New and Integrated Approaches to Successful Accelerated Drug Development
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0092-8615/99 Copyright 0 1999 Drug Information Association Inc.
NEW AND INTEGRATED APPROACHES TO SUCCESSFUL ACCELERATED DRUG DEVELOPMENT ANTHONY CLEMENTO, MA G c e President, Regulatory Affairs, Covance Laboratories, Inc., Madison, Wisconsin
Traditionally, the development of a new drug from discovery to market takes 10 to 15 years and costs hundreds of millions of dollars. Accelerated drug development, therefore, is of critical importance to both maximizing return on this investment and bringing drugs for unmet medical needs to patients as rapidly as possible. New structure-based development strategies are being combined with integrated, multidisciplinary approaches to speed the processes of physicochemical and pharmacological characterization, toxicological investigation, and clinical testing. The process of accelerated drug development, however, presents unique challenges as well as opportunities. Key Words: Clinical testing; Accelerated drug development; Drug discovery; Preclinical testing; Product development; Research
INTRODUCTION CURRENTLY THERE ARE approximately 5000 compounds in preclinical or nonclinical development (Figure 1) and almost 2100 in clinical development (Figure 2). Traditionally, the drug development process has been a lengthy and expensive series of nonclinical and clinical evaluations followed by regulatory reviews. The ultimate goal of the drug development process is to bring safe, effective, and needed pharmaceutical products to the market. Accelerated drug development, a highly structured, cost-effective, and viable means of achieving this goal sooner than had been previously possible, should be given serious consideration. Drug discovery is the first step in drug development. Once a potential new drug en-
Reprint address: Anthony Clemento, MA, Vice President, Regulatory Affairs, Covance Laboratories, Inc., Madison, W1 53704. E-mail: anthony.clemento9 Covance.com.
tity is identified, discovered, or designed and synthesized, it must undergo extensive testing in the laboratory and in animals to characterize and assess its biological activity and safety. This phase of development traditionally takes three to four years. A potential drug must then undergo a series of clinical tests in human subjects to establish its efficacy and safety. All of this information is ultimately assembled into a New Drug Application (NDA) or dossier and filed with health authorities such as the United States Food and Drug Administration (FDA) or the Canadian Health Protection Branch for evaluation and approval. The entire development process from discovery to regulatory approval takes an average of 10 to 15 years (1,2) and costs an average of $100 to $400 million (2,3). In addition, the complexity of drug development and clinical testing procedures has increased significantly (4). After examining diversification strategies in the 1980sand 1990s,pharmaceutical com-
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