Sarah Wicks is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic and medical device companies on FDA regulatory compliance issues, including advertising, promotion and labeling review, drafting and review of standard operating procedures, drug and device development issues, interactions with FDA, internal corporate investigations and responding to FDA inspection observations and enforcement actions. Ms. Wicks also advises FDA-regulated entities in corporate transactions, offerings and licensing matters.

Areas of Practice
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Experience

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EXPÉRIENCE

工作经历

  • 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.
  • Advises on regulatory compliance with good clinical practices, including informed consent, adverse event reporting, trial initiation and monitoring, sponsor and investigator responsibilities, financial disclosures and data integrity.
  • Negotiates the regulatory terms of clinical trial agreements, pharmacovigilance 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.
  • Provides advice to companies relating to general website and social media policies and seller guidelines relating to the marketing and promotion of hemp-derived CBD products.

Ms. Wicks’ 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:

  • 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
Professional Activities

Ms. Wicks is a member of the Society of Clinical Research Associates, Women in Bio and the Food and Drug Law Institute (FDLI).

Ms. Wicks’ 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.

Professional Experience
While in law school, Ms. Wicks 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.

Recognition

In law school, Ms. Wicks 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.

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专业资格

Education

J.D., Health Law and Intellectual Property, 2019
University of Maryland Francis King Carey School of Law
M.P.H., Focus on Clinical Trials & Pharmaceutical Regulations and Policy, 2019
Johns Hopkins Bloomberg School of Public Health
Pharmacoepidemiology and Drug Development Certificate, 2019
Johns Hopkins Bloomberg School of Public Health
B.S., Cell and Molecular Biology, 2014
Towson University
(cum laude)

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District of Columbia
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