New Fellowship Bolsters Clinical Trials Research Opportunity at Temple University
With Philadelphia at the epi-center of the pharmaceutical industry, Temple University is strategically positioned to offer unique educational opportunities in clinical research. To harness these opportunities, Temple University's Schools of Pharmacy and Medicine have jointly developed the PharmD post-doctoral clinical research fellowship. Fellows learn to operate as investigators, sub-investigators and research professionals.

Extremely complex, clinical trials research involves multiple agencies, myriad rules and increasing scrutiny, policies and regulation. Clinical trials coordinators need to be fluent in FDA regulations, drug company protocols and the inner workings of academic medicine, firmly linking the clinical research site with the sponsor, usually a pharmaceutical company or medical device manufacturer. Additionally, coordinators are responsible for recruiting and retaining research participants, managing the collection of research data, and thoroughly understanding the ethical and legal issues inherent in clinical research.

The first two fellows, Drs. Fouad Ghannam and Tom Jacobsen, are working on clinical trials with School of Medicine faculty in nephrology, general internal medicine, gastroenterology, pulmonology and infectious diseases.

"It's a win-win arrangement," explains Dr. Henry Parkman, associate professor of medicine and physiology and medical director of Temple's Office of Clinical Trials (OCT). "Our physicians get additional support for conducting clinical trials. The fellows receive extremely valuable education and experience. And the pharmaceutical industry sees that Temple University is adding to its clinical trials infrastructure."

"The pharmaceutical industry works at break-neck speed and wants a partner who is ready to begin work immediately," said Michael Jacobs, PharmD, professor of clinical pharmacy at the School of Pharmacy. "This fellowship helps improve our readiness to collaborate." Jacobs developed the fellowship with Bill Hirschhorn, director of the OCT.

The program, which began last summer, continues to evolve. "In their second year of the fellowship, the fellows will interact with some of the region's major pharmaceutical companies including Wyeth, Johnson & Johnson, GlaxoSmithKline and Merck. They will focus on such areas as post-marketing surveillance, the investigational drug supply, data management and drug development strategic planning," said Hirschhorn.

Upon completion of the two-year program, fellows will find that career opportunities abound in areas including clinical drug development, the pharmaceutical and biotechnology industries, regulatory affairs, academic medicine, and the Food and Drug Administration.

The fellowship was launched with funding support from Temple University's President's office and the Master Settlement Agreement with the tobacco industry. Hirschhorn and Jacobs are expanding the program to four fellowships. "There's a gold mine of opportunity in clinical trials research and this program puts Temple squarely on the front lines," explains Hirschhorn
Applicants are required to have a doctorate of pharmacy, or PharmD degree. Additionally, Hirschhorn and Jacobs are seeking candidates specifically focused on a career in drug development in industry, academia or government. It is preferred that applicants are knowledgeable about the drug development process and have performed residencies in pharmacy practice or a related area.

Editor's Note: Both Ghannam and Jacobsen are TUSP graduates. Ghannam also holds a certificate in clinical research from TUSP, and Jacobsen, who formerly worked as a scientist in the pharmaceutical industry, also holds an M.S. in microbiology.

A Message from John Daly, Sandy McDade, Henry Parkman, and Bill Hirschhorn on the Office of Clinical Research
We want to provide you an update on the Office of Clinical Research and Clinical Trials since its restructuring earlier this academic year by the Provost Office and the Deans of the Health Sciences Center.

The mission of the Office of Clinical Research at the Temple University Health Sciences Center is to enhance and help to facilitate clinical research opportunities at the Temple University Health Sciences Center for the Schools of Medicine, Pharmacy, Dentistry, Podiatric Medicine, and Health Professions. Services range from identifying research opportunities, designing clinical trials, developing case report forms, preparing IRB submissions, developing and negotiating clinical trial budgets, regulatory filing documents, coordinating sponsor visits, designing databases, report preparation, monitoring trials that are investigator-initiated, to assuming a lead in assisting the site in preparing for both data audits by the sponsor and FDA inspections.

In the last several months, we have been reviewing clinical trial budgets for their appropriateness by itemizing the study costs and using appropriate estimates. In many instances after this review, we have been able to negotiate with the pharmaceutical company for a substantial increase on the trial budget. Our office in conjunction with the Office of Sponsored Projects will be holding a seminar on formulating clinical trial budgets on Thursday January 15, 2004 at 8:30 am in the Student Faculty Union Center fourth floor auditorium.

In the future, we will be providing help, if needed, with patient recruitment by developing strategies for enrollment expectations.

Initial seed funding to cover the start up costs of the office was provided by the University, Vice President for Research, Health System, and the Health Science Center Deans. To help provide on going support for the Office of Clinical Trials, 10% of the direct net revenue of pharmaceutically supported clinical trials will be used to support the office of clinical research. This will start January 2004. None of the indirect cost recovery will be returned to the schools of medicine, pharmacy, dentistry, and podiatric medicine.

The Office of Clinical Research including the Office of Clinical Trials, Research Quality Improvement, Biostatistics, and the General Clinical Research Center are here to provide a broad range of support and service to conduct high quality clinical research. Visit our web pages of the Office of Clinical Trials at http://www.research.temple.edu/oct/index.html and the Office of Clinical Research at http://www.research.temple.edu/ocr/index.html. If you need help in your clinical research, please contact us by telephone 2-5245, or email doct@temple.edu.