Mentoring in Clinical Pharmacology and Early Phase Trials

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Historically, >50% of drugs have insufficient labeling to inform physicians on dosing, safety, or efficacy in vulnerable populations including children, pregnant women, and the elderly. Mechanisms requiring the study of new products in vulnerable populations are relatively new and highlight a training gap in junior scientists related to the investigation of therapeutic agents. There is an urgent need for well-trained adult and pediatric investigators with quantitative research skills in clinical pharmacology and clinical trials. In this award, the investigator, Michael Cohen-Wolkowiez, MD, PhD, will prepare adult and pediatric junior scientists for a career in patient-oriented research to bridge this gap in accordance with his own long-term research goals: to improve drug development by establishing proper dosing, safety, and efficacy of drugs used in vulnerable populations. To date, Dr. Cohen-Wolkowiez has achieved early success in training beginning scientists by leveraging every research mechanism for training in clinical pharmacology and clinical trials. Most of these research projects and trainees have been focused on anti-infectives. In this award, he will further expand his training program to include more adult trainees and use several research infrastructures for training. These include funding mechanisms such as the NIAID Phase 1 Clinical Trial Unit (P1CTU) of Anti-Infectives contract, the Pediatric Trials Network (PTN), and the FDA Global Pediatric Clinical Trials Network (GPCTN). The NIAID-sponsored P1CTU is a 10-year contract to conduct early phase studies of anti-infectives at the Duke Phase 1 Clinical Research Unit, which he directs. The NICHD-sponsored PTN, for which the applicant is an Executive Committee Member and PI of several clinical trials within the network, has ~30 ongoing clinical trials that the applicant has used for training of junior investigators. Through this mechanism, the candidate has successfully developed four young investigators who have secured their own NIH funding. The FDA-sponsored GPCTN is a recent mechanism that aims to provide pediatric clinical trial infrastructure to conduct studies for labeling. Additional strengths of Dr. Cohen-Wolkowiez program include the unparalled research infrastructure of the Duke Clinical Research Institute, and a longstanding academic partnership with the renowned University of North Carolina School of Pharmacy. Through this integral partnership, Dr. Cohen-Wolkowiez serves as the Duke Fellowship director of an NIH-sponsored T-32 clinical pharmacology fellowship training program and a pathway for junior investigators to secure PhD or Masters level training in clinical pharmacology.Trainees in clinical pharmacology and clinical trials will be recruited at Duke University to lead research projects. Specifically, the proposed studies, will offer mentees the opportunity to capitalize on the diverse research program that Dr. Cohen-Wolkowiez has developed. Feasibility of the proposed award is shown by Dr. Cohen- Wolkowiez' early success in funding and career development of current trainees at Duke and UNC and by trainees' publication track record; >80 peer-reviewed articles with trainees as first author.