Excerpts from PharmaVoice’s article:

“Agile project management, first introduced in 2001, started out as a method used in software development that challenged the traditional, linear development model. The same benefits realized by the software industry, experts say, can be realized in pharmaceutical R&D. Agile takes a more iterative development approach with small parts of projects being built and tested simultaneously.

Adaptive trials are an example of an agile approach, says Barinder Marhok, associate VP and head R&D center of excellence, life sciences, Cognizant. ‘The ability to change the protocol while the trial is still in progress was an absolutely brand new concept,’ he says. ‘Adaptive trials take a smaller proof-of-value cohort of data, which allows researchers to decide whether to continue with the current design or the current protocol requirements or refine the protocol.’

He says agile involves determining proof of value, with more iterative inputs as the project moves along. ‘I’ve worked with some pharmaceutical company partners that would not stop the investment despite high-profile trial failures because there was always a hope that the next trial would show something,’ he says. ‘This hope has been a drag on the cost of trials and the cost of developing a drug to the point where it is becoming prohibitive vis-à-vis the benefits of narrowing down the use case of a drug.’

Failing fast is part of the agile process, and he says the aim is to make adjustments quickly. ‘Companies can use a smaller cohort to determine if there are different adjusted statistical endpoints that would provide value. This allows companies to focus more of their energy on areas where a drug is showing more promise.’”

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