Sarah L. Wicks Associate 202-800-3277
Sarah L. Wicks
Practice Areas
Industries
FDA Regulatory Categories

Overview

Sarah L. Wicks counsels innovative drug and biologics companies on FDA regulatory and compliance matters that arise in the development and commercialization of new products and indications. These issues regularly include those relating to human subject protections and the conduct of clinical trials, product development strategies, interactions with the FDA, advertising, promotion and labeling, internal investigations and responding to FDA inspection observations and enforcement actions. Ms. Wicks also advises FDA-regulated entities in corporate transactions, offerings and licensing matters.

Ms. Wicks is also an adjunct professor at the George Washington University Law School where she coaches teams competing in health law moot court and other FDA and healthcare law related competitions. Ms. Wicks 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).

Ms. Wicks originally joined the firm in 2019 and was an associate in the life sciences regulatory and compliance practice of a large international law firm in Washington, D.C. While in law school, Ms. Wicks interned at FDA’s Office of Generic Drugs Policy within the Center for Drug Evaluation and Research and the Office of Legislation within the Office of the Commissioner. She also served as a judicial intern at the United States Court of Federal Claims’ Vaccine Claims/Office of Special Masters.

Education & Admissions

Education

BS, Towson University, cum laude
Cell and Molecular Biology

J.D. University of Maryland School of Law
Health Law and Intellectual Property Concentrations

M.P.H. Johns Hopkins Bloomberg School of Public Health

Admissions

Maryland
District of Columbia

Experience

  • 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 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.
  • Counsels the medical affairs and promotional review committees of drug and biologic companies on ensuring compliant pre- and post-approval promotional materials and activities.
  • Conducts internal investigations on regulatory compliance matters, including investigations relating to good clinical practices and data integrity.
  • Counsels on the resolution of Form FDA 483 observations and warning letters.
  • Negotiates the regulatory terms of research agreements. clinical trial agreements, pharmacovigilance and safety data exchange agreements, consulting agreements, clinical collaboration and development agreements, supply and quality agreements, and master services agreements with CROs and CMOs/CDMOs.
  • 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.
  • Conduct regulatory due diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotechnology companies and other mergers, acquisitions, capital market transactions, and other corporate matters involving FDA-regulated entities.

Honors & Awards

  • Best Lawyers Ones to Watch, 2023, 2025
    Life Sciences
  • Best Lawyers Ones to Watch, 2024, 2025
    Administrative and Regulatory Law
  • Super Lawyers, 2024
    Washington DC Rising Stars, FDA Law
  • CALI Excellence for the Future Awards
    Written and Oral Advocacy and Trademark Law

Speaking Engagements

  • Presenter, Baltimore Chapter of the Society of Clinical Research Associates (SOCRA), Pregnant and Lactating Individuals in Clinical Research – FDA’s Authority and Moving from Exclusion to Inclusion, September 12, 2024
  • Co-Panelist, WCG/MAGI West Clinical Research Conference, Investigator-initiated Trials (IIT) Breakout: I’m Doing What?! Regulatory Responsibilities When the Investigator is Also the Sponsor, October 2022*
  • Co-Panelist, WCG/MAGI West Clinical Research Conference, Investigator-Initiated Trials (IIT) Breakout: Pros and Cons of IIT Program Structures – Which One is Right for Your Organization, October 2022*
  • Speaker, WCG/MAGI East Clinical Research Conference, You Want What? Practical Negotiation Techniques Workshop, May 2022*
  • Keynote Speaker, University of Minnesota’s Rare Disease Day 2020, The Rare Disease Treatment Approval Process: Balancing Gold Standard Evidence with Patient-Centered Flexibility, February 28, 2020
  • Speaker, University of Minnesota’s Rare Disease Day 2020, Patient-Focused Drug Development: An Overview, February 28, 2020

*Denotes presentation given prior to joining the firm

Education

BS, Towson University, cum laude
Cell and Molecular Biology

J.D. University of Maryland School of Law
Health Law and Intellectual Property Concentrations

M.P.H. Johns Hopkins Bloomberg School of Public Health

Admissions

Maryland
District of Columbia

Practice Areas
Industries
FDA Regulatory Categories