Phillip Davis, MD

Phillip Davis, MD

Senior Clinical Consultant

Dr. Davis joined Biologics Consulting as a Senior Clinical Consultant in December 2018 after 10 years with the Food and Drug Administration in the Division of Medical Imaging Products.

At FDA’s Center for Drug Evaluation and Research, Dr. Davis was the lead clinical reviewer on over 100 INDs, NDAs and combination drug/device product submissions for diagnostic imaging and radiation emitting drugs. His drug development experience covers a wide range of therapeutic areas including oncology, neurology, cardiology, rheumatology, pulmonary medicine and infectious disease as well as products designated orphan drugs for rare diseases. At FDA, he was frequently called upon to act as the lead spokesperson for his division at national meetings and has extensive experience in expanded access and request to charge submissions.

Phillip received his BS in Biology from the University of South Carolina in 1997 (Minor in Business Administration), and his MD from the Medical University of South Carolina (Charleston) in 2004; he completed a postdoctoral research fellowship in 2005, an internal medicine internship 2006 and a nuclear medicine residency in 2008. Dr. Davis has also completed graduate level coursework at The Citadel Military College in the College of Business.

At Biologics Consulting, Dr. Davis uses his clinical, regulatory and public health experience combined with a sound business acumen to assist clients in the following:

  • Design of phase 1, 2 and 3 clinical trials to support U.S. marketing authorization
  • Regulatory and clinical development strategy planning
  • Expanded Access and Request to Charge submissions to FDA
  • Review and authoring of clinical sections of FDA meeting packages, pre-IND, IND and NDA submissions
  • Preparation for FDA and FDA Advisory Committee meetings and responses to FDA information requests
  • Assistance with clinical and reimbursement initiatives involving outreach to government agencies, legislative bodies or other key stakeholders

Education

MBA Program Studies (non-degree seeking), Citadel Military College, Charleston, SC (2014-2015)

M.D. The Medical University of South Carolina, Charleston, SC (2004)

B.S. Biology, minor in Business Administration, University of South Carolina, Columbia, SC (1997)