Enhanced Strategic FDA Collaboration: Working with CDER and CBER

Peter Francis is a highly experienced biotechnology executive and an ophthalmologist clinician- scientist with expertise in ophthalmic genetics and retinal disease. He graduated from medical school in the U.K. and undertook residency in London. He obtained his PhD in ophthalmic genetics from University College, London and is fellowship trained in Retina. Peter has almost two decades of experience in the biotechnology and pharmaceutical industries where he has led a number of gene therapy products from discovery to early-stage clinical development. Most recently he served as Chief Scientific Officer at 4D Molecular Therapeutics, a leader in AAV-based gene therapy and was prior, their first Chief Medical Officer and Head of Translational Research. Previously, Peter was Chief Medical Officer at RetroSense Therapeutics, the first visual optogenetics company which was successfully sold to a large pharmaceutical company. Peter is a member of the Macula Society, the American Ophthalmological Society and the American Academy of Ophthalmology. He has held academic faculty positions at St. Thomas’ Hospital, London and Casey Eye Institute, OHSU, Portland, OR. He has published about 100 peer-reviewed articles.

Norman L. Sussman, M.D., FAASLD, joined DURECT as Chief Medical Officer in November 2020. He has extensive clinical experience and expertise in the field of liver disease and brings over 30 years of clinical research and development experience in academia and industry. Prior to joining DURECT, he was an Associate Professor of Medicine and Surgery at Baylor College of Medicine and a faculty member of Baylor College of Medicine from 1985 to 1990 and again from 2003 to 2020 with some time also spent as the Chief of Hepatology at the University of Utah School of Medicine. During his academic career, he served as a principal investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman gained leadership experience in industry as the Founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as director of the telehealth program, Project ECHO®, at Baylor St. Luke’s Medical Center. Dr. Sussman received his Bachelor of Medicine and Surgery from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his postdoctoral fellowship at Washington University. He is board certified in internal medicine, gastroenterology, and transplant hepatology. Dr. Sussman is also a fellow of the American Association for the Study of Liver Diseases, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.

Dr Harpreet Singh currently serves as the Chief Medical Officer at Precision for Medicine. With a distinguished career at the U.S. Food and Drug Administration (FDA), Oncology Center of Excellence (OCE), Dr. Singh brings a wealth of experience in oncology and rare diseases to Precision. During her time as an FDA Oncology Director, she oversaw multiple drug development programs in solid tumors, pediatric tumors, and spearheaded initiatives such as Project Pragmatica to streamline clinical trial conduct. In her current role, Dr Singh provides medical and strategic support for Precision, overseeing the Medical and Operational Strategy teams while supporting business development activities. She maintains her active public presence as a thought leader in the life sciences industry. Dr Singh completed medical school, and training in both Internal Medicine and Geriatrics at the University of Southern California’s (USC) Keck School of Medicine, followed by Medical Oncology Fellowship at the National Cancer Institute (NCI), National Institutes of Health (NIH), before joining FDA’s Oncology Center of Excellence.

Dr. Scranton received his BA from the University of Tennessee and his Medical Degree from the Quillen College of Medicine at Eastern Tennessee State University.  He completed his Internal Medicine training at the Naval Medical Center in Portsmouth, where he served as the Chief Resident and Assistant Clinical Professor of Medicine at the F. Edward Hebert School of Medicine at the Uniformed Services University of the Health Sciences.  He completed his Harvard General Medicine Fellowship and received an MPH from the Harvard School of Public Health and was appointed as a Senior Research Fellow at the Massachusetts Veterans Administration Epidemiology, Research and Information Center (MAVERIC).  He was appointed as Assistant Professor at the Division of Aging at Brigham and Women’s Hospital and served as the Associate Medical Director and research consultant for Phase V Technology.  He then served as CMO at Veroscience where he led the efforts leading to the FDA approval of a first in class treatment for type 2 diabetes. Dr. Scranton joined Pacira Pharmaceutical where he also served as the CMO and led the global development and advancement of EXPAREL a non-opioid long lasting injectable local anesthetic.   Dr. Scranton now serves as the Chief Operating Officer and Chief Medical Officer at Lyndra Therapeutics where he is responsible for the global development of their pioneering weekly oral platform delivery technology.  Dr. Scranton has 15-years of combined federal service having served as a clinician, mentor, educator, administrator and researcher and 25 years of clinical and drug development research experience.