Establishing Consortia

The Challenge

The challenge was to create a productive environment amongst private sector competitors while balancing their needs with those of the FDA, academic scientists, and the public health.

In C-Path's early discussions with scientists, the following perceived barriers were identified:

  • Concern that anti-trust laws might prohibit sharing and collaboration;
  • Potential threats to proprietary interests of drug development programs (For example, what if a company shares data on the safety of a compound and doing so discloses their commitment to commercialize a related class of compounds?);
  • Intellectual property concerns that their company might be giving away information that could someday generate profits;
  • Liability issues such as who is responsible if the work is done by another company and outside the control of their organization; and
  • How could the collaborative work be funded?

To address these concerns, C-Path engaged Cooley Godward Kronish, LLP, a nationally respected law firm to work with representatives from the legal departments of each of the major pharmaceutical companies interested in partnering. C-Path's Chief Operating Officer (a former US anti-trust attorney) and attorneys from Cooley Godward Kronish, LLP, drafted a legal consortium agreement to create the "Toxicogenomics Cross-validation Consortium Agreement," now known as the Predictive Safety Testing Consortium, (PSTC). This document that has now been signed by over twenty pharmaceutical companies and research organizations and is the template for two other consortia (below).

Consortia Selection Criteria

C-Path employs a now proven process, utilizing the following criteria for selection of its projects:

  • The problem (or the opportunity) must be important to the public health and one that was identified in the Critical Path Opportunity List1 or one subsequently identified by FDA scientists at multiple levels. That is, it must have the support of upper management in FDA and the interest and commitment of scientists in the review divisions, and/or the scientific support teams, e.g. clinical pharmacology.
  • The project must be acknowledged by the industry as important and therefore one that multiple companies are willing to dedicate the time and efforts of their employees.
  • There must be a "neutral source" of funding for C-Path to rise to support the project.
1. Food and Drug Administration. Critical Path Opportunities Report and List; http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf. 3-16-2006. Internet Communication