- 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
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.