The Very Critical Path

  • by: |
  • 08/01/2005

When Thomas Edison was asked why he was so successful he responded, “Because I fail so much faster than everyone else.” Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.

In partnership, regulators, industry and academia can apply modern engineering and cutting-edge scientific knowledge to medical product manufacturing. In partnership we can improve standardization and automation of clinical research. And in partnership we can develop novel and improved clinical trial designs and analytical methods for evaluation of safety and effectiveness that can reduce costs. Currently, 50% of drugs that undergo large scale Phase 3 trials turn out to be too unsafe or not effective enough for marketing. That is not a sustainable model for the 21st century.

Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number …

* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.

* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million.

* Shifting 1/4 of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.

FDA’s critical path activities and research must complement, not compete with, what industry and other regulatory agencies in the US and around the world and are already doing.

I believe that FDA should assume an organizational role, because FDA is at the crossroads of the translational process.

FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.

FDA has the technical expertise that can draw together stakeholders, help prioritize research that is most needed, and to partner with others to conduct this research. Obviously solutions will have to come from sources with the greatest expertise. This could entail contracting with academic organizations, private industry and other global translational research groups.

FDA’s Critical Path initiative will enable innovative growth companies to better and more efficiently attack the steep hurdles facing them, allowing them to compete more effectively against the bigger, better-funded players in the market on a more level playing field. That means a real change in the risk/benefit equation for both emerging growth companies and the public health.

Consider FDA’s critical path initiative as a revised game of Shoots and Ladders. Rather than relying on a roll of the dice, FDA can be a bridge over the shoots and a guide to the ladders.

The most important tool is collaboration. Regulators must embrace stakeholders as partners in the public health process.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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