The Indiana University Training Program in Clinical Pharmacology has evolved significantly over the past five years, such that it now represents a more comprehensive and cutting edge training program. It is designed to provide a robust supply of clinician scientists trained in clinical pharmacology, a discipline ideally suited to our nation's current efforts to augment the translation of new and effective therapies into clinical practice. This application seeks to continue an established program that has a track record of excellence in training successful translational clinician scientists. The program has added formal training in pharmacometrics, pediatric clinical pharmacology and personalized medicine over the last funding period and has been made more robust by the establishment of the Indiana Institute for Personalized Medicine. The established program excellence in drug disposition, pharmacogenomics and drug development has been augmented with deeper didactic training by a new Center for Excellence in Pediatric Therapeutics and PREGMED, an NICHD Obstetric Pharmacology Research Network site. A core faculty of 15 has been selected on the basis of quality research related to clinical pharmacology, peer-reviewed funding and training success. This core faculty has funded research programs in both basic and clinical approaches to cancer, cardiovascular, HIV, gastrointestinal, pediatric, obstetric and geriatric clinical pharmacology, as well as drug-induced liver disease, drug metabolism and disposition, drug interactions, pharmacogenomics, and ethics in therapeutic research. The core faculty together with 22 supporting faculty now allow this program to serve as a central pillar within the institution's clinical research enterprise. The program contributes to a wide range of peer-reviewed research and provides critical synergies within the Indiana CTSI-catalyzed training for translational research. Trainees attend weekly team journal clubs specifically organized to break down silos between laboratories and clinical specialties, seminars in clinical pharmacology and personalized medicine, and an organized weekly didactic program that runs year round in a two year cycle. In depth didactic training now concentrates on pharmacokinetics, drugs and metabolites analysis, pharmacogenomics, pharmacometrics, drug development, individualized therapeutics, and clinical trial design in obstetric, pediatric, adult and geriatric clinical therapeutics. Trainees may also elect to participate in the Indiana University Master of Science in Clinical Investigation. The core faculty selects trainees for the 2 to 3 year program based on their potential as clinician scientists from candidates with M.D., PharmD, PhD, or M.D./ Ph.D. degrees and sufficient clinical training for primary specialty certification. Since first funded in 1992, qualified applicants have filled the training grant slots, and a robust applicant pipeline no exists. Our program has generated stably funded academic physician scientists and leaders in the pharmaceutical industry and continues to serve a prominent national role in training clinical pharmacologists.

Public Health Relevance

The Indiana University Research Training Program in Clinical Pharmacology proposed in this application is designed to generate new leaders able to implement the science of Clinical Pharmacology and Therapeutics in academic, industry or drug regulatory settings. The availability of a well-established Division of Clinical Pharmacology with a documented track record in accomplishing the goals of this training grant for many years, multiple well-funded and experienced investigator teams assembled to mentor trainees, a robust pipeline of applicants and an outstanding institutional training environment will continue to provide trainees the highest possible quality of training in this critical translational field.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Institutional National Research Service Award (T32)
Project #
5T32GM008425-22
Application #
8691842
Study Section
Special Emphasis Panel (ZGM1-BRT-5 (PD))
Program Officer
Okita, Richard T
Project Start
1992-07-01
Project End
2018-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
22
Fiscal Year
2014
Total Cost
$290,181
Indirect Cost
$20,025
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Burgess, Kimberly S; Ipe, Joseph; Swart, Marelize et al. (2017) Variants in the CYP2B6 3'UTR Alter In Vitro and In Vivo CYP2B6 Activity: Potential Role of MicroRNAs. Clin Pharmacol Ther :
Hertz, Daniel L; Speth, Kelly A; Kidwell, Kelley M et al. (2017) Variable aromatase inhibitor plasma concentrations do not correlate with circulating estrogen concentrations in post-menopausal breast cancer patients. Breast Cancer Res Treat 165:659-668
Pierson, Rebecca C; Gufford, Brandon T; Desta, Zeruesenay et al. (2017) Clinical and educational impact of pharmacogenomics testing: a case series from the INGENIOUS trial. Pharmacogenomics 18:835-841
Robarge, Jason D; Metzger, Ingrid F; Lu, Jessica et al. (2017) Population Pharmacokinetic Modeling To Estimate the Contributions of Genetic and Nongenetic Factors to Efavirenz Disposition. Antimicrob Agents Chemother 61:
Towns, Rachel; Quinney, Sara K; Pierson, Rebecca C et al. (2017) Survey of Provider Preferences Regarding the Route of Misoprostol for Induction of Labor at Term. AJP Rep 7:e158-e162
Kadakia, Kunal C; Kidwell, Kelley M; Seewald, Nicholas J et al. (2017) Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors. Breast Cancer Res Treat 164:411-419
Gufford, B T; Ainslie, G R; White Jr, J R et al. (2017) Comparison of a New Intranasal Naloxone Formulation to Intramuscular Naloxone: Results from Hypothesis-generating Small Clinical Studies. Clin Transl Sci 10:380-386
Hertz, D L; Kidwell, K M; Seewald, N J et al. (2017) Polymorphisms in drug-metabolizing enzymes and steady-state exemestane concentration in postmenopausal patients with breast cancer. Pharmacogenomics J 17:521-527
Eadon, M T; Desta, Z; Levy, K D et al. (2016) Implementation of a pharmacogenomics consult service to support the INGENIOUS trial. Clin Pharmacol Ther 100:63-6
Cho, Doo-Yeoun; Shen, Joan H Q; Lemler, Suzanne M et al. (2016) Rifampin enhances cytochrome P450 (CYP) 2B6-mediated efavirenz 8-hydroxylation in healthy volunteers. Drug Metab Pharmacokinet 31:107-16

Showing the most recent 10 out of 110 publications