Phillip DeFedele counsels clients in the life sciences industry on regulatory, transactional, compliance, and enforcement matters. His areas of focus include FDA regulation of drugs, devices, and biologics, fraud and abuse, research and development, advertising and promotion, and compliance programs. Phil assists life sciences companies with regulatory matters throughout the entire product life cycle, including FDA inspections and enforcement and advisory actions as well as matters that are essential for FDA approval, clearance, or licensure.
Phil also conducts regulatory due diligence in connection with business transactions and assists in drafting and negotiating various contractual arrangements. He has worked on a significant number of life sciences transactions at, and prior to joining, Arnold & Porter that have collectively exceeded US$100 billion in value. His experience in this area includes applying and analyzing applicable FDA requirements while accounting for general contractual, practical, and business considerations in order to draft contractual provisions and revise agreements from a regulatory perspective.
Experience
- Clinical-stage biopharmaceutical company in drafting a template agreement, including quality agreement, for use with treatment centers that will collect and provide the company with cellular starting material for its novel cellular therapy and in analyzing applicable requirements
- Global biotechnology company in counseling on U.S. regulatory considerations for de-centralized manufacturing model for cellular therapy
- Global biotechnology company in counseling on handling requests for product samples and preparing associated authorization agreements
- Clinical-stage pharmaceutical company in negotiating agreements with antimicrobial susceptibility test (AST) manufacturer and in establishing AST program for antibiotic
- Pharmaceutical company in working with independent quality consultant to establish interim controls and ultimately resolve FDA inspectional observations issued to its contract manufacturer necessary to address Complete Response Letter
- Multi-national contract development and manufacturing organization in responding to FDA inspectional observations and analyzing the regulatory status of cell and gene therapy ancillary materials and manufacturing equipment and assays
- Multinational technology company in counseling on FDA implications and strategies for medical artificial intelligence technology
- National diagnostic company in counseling on FDA implications and strategies for various digital health tools, including briefing and preparation for pre-submission meeting with FDA
- Late-stage clinical biotechnology company in reviewing clinical trial recruitment materials
- Sat on promotional and medical review committees for global mid-sized biopharmaceutical company
Perspectives
Recognition
Credentials
Education
- J.D., Health Law, Seton Hall University School of Law, 2015, summa cum laude, valedictorian
- B.A., History, Italian minor, The College of New Jersey, 2011
Admissions
- New York
- New Jersey