How Phillip Helps Clients
Phillip V. DeFedele focuses his practice on matters relating to the Food and Drug Administration (FDA) and the life sciences industry, including research and development, premarket approval processes, and sales and marketing. He frequently drafts and negotiates contracts for domestic and international use concerning the development, commercialization and post-marketing surveillance of pharmaceutical products; reviews promotional materials; and provides general legal support through the life cycle of a product. Phillip also provides on-site counseling to life sciences companies, so he understands the realities and everyday issues his clients face. Phillip assists with guiding companies on a wide range of legal issues affecting the life sciences industry, including anti-corruption, the False Claims Act, off-label communications and data privacy.
What Clients Can Expect
Phillip takes a practical approach when addressing his clients’ needs and works to establish a collaborative relationship with his clients and their internal stakeholders. He focuses on both the legal and practical consequences when counseling a client and understands the complex and intertwining legal frameworks under which life sciences companies operate.
Outside the Office
When not practicing law, Phillip enjoys spending time with his immediate and extended family and friends. Being a musician, Phillip has been writing original music and performing in bands since he was 13 years old and is also an avid soccer fan who plays casually as a left winger. Phillip also loves to travel and has been all over the world but often finds himself returning to Sicily.
An attorney’s role is more than just being a counselor and understanding the law; it is also being a partner to the client and understanding the client’s objectives and how best to achieve them within the confines of the law.
- Provided legal and contracting support to a pharmaceutical company for its clinical research programs, including Phase I pediatric clinical trials and global Phase III clinical trials
- Served as the legal representative on various review committees for a pharmaceutical company, including its promotional review committee, grant review committee, and medical review committee
- Counseled a pharmaceutical company on revisions to its patient support programs, including its copay assistance program
- Provided legal guidance and training to a pharmaceutical company while on-site at a scientific conference
- Advised a foreign start-up biotechnology company on how to use data derived from the compassionate use of its product outside of the United States in FDA regulatory filings to support product approval
- Worked with intellectual property attorneys within the firm to support a pharmaceutical company’s Lanham Act claims against a competitor based on, among other things, the competitor’s labeling of its pharmaceutical product
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