Washington, D.C. and Boston – Sidley is pleased to announce that Jim Johnson, Scott Kaplan, and Chris Fanelli have joined the firm’s Global Healthcare and FDA practice. Mr. Johnson and Mr. Fanelli join in Washington, D.C. and Mr. Kaplan joins in Boston. Previously, they were at Hogan Lovells, where Mr. Johnson led the FDA Good Manufacturing Practice (GMP) compliance practice.
“Serving our life sciences clients around the world is a key strategic priority for the firm,” said Larry Barden, Chair of the firm’s Management Committee. “With Jim, Scott, and Chris joining our high-performing practice, we believe that we will be unmatched in our ability to advise clients – ranging from cutting-edge start-ups and the world’s leading multinational manufacturers to sophisticated investors – on key manufacturing and related compliance issues. We’re particularly excited about the team’s connection to Boston, where Scott is resident. The Boston/Cambridge area is an important geographic focus for us.”
Mr. Johnson advises life sciences clients on U.S. Food and Drug Administration (FDA) compliance and enforcement matters, focusing on FDA inspections, GMP requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations. He assists pharmaceutical, biotechnology, and cosmetic companies worldwide and regularly conducts GMP assessments and investigations. Mr. Johnson also counsels life science companies on drug approval and life-cycle management strategies. Previously, he served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel where he handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research's (CDER) Office of Compliance.
Mr. Kaplan’s practice focuses on working with clients on manufacturing issues associated with various cutting-edge therapies, including cell and gene therapy. He advises on GMP regulations, data integrity issues, product labeling, and Drug Supply Chain Security Act implementation, among other issues. Previously, he served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. At the FDA, Scott helped the agency resolve seizures, injunctions, administrative detentions, and criminal prosecutions in addition to serving as a Special Assistant U.S. Attorney. Mr. Kaplan also acted as counsel for compliance matters to the FDA's district offices.
Mr. Fanelli has led internal quality investigations into data integrity issues, developed and overseen global remediation plans for sites with regulatory compliance issues, and performed quality systems assessments of device manufacturers. He also has experience providing strategic compliance and regulatory advice to early-stage biotech companies in connection with scale-up and commercialization activities. Previously, Mr. Fanelli worked in the FDA Office of Chief Counsel as an Associate Chief Counsel on a broad range of enforcement matters related to drugs, dietary supplements, medical devices, and foods, as well as counseled FDA centers, including investigators and compliance personnel in the FDA District offices.
In total, the firm has added nearly 30 life sciences-focused lateral partners to its 200-person group since 2019.
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