Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development

Authors


Address for correspondence: Pravin R. Jadhav, PhD, FCP, Office of Clinical Pharmacology, 10903 New Hampshire Ave, Bldg 51, Rm 3160, Silver Spring, MD 20993; e-mail: Pravin.Jadhav@fda.hhs.gov.

Abstract

This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.

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