Service providers are often asked to show a return on investment (ROI) or the quantifiable results of their service. This is especially so in clinical development where everyone is experimenting with various types of technologies, such as artificial intelligence (AI), machine learning and various types of predictive analytics. Although the ROI may be present, it is usually difficult to show it at the outset because a typical study in a clinical development plan (CDP) takes a long time to complete from design through enrollment.

We at Phesi have been delighted to see one of the most significant, positive financial impacts our work has had on the valuation of a company. We thought it would be of interest to people in the clinical development community, including those in the Boardroom, business development and venture capital communities, and especially those in the biotechnology space who have limited funds and need to maximize the value of the assets you are developing.

Phesi was asked to work on a biotech’s lead asset at a strategic level, defining the integrated development plan. The priority asset was about to enter first in man trials. Support was required to develop the target product profile (TPP), CDP and protocol and to select KOLs, investigators and sites as part of proactive planning activities.


Phesi identified opportunities to secure orphan drug status in 2 lead indications, increasing the potential peak sales by £1.6bn, leading to investment by a third party and a dramatic rise in stock value:

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