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NIH-FDA Workshop: Pluripotent Stem Cells in Translation: Early Decisions


March 21-22, 2011
Lister Hill at NIH

AGENDA

Day 1 - March 21, 2011

8:00 - 8:30 a.m.
Registration and AM Refreshments

Moderator for Day 1
Sonia Skarlatos, Ph.D., Deputy Director, Division of Cardiovascular Sciences, NHLBI/NIH
8:30 - 10:00 a.m.
Session 1: Introduction

NIH Welcome
James M. Anderson, M.D., Ph.D., Director, NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)  5 min

FDA Welcome
Karen Midthun, M.D., Director, Center for Biologics Evaluation and Research (CBER) 5 min

FDA Roles in the Translation Process
Celia Witten, Ph.D., M.D., Director, Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER/FDA 15 min

NIH Roles in the Translation Process
Story Landis, Ph.D. , Director, National Institute for Neurological Disorders and Stroke (NINDS) and Chair, NIH Stem Cell Task Force 15 min

Roadmap to Translation
Mahendra Rao, Ph.D., M.D., Vice President, Regenerative Medicine, Life Technologies  50 min including questions
10:00 - 10:30 a.m.
Break
10:30 - 12:00 p.m.
Session 2: Pluripotency and Its Challenges

Keynote Address on Promise and Therapeutic Challenges
Gordon Keller, Ph.D., Director/Senior Scientist, McEwen Centre for Regenerative Medicine/University Health Network, Division of Stem Cell and Developmental Biology, Ontario Cancer Institute 50 min + 10 min questions 

Regulatory Challenges
Steven Bauer, Ph.D., Branch Chief, Cell and Tissue Therapy Branch, Division of Cellular and Gene Therapies, OCTGT/CBER/FDA 20 min + 10 min questions
12:00 - 1:00 p.m.
Lunch on your own
1:00 - 4:45 p.m.
Session 3: Translation: What is the source of your pluripotent cells?

NIH Guidelines
Ellen Gadbois, Ph.D, Science Policy Analyst, OD/NIH 10 min

FDA Donor Eligibility and Cell Banking Requirements
Deborah Hursh, Ph.D., Senior Investigator, Division of Cellular and Gene Therapies, OCTGT/CBER/FDA 25 min +  5 min questions

Methods of Reprogramming
Kevin Eggan, Ph.D., Associate Professor, Department of Stem Cell and Regenerative Biology, Principal Investigator, Harvard Stem Cell Institute, Harvard University 30 min + 10 min questions 

Controlling Stem and Progenitor Cell Properties with Small Molecules
Lee Rubin, Ph.D., Professor, Department of Stem Cell and Regenerative Biology, Director of Translational Medicine, Harvard Stem Cell Institute, Harvard University 30 min + 10 min questions
3:00 - 3:25 p.m.
Afternoon coffee break

Pluripotent Stem Cell Banks in the United States
Derek Hei, Ph.D., Technical Director, Waisman Clinical Biomanufacturing Facility, University of Wisconsin-Madison 30 min + 10 min questions

Pluripotent Stem Cell Banks in the United Kingdom 
Glyn Stacey, Ph.D., Director, U.K. Stem Cell Bank 30 min + 10 min questions
4:45 - 5:25 p.m.
First Day Wrap-up Summaries

FDA
Malcolm Moos, M.D., Ph.D., Senior Investigator, Division of Cellular and Gene Therapies, OCTGT/CBER/FDA

NIH 
Sonia Skarlatos, Ph.D., Deputy Director, Division of Cardiovascular Sciences, NHLBI/NIH
5:25 p.m.
Adjourn




Day 2 - March 22, 2011

7:30 - 8:00 a.m.
Coffee and Welcome Back
7:55 a.m.
Welcome Back

Moderator for Day 2
Dave Owens, Ph.D., Program Director, Repair and Plasticity Cluster, NINDS/NIH
8:00 - 10:00 a.m.
Session 4: Translation: How will you make your pluripotent cells into a product?

