LOS ANGELES, Nov. 8, 2011 -- The School of
Pharmacy at the University of Southern California has established the
International Center for Regulatory Science to help assure that promising new
medical products reach the marketplace faster--while also maintaining proper
safety standards. The new Center's research is aimed at meeting the challenges
caused by increasingly complex regulations that result from rapid changes in
technology and economic globalization.
"During my recent visit to universities
in Asia, several academic leaders noted USC's preeminent reputation in the
study of healthcare management and regulatory policy, specifically the
regulatory science program and the USC Schaeffer Center for Health Policy and
Economics," notes USC provost and senior vice president for academic
affairs Elizabeth Garrett. "The new International Center for Regulatory
Science further solidifies USC's commitment to transnational collaboration
focused on the safety and effectiveness of medical products, practices, and
devices that enhance the well-being of our global community."
Many pharmaceutical and medical device
companies face cost constraints that have only been tightened by the economic
crisis. And, unfortunately, agencies such as the FDA are threatened with budget
cutbacks. Although the FDA collects fees from the pharmaceutical and medical
device industries to review their products for approval, it also receives
federal funding. Cutbacks to the FDA might have the perverse affect of
worsening the agency's response time for reviewing much-needed products.
"The Center's main goal is to help ensure
medical products are made faster, safer and better," explains Frances
Richmond, the Center's director and a USC School of Pharmacy professor.
"We're concerned with the successful transition from laboratory
discoveries to the ultimate outcome of a patient's treatment."
Dr. Richmond and her collaborative team at USC
believe the International Center for Regulatory Science's mission is vital, and
the timing for its launch critical. The Center will work with companies to
understand and improve best practices to help their FDA submissions proceed
more quickly. The Center also will facilitate communication between industry
and such government regulators.
"We'll work to understand the problems
facing both sides--the regulator and the industry--that could become
bottlenecks to product development," says Dr. Richmond.
Since the marketplace is now global, the
Center will work not only with the FDA and U.S. companies, but with their
counterparts around the world in increasing speed while ensuring safety for
medical product marketplace. Memoranda of understanding with programs in China
and Korea, as well as visiting scholar opportunities, complement exchange
programs for students who are pursuing education in regulatory, quality and
clinical sciences.
"The Center promises to be a proactive
voice impacting how pharmaceutical and medical device products are brought to
market," said School of Pharmacy Dean R. Pete Vanderveen. "The
university offers tremendous collaborative opportunities, including our own
Leonard D. Schaeffer Center for Health Policy and Economics that will surely
work with Dr. Richmond and her group."
The Schaeffer Center will house the School's
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation which
has been made possible by a gift from Quintiles. A search for the holder of
this chair is currently underway, and collaboration with the eventual chair and
the International Center for Regulatory Science presents unique opportunities
for research.
The USC School of Pharmacy is well suited for
such an enterprise, as the Center will build upon the School's longstanding
leadership in regulatory science education. The School established the world's
first doctorate in regulatory science and has a longstanding history of
innovative educational programs, including a master's degree and several
certificate programs.
About the
USC School of Pharmacy
Founded in 1905, the University of Southern California School of Pharmacy
pioneered the doctor of pharmacy degree, established the nation's first
clinical pharmacy program, launched the first doctorate in regulatory science
and remains an innovator in pharmacy education, research and patient care.
Consistently the top-ranked private school of pharmacy by U.S. News and World
Report, the School is second in the nation in total National Institutes of
Health funding for pharmacy schools. The School also has helped transform the
pharmacist's role from a traditional dispenser of medicines to a direct
provider of patient care. The USC School of Pharmacy's three research centers
serve to help further re-shape the future of the profession and the quality and
cost-effectiveness of the nation's health care system.
Contact: Kukla VeraO: 323.442.3497C:
310.795.5552kvera@pharmacy.usc.edu
SOURCE USC School of Pharmacy
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