agency (CIRM) is to advance stem cell based science toward clinical trials to create opportunities to bring new effective and curative therapies to patients. At the March 6-8, 2013 CIRM Grantee Meeting, Senior VP of R&D Ellen Feigal held a workshop for CIRM grantees to help them increase their understanding of the pathway to develop a stem cell based product for patients. In her presentation, Feigal sets the context for the workshop and describes the CIRM research portfolio and lessons learned about product development.
Stem Cell Clinical Trials: Manufacturing and Regulatory Issues | Keith Wells
Developing an idea for a therapy from the lab bench all the way through approval by the Food and Drug Administration is an extremely challenging and complex process. Keith Wells, Senior Consultant for Biologics Consulting Group, spoke to CIRM-funded stem cell scientists to help them anticipate the manufacturing and regulatory issues that can crop up while developing a stem cell based product for patients.
Stem Cell Clinical Trials: Designing Preclinical Studies for First in Human Trials | Joy Cavagnaro
Before bringing a therapy to trials in patients, it must first be tested for safety and effectiveness in animals. Performing these pre-clinical studies for stem cell-based products present added challenges since many represent novel therapeutic approaches that have never been tried in humans. At the March 6th CIRM-hosted Staying on the Critical Path Workshop, Joy Cavagnaro, president of Access BIO, provides CIRM-funded scientists advice about optimizing these studies.
Stem Cell Clinical Trials: Staying on the Critical Path, Q&A Session | Keith Wells & Joy Cavagnaro
Joy Cavagnaro and Keith Wells led the question and answer session for the CIRM-hosted Staying of the Critical Path Workshop which addressed the preclinical, manufacturing and regulatory issues for developing stem cell based therapy products for patients.
Joy Cavagnaro is president of Access BIO; Keith Wells is senior consultant for Biologics Consulting Group.