- Represents clinical-stage companies developing COVID-19 focused treatment and vaccines and counsels OTC drug developers on allowable product claims and formulations.
- Advises early- to late-stage developers in the drug, device, digital health and diagnostic areas on product development pathway strategies, regulatory submissions, meetings with the FDA, data disclosures, expedited program designations, patient engagement, disease awareness programs and corporate communications.
- Counsels numerous public biopharmaceutical companies on the resolution of clinical holds, including those issued following unexpected patient deaths.
- Counsels the medical affairs and promotional review committees of biologic, drug, medical device, diagnostic and laboratory companies on managing regulatory risks and ensuring compliant materials and activities across a broad portfolio of products and uses.
- Drafted a research site agreement and advised on a patient informed consent for the first right to try program in ALS and counsels numerous biopharmaceutical companies on expanded access program policies, agreements, INDs, and related clinical documentation.
- Conducts internal investigations on regulatory compliance matters, including investigations relating to good clinical practices, product promotion and drug sampling.
- Counsels on the resolution of Form FDA-483 observations and warning letters.
- Negotiates the regulatory terms of clinical trial agreements, pharmacovigilance agreements, study site letters of indemnification, clinical collaboration and development agreements, and supply and quality agreements.
- Advises manufacturers, healthcare providers and distributors on DEA and state controlled substance registration and reporting requirements for the distribution of controlled substances.
- Provides BridgeBio Pharma and its subsidiaries with regulatory counseling in connection with data releases, clinical operations, medical and corporate communications and regulatory disclosures.
- Represented AMAG Pharmaceuticals in the sale of its rights to Intrarosa® to Millicent Pharma for up to $125 million.
- Represented Morgan Stanley & Co. LLC on regulatory matters in conjunction with its underwriting of a $276 million follow-on public offering of Immunomedics, Inc. shares.
- Represented Akero Therapeutics on regulatory matters in conjunction with its $216.4 million upsized public offering of common stock and full exercise of underwriters’ option to purchase additional shares.
- Represented Pliant Therapeutics on regulatory matters in conjunction with its $165.6 million IPO and full exercise of option to purchase additional shares.
- Represented SpringWorks Therapeutics on regulatory matters in conjunction with its $186.3 million IPO.
- Represented Fresenius Medical Care in regulatory due diligence for its $150 million equity investment in Humacyte, Inc. and exclusive distribution rights for Humacyte’s investigational human acellular vessel, a regenerative medicine product, to dialysis patients worldwide.
- Represented Nautic Partners on its acquisition of Mikart, Inc., a contract development and manufacturing organization.
Ms. Tibbets represents The Fed Is Best Foundation in its national pursuit of regulatory, legislative, and policy changes to set minimum newborn nutritional requirements and to increase parent and health care provider education regarding newborn nutrition and safe feeding practices.
In 2020, Ms. Tibbets began representing VoteRiders, a nonpartisan, nonprofit organization founded in 2012 with a mission to ensure that all citizens are able to exercise their right to vote.
Ms. Tibbets is a member of the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, and the Drug Information Association.