Vaccines, Blood & Biologics

Final Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products

Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products


September 12-13, 2016
National Institutes of Health (NIH)
9000 Rockville Pike, Building 10, Masur Auditorium
Bethesda, MD 20892

Panel Members

Celia M. Witten, Ph.D., M.D., Presiding Officer                    
Deputy Director                                                                       
Center for Biologics Evaluation and Research                     
Food and Drug Administration  
                                         
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Food and Drug Administration

Diane M. Maloney, J.D.                                                              
Associate Director for Policy                                                    
Center for Biologics Evaluation and Research                      
Food and Drug Administration                                                  

Angela C. Krueger
Associate Director for Guidance and Regulations
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration

Sheryl Lard-Whiteford, Ph.D.                                                    
Associate Director for Quality Assurance                               
Center for Biologics Evaluation and Research                      
Food and Drug Administration                                                  

John B. Weiner
Associate Director for Policy
Office of Combination Products
Food and Drug Administration

Rachael F. Anatol, Ph.D.                                                            
Associate Director of Policy                                                      
Office of Cellular, Tissue and Gene Therapies                       
Center for Biologics Evaluation and Research                      
Food and Drug Administration

Denise Zavagno, J.D.
Senior Counsel
Office of the Chief Counsel
Food and Drug Administration

Agenda

September 12, 2016

9:00-9:10: Presiding Officer Opening Remarks and Introduction of Panel Members

9:10-10:57: Session 1

  • 9:10-9:15: Alliqua Biomedical
  • 9:16-9:21: Allosource
  • 9:22-9:27: Atlanta Medical Center
  • 9:28-9:33: Birth Tissue Recovery, LLC
  • 9:34-9:39: INCELL Corporation LLC
  • 9:40-9:45: Intellicell BioSciences
  • 9:46-9:51: Johnson & Johnson
  • 9:52-9:57: Kerastem Technologies
  • 9:58-10:03: LifeLink Tissue Bank
  • 10:04-10:09: LifeNet Health
  • 10:10-10:15: MedCentris
  • 10:16-10:21: Millennium Medical Technologies
  • 10:22-10:27: MiMedx Group, Inc.
  • 10:28-10:33: Musculoskeletal Transplant Foundation
  • 10:34-10:39: Organogenesis
  • 10:40-10:45: RTI Surgical
  • 10:46-10:51: StemGenex Inc
  • 10:52-10:57: US Stem Cell Inc

10:57-11:07: Questions from Panel

11:07-11:27: Break

11:27-11:57: FDA presentation on September 8, 2016 workshop “Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval”

11:57-1:12: Lunch:  Ala Carte items will be available for purchase on site

1:12-2:29: Session 2

  • 1:12-1:17: Boston College Law School
  • 1:18-1:23: Case Western University
  • 1:24-1:29: Indiana University School of Medicine
  • 1:30-1:35: NYU Langone Medical Center
  • 1:36-1:41: Wake Forest University School of Medicine
  • 1:42-1:47: Alston & Bird LLP
  • 1:48-1:53:  Navigant Consulting
  • 1:54-1:59: OrthoKinetic Technologies, LLC
  • 2:00-2:05: Parenteau BioConsultants
  • 2:06-2:11: California Stem Cell Treatment Center and Cell Surgical Network
  • 2:12-2:17: Celebration Stem Cell Center
  • 2:18-2:23: Long Island Plastic Surgical Group
  • 2:24-2:29: National Spine and Pain Centers-VA

2:29-2:39: Questions from panel

2:39-4:49: Session 3

  • 2:39-2:47: Academy of Regenerative Practices
  • 2:48-2:56: Alliance for Regenerative Medicine
  • 2:57-3:05: Alliance for the Advancement of Cellular Therapies
  • 3:06-3:14: Alliance of Wound Care Stakeholders

3:14-3:29: Break

  • 3:29-3:37: American Association of Blood Banks
  • 3:38-3:46: American Association of Tissue Banks
  • 3:47-3:55: American College of Surgeons
  • 3:56-4:04: American Society of Plastic Surgeons
  • 4:05-4:13: Biologic Orthopedic Society
  • 4:14-4:22: Bipartisan Policy Center
  • 4:23-4:31: California Institute for Regenerative Medicine
  • 4:32-4:40: California Life Sciences Association
  • 4:41-4:49: Coalition of Wound Care Manufacturers

4:49-4:59: Questions from Panel

4:59-close:  Closing remarks/adjournment

September 13, 2016

9:00-9:14: Presiding Officer Opening Remarks and Introduction of Panel Members

9:14-10:43: Session 3, Continued

  • 9:14-9:22: Foundation for the Accreditation of Cellular Therapy
  • 9:23-9:31: Info Health Global
  • 9:32-9:40: Institute for Regenerative and Cellular Medicine
  • 9:41-9:49: International Federations for Adipose Therapeutics and Science
  • 9:50-9:58: International Society for Cellular Therapy
  • 9:59-10:07: International Society for Stem Cell Research
  • 10:08-10:16: National Center for Health Research
  • 10:17-10:25: The Cord Blood Association
  • 10:26-10:34: The Cure Alliance
  • 10:35-10:43: The Plastic Surgery Foundation

10:43-10:53: Questions from Panel

10:53-11:08: Break

11:08-4:46: Session 4

  • 11:08-11:13: Waldo Acebo
  • 11:14-11:19: Rebecca Baergen
  • 11:20-11:25: Harold Brem
  • 11:26-11:31: Julie Cerrone
  • 11:32-11:37: Kara Couch
  • 11:44-11:49: Georgianna Crocker
  • 11:50-11:55: Fiona Cunningham
  • 11:56-12:01: Roxana Daftarian
  • 12:02-12:07: Rahul Desai
  • 12:08-12:13: Yoelma Eid Sandoval
  • 12:14-12:19: Ryan Fitzgerald

12:19-1:34: Lunch: Ala Carte items will be available for purchase on site

  • 1:34-1:39: Timothy Freeman
  • 1:40-1:45: Brian Gates
  • 1:46-1:51: Marie Gehling
  • 1:52-1:57: Ted Gradel
  • 1:58-2:03: R. Scott Graham
  • 2:04-2:09: Sarah Hughes
  • 2:10-2:15: Scott James
  • 2:16-2:21: Kristen King
  • 2:22-2:27: John Klimkiewicz
  • 2:34-2:39: Jeanne Loring
  • 2:40-2:45: Norman Marcus
  • 2:46-2:51: Brian Marr
  • 2:52-2:57: Kristen Marr
  • 2:58-3:03: Carl Nicastro
  • 3:04-3:09: Michael Sabolinski
  • 3:10-3:15: Sheila Sabon DeCastro
  • 3:16-3:21: Carolyn Salafia

3:21-3:41: Break

  • 3:41-3:46: John Samies
  • 3:47-3:52: George Sauter
  • 3:53-3:58: Rosemary Tambouret
  • 3:59-4:04: Tracy Thompson
  • 4:05-4:10: Amy Tucker
  • 4:11-4:16: Leigh Turner
  • 4:17-4:22: Eliza Tyler
  • 4:23-4:28: Newton Vaughn
  • 4:29-4:34: Samantha Wilkinson
  • 4:35-4:40: Joan Woodward
  • 4:41-4:46: Jennifer Ziegler

4:46-4:56: Questions from Panel

4:56-close: Closing remarks/adjournment

Page Last Updated: 09/08/2016
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