Jonathan M. Davis, MD

Tufts CTSI Associate Director; Vice-Chair of Pediatrics and Chief of Newborn Medicine; Professor of Pediatrics
Tufts CTSI; Tufts Medical Center; Tufts University School of Medicine

As the Associate Director of Tufts CTSI, Dr. Jonathan Davis provides leadership across many of the institute’s programs in areas of emphasis related to his considerable expertise in multisite clinical trials and regulatory science. His roles have included directing Tufts CTSI’s Clinical and Translational Research Center, Regulatory Affairs program, Trial Innovation Network (TIN) Liaison Team, and Clinical Research Operations and Innovations program.

A neonatologist, Dr. Davis’ research has contributed to the development of treatments and diagnostics for a variety of conditions affecting newborns and infants and to improved processes of evidence generation for neonatal care. His recent NCATS-funded GEMINI trial examined genomic sequencing in 400 infants with a suspected genetic disorder and found a variant related to phenotype in 52% of patients with over 130 new variants detected. These results published in JAMA have generated significant interest in developing novel therapies to treat many rare diseases and led to numerous awards.

Dr. Davis is funded by the FDA to examine the use of real-world data to generate real world evidence for regulatory decision making. Dr. Davis also has published extensively on how the opioid epidemic has impacted pregnant women and their newborns, reporting that genetic and epigenetic factors are emerging as crucial components of opioid withdrawal. This background and expertise has provided opportunities for advocacy including helping to pass legislation such as the FDA Safety and Innovation Act and the Protecting Our Infant Act.

Dr. Davis has also participated in approximately 70 FDA and NIH Advisory Committees with many involving drug and device development. He is Director of the International Neonatal Consortium (INC; FDA/European Medicines Agency/Critical Path Institute), chair of the Neonatal Advisory Committee in the Office of the Commissioner at FDA, and an advisor to the Office of the Assistant Secretary of Health at HHS and the Critical Path Institute. Dr. Davis is currently funded through the Pediatric Device Consortium program at FDA and is on the Executive Committee of the Systems of Hospitals for Innovation in Pediatrics: Medical Devices funded by FDA and the Foundation for the National Institutes of Health.