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JPM2023 Trendspotting: investment insights for innovative medicines
03 January 2023
PartnerWashington, D.C.
Email [email protected]hoganlovells.com
Phone +1 202 637 3567
Fax +1 202 637 5910
Practice groupGlobal Regulatory
Bridging his experience at the highest levels of the FDA and regulatory practice, Lowell Zeta provides sophisticated legal counsel to life science clients on critical regulatory and compliance matters impacting their essential medicines and product portfolios. Innovative startups and global biopharmaceutical companies and their investors seek his strategic guidance on matters that require an integrated analysis of the science, data, and the law.
He counsels extensively on product quality, safety, and compliance with current good manufacturing practice (GMP) requirements and data integrity standards for clinical and commercial stage products, with a focus on next generation products with complex manufacturing and global supply chain considerations. He helps to resolve complicated quality issues, including by advocating for clients before FDA in regulatory meetings, inspection and enforcement action, and government investigations.
He has deep experience supporting complex contract manufacturing arrangements, including manufacturing services agreements, quality agreements, and safety data exchange agreements. He excels by leveraging his awareness of the pressures facing life science companies, his on-site experience providing clients with real-time support at manufacturing facilities around the world, and his perspective on intra-agency decision-making processes.
He is at the forefront of the industry's digital transformation initiatives, helping to propel drug development programs by navigating evolving regulatory frameworks for digital health technologies, real-world evidence (RWE), novel biomarkers, and patient focused drug development.
While at the FDA, he served as Senior Counselor to the FDA Commissioner providing leadership on cross-cutting and high-priority strategic initiatives, including the FDA COVID-19 PREPP initiative. He is a published author in peer-reviewed journals, and a public speaker on life science related topics.
FDA Award of Merit (nominated)
FDA
Food and Drug Law, Rising Star
Super Lawyers
Health Law, Rising Star
Super Lawyers
Larry M. Simonsmeier Writing Award
American Society for Pharmacy Law
Education
LL.M., Georgetown University Law Center, 2015
J.D., Creighton University School of Law, 2008
B.A., The University of Iowa, 2004
Memberships
Member, American Bar Association
Member, California Life Sciences Association
Member, Food and Drug Law Institute
Member, Parenteral Drug Association
Member, Food and Drug Law Journal Editorial Advisory Board, Food and Drug Law Institute (2016-2020)
Bar admissions and qualifications
District of Columbia
California
Court admissions
U.S. Supreme Court
U.S. Court of Appeals, Ninth Circuit
U.S. District Court, Central District of California
U.S. District Court, Eastern District of California
U.S. District Court, Northern District of California
U.S. District Court, Southern District of California
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