- Provides strategic advice on matters involving product development and marketing approval, including clinical trial design, expedited pathways, exclusivity and incentives programs.
- 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.
- Conducts regulatory due diligence reviews and provides corporate support for mergers, acquisitions and other corporate matters involving FDA-regulated entities.
- Advises on the federal and state regulatory status of hemp-derived CBD products, including product-specific labeling and registration requirements and manufacturer and distributor licensing/registration requirements.
Ms. Wicks is a member of Women in Bio and the Food and Drug Law Institute (FDLI).
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.