- Email: [email protected]
FDA's Critical Path Initiative
Drug Discovery Today: Technologies
Vol. 4, No. 2 2007
Editors-in-Chief Kelvin Lam – Harvard Stem Cell Institute, Harvard University, USA Henk Timmerman – Vrije Universiteit, The Netherlands DRUG DISCOVERY
TODAY
TECHNOLOGIES
Critical path
EDITORIAL
FDA’s Critical Path Initiative Janet Woodcock Food and Drug Administration, Rockville, MD, United States. Email: [email protected]
A previous section of Drug Discovery Today: Technology presented a series of articles describing activities under way at FDA as part of the agency’s Critical Path Initiative, launched in March 2004. The Critical Path Initiative emerged from recognition that a new generation of tools – new assays, new biomarkers, improved animal models, better clinical trial designs and endpoints, in silico testing, new approaches to manufacturing – would be needed to make the medical product development pathway more efficient and effective. FDA felt up to the task of leading this initiative, but knew it would take a joint effort of federal agencies, academia, industry, patients and other health-related organizations working together to modernize the processes used to help develop, evaluate and use regulated products. The articles presented here illustrate how some of these new Critical Path tools are being put to work as part of collaborative approaches to modernizing product development while improving medical product safety. The Critical Path Initiative is more than a discrete, time-limited initiative. It is a new perspective, a new way of doing business and we believe the Initiative is leading to creation of a Critical Path infrastructure, with new ways of working together, new academic programs, new career
1740-6749/$ .Published by Elsevier Ltd.
DOI: 10.1016/j.ddtec.2007.11.002
Box 1. Section Editor Janet Woodcock Janet Woodcock, MD is Deputy Commissioner and Chief Medical Officer, FDA. She oversees scientific and medical regulatory operations for FDA. Dr Woodcock most recently served as Deputy Commissioner for Operations and Chief Operating Officer, FDA 2005–2007. Dr Woodcock served as Director, Center for Drug Evaluation and Research (CDER) at FDA 1994–2005. She previously served in other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research. Currently she is serving as Acting Director, CDER. Dr Woodcock received her MD from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.
models for multidisciplinary researchers and new implications for all FDA-regulated products.
33
Vol. 4, No. 2 2007
Editors-in-Chief Kelvin Lam – Harvard Stem Cell Institute, Harvard University, USA Henk Timmerman – Vrije Universiteit, The Netherlands DRUG DISCOVERY
TODAY
TECHNOLOGIES
Critical path
EDITORIAL
FDA’s Critical Path Initiative Janet Woodcock Food and Drug Administration, Rockville, MD, United States. Email: [email protected]
A previous section of Drug Discovery Today: Technology presented a series of articles describing activities under way at FDA as part of the agency’s Critical Path Initiative, launched in March 2004. The Critical Path Initiative emerged from recognition that a new generation of tools – new assays, new biomarkers, improved animal models, better clinical trial designs and endpoints, in silico testing, new approaches to manufacturing – would be needed to make the medical product development pathway more efficient and effective. FDA felt up to the task of leading this initiative, but knew it would take a joint effort of federal agencies, academia, industry, patients and other health-related organizations working together to modernize the processes used to help develop, evaluate and use regulated products. The articles presented here illustrate how some of these new Critical Path tools are being put to work as part of collaborative approaches to modernizing product development while improving medical product safety. The Critical Path Initiative is more than a discrete, time-limited initiative. It is a new perspective, a new way of doing business and we believe the Initiative is leading to creation of a Critical Path infrastructure, with new ways of working together, new academic programs, new career
1740-6749/$ .Published by Elsevier Ltd.
DOI: 10.1016/j.ddtec.2007.11.002
Box 1. Section Editor Janet Woodcock Janet Woodcock, MD is Deputy Commissioner and Chief Medical Officer, FDA. She oversees scientific and medical regulatory operations for FDA. Dr Woodcock most recently served as Deputy Commissioner for Operations and Chief Operating Officer, FDA 2005–2007. Dr Woodcock served as Director, Center for Drug Evaluation and Research (CDER) at FDA 1994–2005. She previously served in other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research. Currently she is serving as Acting Director, CDER. Dr Woodcock received her MD from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.
models for multidisciplinary researchers and new implications for all FDA-regulated products.
33