In this second lunch and learn program, speakers will discuss the most important aspects of practicing drug law and what makes the drug industry unique. Panelists will answer key questions about the industry, such as: What makes FDA regulation of drugs different from other industries? What challenges are impacting the drug industry? When can a drug be regulated as more than one type of product, such as a cosmetic or device? Panelists will further explain how to get started in the practice of drug law and discuss recent important hot topics.
Speakers
Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors
David M. Fox, Partner, Hogan Lovells US LLP
Moderated by Matthew Piscitelli, Associate, DLA Piper LLP (US)
CARLA CARTWRIGHT is a member of the Johnson & Johnson Government Affairs & Policy (GA&P) policy team where she leads a variety of global regulatory policy issues across the pharmaceutical, consumer and medical device sectors including importation, harmonization, and biosimilars. Regularly convening and leading cross functional team on key issues, Carla works with partners in legal, privacy, commercial, regulatory affairs, and supply chain. She leads on global policy issues related to digital technology, data governance, and AI for GA&P, is the co-lead of the Digital and Emerging Technology Platform Team and is a member of the Johnson & Johnson Data Science Council. Carla was previously a part of the Federal Affairs team where she led on FDA matters and supported the oncology and immunology portfolios and worked for Janssen’s Global Regulatory Policy and Intelligence team where she was the US policy lead on topics including clinical trial innovation, patient engagement, expedited approval pathways, disease interception, and combination products. Prior to joining Johnson & Johnson, Carla was an attorney and team leader in FDA’s Office of the Chief Counsel where she advised the Center for Drug Evaluation and Research on legal and policy issues, working closely with the Offices of Policy and Legislation. She serves on the board of the Food and Drug Law Institute and her son’s Parent Teacher Student Association. Carla is a graduate of Washington University in St. Louis and has a JD from Yale Law School and an LLM from Georgetown University Law Center.
DAVID FOX is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. He advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). David is closely integrated with funding sources for the industry and is frequently retained as a strategic advisor on assessing the value of life sciences assets. Known for his collaborative approach to complex regulatory issues, David has successfully resolved numerous disputes between sponsors and staff at FDA on products that raise novel regulatory issues. As a former senior lawyer for FDA and throughout his career in private practice, David has been deeply immersed in the regulatory side of the Hatch-Waxman Act, including pioneer-generic disputes and numerous cases of first impression involving exclusivity issues, Orange Book listings, and patent term extensions. David previously led our Pharmaceutical and Biotechnology practice group and served on the firm’s global Life Sciences management team. During his FDA tenure, David received the Secretary’s Award of Merit and an FDA Special Citation for his work on the FDA Tobacco Rule. David is a founding member of the Kitalys Institute to support interventions that delay the onset of diseases of aging, and David is on the Advisory Board of the Cancer Support Community. David also serves as pro bono counsel on a variety of programs to improve patient and care-giver welfare.
MATTHEW PISCITELLI is a member of DLA Piper’s FDA Regulatory Group where he advises clients who develop a wide range of products, with an emphasis on manufacturers of medical devices, drugs, and biological products. Matthew counsels clients in regulatory matters across all stages of the product life cycle, from research and development to nonclinical testing, clinical trials, premarket clearance and approval, manufacturing, labeling compliance, and post-market surveillance. Matthew represents clients across a broad range of agency proceedings such as Orange Book listing disputes, citizen petitions, establishment inspections, and enforcement actions. Matthew has extensive experience in conducting regulatory due diligence on behalf of companies seeking to acquire or invest in companies with a portfolio of FDA-regulated products.October 25, 2022
12:00–1:00 PM ET
This program is limited to FDLI members who are a part of the New to Food and Drug Law Group (NFDL), and student members. Registration expires on October 23.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to Food and Drug Law Group
NFDL offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
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