Establishing The Patient Access Mission During Clinical Development

By Adam Hardy, VP, Commercial Operations

An inescapable but disappointing characteristic of pharmaceutical research and development is that at the end of a process costing billions of dollars, the majority of launches fail to reach expectations. The ultimate tragedy of this is that the fundamental purpose of pharmaceutical R&D is undermined: patients are either delayed in receiving the best products to treat their conditions, or worse, if products fail to achieve reimbursement, they may be unable to access them at all. Financially, the impact of the loss of time can be considerable (costs of up to $13M per day of delay in getting to market)¹.

With a CRO, if approval is achieved, the chance of a successful launch is only about 63%² and meeting forecast is 26%³, testament to the fact that CROs are not commercially thinking and are not operating with the goal of optimizing the commercial success of the product at launch and across its life cycle. Many working in clinical development consider gaining marketing approval as the end-goal of pharmaceutical R&D, losing sight of the fact that the real “win” is to get the right product into as many patients’ hands, as quickly as possible.

To tackle this, we must all firmly establish patient access as our mission statement, and in so doing, establishing a true continuum throughout the process. In pursuit of this mission and based on our work at EVERSANA, this article offers some thoughts on the key areas that will help to “bridge the divide” between pre- and post-approval activities.