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  5. Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval - Agenda
  1. Workshops, Meetings & Conferences (Biologics)

Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval - Agenda

September 8, 2016

Food and Drug Administration
White Oak Campus - 10903 New Hampshire Ave
Building 2 Great Room B&C
Silver Spring, MD 20903

8:30-8:40: Welcome/Opening remarks: Celia Witten, PhD, MD

8:40-9:45: Session 1: Keynote and Regulatory Scheme

  • 8:40-9:10: Keynote address: Irving Weissman, MD, Stem Cell Biology and Regenerative Medicine

  • 9:10-9:15: Questions to keynote speaker

  • 9:15-9:45: Steven Bauer, PhD,  FDA Perspectives on Scientific Evidence and HCT/P Development

9:45-11:40: Session 2:  Experiences in Product Development

  • 9:45-10:05: Jacques Galipeau, MD, How Mechanistic Studies on Mesenchymal Stromal Cells Inform Design of Human Clinical Trials for Autoimmune Ailments – The Fitness Paradigm

  • 10:05-10:25: Michael Matthay, MD,  Mesenchymal Stem Cells for Treatment of ARDS Patients: Challenges & Lessons Learned in Pre-Clinical Testing, FDA Approval, and Ongoing Clinical Trial

10:25-10:40: Break

  • 10:40-11:00: Gregory Russotti, PhD, Drivers and Methodologies for Making Cell Therapy Process Changes

  • 11:00-11:20: Dennis Clegg, PhD, Development of ES-derived Retinal Pigmented Epithelium on a Scaffold for Age-related Macular Degeneration

  • 11:20-11:40: Christopher Breuer, MD, The Development and Translation of the Tissue Engineered Vascular Graft: From the Bench to the Bedside and Back Again

11:40-12:20: Panel Discussion 1: Galipeau, Matthay, Russotti, Clegg, Breuer, Weisman

12:20-1:20: Lunch

1:20-2:20: Session 3: Views from Professional Societies

  • 1:20-1:40: Jonathan Kimmelman, PhD, Ethics, Evidence, and Regulatory Approval for Cell-Based Interventions

  • 1:40-2:00: Massimo Dominici, MD, Dissecting Unproven Cellular Therapies: The International Society for Cellular Therapy (ISCT) Position

  • 2:00-2:20: Peter Rubin, MD, Clinical Adipose-Based Therapies

2:20-2:40: Session 4: Views from other Government Agencies

  • 2:20-2:30: Kristy Pottol, Delivering Mission Ready Medical Solutions to the Warfighter

  • 2:30-2:40: Martha Lundberg, PhD, Enabling Development of Regenerative Medicine Technologies and Therapies at the NHLBI

2:40-2:55: Break

2:55-4:15 Session 5:  Patient and Society Experience and Expectations

  • 2:55-3:15: Jeffrey Kahn, PhD, Societal Perspectives on Development and Oversight of Novel Cell-Based Therapies

  • 3:15-3:35: Brian Mansfield, PhD, Perspectives of Stem Cell Therapy for Orphan Inherited Retinal Dystrophies

  • 3:35-3:55: Thomas Albini, MD, Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration

  • 3:55-4:15: Michael Miller, MD, PhD, Glioproliferative Lesion of the Spinal cord Arising from Exogenous Stem Cells

4:15-4:50: Panel Discussion 2: Kahn, Kimmelman, Dominici, Rubin, Pottol, Lundberg, Mansfield, Albini, Miller

4:50-5:00: Closing Remarks: Irving Weissman, MD

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