Jonathan Davis

Research/Areas of Interest

I do not accept students for research at this time.

I provide leadership across many programs associated with the Tufts Clinical and Translational Science Institute (CTSI), with considerable expertise in multisite clinical trials and regulatory science. I have served as Director of the Clinical and Translational Research Center, Director of Regulatory Affairs, Director of the Trial Innovation Network Hub, Director of Clinical Research Operations and Innovations, and now Associate Director of Tufts CTSI. I am active at FDA and NIH, conducting numerous national consultations that have led to multiple awards. Our own GEMINI trial was published in JAMA and 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 (receiving numerous awards). These results have generated significant interest in developing novel therapies to treat rare diseases. I was funded by FDA to examine the use of Real-World Data (RWD) to generate Real World Evidence (RWE) for regulatory decision making. Can FDA use RWD to simulate a control group when conducting clinical trials? We have also reported that genetic
and epigenetic factors in mother and infant are crucial in opioid withdrawal and conducted the first multisite randomized trial (funded by NIH) examining the best pharmacologic treatments and novel devices to prevent severe opioid withdrawal in neonates. I am funded by the FDA's Pediatric Device Consortium and served on the Executive Committee for the System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD; Rosenthal G, Pediatr Res 2026) which is being operationalized by the foundation for the NIH. This background and expertise in regulatory science including Chair of the Neonatal Advisory Committee and an ad hoc member of the Pediatric Review Committee at FDA has provided opportunities for advocacy including an integral role in the passage of legislation such as the FDA Safety and Innovation Act and Protecting Our Infant Act. I have also participated in numerous federal advisory committees with many involving drug and device development. My significant expertise in innovative approaches to developing better diagnostics, drugs, biologics, and devices and my strong interest in regulatory science will allow me to provide unique input for this project. The hope is to dramatically alter the clinical landscape for innovation in order to benefit many high-risk populations including infants and children