Through its Center for Drug Development and Evaluation (CDDE), Western

University of Health Sciences (WesternU) has initiated its first clinical

trial for a drug. The CDDE is testing a diabetes medication formulated by

a regional pharmaceutical company.

The CDDE exists to help pharmaceutical, biotech, medical companies and

researchers in their drug development process, said CDDE Director Krishna

Kumar, MPharm, PhD, MPS.

“”We are a true ‘one-stop shop,'”” Dr. Kumar said. “”We can provide a wide

variety of services quickly and cost-effectively through our organized and

highly qualified team of scientists and clinicians and our state-of-the-

art facilities.””

Among the drug development processes the CDDE can perform are data

analysis; submission to the Federal Drug Administration (FDA) for

approval; clinical trial design and management; formulation and dosage

form development; protocol design and approval; documentation and

regulatory services; and others.

Negotiations with area and regional pharmaceutical companies are ongoing,

Dr. Kumar added.

Opened last year and located in WesternU’s College of Pharmacy, the CDDE

is comprised of approximately 15,000 square feet of space dedicated to

drug development research, and houses pre-clinical, formulation and

analytical development research laboratories.

Dr. Kumar specializes in the development of pharmaceutical products and

evaluation of their bioavailability, pharmacokinetics, safety and

efficacy. He has worked as a consultant to the pharmaceutical industry in

the United States and overseas. Last October/November, for the second year

in a row, Dr. Kumar presented a three-day course in Switzerland and

Slovenia to pharmaceutical academics and scientists on the differences in

development criteria between the FDA and its various European counterparts.

In addition, Dr. Kumar is a board member of CORE21, an organization

designed to bring academia and industry together within the Inland Empire.

For more information on the Center for Drug Development and Evaluation,

contact Dr. Kumar at (909) 469-5601. You may also e-mail him at

kkumar@westernu.edu.

You may also access information on the CDDE at WesternU’s World Wide Web

site at http://westernu.edu/cdde.html.