Brian Dow

North America Regulatory Scientist @The Janssen Pharmaceutical Companies Of Johnson & Johnson

Bridgewater, NJ, US

Define and execute regulatory strategies for compounds in development and marketed products in oncology\\\\n\\\\n-Influence functional areas and management by providing regulatory guidance to drive clinical trial & marketing application content and regulatory filing strategy\\\\n\\\\n- Led and supported supplemental BLAs for an oncology marketed product\\\\n\\\\n- Provided clinical regulatory guidance and led rapid response teams for FDA information requests during opening of initial INDs and successfully responding to FDA complete responses\\\\n\\\\n- Drove North America regulatory strategy on reduction of biomarker collections in clinical protocol\\\\n\\\\n- Provided North American regulatory support for products from early clinical development to post-marketed compounds\\\\n\\\\n- Led and supported FDA Type B pre-sBLA meetings\\\\n\\\\n- Contributed regulatory guidance on clinical protocols, clinical study reports, safety reports (including annual reports), and responses to FDA information requests\\\\n\\\\n- Regulatory business process owner for FDA financial disclosures\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

University of Central Florida

Doctor of Philosophy (PhD), Biomedical Sciences

Georgetown University

Terrorism and Counterterrorism

Missouri Western State University

Bachelor of Science (BS), Biotechnology, Chemistry