This session begins with a brief history behind FDA regulations and processes which set the stage for modern regulations and requirements. Both the regulations and the process for IND and INEs will be examined, practical considerations, misconceptions, and waivers will be covered. The start-up process for clinical trials includes discussion of study feasibility, budget, staff training, and UW & ITHS resources. Finally, the significant resources of the ITHS - Institute of Translational Health Sciences - will be reviewed.
Research Associate Professor, Pediatrics; Director, Clinical Operations, Cystic Fibrosis TDN Coordinating Center
Lynn Rose is a Research Associate Professor in the Department of Pediatrics, UW School of Medicine and Director of the Office of Regulatory and Clinical Affairs for the Center of Clinical and Translational Research, Seattle Children's Research Institute. Dr. Rose is also the faculty director of the Preclinical Research and Development Core (PRDC) of the Institute of Translational Health Sciences, funded by a CTSA to the University of Washington. In that capacity, Dr. Rose is responsible for facilitating the development and commercialization of translational research inventions through consultation with entrepreneurial scientists. Dr. Rose specifically assists in the development of regulatory strategies and regulatory submissions for investigational medical products.
Dr. Rose is an experienced translational researcher. She has been the Director of Clinical Operations and Regulatory Affairs for the Cystic Fibrosis Therapeutics Development Network Coordinating Center (TDNCC) for the past seven years. Prior to joining the CF TDNCC, she gained extensive experience in biomedical research and product development in corporate settings. She is skilled at critical review of biomedical product concepts and development of regulatory strategies. Dr. Rose's primary clinical experience is in areas of infectious disease, cystic fibrosis, autoimmune disease, thrombosis and hemostasis. Her drug development experience has included management of manufacturing, preclinical, and clinical programs for the companies she has worked for. In addition, her many years of direct regulatory experience with both small molecule products (oral and aerosol delivery) and biologics positions her to provide accurate and up-to-date information on FDA requirements for drug development.
Physician, Associate Professor, Pediatrics - Infectious Diseases, Children's Hospital & Medical Center
Ann J. Melvin, MD, MPH is an Associate Professor in the Department of Pediatrics, Division of Pediatric Infectious Disease, Seattle Children's Hospital. She is medical director of the Pediatric HIV program at Seattle Children's Hospital and co-principle investigator of the International Maternal Pediatric Adolescent Clinical Trials unit at the University of Washington, sponsored by the NIH, through which she has conducted clinical and translational research trials for the past twenty years. She is the co-director of the Regulatory Support and Bioethics Core of the Institute for Translational Health Sciences of the University of Washington. In this capacity, Dr. Melvin provides regulatory and bioethics consultations for researchers and directs the ITHS Safety Monitoring Program.