What Ever Happened to Critical Path - Pharmaceutical Executive

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What Ever Happened to Critical Path
FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?


Pharmaceutical Executive


Anotehr exciting NCI initiative is to examines the use of imaging technologies to monitor the impact of therapies on cancer tumors in drug development as well as treatment. An NCI group is examining how FDG-PET scans could be used in very early clinical trials to help screen molecules for action in humans. This data could then be used to identify possible surrogate endpoints.

FDA Launches Collaborations

Several joint research initiatives have been announced in recent months:

Liver toxicology biomarker FDA announced in November that its National Center for Toxicological Research (NCTR) and Massachusetts-based BG Medicine have signed a CRADA for a project that will determine whether a standard test used in early drug development can discover early signs of human liver toxicity, one of the main causes for drug development failure. The study uses data from pharma companies, which, in turn, gain access to project data and the opportunity to license discovered biomarkers.

Manufacturing survey CDER's Office of Pharmaceutical Science is establishing a CRADA with Conformia Software of California to conduct a confidential survey of industry R&D and regulatory personnel on the causes of drug development bottlenecks. Conformia will seek information from 20 manufacturers on development information problems, pilot plan information management, pre-clinical development challenges, and manufacturing science. The goal is to gain a clearer picture of current industry development practices and problems.

Simulation software The Office of Biostatistics is collaborating with PharSight Corporation to develop software that will emulate clinical trial outcomes based on pharmacodynamic data.

C-Path Institute, a non-profit organization founded by Ray Woosley with support from FDA, SRI International, and the University of Arizona, has launched a Toxicogenomic Cross Validation Consortium to bring together pharma companies to validate each other's safety test methods. Six leading firms are participating, and FDA hopes to use the results to develop guidance on applying new technology for pre-clinical safety screening. C-Path also partners with an Arizona pharmacy chain to create a public network for reporting adverse events, which aims to help FDA improve its drug safety monitoring system.

Novartis is working on three research collaborations with FDA. One examines how to apply process analytical technology (PAT) to identify new methods for assuring quality manufacturing. FDA and Novartis are negotiating a CRADA calling for joint evaluation of research findings, which will give FDA experience implementing and validating proposals under its PAT guidance.

Another project involves a CRADA to develop preclinical biomarkers that evaluate renal toxicity. And a third collaboration will address hurdles related to developing a diagnostic kit with a drug product. Novartis plans to conduct an observational study involving several compounds in its pipeline where a genomic diagnostic may be of value.

National Institute for Pharmaceutical Technology & Education is a non-profit consortium formed by 11 universities, headed by Purdue, to address manufacturing and scientific issues affecting variability in drug development. In June, NIPTE signed an agreement with FDA to work jointly with manufacturers and FDA on research and educational projects to improve pharmaceutical manufacturing science and technologies. FDA will provide scientific expertise to NIPTE and consider its recommendations in developing new policies and guidances. The group seeks $25 million a year for five years from Congress and other government agencies to establish Centers of Excellence that will launch specific projects to reduce the high cost of drug development.

Moving Forward

Critical Path faces many hurdles. It's not clear how the concept will play on Capitol Hill: Will legislators zero in on the element of industry-agency collaboration and resist it, or will they perceive it (as FDA does) as a key to improving drug safety? Many Critical Path initiatives are funded with money from industry or other outside sources, but there will be a high resource burden on the agency—especially in the form of post–Phase IIa meetings and analyses of voluntary genomic submissions. And companies need to buy into the idea that sharing science is more productive than hoarding it.


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