This is a proposal to continue the evolution of postdoctoral training in clinical pharmacology as a collaborative program in pediatric and adult therapeutics in the joint program between Thomas Jefferson University (TJU) with the Children?s Hospital of Philadelphia (CHOP). The goal is to realize one key objective of the NIGMS-NICHD collaboration in clinical pharmacology as a leading joint program training clinician investigators to translate novel discoveries into therapeutic paradigms that transform disease management for children and adults. The program is designed for eight postdoctoral fellows, including MDs and MD-PhDs, and PharmDs, focused on human pharmacology and therapeutics. While training integrates therapeutics across the developmental continuum for fellows, half pursue careers in pediatric and half in adult clinical pharmacology to address shortages in these communities of practice nationally. The program, which is two years with the potential to extend for a third year, expands a well-established curriculum of didactic coursework, conferences, and rotations (20% effort) and research (80% effort). The breadth of pediatric and adult clinical pharmacology is delivered using a framework built on the TJU Training Program in Human Investigation (former NIH K30 Program). Courses cover clinical pharmacology, clinical trials design, statistics, pharmacoepidemiology, pharmacometrics, drug development, ethics, management, leadership, grant writing and presentation skills. Advanced training in academic and industrial pharmacometrics is an elective offering. Conferences include journal club in human therapeutics, research ethics, and seminars in human therapeutics. Rotations provide experience in the critical analysis of the scientific literature on the editorial board of the Annals of Internal Medicine; critical review of pediatric (CHOP) and adult (TJU) human subjects research on institutional review boards (IRBs); clinical trial execution in the TJU Clinical Research Unit; special issues in pediatric therapeutics on the CHOP formulary and investigational new drug (IND) committees, or analytic method development to support trainee pharmacokinetic studies. Fellows customize their education by selecting electives congruent with career aspirations, including drug development at Merck and/or rotation at the Food and Drug Administration (FDA). The majority of fellows? time is focused on independent, hypothesis-driven research. Opportunities in pediatric and adult experimental therapeutics are offered by 54 preceptors representing 9 broad areas of distinction, including cancer, cardiopulmonary medicine, neurosciences, virology and immunology, connective tissue biology, pediatric oncology, systems and clinical pharmacology, gastroenterology, and pediatric therapeutics. Preceptors are selected based on their productive research programs related to therapeutics, training success, and commitment to train fellows. This program will continue to build upon an exemplary record of recruiting qualified diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and FDA.

Public Health Relevance

Advances in the new biology are transforming drug therapy, the most cost-effective component of healthcare. Yet, at this time of scientific opportunity, shortages in specialized workforces limit the discovery and development of drugs and their safe use in adults and children. To fill that gap, Thomas Jefferson University and the Children?s Hospital of Philadelphia have developed a successful joint Clinical Pharmacology Fellowship Program to train clinician scientists that translate new discoveries into drugs that revolutionize care of adults and children.

National Institute of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Institutional National Research Service Award (T32)
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Special Emphasis Panel (ZGM1)
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Garcia, Martha
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Thomas Jefferson University
Schools of Medicine
United States
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Tran, Benjamin Duy; Moorthy, Ganesh S; Zuppa, Athena F (2018) Ketamine and norketamine stability in whole blood at ambient and 4°C conditions. Biomed Chromatogr 32:
Moore, Jason N; Gastonguay, Marc R; Ng, Chee M et al. (2018) The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome. Clin Pharmacol Ther 103:1029-1037
Li, Peng; Lin, Jieru E; Snook, Adam E et al. (2017) ST-Producing E. coli Oppose Carcinogen-Induced Colorectal Tumorigenesis in Mice. Toxins (Basel) 9:
Zane, Nicole R; Reedy, Michael D; Gastonguay, Marc R et al. (2017) A Population Pharmacokinetic Analysis to Study the Effect of Therapeutic Hypothermia on Vancomycin Disposition in Children Resuscitated From Cardiac Arrest. Pediatr Crit Care Med 18:e290-e297
Weinberg, David S; Lin, Jieru E; Foster, Nathan R et al. (2017) Bioactivity of Oral Linaclotide in Human Colorectum for Cancer Chemoprevention. Cancer Prev Res (Phila) 10:345-354
Healy, Jason R; Bezawada, Padmavani; Griggs, Nicholas W et al. (2017) Benzylideneoxymorphone: A new lead for development of bifunctional mu/delta opioid receptor ligands. Bioorg Med Chem Lett 27:666-669
Avant, Debbie; Baer, Gerri; Moore, Jason et al. (2017) Neonatal Safety Information Reported to the FDA During Drug Development Studies. Ther Innov Regul Sci 2017:1-9
Mantravadi, Santhi; Ogdie, Alexis; Kraft, Walter K (2017) Tumor necrosis factor inhibitors in psoriatic arthritis. Expert Rev Clin Pharmacol 10:899-910
Li, Peng; Wuthrick, Evan; Rappaport, Jeff A et al. (2017) GUCY2C Signaling Opposes the Acute Radiation-Induced GI Syndrome. Cancer Res 77:5095-5106
Mari, Elisabeth R; Rasouli, Javad; Ciric, Bogoljub et al. (2016) Galectin-1 is essential for the induction of MOG35-55 -based intravenous tolerance in experimental autoimmune encephalomyelitis. Eur J Immunol 46:1783-96

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