UCSF is co-sponsoring a symposium on September 27 and 28 featuring speakers from academia, industry, the US Food and Drug Administration (FDA), and the California Institute for Regenerative Medicine (CIRM).
The symposium titled “Stem Cell Translation: Strategies, Best Practices & Regulatory Considerations” is designed to provide scientists and physicians with the “nuts and bolts” of translating stem cell science into cell-based products for clinical trials.
The experts will share their perspectives on various issues that define the successful application of novel stem cell-based approaches, including human subjects and ethical issues, product characterization, development and testing of cell lines, preclinical animal studies, design and manufacturing of cell products, and complying with regulatory requirements.
The symposium is slated for Monday and Tuesday, Sept. 27 and 28, from 8 a.m. to 4:30 p.m. in the UCSF Mission Bay Conference Center. Fees range from $350 to $450. Partial scholarships are available to UCSF postdocs. The application deadline is Monday, Sept. 13, 2010.
For the agenda and event details, visit the symposium website.
Symposium topics include:
- Stem cell characterization and assay development
- Cell source selection, qualification, banking, and testing
- Preclinical animal studies: efficacy and safety
- Investigational New Drug (IND) development for cell, tissue, and gene therapies
- FDA regulatory requirements & regulatory process
- Development of good manufacturing practice
- Standards for manufacturing, ancillary reagents, and biomaterials
- Novel approaches for tissue and organ regeneration
Participants at last year’s symposium found the event worthwhile. Marie Csete, MD, PhD, executive vice president of Research & Development at Organovo, Inc. said that large and small industry problems were well represented so that companies at any stage of developing a cell product could benefit from the symposium.
“I learned about all kinds of scientific cultural barriers and how to navigate them,” Csete said. “Even the academic-industry interface and the adult versus embryonic stem cell regulatory concerns were represented in ways that resulted in an effective cross-fertilization of ideas.”
Academics found the symposium a great way to make new connections. “This symposium provides investigators with a development framework for stem cell products. It’s a great forum to network with and learn from others who are moving their therapies into clinical trials,” said Elizabeth Read, MD, adjunct professor of Laboratory Medicine and Neurological Surgery at UCSF and project co-manager of the CIRM Glioblastoma Disease Team at UCSF.
The symposium is sponsored by International Society for Cellular Therapy, California Institute for Regenerative Medicine, UCSF’s Clinical & Translational Science Institute, Becton Dickinson, Inc. and NHLBI Production Assistance in Cellular Therapies.