Video Topic: Webinars and Workshops
Webinar: Reimbursement Strategies for Stem Cell Therapy Products
Webinar Event: “Reimbursement Strategies Webinar: Planning Your Payment Strategy in Early Regenerative Medicine Product Development” Presented June 20, 2013 Click here to download the powerpoint slides from the presentation WEBINAR AGENDA EXPERT SPEAKERS: Michael Werner, J.D., Executive Director, Alliance for Regenerative Medicine; Partner at Holland & Knight, LLP Randy Fenninger, J.D., Principal, Creek Crossing Advisors TOPICS: […]
Webinar: Moving Stem Cell based Therapies to the Clinic – Intro: Ellen Feigal
Webinar Event: “Clinical Trials: Moving Stem Cell based Therapies to the Clinic – Presentations from FDA and Leading Experts” Introduction by Ellen Feigal, M.D., Senior Vice President of Research and Development, CIRM Presented April 15, 2013 The focus of the webinar is on the lessons learned from IND/Phase I trials including […]
Webinar: First-in-Human Trials of Stem-Cell Based Therapies – John Hyde
Title: First-in-Human Trials of Cellular Therapies Speaker: John Hyde, M.D., Ph.D, Medical Officer, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) Presented April 15, 2013 This presentation was part of the […]
Webinar: Stem Cell Clinical Trial for Heart Disease – Lessons Learned | Eduardo Marbán
Title: Lessons learned from Phase 1 trial of heart-derived stem cells as we move into Phase 2 Speaker: Eduardo Marbán, M.D., Ph.D. Founder and Chairman of Scientific Advisory Board, Capricor, Inc. and Director, Cedars-Sinai Heart Institute, Mark S. Siegel Family Professor Presented April 15, 2013 This presentation was part of the webinar event, “Clinical […]
Webinar: Injecting Neural Stem Cells into ALS Patients: Results of a Phase 1 Trial | Jonathan Glass
Title: Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients Speaker: Jonathan D. Glass, M.D. Professor, Neurology and Pathology, Emory University School of Medicine Presented April 15, 2013 This presentation was part of the webinar event, “Clinical Trials: Moving Stem Cell based Therapies to […]
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 […]