Rapidly evolving changes in health care economics and consumer expectations have caused the pharmaceutical industry to recognize that traditional drug development approaches are unlikely to succeed in the future. Limited reimbursements, restrictive formularies, and generic and therapeutic substitution are reducing the industry's ability to recover its investment in new drug development.
Because of these concerns, it is widely perceived that clinical drug development must become significantly more efficient and informative, now and in the years to come, despite reduced R&D budgets and smaller staffs. In the future, every preclinical study and clinical trial must contribute critical and corroborating data in support of the registration document and the drug label. Noncontributory data and failed clinical trials must be minimized by employing scientific methodologies and science management strategies.
However, these issues have been ignored in academia although the practical impacts in drug development practices are significant. It is no doubt that translational research, advancing to non-clinical and clinical evaluations of potentially useful diagnostic and therapeutic products, is value-enhanced by meeting FDA regulatory standards and industrial good practices. Since awareness and knowledge of regulatory requirements and best development practices for medical products have not been emphasized in traditional academic environments, an educational and consultative service is needed to meet the needs of clinical and translational investigators who wish to incorporate them into their research projects that have commercial potential.
Therefore, an independent, academic drug development science center is needed to stimulate innovation and investigation of novel strategies to achieve these needed changes.
The overall mission of the center is to establish clinical drug development science as a rigorous academic discipline for advancing new scientific methodologies, to contribute to the education of scientists engaged in clinical evaluation of drugs, and to provide solutions to real-world drug development problems.
Specifically, with the guidance and involvement of its Science Board, center scientists will collaborate with academic and industry scientists worldwide, investigating a variety of research methodologies that are directly relevant to improving the clinical evaluation of drugs in development. The educational objectives of the center will be realized through center-sponsored courses, conferences, workshops, and fellowship training. The technical assistance program of the center will provide mechanisms for the application and evaluation of new or proven scientific and science management methodologies for meeting challenges facing individual drug developers.
The center's research agenda will be influenced by the Science Board and issues that arise in the scientific arena of drug development and regulatory review. Members of the Board are academic, government, and pharmaceutical industry scientists who have the special qualifications and desire to advance clinical drug development science. An International Advisory Board may also be formed to enable international perspective to be brought to the attention of the center.
Initially, the center will accomplish its mission with a core staff, in collaboration with a worldwide network of associated scientists, including the members of the Science Board. As the center's programs grow in both demand and financial support, additional research, educational, and administrative staff will be recruited.
The center enjoys the rich intellectual environment of The University of California San Francisco and its School of Pharmacy. In particular, the Departments of Biopharmaceutical Sciences and the Department of Clinical Pharmacology provide a breadth of available expertise in various disciplines of pharmaceutical and clinical science. The center's director and the members of the Science Board have broad experience in pharmacometrics, clinical pharmacology, biopharmaceutics, drug development, and regulatory science. Members of the Science Board represent the core of a worldwide network of collaborating academic centers. Scientific staffs in these centers will contribute to the research, educational, and service functions of the Center for Drug Development Science.
Members of the Science Board represent the core of a worldwide network of collaborating academic centers. Scientific staffs in these centers will contribute to the research, educational, and service functions of the Center for Drug Development Science.
Improving Drug Development Using Patient Adherence Data
in Clinical Trials, May 6-7, 2008.
Brochure (PDF)
Registration site
Advanced NONMEM workshop – March 17–19, 2008 at Mission Bay Conference Center, San Francisco, CA.
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UCSF-CDDS to launch The American Course on Drug Development and
Regulatory Science- September 2007
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CDDS – Pharmacometric Services is available to drug researchers
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Howard Lee, MD, PhD, named Director of CDDS
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Lewis B. Sheiner Memorial. Symposium held at CDDS in December 2006
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