Attorney, Member of the Firm
Holly Little is a seasoned attorney with particular experience in life sciences and health care law, including all types of contracts, reimbursement issues, healthcare management, and compliance. Before joining Outside GC, Holly served for nearly 15 years as General Counsel and COO for Houston Heart & Vascular Associates, a clinical research organization (CRO), which conducted clinical trials and related services for major pharmaceutical sponsors, including Amgen, Novartis, Novo Nordisk, GSK and Sanofi. In this role, Holly led negotiations with sponsors, and drafted and finalized agreements for all phases of clinical development including clinical trial agreements, informed consent forms, contract research organization agreements, Master Services Agreements and other trial-related agreements. Holly advised on development issues including healthcare fraud and abuse, pharmacovigilance, regulatory, privacy and other matters relevant to the development of innovative investigational agents. Holly has significant experience and a strong working knowledge of the laws, regulations and industry standards governing clinical trials, including FDA regulations, ICH guidelines, GCP guidelines as well as data protection and privacy laws.
Before turning her focus to life sciences and healthcare, Holly worked as a securities lawyer, both in government for the investment management division of the Securities and Exchange Commission in Washington, DC, and in private practice at Morrison & Foerster, where she worked on mergers and acquisitions for Fortune 500 companies. Holly also worked in the entertainment world as in-house counsel for BET Holdings, and is the co-founder of Hill & Little, PLLC, a minority and woman owned law firm working with the FDIC outside counsel management group.
Holly holds a B.A. in Economics (with Honors) from the University of Massachusetts at Amherst, a JD from Northeastern University School of Law, and an LLM in Corporate & Securities Law from Georgetown University School of Law.
Holly has served as the Head of Advocacy for the Human Trafficking Ministry for the Woodlands Church Atascocita. She holds a board position with the Houston Chapter of the Lupus Foundation and serves as National Council Member of the American Film Institute.