Microbiota Transplantation: Recommendations for a Regulatory Framework
Working Group Meeting #1
December 3-4, 2015
- Microbiota Transplantation Project Final Report on Meeting #1 (December 3-4, 2015)
- Agenda
- Working Group Members and Invited Speakers
- Presentations
- Overview of Human Microbiome Project, Dr. L. Clifford McDonald, Senior Adviser for Science and Integrity, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention
- Emergence of Fecal Microbiota Transplantation and Microbiota Therapeutics, Dr. Alexander Khoruts, Department of Gastroenterology, University of Minnesota Medical School
- Vaginal Microbiota, Dr. Richard Cone, Thomas C. Jenkins Department of Biophysics, Johns Hopkins University
- Skin microbiota transplant overview, Dr. Elizabeth Grice, Penn Institute for Immunology, Perelman School of Medicine, University of Pennsylvania/li>
- Microbiota Transplantation Workshop: Oral Cavity, Dr. Floyd Dewhirst, Department of Microbiology, Forsyth Institute and Harvard School of Dentistry
- Nasal and Sinus Microbiome: the potential for microbiota-targeted therapeutics, Dr. Katherine Lemon, Department of Microbiology, Forsyth Institute and Harvard Medical School
- The Current Regulatory Framework for Fecal Microbiota Transplantation, Rachel Sachs, Academic Fellow, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
- Alternative Regulatory Framework for FMT: transplantation and implantation of human cells, tissues and cellular and tissue-based products (HCT/Ps), Scott A. Brubaker, CTBS, Senior Vice President of Policy, American Association of Tissue Banks
- Regulatory Schema for Blood Transfusion, Dr. John R. Hess, Professor of Laboratory Medicine and Hematology, University of Washington
- Recommended Readings
- Johan S. Bakken [and others], Treating Clostridium difficile Infection with Fecal Microbiota Transplantation, 9 (12) Clinical Gastroenterology and Hepatology 1044-1049 (2011)
- Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies, Draft Guidance, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (March 2014)
- Gail A. Hecht [and others], Editorial: What is the Value of a Food and Drug Administration Investigational New Drug Application for Fecal Microbiota Transplantation to Treat Clostridium difficile Infection? 12 Clinical Gastroenterology and Hepatology 289-291 (2014)
- Janis C. Kelly, Fecal Transplants Bring Hope to Patients, Challenge the FDA, Medscape.com (Dec. 15, 2014)
- Francis Megerlin [and others], Faecal Microbiota Transplantation: A Sui Generis Biological Drug, Not a Tissue, 72 (4) Annales Pharmaceutiques Francaises 217-220 (July 2014)
- Elaine O. Petrof & Alexander Khoruts, From Stool Transplants to Next-generation Microbiota Therapeutics, 146 (6) Gastroenterology 1573-1582 (May 2014)
- Margaret F. Riley & Bernat Olle, FDA’s Pathway for Regulation of FMT: Not So Fraught, 10 Journal of Law and the Biosciences 1-5 (2015)
- Rachel E. Sachs & Carolyn A. Edelstein, Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation, 10 J. of Law and the Biosciences 396-415 (2015)
- Jeffrey K. Shapiro & Brian J. Wesoloski, FDA’s Regulatory Scheme for Human Tissue: A Brief Overview, Update Magazine (Nov-Dec 2007)
- Mark B. Smith, Colleen Kelly & Eric J. Alm, How to Regulate Faecal Transplants for Medicinal Use, Human Stool Should Be Considered a Tissue, Not a Drug, 506 Nature 290 (Feb. 20, 2014)
- Tim Spector & Rob Knight, Faecal Transplants: Still Need Good Long-Term Trials and Monitoring, 351 BMJ 5149 (Oct 20, 2015)
- Pritish K. Tosh & L. Clifford McDonald, Infection Control in the Multidrug-Resistant Era: Tending the Human Microbiome, 54 Healthcare Epidemiology 707 (2012)