ICON has developed and implemented a “virtual development model”, as result of changes in the pharmaceutical and financial communities. This approach integrates strategic drug development expertise with execution and operational excellence, specifically for biotechnology companies and venture capital or private equity funded organisations, who do not plan to build infrastructure or deploy resources. It is also useful for large and mid-sized pharmaceutical companies who are
looking to accelerate the development of new assets, without over-burdening existing resources. By avoiding duplication of roles, the focus is on efficient delivery.

A venture-backed biopharmaceutical company sought to accelerate the development of therapies for patients with chronically debilitating life-limiting rare diseases that had few treatment options. The company specifically focussed on programmes that originated in pharmaceutical companies where, for strategic reasons, they were not being progressed. The company needed a partner who could support and collaborate to rapidly progress these programmes into late-stage development and subsequent commercialisation.

ICON developed a working model to provide technical and commercial assessment of assets from due diligence, program design and program execution perspectives, where ICON effectively would act as the drug development arm of the company, combining strategic thinking with execution.

ICON played a key role in the due diligence process providing evaluation of an asset focusing on a rare disease indication. By working closely with the sponsor organization, our experts were responsible for moving the asset from the originator company, designing studies, preparing protocols, integrated development plans as well as regulatory dossiers which including orphan drug status requests.

Utilizing its depth in PK/PD modelling, ICON simplified the development program significantly, by moving from a complex two-study approach employing loading doses, to a single study. ICON also developed a number of electronic patient-reported outcomes (ePROs) and a novel biomarker approach, based on functional imaging, for the rare disease asset.

The virtual development model integrates expertise throughout ICON, including scientific consulting, clinical research, laboratories, and commercialisation and outcomes teams.