Office of External Communications

Houston, TX 77204-5017 Fax: 713.743.8199

FOR IMMEDIATE RELEASE
July 19, 2004

Contact: Lisa Merkl
713.743.8192 (office)
713.605.1757 (pager)

HOUSTON, July 19, 2004 – A partnership between the FDA and the University of Houston that puts the College of Pharmacy in the vanguard of developing new drugs and biomedical policy is being revised and expanded.

Making their respective resources more available to one another, the University of Houston College of Pharmacy and the Food and Drug Administration are providing a path for science to advance in medically related fields of higher education. The University of Houston College of Pharmacy is the only pharmacy college in the country with this type of partnership with the FDA.

In a Memorandum of Understanding originally signed in 2003, a revised framework is being established for the exchange of scientific resources and educational opportunities between the two institutions. Specifically, the two institutions will promote the training of UH academicians and students in the various departments within the FDA and vice versa. The lead FDA center for this partnership with UH is the Center for Devices and Radiological Health in Rockville, Md.

“The private sector, academia and the FDA have to be partners in advancing the development of science to promote and protect the public health,” said V. Michelle Chenault, associate director for the Medical Device Fellowship Program in the Center for Devices and Radiological Health of the FDA. “Partnerships with premier universities like the University of Houston are a proactive step toward this goal.”

Chenault recently spoke to faculty and graduate students of the UH College of Pharmacy about the various departments, programs and research opportunities available at the FDA. Citing recent developments in the research partnership between the two institutions, she noted the strengthening of the FDA and UH’s shared mission to promote and protect public health.

“The partnership between the University of Houston and the FDA advances the university’s position to becoming one of the nation’s premier academic institutions in biomedical and pharmaceutical research,” said Isaac Montoya, clinical sciences professor at the UH College of Pharmacy. “Training and research opportunities for faculty and students, at both institutions, are greatly enhanced by this partnership. This exciting opportunity will link our college closer to the process of developing new drugs and devices, as well as formulating biomedical policy.”

Functioning as a guideline for faculty sabbatical programs, graduate student internships and appointments for post-doctoral fellowships, the newly revised Memorandum will expand academic access to many funding opportunities, lab and office space, supplementary coursework, as well as availability to a multi-disciplinary faculty and research staff. The Memorandum also outlines activities for both faculty and student participants that include a human subjects workshop, the development of a working group to study home care technology for disadvantaged populations and a diabetes animal model cooperative research and development study.

“There are tremendous opportunities for our faculty and students to engage in research,” Montoya said. “They will have the chance to conduct the research, analyze data and, most importantly, gain practical experience about the process of having a drug or device approved by the FDA.”

UH faculty on sabbaticals at the FDA will be at the forefront of cooperative research and development. They will have access to government scientists and facilities, experience the device and drug approval pipeline firsthand, learn how the FDA protects the public health, have an opportunity to provide public service and gain insight into the decision-making process behind drug and device approvals for commercial marketing.

“This partnership is incredibly important by means of educating our students,” Montoya said. “Instead of educating them with literature about device and drug approval, faculty will be able to provide them valuable insight into the actual process.”

Being onsite at FDA facilities also provides UH College of Pharmacy participants the opportunity to evaluate products from the commercial sector in an effort not only to learn the rules and regulations of the submission process, but also to contribute in product investigative research. Students will have the chance to experience medical research, while exploring the options of a government-related career. In turn, the college atmosphere provides FDA staff and researchers with experiences in a real-world setting and access to a large, diversified population base. Participants from the FDA will have opportunities to study in a clinical setting.

About the Food and Drug Administration
FDA is an agency with the Department of Health and Human Services and consists of eight centers/offices. These are the Office of the Commissioner, Office of Regulatory Affairs, the Center for Veterinary Medicine, the Center for Food Safety and Applied Nutrition, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the National Center for Toxicological Research and the Center for Devices and Radiological Health.

About the University of Houston
The University of Houston, Texas’ premier metropolitan research and teaching institution, is home to more than 40 research centers and institutes and sponsors more than 300 partnerships with corporate, civic and governmental entities. UH, the most diverse research university in the country, stands at the forefront of education, research and service with more than 35,000 students.

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For more information about UH visit the university’s ‘Newsroom’ at www.uh.edu/admin/media/newsroom.