A newly formed company needed expertise to support asset due diligence and strategic development planning to build their portfolio. The company also wanted to develop a new working model whereby they could remain a lean organisation building minimum infrastructure. The company was transferring several assets, including a respiratory compound, from a large pharma company, and the Sponsor asked ICON to verify the company’s own due diligence assessments. Also, the sponsor requested ICON’s experience in designing and executing a more efficient clinical development programme.

ICON ensured the projects moved forward — providing an integrated drug development solution involving regulatory strategy, preclincal support and clinical trial design — while the Sponsor focused on the business aspects of the company. ICON reviewed available data sets from pre-clinical and clinical pharmacology as well as chemistry, manufacturing and controls, to evaluate the original clinical development plan from the large pharma company. The team then ran a series of simulations to optimise the dose and dosing frequency.

After a detailed review of the data, the ICON team streamlined the original programme from two protocols into one, creating a more efficient clinical design. This development plan optimisation reduced projected costs by approximately $30 million. In parallel with the design activities the ICON team compiled and submitted the IND which raised no concerns with the FDA and allowed a rapid progression for the asset into the clinic. The first site was opened within 6 months of the company being formed.