Clinical Leverage Strategy In Accelerating Drug Development

By the late 1990s the industry began to question the wisdom of developing a new drug candidate with multiple therapeutic targets using sequential, independent clinical trials for each indication. With the advances in basic and integrated research, a fuller picture emerged regarding the mechanisms of disease manifestation and revealed potential points of intervention for many medical conditions. Consequently new drug candidates with broad therapeutic potential are increasingly being studied in parallel.

Furthermore the ability of a biotechnology companies to raise funds increases greatly when a biopharmaceutical candidate is in clinical trials. Having a new drug in the clinic for more than one indication gives the company greater leverage to attract venture capital as well as public offerings.

The accumulated statistical data on success rate for all new drug candidates committed to clinical testing indicate that only one of four or five agents entering phase I will be approved by the FDA. To increase the chance of success of getting a biopharmaceutical to market, the alternative or newer strategy is to seek more than one indication for a given drug by initiating several clinical studies at about the same time. In theory, if a company identifies four indications for a given candidate, chances are very good that one indication will be successful and approved by the FDA. Thus the goal is to select the most promising indications, hoping to save time and increase the likelihood that one of the indications will lead to FDA approval (Table 3.4). This idea is generally known as the clinical leverage strategy. Table 3.5 lists some of the new drug candidates that are being tested in parallel human trials for multiple indications. The success rate of this strategy remains to be seen.

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