PQRI and NIPTE Facilitate Collaborative Effort

Regulatory Institution Promotes Academic Understanding

ARLINGTON, Virginia (April 3, 2008) — The Product Quality Research Institute (PQRI) has announced an upcoming collaborative agreement with the National Institute for Pharmaceutical Technology and Education (NIPTE), which the two organizations hope will lead to more opportunities to perform valuable pharmaceutical development and manufacturing research in a neutral operational environment.

“PQRI is very excited about the recent agreement to collaborate with NIPTE, which will allow the development of a shared portfolio of science-based projects aimed at increasing the understanding of pharmaceutical materials and manufacturing processes,” Gordon Hansen, chair of PQRI’s steering committee, said. “We are looking forward to a synergistic and highly productive working relationship.”

PQRI is a collaborative institute that works to ensure the quality, safety and performance of drug products, while being guided by a Steering Committee composed of representatives from its sponsoring organizations. NIPTE is a non-profit organization dedicated to interdisciplinary research and education in pharmaceutical science, technology and engineering, with the goal of developing, manufacturing, and delivering high quality pharmaceutical products safer and faster to the market at a reduced cost. Eleven leading U.S. universities are the supporting institutions of NIPTE.

With this collaboration, the two institutes agree to work together on selected projects, while providing each other with expertise in manufacturing and pharmaceutical development. Each side will also organize and participate in co-sponsored meetings to discuss research findings and recommendations for implementation, with NIPTE also utilizing member academic participants to conduct research that will look to improve the scientific basis for understanding product development and manufacturing. Each group will participate in strong research programs in drug development, pharmaceutical manufacturing and regulatory science, while also developing a shared portfolio of science-based projects.

About PQRI
The Product Quality Research Institute (PQRI) is a collaborative process involving FDA’s Center for Drug Evaluation and Research (CDER), Industry, and Academia. The mission of PQRI is to conduct research to generate specific scientific information that should be submitted in a regulatory filing to CDER. PQRI has been in development since January of 1996, guided by a Steering Committee composed of representatives from its sponsoring organizations. For additional information, visit http://www.pqri.org/index.asp.

About NIPTE
The National Institute for Pharmaceutical Technology and Education (NIPTE) is a not-for-profit organization founded by eleven leading universities in the U.S. NIPTE will seek to establish a program that will allow FDA researchers to partner with the academia to better understand the science behind drug development and manufacturing. Problems in physical design, characterization, manufacturing scale-up and quality control routinely derail or delay development programs and delay patient access to new treatments. A better understanding of the science behind the manufacturing process will insure that available treatments reach the market as soon as possible and that the resultant manufacturing processes are more efficient, cost effective and produce products of higher quality. This will increase the FDA’s knowledge base and will facilitate implementation of science-based regulations. Normally, it is not possible to conduct such research ! in one industry or by a single institution with limited resources. NIPTE, with the support of the FDA and other non-profit organizations such as PQRI, can sponsor such projects of real long-term significance. The National Institute will be a unique place where scientists from academia, the FDA, and the pharmaceutical industry will collaborate to pool their scientific expertise and institutional perspectives to address the technology and educational challenges now facing the pharmaceutical industry. For additional information, visit http://www.nipte.org.

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