Therapeutics case studies

A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.

A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues that were overcome through collaboration and communication.

A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and ICON helped manage the imaging data for each participant.

Despite effective treatments, osteoporosis still needs better, affordable options. A sponsor ran a 3-arm, double-blind study on a denosumab biosimilar in 225 healthy men over 10 months at two ICON sites.

To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required.

An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study.

A major Point of Care (PoC) Publisher partnered with Symphony Health to evaluate an unbranded cardiovascular treatment campaign targeting hospital-affiliated physicians nationwide. The campaign used printed condition guides to engage HCPs and patients during key decision-making moments.

A pharma client partnered with ICON to support EU and US approval of a new diabetes therapy. ICON’s APS team sourced, labeled, and shipped comparator and study drugs for a complex phase 1 trial, helping meet the sponsor’s accelerated timeline.

ICON enabled successful enrollment and data integrity in two global Phase 3 HCM trials through expert site selection and CPET standardization. Despite rare disease challenges and competitor pressure, the program advanced smoothly.

A top 20 pharma subsidiary scaling plasma-derived therapies asked ICON to review their processes and plan for growth. With plasma reliant on donations, new centers were opening to meet demand and ensure patient access to life-saving treatments.

A small Asia-based biotech engaged ICON to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.

ICON partnered with a leading pharma company to scale its global vaccine program using flexible, custom FSP solutions. By combining dedicated teams with on-demand support, ICON helped expand trial reach, adapt to changing needs, and deliver nearly $10M in annual cost savings.