Sarah L. Wicks

• 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.

• Best Lawyers Ones to Watch, 2023
  Life Sciences
• Best Lawyers Ones to Watch, 2024
  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

• 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

• FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/ClarificationsApril 25, 2024

  By Sarah Wicks & Dara Katcher Levy —

• Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA DiscretionMarch 8, 2020

  By Sarah Wicks & David B. Clissold —

• A Small Victory for Theranos – Judge Dismisses 4 Counts of Conspiracy and Wire Fraud Against Former ExecutivesMarch 1, 2020

  By Sarah Wicks & Véronique Li, Senior Medical Device Regulation Expert —

• FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a BackseatJanuary 15, 2020

  By Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks —

• Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative MedicineNovember 21, 2019

  By Sarah Wicks & James E. Valentine & Frank J. Sasinowski —