Dr. Brian Rogers, PhD, MBA, DABT
Founder, Pacific Biodevelopment, Inc.
Dr. Rogers has years of experience in drafting and review of nonclinical sections of INDs, NDAs, and BLAs and other forms of oral/written correspondence with regulatory authorities and the design, implementation, and oversight of nonclinical programs. He has consulted on development projects involving a wide variety of drug and device products (including various forms of biotechnology engineered products), routes of administration, and clinical indications. He has actively participated in nonclinical toxicology activities for INDs and NDAs/BLAs. He has also participated in face-to-face meetings with the FDA, including FDA Advisory Panel meetings.