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).
Much has been written about the various factors that may contribute to poor launch performance but having spent many years working in different parts of the pharmaceutical R&D process, including pre-clinical research, clinical development and now commercialization at EVERSANA, one characteristic has struck Adam Hardy, more than anything else: the siloed nature of pharmaceutical research, development and commercialization.
In his article, he highlights 3 strategies for clinical teams to think beyond gaining marketing approval as the end-goal of pharmaceutical R&D, and gain sight of the fact that the real “win” is to get the right product into as many patients’ hands, as quickly as possible. He offers some thoughts on the key areas that will help to “bridge the divide” between pre- and post-approval activities:
- Clinical Development Strategy and Individual Study Protocol Design
- Clinical Trial Awareness Campaigns and Market Shaping
- Expanded Access Programs and Phase IV Planning
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Author
Adam Hardy is a leader in the pharmaceutical industry, having worked in the industry for over 15 years in both European and US-based organizations. This experience includes working in all phases of pharmaceutical R&D,…