P E P P | Pharmacogenomics, Ethics and Public Policy
Note - Archived content, PEPP is a retired program.
What is Pharmacogenomics?
Pharmacogenomics is the latest enterprise in a number of genetic-based fields of study emerging from the Human Genome Project. As a result of the increasing knowledge of the human genome, there have been unprecedented advances in recent years in the understanding of genetic factors that influence the activity of drugs. Pharmacogenomics encompasses the study of the myriad interactions between genes and pharmacotherapy, and the application of genomic information to drug design and discovery. Pharmacogenomics promises a futuristic era of "personalized medicine" where the discovery of genetic variances that affect drug action will lead to the development of new diagnostic procedures and therapeutic products that will enable clinicians to prescribe drugs selectively to patients for whom they will be effective and safe.
As a new paradigm for drug development and clinical medicine, pharmacogenomics will raise important social and ethical questions related to the use and storage of genetic samples and data; genotypic stratification of patients in clinical trials; informed consent, confidentiality, and privacy within such trials; clinical inclusion in or exclusion from drug delivery regimes; the regulation of diagnostics and medicines; and the organization of health policy in the genomic era.
Goals of the Program
The goal of the PEPP program is to foster scholarship and career advancement in pharmacogenomics, bioethics, and public policy. The program provides fellows with a broad understanding of the key problems, ethical, social, legal and regulatory issues in pharmacogenomics research and clinical application. Additionally, the program provides opportunities for fellows to hone skills in critically examining pharmacogenomics and related literature; initiate and execute fully developed research proposal; and prepare presentations and articles for publication. Competence in all of these areas will be achieved through an individualized didactic training and an intensive program of mentored research. During the first year, the fellow develops a performance plan that will identify goals, key action steps, target date, dimensions, standards of performance (measurements) as well as proposed development needs. These performance plans are evaluated quarterly in conjunction with the fellow's mentor.
Program Description
The pharmacogenomics, ethics, and public policy program at Indiana University offers:
- A research program for highly motivated individuals with the skills necessary to contribute to knowledge at the intersection of pharmacogenomics, ethics, and public policy.
- A training program designed for the development of competence in pharmacogenomics, public policy, research ethics, and bioethics.
- Internship in a health policy setting.
- Individualized academic program
- Supervised research and/or teaching opportunities
Funded, in part, by the PhRMA Foundation, the PEPP program offers qualified post-doctoral candidates a strong foundation for a career of teaching and research in the ethical, legal, and social aspects of pharmacogenomics.
The PEPP program is offered through the Indiana University Division of Clinical Pharmacology and the Indiana University Center for Bioethics. The setting provides an excellent environment in which multidisciplinary research is an important and well-established tradition. The Division of Clinical Pharmacology and the Center for Bioethics bring together nationally recognized core and affiliated faculties with specialties in medicine, pharmaceutical science, law, bioethics, and humanities, social science, medical genetics, and philosophy.
PEPP fellows will undergo didactic training and research at the intersection of pharmacogenomics, ethics and public policy under the mentorship of selected core and affiliate faculty. These senior researchers will guide each PEPP fellow through a rigorous, systematic, and integrated course of study.
Fellows entering the PEPP program hold advanced degrees such as PhD, MD, or Pharm. D. Selection of fellows is designed to reflect variety in field, discipline, and diversity in levels of prior experience, research interest and goals. Each fellow's program of study and research is tailored to his or her prior training, needs and interest, and includes a curriculum of coursework, in-depth hands-on research opportunities, and active participation in workshops, seminars, symposia and journal club meetings. Length of time in the program is two years.
