Adding Value To The Drug Development Process

By William Crown, Ph.D.

One of the greatest challenges facing life sciences companies today is the growing move to evidence-based medicine with a need to generate health outcomes data throughout the full drug or device
development process. The so-called “value proposition” is increasingly important in guiding everything from
the creation of protocols for registration for clinical trials to providing a clear indication of the value and benefit of medicines, vaccines, and devices, which affects pricing and uptake. This is a fundamental change from the way drugs historically have been developed. The change is being influenced by external and internal factors. The drive to limit ever-escalating healthcare costs is leading to a growing move to value-based pricing. Meanwhile, life sciences companies are struggling to cut the high costs of successfully developing and delivering new medicines and devices.

The current environment places a new, compelling need for life sciences companies to obtain, analyze, and demonstrate real-world evidence of the value of their products from discovery through clinical development and then on throughout commercialization. If done properly, starting early, this evolution in product development and commercialization can help ensure that life sciences companies realize the full value of their products throughout the full life cycle.