Sarah Wicks

Sarah Wicks is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s Life Sciences Regulatory & Compliance practice. She counsels pharmaceutical, biologic and medical device companies on FDA regulatory compliance issues, including those relating to human subject protections and the conduct of clinical trials, drug and device development, interactions with the FDA, advertising, promotion and labeling, internal corporate investigations and responding to FDA inspection observations and enforcement actions. Sarah also advises FDA-regulated entities in corporate transactions, offerings and licensing matters.

• Advises on regulatory compliance with good clinical practices, including informed consent requirements, IRB approval and oversight, adverse event reporting, trial initiation and monitoring, sponsor and investigator responsibilities, financial disclosures and data integrity
• Provides strategic advice on matters involving product development and marketing approval for drugs and biologics, including clinical trial design, expedited pathways, exclusivity and incentives programs
• Advises novel consumer technology and digital health companies on product development and regulatory pathway issues
• Negotiates the regulatory terms of clinical trial agreements, pharmacovigilance and safety data exchange agreements, consulting agreements, clinical collaboration and development agreements, and supply and quality agreements
• Provides extensive review of corporate communications and regulatory disclosures in securities filings for pharmaceutical and medical device companies across the preclinical to commercial stages, including for corporate presentations, press releases, exhibit booth content, and communications with patient advocacy groups
• Advises on the federal and state regulatory status of hemp-derived CBD products, including product-specific labeling and registration requirements, manufacturer and distributor licensing/registration requirements

Sarah’s practice focuses on all aspects of regulatory counseling. She often works alongside her corporate and public company colleagues to conduct regulatory due diligence reviews and provides support for mergers, acquisitions, capital market transactions, and other corporate matters involving FDA-regulated entities.

Recent notable matters include:

• Intellia Therapeutics in its $600 million public offering
• Centessa Pharmaceuticals in its $379.5 million initial public offering
• AbCellera Biologics in its $555.5 million initial public offering
• argenx SE in its $1.15 billion global follow-on offering
• The underwriters in Ambrx’s $126 million initial public offering
• The underwriters in Taysha Gene Therapies’ $181 million initial public offering
• The underwriters in Decibel Therapeutics’ $135 million initial public offering
• Special Committee of NantKwest in NantKwest’s merger with ImmunityBio
• LumiraDx Limited on its definitive business combination with CA Healthcare Acquisition Corp., a special purpose acquisition company

Sarah serves on the Committee for the Baltimore Chapter of the Society for Clinical Research Associates (SOCRA) and is a member of Women in Bio and the Food and Drug Law Institute (FDLI).

Sarah’s pro bono activities include working alongside the Lawyers Clearinghouse CORI Sealing Clinic, which provides assistance to those looking to seal and/or expunge their criminal record, and the Last Prisoner Project, working to identify state social equity programs that encourage cannabis companies to hire those with cannabis-related convictions.

While in law school, Sarah interned at FDA’s Office of Generic Drugs Policy at the Center for Drug Evaluation and Research and the Office of Legislation within the Office of Policy, Planning, Legislation, and Analysis. She also served as a judicial intern at the United States Court of Federal Claims’ Vaccine Claims/Office of Special Masters.

Sarah was named to The Best Lawyers in America Ones to Watch in 2023 for her work in Life Sciences.

In law school, Sarah received the William P. Cunningham award for her exceptional achievements and service to the law school, particularly for her work as a Student Attorney in the Intellectual Property Clinic, Staff Editor and Symposium Chair for the Journal of Health Law and Policy, Research Assistant to Professor Leslie Meltzer Henry, and a mentor to fellow students interested in food and drug law.

Sarah frequently writes and presents on topics related to drug, biologic and device law and regulation and is a frequent contributor to Goodwin’s Life Sciences Perspectives blog. Her other recent publications and presentations include:

• Contributor, “How FDA Really Works: Insights from the Experts, Chapter 4: Navigating Alternative Pathways for Drugs and Biologics, “ Food and Drug Law Institute, November 2022
• Co-Panelist, “Investigator-initiated Trials (IIT) Breakout: I’m Doing What?! Regulatory Responsibilities When the Investigator is Also the Sponsor, “ WCG/MAGI West Clinical Research Conference, October 2022
• Co-Panelist, “Investigator-Initiated Trials (IIT) Breakout: Pros and Cons of IIT Program Structures – Which One is Right for Your Organization,” WCG/MAGI West Clinical Research Conference, October 2022
• Speaker, “You Want What? Practical Negotiation Techniques Workshop,” WCG/MAGI East Clinical Research Conference, May 2022
• Co-Author, “ClinicalTrials.Gov: Pitfalls for pregnant women looking to enroll in studies,” Contemporary Clinical Trials Communications, April 2022 
• Co-Author, “The Pathway Forward: Insights on Factors that Facilitate Research with Pregnant Women,” Ethics & Human Research, July-August 2020
• Contributor, “Gold nanoparticles loaded with Cullin-5 DNA increase sensitivity to 17-AAG in Cullin-5 Deficient Breast Cancer Cells,” International Journal of Pharmaceutics, June 2019
• Prior to joining Goodwin, Sarah frequently wrote for the FDA Law Blog
• Keynote Speaker, “The Rare Disease Treatment Approval Process: Balancing Gold Standard Evidence with Patient-Centered Flexibility,” University of Minnesota Rare Disease Day, February 2020*
• Speaker, “Patient-Focused Drug Development: An Overview,” University of Minnesota Rare Disease Day, February 2020*

*Denotes presentation given prior to joining Goodwin