Video Event: Critical Path Workshop: March 2013
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 […]
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 […]
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 […]
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. […]
Stem Cell Clinical Trials: Opportunities for California Research Teams in the UK
Several clinical trial experts from the United Kingdom spoke at the CIRM-hosted Staying on the Critical Path Workshop to raise awareness about opportunities for California researchers to collaborate on clinical trials with the U.K. The workshop was held at the 2013 CIRM Grantee Meeting in San Francisco. The speakers included: Natalie Mount, Phd, Chief […]