API Management Practices

It is no secret: today’s pharmaceutical marketplace is alive with innovative products, drug delivery systems, new drug substances and modifications to existing APIs. Improved drug product formulations and delivery technologies1-3 are addressing everything from consumer preferences to financially competitive positions and improved bioavailability. Simultaneously, therapeutic specific APIs are arising from genomic/proteomic investigations4—both large and small molecules—that hold immense promise for treating diseases without complicated side effects. Additionally, modifications to existing APIs have led to direct improvements in efficacy or allowed for more user-friendly applications. The potential financial rewards emanating from these activities are enormous and two major questions plague executives managing these innovations: 1) How soon can intellectual property be established to protect the investment, and 2) How soon can the innovation be commercially implemented to generate revenues?

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