Industry:  ES Cells to Product
Eugene P. Brandon, Ph.D., Director, Strategic Relations and Project Management, ViaCyte, Inc. 30 min + 10 min questions

Industry:  iPS Cells to Product
Peter Flynn, Ph.D., Senior Director, Protein Discovery, Fate Therapeutics, Inc. 30 min + 10 min questions

Scalability
Jane Lebkowski, Ph.D., Senior Vice President, RegMed, and Chief Scientific Officer, RegMed, Geron Corporation 30 min + 10 min questions
10:00 - 10:30 a.m.
Light Refreshments
10:30 - 12:00 p.m.
Session 5: Translation: How do you know you have what you want?

Cell Characterization
Melissa Carpenter, Ph.D., Carpenter Group, San Diego, CA 30 min + 10 min questions

Here’s What We Expect
Thomas Finn, Ph.D., Reviewer, Division of Cellular and Gene Therapies, OCTGT/CBER/FDA 25 min + 10 min questions

Panel Discussion on Real-World Therapies
40 min including the two 5 min presentations below
Anthony Oro, Ph.D., M.D., Associate Professor, Program in Epithelial Biology, Stanford University School of Medicine 5 min + panel

Dennis Clegg, Ph.D., Department of Molecular, Cellular and Developmental Biology, University of California, Santa Barbara 5 min + panel

Previous Industry Speakers (Drs. Brandon, Flynn, and Lebkowski)

Panel Moderator: Pam Robey, Ph.D., Chief, Craniofacial and Skeletal Diseases Branch (CSDB), Division of Intramural Research (DIR), Chief, Skeletal Biology Section, CSDB, DIR, NIDCR/NIH
12:00 - 1:10 p.m.
Lunch on your own
1:10 - 3:00 p.m.
Session 6: Looking Forward

Session 6 Co-moderators: Christine Kelley, Ph.D., Director of the Division of Discovery Science and Technology, NIBIB and Malcolm Moos, M.D., Ph.D., Senior Investigator, Division of Cellular and Gene Therapies, OCTGT/CBER/FDA

Emerging Technology
Jeanne Loring, Ph.D., Center for Regenerative Medicine, Department of Chemical Physiology, The Scripps Research Institute, La Jolla, CA 30 min + 10 min questions

Panel on new technologies: 10-minute presentations from four scientists followed by discussion and questions  70 minutes including the four ten minute presentations below
  • Scale up/cell bioprocess technologies: Wei-Shou Hu, Ph.D., Distinguished McKnight University Professor, Department of Chemical Engineering and Materials Science, University of Minnesota  10 min + panel
  • High throughput microfluidic platform technologies for stem cell culture and analysis: Joel Voldman, Ph.D., Associate Professor, Department of Electrical Engineering and Computer Science, MIT 10 min + panel
  • Tissue engineering using stem cells: Karen K. Hirschi, Ph.D., Departments of Pediatrics and Molecular & Cellular Biology, Center for Cell and Gene Therapy, Baylor College of Medicine and Department of Bioengineering, Rice University 10 min + panel
  • Mathematical modeling of stem cell behavior: David Umulis, Ph.D., Assistant Professor of Agricultural and Biological Engineering, Purdue University, Department of Agricultural and Biological Engineering 10 min + panel
  • NIST panelist: Anne L. Plant, Ph.D., Leader, Cell Systems Science Group, Biochemical Science Division, National Institute of Standards and Technology (NIST) panel only
3:00 - 3:25 p.m.
Wrap-up and Summary of Meeting

Gordon Keller Ph.D., Director/Senior Scientist, McEwen Centre for Regenerative Medicine/University Health Network, Division of Stem Cell and Developmental Biology, Ontario Cancer Institute
3:25 p.m.
Adjourn

Last updated February 6, 2013