Julie Tibbets is a partner in Goodwin’s Technology and Life Sciences group and a member of its FDA practice.

Ms. Tibbets focuses her practice on FDA-regulated product development, marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, in vitro diagnostics, lab-developed tests, as well as digital health tools and apps. Ms. Tibbets advises clients on product development strategy, interactions with the FDA, clinical trial documentation, adverse event reporting, commercial strategy, product labeling and advertising. She also leads the regulatory due diligence reviews of FDA-regulated M&A or investment targets, potential collaborators and licensees, and guides the regulatory disclosures of FDA-regulated entities in their initial public offerings. Ms. Tibbets also works closely with the Food + Healthy Living practice team at Goodwin on the intersection of food, supplement and cosmetic regulation with FDA’s drug and device authorities.

Prior to joining Goodwin in 2018, Ms. Tibbets was a partner at Alston & Bird LLP.

Areas of Practice
TÄTIGKEITSFELDER
Domaines D’Expertise
业务范围

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

  • 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.

PRO BONO

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.

PROFESSIONAL ACTIVITIES

Ms. Tibbets is a member of the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, and the Drug Information Association.

Recognition

Ms. Tibbets was selected as an “Up and Coming” lawyer in Washington, D.C. for Pharmaceuticals / Medical Products Regulatory by Chambers USA 2019. Since 2013, she has appeared on the Washington, D.C., Super Lawyers list of “Rising Stars” in the FDA area and was selected by her peers for inclusion in The Best Lawyers in America every year since 2016 for FDA law. In 2018, LMG named Ms. Tibbets a “Regulatory Star.”

In The News

MELDUNGEN

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Credentials

WERDEGANG

RÉFÉRENCES

专业资格

Education

J.D., 2004
University of North Carolina, Chapel Hill

(Member, Law Review)

B.A., 2001
Purdue University

(Highest Honors, Phi Beta Kappa)

Admissions

Bar

District of Columbia
North Carolina
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