FDA Seeks Participants in Pharmaceutical Development Study

The US Food and Drug Administration’s Office of Pharmaceutical Development (OPS) has proposed a collaborative study with Conformia Software, Inc. (Redwood City, CA) to determine the factors currently influencing pharmaceutical development.

The study aims to gain clarification into development information bottlenecks, pilot-plant information management, manufacturing science, information retrieval, quality systems, and preclinical development challenges, according to a Sept. 14 notice published in the Federal Register. Specifically, information collected through a series of industry focus group discussions will “augment and support” three of the agency’s recently introduced initiatives:

• Challenge and Opportunity on the Critical Path to New Medical Products (the “Critical Path Initiative");

• Pharmaceutical CGMPs for the 21st Century-A Risk Based Approach;

• International Conference on Harmonization Steering Guidelines-Pharmaceutical Development, ICH Q8 (Defining a Design Space).

Conformia Software will post an invitation for industry to participate in the study on its Web site as well as fax an invitation to 20 of the top pharmaceutical and biotech companies. FDA also plans to post an abstract on its Web site along with instructions about how to participate in the study.

According to the notice, as an incentive to participate in the pharmaceutical development study, Conformia will prepare a confidential report that will contrast practices in each company in comparison with aggregated information from other companies. (Knowledge of a participating firm’s identity will be restricted to the company itself and Conformia). Participants will be given an “Informed Consent” form and Confidential Disclosure agreement ensuring confidentiality of disclosed information and adherence to the Privacy Act.

–Maribel Rios