CPSA Digest 2002

Proceedings -Thursday, October 10, 2002

ThOC1

Outsourcing Discovery: Obtaining Maximum Data with Minimum Proprietary Information under Continuously Changing Experimental Requirements

Premise:
The premise that a contract research organization (CRO) can be a contributing member of a discovery project team with respect to data quality and turnaround was proposed by Zamas Lam of Quest Pharmaceutical Services (Newark, Delaware). A support laboratory to discovery research must meet defined criteria and operate under important constraints. In terms of criteria, the laboratory must provide data that answer critical questions to help guide the selection of a drug candidate. Turnaround time in obtaining these data is of paramount importance; a working goal is 1-2 weeks to complete a study after receipt of test material. The reliability and quality of these data are also essential. In terms of constraints, the supporting laboratory must provide demanding quality (the same quality guidelines as the sponsor follows and obtains), meet the sponsor's timing and provide a value-added service.

Value of the Technology
Support provided to a discovery laboratory provides critical information that is used in the decision-making process of selecting optimal candidates among a test screen. Shown below is a typical list of support activities that a CRO can provide.

One of the very important activities that a laboratory can provide to discovery research is an evaluation of the pharmacokinetic profiles of test compounds. Shown below are some examples of how a CRO can provide this service, in the context of early discovery (cassette dosing) and late discovery (discrete dosing) support activities.

Detailed protocols and procedures are available from each CRO for evaluation and discussion by the sponsor. Different scenarios can be envisioned for support, depending on the exact needs of the program. In addition to pharmacokinetics, other valuable support functions can be provided by CROs, such as protein binding, metabolic stability, CYP450 markers and the tendency for CYP inhibition and induction.

References and/or Links
Quest Pharmaceutical Services website:
http://www.questpharm.com/

Franklin Hoke, "Contract Research Organizations Help Guide Compounds To Approval," The Scientist 8[18]:1, Sep. 19, 1994.

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