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Drug Development Overview

Steven R. Schow, Ph.D

For the purpose of this summary, drug development is defined as those activities required for advancing a biomedical concept to a medical product in commerce. This definition encompasses such endeavors as genomics, target validation, drug discovery, development candidate identification, drug safety assessment, regulatory filing, clinical studies, and registration for market. After a successful drug development effort, commercial launch, marketing, distribution, pricing, reimbursement, and product life-cycle management are the kinds of activities that occur. During drug development, collateral support work is typically ongoing. These activities include intellectual property creation and securing patents, pharmacoeconomic and pricing range assessment for the potential product, identification of physicians who would eventually prescribe the approved drug, and physician surveys on the product candidate and the medical need for it.

The general steps for drug development are very well delineated. However, the specific details of drug development are extremely elastic and highly dependent upon the nature of the medical problem and various approaches to that problem, the risk tolerance of the drug development organization, the ever-changing landscape of medical care and reimbursement, the fluid but highly conservative nature and demands of regulatory bodies, and the work of other organizations on similar product candidates. Development activities are discussed below. A tiered structure is presented wherein the levels of development represent natural break points in the cost and regulatory requirements for the specific stages of drug development. Of course, there will always be some overlap between the levels as the product candidate profile evolves and as the specifics of the project demand. Most importantly, every drug development effort is unique in some way. Each will require its own roadmap to registration, the details of which are highly dependent on the specific issues that arise in the course of discovering and advancing that drug candidate.

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