- 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 FDA regulatory due diligence for its $150 million equity investment in Humacyte, Inc. and exclusive distribution rights for Humacyte’s investigational human acellular vessel to dialysis patients worldwide.
- 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-stage biopharmaceutical companies on product development strategy, regulatory submissions, expedited program eligibility, expanded access and “right-to-try” access, clinical hold resolution, clinical development meetings with the FDA and related corporate communications.
- Negotiated clinical trial agreements, pharmacovigilance agreements, study site letters of indemnification, clinical collaboration agreements and development agreements.
- Advised biologic, drug, device and diagnostic companies on the application of Physician Payments Sunshine Act reporting requirements to their businesses.
- Conducted FDA regulatory due diligence reviews of food, drug, device, clinical laboratory and dietary supplement companies and advised clients on the regulatory risk profiles of target companies and business units subject to pending mergers and acquisitions.
- Advised manufacturers, healthcare providers and distributors on DEA and state controlled substance registration and reporting requirements for the diversion or loss of controlled substances.
- Assisted food, dietary supplement and cosmetic manufacturers with new product launches, including review of product branding, labeling, marketing claims and substantiation.
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.