Mentoring in Anti-Infective Clinical Pharmacology and Pharmacometrics

Invasive infections caused by resistant pathogens are a growing public health threat. Optimizing the use of anti- infective drugs is critical to reduce the morbidity and mortality associated with invasive infections. Anti-infective dose optimization studies depend on the characterization of pharmacokinetic/pharmacodynamic (PK/PD) relationships and drug safety. Yet these studies are challenging due to the limited number of investigators with expertise in clinical pharmacology and pharmacometrics. My K24 Midcareer Investigator Award proposal aims to address this gap by mentoring junior researchers in clinical pharmacology and pharmacometrics, equipping them with the skills needed to design and execute PK/PD studies, optimize anti-infective drug dosing, and tackle anti-infective drug resistance. I am uniquely positioned to mentor the next generation of researchers in this field due to my PharmD and PhD training, postdoctoral fellowship in clinical pharmacology, K23 Career Development Award training, my success in securing independent R01 grants, and leadership roles in federally funded T32 and K12 training programs. My research has helped to guide anti-infective drug dosing guidelines for pediatric populations, including premature infants and children with obesity. I have published 117 peer-reviewed articles, and 64 of these publications were published together with my mentees. As a mentor, I have successfully guided over 30 mentees, many of whom now hold faculty positions. By serving as the contact Principal Investigator for T32 and K12 grants, I have established a robust pipeline of trainees in clinical pharmacology and pharmacometrics. This K24 application will leverage my NIH-funded research programs, the infrastructure of the Duke Clinical Research Institute (DCRI), and partnerships with the Pediatric Trials Network (PTN) and the Antibacterial Resistance Leadership Group (ARLG). Mentees will receive access to rich clinical datasets, and structured mentorship in PK/PD study design, pharmacometrics methods, grant writing, and research dissemination. Mentees will be expected to complete graduate-level didactic coursework and hypothesis-driven research projects, culminating in peer-reviewed publications and preliminary data for independent grant applications. Through protected time and focused effort, I aim to foster a talented pool of mentees committed to addressing challenges in anti-infective dose optimization in vulnerable patient populations. This K24 award will enhance my capacity to mentor junior investigators while cultivating future leaders equipped to advance clinical pharmacology research across vulnerable patient populations and contribute to developing safe and effective anti-infective therapies with scalable mentoring approaches applicable to other therapeutic areas. Project Number: 1K24AI196322-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator: Daniel Gonzalez | Institution: DUKE UNIVERSITY, DURHAM, NC | Award Amount: $203,556 | Activity Code: K24 | Study Section: Special Emphasis Panel[ZRG1 IIDA-N (82)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1K24AI19632201