OCTGT is collaborating with the FDA’s Office of Good Clinical Practice and Office of Pediatric Therapeutics, the National Institutes of Health’s Office of Biotechnology Activities, the American Society of Gene and Cell Therapy, the International Society for Stem Cell Research, the American Academy of Pediatrics and the Public Responsibility in Medicine and Research, a public interest group, to sponsor the workshop. The purpose of the workshop is to gather information from Institutional Review Boards (IRB), gene and cellular therapy clinical researchers, and other stakeholders on best practices in planning cell and gene therapy trials in pediatric populations. Specifically, the best practices will focus in three areas: evaluating novel therapeutic products prior to initiating pediatric clinical studies; identifying and minimizing risks associated with the administration of cell and gene therapy products in pediatric studies; and determining the data submitted to the IRB and FDA prior to initiating pediatric clinical trials.OCTGT collaborated with FDA’s Office of Good Clinical Practice and Office of Pediatric Therapeutics, the National Institutes of Health’s Office of Biotechnology Activities, the American Society of Gene and Cell Therapy, the International Society for Stem Cell Research, the American Academy of Pediatrics and the Public Responsibility in Medicine and Research, a public interest group to sponsor the public workshop. The purpose of the workshop was to gather information from Institutional Review Boards (IRB), gene and cellular therapy clinical researchers, and other stakeholders on best practices in planning cell and gene therapy trials in pediatric populations. Specifically, the best practices focused on three areas: evaluating novel therapeutic products prior to initiating pediatric clinical studies; identifying and minimizing risks associated with the administration of cell and gene therapy products in pediatric studies; and determining what data need to be submitted to the IRB and FDA prior to initiating pediatric clinical trials. The workshop provided education for FDA staff as well as IRBs and investigators. As a result of the workshop, OCTGT developed a training program for staff regarding best practices of informed consent review and develop internal policy regarding informed consent documents.A. Invite speakers for workshop7/23/2010Completed7/20/2010B. Publish Federal Register notice9/3/2010Completed9/7/2010C. Finalize FDA presentations10/27/2010Completed10/22/2010D. Hold joint public workshop11/2/2010Completed11/2/2010E. Hold post-workshop meeting to evaluate possible output for educational programs1/31/2011Completed12/21/2010F. Provide webcast and publish transcript of the workshop3/23/2011Completed12/15/2010Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.http://www.fda.gov/AboutFDA/Transparency/track/ucm206349.htm#KeyProjectFDA-TRACK CBER Research and Review Offices Dashboard