Therapeutics case studies
How we maximise the value of our clients' development approach while reducing costs and timelines
Learn more on how we bring life changing therapies to market.
Providing empirically based guidance and built-to-spec models and solutions across every phase of clinical research and lifecycle management for therapeutic development.
Consolidation of multiple protocols into a single LTE oncology study
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.
Integration of multiple oncology studies into a single OLE study
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.
Impact of point of care marketing in hospital settings
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.
Global coordination for phase 1 success
A pharma client partnered with ICON to support EU and US approval of a new diabetes therapy. ICON’s Manufacturing & Pharmacy Services team sourced, labeled, and shipped comparator and study drugs for a complex phase 1 trial, helping meet the sponsor’s accelerated timeline.
Strategic site selection and endpoint integrity in hypertrophic cardiomyopathy trials
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.
Creating a roadmap for growth for a blood products company
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.
Regulatory support for Asian biotech’s EU orphan drug designation
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.
Quantifying the impact of SDOH
Understanding Social Determinants of Health (SDOH) is key to addressing disparities and improving outcomes in Type 2 Diabetes. While factors like diet and access to care are known, quantifying their impact on diagnosis, treatment initiation, and adherence remains an emerging focus.
Leveraging Real-World Data and machine learning
Early cancer detection is vital, yet many cases—especially lung cancer—are diagnosed late, limiting treatment options. Life sciences organizations now use real-world data and machine learning to identify subtle, pre-diagnostic signals in patient journeys, enabling earlier intervention and improved outcomes.
Line of therapy analysis to support commercialisation efforts of rare disease
Pulmonary arterial hypertension (PAH) often presents with vague symptoms, making diagnosis difficult and leading to frequent delays or misdiagnoses. While current treatments have improved outcomes, underserved populations with limited access to specialized care remain under treated.
Scaling an optimised global vaccine trial with flexible FSP
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.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. ICON Regulatory Consulting was engaged to support market entry.