Does your startup need to work with to get FDA approval? Interacting with the Food & Drug Administration (FDA) on regulatory matters is something that many life science and medical-based startups fear. The process can be complex, confusing, and daunting. During this talk, Dr. Swick will discuss how to best develop a game plan for interacting with the agency. The topics covered will include when and how to contact the FDA, who to engage with, and more importantly, pitfalls to avoid.
WHEN:
Tuesday, October 30, 2018, 11:30AM – 1:00PM
WHERE:
Oak Park Research Building, UC Davis Health Campus
2700 Stockton Blvd, Seminar Room 1305
Sacramento, CA 95817
About James (Jim) Swick, Ph.D.,
Jim is currently an independent consultant and advisor assisting medical device and biotech companies with development. Prior to his role as an independent consultant, he was the founder and Chief Scientific Officer at LyChron, LLC. LyChron was a privately held in vivo studies contract research organization (CRO) located in Mountain View, CA. LyChron’s focus was to assist medical device companies in the development of cutting-edge technologies to enhance the science of medicine and was considered the preeminent research facility of its kind in the US and internationally. He is also currently on the faculty of the Stanford University School of Medicine lecturing in the Biodesign and Innovation Fellowship Program and has more than 30 years experience as a preclinical and clinical investigator both in academia and industry. He has been on the faculty of several institutions in the departments of neurosurgery, physiology, and ophthalmology. In addition, he consulted for companies, which are considered pioneers in the medical device industry. Prior to starting LyChron, he was Senior Clinical Scientist at Berkeley Antibody Company in their in vivo studies division, chief executive at Estudillo Surgery Center in San Leandro, CA orchestrating a successful purchase by Columbia HCA, and Director of the Eye Center at St. Mary’s Medical Center in San Francisco, CA. Most recently, he has authored a book chapter in the Medical Device R&D Handbook on preclinical research. He attended the University of California at Berkeley where receiving a B.S. degree in Molecular Biology and Baylor College of Medicine receiving a Ph.D. in Neurophysiology. This was followed by a postdoctoral fellowship in neuro-ophthalmology at Baylor College of Medicine’s Cullen Eye Institute.
