Intellectual Property, the Drug Development Process, and the Ticking Clock

Post by
Andrew Paier

A typical pharma product or medical device requires 10 or more years to research and develop before gaining approval to market.

The Medicines Development Process

Medicine R&D

But consider this, once a disease mechanism and lead molecule is revealed, numerous big pharm heavy weights pile on.? It used to be that the time from first to second medicines in a therapeutic class was nearly 10.2 years in 1970, but that has dropped to only 2.3 years by 2011 Tufts Univ. School of Medicine, Center for the Study of Drug Development.? Innovators will always be king, but the winner-take-all game is over.

Patents protect the innovators? intellectual property and provide the market exclusivity needed for investments to be recouped. But there is increasing political pressure to reduce patent life which ultimately will drive up costs to patients for the newest products and reduce the level of early stage investment by innovators.

Regardless, at patent expiry, generic firms, who don?t bear the upfront investment costs, can provide lower costs versions of products. Unfortunately, a growing number of firms are willing to begin violating patents on the first day products enter the market, exploiting the investments made by the innovators and creating added legal costs. Benefit providers, insurers, wholesalers, and pharmacies also claim pieces of the profit pie.

To realize the years of sales necessary to recoup decades of investment in a drug, there will always by an internal ticking clock that creates an imperative to speed up the process from discovery-to-market.? Drug development is a complex, multi-year process that must itself be well understood and maintained as a core business process and stewarded for consistent, fast execution. The process must be agile to account for unique aspects of each molecule?s development needs, but should not be allowed wander down its own development path.

Second only to innovation, the drug development process speed imperative will reign supreme among C-suite strategies for pharma differentiation. The executive mindset for speed for the process must be a stopwatch, not a clock.? The companies that establish an end-to-end system view and measure accurately the rate of delivery of milestones across their complex drug development and clinical trial design and execution processes will lead.

At BP3 Global, we are combining our business process management and digital business process automation expertise to speed up the drug development and clinical trial processes of our pharmaceutical clients. We are also capturing business process performance analytics that we display in customized execution dashboards to allow process owners and executives the clear view needed to monitor the speed and quality of their processes end-to-end.

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