Pharmacometric Training Unit

The Pharmacometrics Training Unit will provide educational and training resources to support the translational research conducted under the auspices of the CTSA. It will also provide an outlet for the great demand for education in this area of research and promote additional collaborations with the drug industry. Dr. Barrett will lead this effort and will collaborate extensively with researchers within the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania . Dr. Barrett has had a history of mentorship in the area of pharmacometric training. Table 3 lists Dr. Barrett's previous and current trainees in modeling and simulation technologies applied to translational medicine. Dr. Raymond Boston, Director of the Biomathematics Unit and Professor of Applied Biomathematics at University of Pennsylvania School of Veterinary Medicine will also co-direct this effort with Dr. Barrett. Dr. Boston's research has been concentrated in two major areas, data analysis and modeling, and the development of new statistical, mathematical, and computational techniques to assist with data analysis and modeling. In the methodological areas Dr. Boston led the team which developed the Consam and WinSAAM modeling software tools sponsored by the US National Institutes of Health and used by an estimated 3000 biomedical investigators around the world today.

The Pharmacometric Training Unit will leverage the existing infrastructure used to support the current Translational Medicine degree program through the University of Pennsylvania School of Medicine to include a pharmacometric track which focuses on the modeling and simulation skills essential to support the quantitative aspects of translational research. The initial foray into this arena will be a two-semester course on Pharmacometric Approaches to Translational Research . The course lectures for this offering will include the following topics: Quantitative Aspects of Translational Research, Compound Progression: Decision Theory Applied to Drug Development; Toxicology, Pharmacology and the Therapeutic Window; Sources of Variation in Experimentation; Statistical Primer on Regression and ANOVA; Basics of Model Building; Modeling Techniques; Applications in Model-based Research; Disease Progression; Simulation Theory; Simulation Application; Clinical Trial Design; Clinical Trial Simulation; Focus on Oncology; Focus on HIV; Focus on Parkinson's Disease. Of course, these courses will provide a framework from which additional education and training can be provided but will not fully address the expected didactic demands for mastery in this area. Table 4 outlines a proposal for a separate degree program in pharmacometrics which could be supported by the CTSA efforts and offered by the University of Pennsylvania .

Recently, the American College of Clinical Pharmacology (ACCP) has provided an on-line training resource ( http://accp1.org/pharmacometrics/index.html ) to promote independent investigation into the science of pharmacometrics. This website is supported by Dr. Joga Gobburu of the US Food and Drug Administration and was tested and evaluated by Dr. Barrett, a Regent of the ACCP. As a member of the FDA's Clinical Pharmacology Advisory Committee, Dr. Barrett continues to work with FDA scientists; FDA is promoting pharmacometric internships within the Office of Clinical Pharmacology and Biopharmaceutics which can likewise be extended to CTSA faculty, staff and students to further enrich their training. The Pharmacometric Training Unit is expected to receive heightened interest from industry with respect to both recruitment of degree graduates and the training of industrial scientists. Hence, future faculty recruitment will likely be an issue for this program. Current plans for faculty staffing will call extensively from the CHOP-Penn community and also leverage relationships with industrial scientists maintaining adjunct appointments at Penn (e.g., Dr. Michael Fossler from Glaxo SmithKine). Junior faculty with demonstrated skills in this area of research (Athena Zuppa, MD) will also support this unit with respect to faculty staffing.