The Critical Path Institute's Approach to Precompetitive Sharing and Advancing Regulatory Science

Many successful large industries, such as computer‐chip manufacturers, the cable television industry, and high‐definition television developers, 1 have established successful precompetitive collaborations focusing on standards, applied science, and technology that advance the field for all stakeholders and benefit the public. 2 The pharmaceutical industry, however, has a well‐earned reputation for fierce competition and did not demonstrate willingness to share data or knowledge until the US Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 (ref. 3 ).

[1]  D P Hamilton.  Sematech: techno-policy in action. , 1991, Science.

[2]  L. Sacks,et al.  Developing new drugs for the treatment of drug-resistant tuberculosis: a regulatory perspective. , 2008, Tuberculosis.

[3]  David C. Mowery,et al.  SEMATECH and collaborative research: Lessons in the design of high‐technology consortia , 1994 .

[4]  P. Keegan,et al.  FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme. , 2009, The oncologist.

[5]  Federico M Goodsaid,et al.  Strategic paths for biomarker qualification. , 2008, Toxicology.

[6]  W. Mattes.  Public consortium efforts in toxicogenomics. , 2008, Methods in molecular biology.

[7]  Felix W Frueh,et al.  The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path. , 2007, Drug discovery today. Technologies.

[8]  WB Mattes,et al.  Translational Toxicology and the Work of the Predictive Safety Testing Consortium , 2009, Clinical pharmacology and therapeutics.

[9]  A. Hunter,et al.  The Innovative Medicines Initiative: a pre-competitive initiative to enhance the biomedical science base of Europe to expedite the development of new medicines for patients. , 2008, Drug discovery today.

[10]  K. Romero,et al.  The Coalition Against Major Diseases: Developing Tools for an Integrated Drug Development Process for Alzheimer's and Parkinson's Diseases , 2009, Clinical pharmacology and therapeutics.

[11]  J. Cossman,et al.  Drug Development and the FDA's Critical Path Initiative , 2007, Clinical pharmacology and therapeutics.

[12]  Janet Woodcock,et al.  The FDA critical path initiative and its influence on new drug development. , 2008, Annual review of medicine.