April 14, 2006 | The FDA’s Critical Path Initiative, announced with great fanfare in March 2004, is an important program in need of cold hard cash and dedicated FDA personnel. This is not to say the Critical Path (CP) hasn’t already done good, but its clear articulation of priorities, goals, and most recently of so-called opportunities is not enough.
Last month, FDA released the latest comprehensive review of CP progress in two pieces, Critical Path Opportunities Report and Critical Path Opportunities List. The former again issues a call to action, not unlike the initial report, and also identifies six areas for attack, based in its outreach to industry since the CP was announced.
FDA should be commended for mounting the CP effort, and this interim report is again filled with good ideas. The six broad areas identified include 1) better evaluation tools, 2) streamlining clinical trials, 3) harnessing bioinformatics, 4) moving manufacturing into the 21st century, 5) developing products address urgent public health issues, and 6) at-risk populations.
The accompanying opportunities list is wide-ranging and identifies both narrow projects such as “surrogate outcomes for cardiovascular drug eluting stents” and broader efforts such as “standards for microarray and proteomics-based identification of biomarkers.” Modeling and simulation, topics close to my heart, are again singled out.
A message from acting commissioner Andrew von Eschenbach reads: “With sufficient funding and effort, the Critical Path sciences could be modernized. Targeted investments, for example, in biomarker development, could help companies identify sooner those product candidates that are likely to fail, while directing more resources to develop promising candidates. Investments in the science of medical product development could also help us better understand new products so they can be used more widely, safely, and effectively, once approved.
“The FDA is committed to rapidly enhancing the Critical Path sciences; however, modernizing the Critical Path of medical product development is a national challenge. It will take the combined efforts of government, industry, academia, and patients to create the robust science needed to fulfill the promise of new biomedical science.”
Very good words. Here’s the issue. There is still no money. Back-room talk of CP funding (it’s not clear how much) quieted in the wake of other pressing federal budgetary needs, notably Katrina relief and Iraq war costs. At least one CRADA has been issued that supports CP objectives: BG Medicine’s liver toxicity biomarker discovery project (see Inside BG Medicine, Feb. 2006 Bio-IT World, p. 18). At the start of the year, BGM was out shopping for pharma volunteers to contribute compounds for that project.
Toxicity prediction is certainly high on everyone’s agenda, and coincident with the release of the CP report was the announcement of the “Predictive Safety Testing Consortium between C-Path and five of America’s largest pharmaceutical companies to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans.” The eight Members of the Consortium are Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Schering Plough, and SRI International.
This is another good step. Congrats.
FYI: C-Path is the C-Path Institute, a not-for-profit created to support the FDA efforts to implement the Critical Path Initiative. Based in Tucson, Ariz., “C-Path has received unrestricted support of more than $10 million over a five-year period to seed the Institute’s programs. Primary sources of support for C-Path include both public and private-sector contributions from southern Arizona municipalities, foundations, area businesses and private individuals,” according to the C-Path Web site.
This is another good step. But it’s not enough. Some federal monies (or incentives) are needed to help tackle the CP’s expansive yet vital agenda. The occasional CRADA, and largesse from opportunistic municipalities (nothing wrong with that) and private donors, isn’t enough.
This month, FDA plans to “look for ways to support selected CP priorities on the Opportunities List” and then announce which CP projects it has decided to undertake. That could be where the rubber meets the road. For more information, see www.fda.gov/oc/initiatives/criticalpath.