- Represented Morgan Stanley & Co. LLC in its underwriting of a $276 million follow-on public offering of Immunomedics, Inc. shares.
- 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.
- Counseled a public biopharmaceutical company on the resolution of a clinical hold following an unexpected patient death in a combination therapy trial.
- Drafted a research site agreement and advised on a patient informed consent for the first right to try program.
- Counseled 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.
- Advised early- to late-stage developers in the drug, device, and diagnostic areas on product development pathway strategies, regulatory submissions, clinical development meetings with the FDA, expanded access programs, expedited program designations, patient engagement, and corporate communications.
- Negotiated the regulatory terms of clinical trial agreements, pharmacovigilance agreements, study site letters of indemnification, clinical collaboration and development agreements, and supply and quality agreements.
- Advised manufacturers, healthcare providers and distributors on DEA and state controlled substance registration and reporting requirements for the distribution of controlled substances.
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.
Ms. Tibbets is a member of the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, and the Drug Information Association.