This is a proposal to evolve postdoctoral training in clinical pharmacology at Thomas Jefferson University (TJU) into a collaborative program in pediatric and adult therapeutics with the Children's Hospital of Philadelphia (CHOP). The goal is to realize one key objective of the NIGMS-NICHD collaboration in clinical pharmacology to create the first program training clinician investigators to translate novel discoveries into therapeutic paradigms that transform disease management for children and adults. The program is designed for four postdoctoral fellows, including MDs and MD-PhDs, PharmDs, and PhDs focused on human pharmacology and therapeutics. While training integrates therapeutics across the developmental continuum for fellows, half will pursue careers in pediatric or adult clinical pharmacology, respectively, 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 the well-established curriculum of didactic coursework, conferences, and rotations (20% effort) and research (80% effort), to compare and contrast pediatric and adult therapeutics. 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 include adult and pediatric clinical pharmacology, clinical trials design, statistics, pharmacoepidemiology, pharmacometrics, drug development, ethics, management, leadership, grant writing and presentation skills. Conferences include journal club in human therapeutics, adult and pediatric 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; and special issues in pediatric therapeutics on the CHOP formulary and investigational new drug (IND) committees. Trainees 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 45 preceptors representing 8 areas of distinction within the TJU-CHOP collaborator, including cancer, cardiopulmonary medicine, neurosciences, virology and immunology, connective tissue biology, pharmacometrics, genomics, and pediatric therapeutics. Preceptors represent a spectrum of disciplines and methodologies to ensure broad training opportunities. They are selected on the basis of their productive extramurally-funded research related to therapeutics, training success, and commitment to train fellows. This evolution of the program will build upon an exemplary record of recruiting qualified diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and FDA.
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 formed a joint Clinical Pharmacology Fellowship Program to train clinician scientists that translate new discoveries into drugs that revolutionize care of adults an children.
| 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 |
| Blanco, Fernando F; Preet, Ranjan; Aguado, Andrea et al. (2016) Impact of HuR inhibition by the small molecule MS-444 on colorectal cancer cell tumorigenesis. Oncotarget 7:74043-74058 |
Showing the most recent 10 out of 75 publications
