The establishment of the Joint Clinical Pharmacology Fellowship Training Program at the Walter Reed Army Institute of Research and the Uniformed Services University of the Health Sciences in 1985 has proven to be not only successful but also beneficial in the area of drug development said U.S. Army Program directors Col. Colin Ohrt and Dr. Louis Cantilena.

What is clinical pharmacology?

Clinical pharmacology is concerned with better understanding the use of existing drugs as well as development of more effective and safer drugs for the future. They make it possible for one to stand between the research lab and the bedside, in a unique position to translate laboratory research into new drug therapies. They are essentially the bridge between the science and practice of medicine.

Founded in 1980 by Dr. Carl Peck, the WRAIR/USUHS Clinical Pharmacology Fellowship Training Program trains individuals, both military and civilian, to serve as clinical pharmacologists in a large variety of roles. Trained clinical pharmacologists are able to serve in regulatory roles, such as the FDA in government and military drug discovery and developmental roles, as well as throughout the drug industry.

This two-year Army training program is jointly located in the Division of Experimental Therapeutics at WRAIR in Silver Spring, Md., and the Division of Clinical Pharmacology and Medical Toxicology at the USUHS in Bethesda, Md.

"The WRAIR/USUHS Clinical Pharmacology program is intended to train a small, specialized cadre of experts on pharmacology, translational medicine and drug development to support the U.S. Army drug development mission," said former fellow Maj. David Saunders, now board certified clinical pharmacologist. "Historically, the program has been focused on antimalarials, but training experiences for fellows are broad, as are post-graduate assignments. In addition to antimalarial drug and vaccine development, recent graduates have led projects in traumatic brain injury, leishmaniasis, pain pharmacology, and post-marketing drug surveillance for the U.S. Army Medical Command."

What makes clinical pharmacology of such interest to the U.S. Army?

In sponsoring this joint Clinical Pharmacology Fellowship Training Program, the Army is training clinical pharmacologists to serve in the Army's drug development programs located throughout various institutions within the U.S. Army Medical Research and Materiel Command.

"The key role of a clinical pharmacologist in the U.S. Army is identifying the good ideas in the basic sciences and 'pulling' them through to proof-of-concept clinical testing and then facilitating FDA approval," said Ohrt. The efforts of these individuals ensures continued protection of our troops from disease.

There are several eligibility requirements that must be met before an individual can enter into this program. The training program is open and available to all active-duty board-certified physicians, especially those in primary care or in specialty areas with military need for product development, such as infectious diseases, neurology, and psychiatry. Active duty PhDs/PharmDs who have a doctoral degree in one of the life or medical sciences from an accredited academic institution in the United States, Canada, or non-U.S. degree equivalent are also eligible.

Following completion of the program, Army physician fellows will receive a number of benefits, to include a 61E MOS sub-specialty certification, special pay rates, and upon passing the ABCP Boards will receiv certification in clinical pharmacology. PhDs become ceritifed in applied pharmacology and retain their original MOS.

One of the graduates of the fellowship is Maj. David Saunders. He is a board certified clinical pharmacologist, who is currently based at USAMC-AFRIMS in Thailand, a Special Foreign activity of the WRAIR, in the Department of Immunology and Medicine.

"Our mission is to conduct advanced clinical and preclinical development of new antimalarial drugs and vaccines for the warfighter," said Saunders. "We are currently focused on developing sites to conduct phase 3 studies of next-generation antimalarial prophylaxis drugs. The target product profile for these drugs include weekly or less frequent dosing, activity against liver stage malaria, and safety and tolerability for long term use (6 months or more). We have conducted multiple clinical trials in malaria endemic areas, and preclinical studies in primates in support of these objectives."

Saunders also said, "We have currently moved most of our field operations to the Thai-Cambodian border which is currently at the epicenter of growing concerns for antimalarial drug resistance, particularly to artemisinins, one of the last remaining classes of effective drugs in the region."

He has helped the advancement of safe and effective drugs for malaria treatment and prevention.

"The fellowship offers unique opportunities for highly motivated individuals with an interest in biomedical research and pharmacology," said Saunders, and "despite the increasing demands, overall, the work is very rewarding."