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-
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
You may also access information on the CDDE at WesternU’s World Wide Web
site at http://westernu.edu/cdde.html.