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.

Regulatory solutions for uncharted scientific waters

Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.
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Complex phase 1 obesity study

ICON was once again selected as a partner to conduct a phase 1 study in individuals who are overweight or have obesity, evaluating the safety and tolerability of a new subcutaneous GLP-1 and amylin peptide formulation.
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Optimising site selection in a rescue study

A pharmaceutical sponsor launched a global trial for elderly UTI patients, opening 125 sites across 15 countries. Enrolment lagged at 1 patient per site per month, with 70% non-enrolling. ICON was brought in to rescue the study.
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Protocol optimisation

A virtual biotech start-up acquired an immunomodulatory mechanism targeting inflammatory pathways. It had undergone phase 1 and small phase 2a studies. With urgency to advance development and limited resources, the client proposed two separate studies, posing challenges in complexity, timeline, and budget. The client turned to ICON to streamline development.
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Pain proof of concept

ICON had he objective to develop a smartwatch mobile app combination that can be used to alert patients, and physicians and drug development teams to physical behaviours that may exacerbate patients’ pain.
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Allergic rhinitis

A Biotech client contracted ICON to conduct a Phase III study that was a double-blinded, randomised, multinational, multicentre, placebo-controlled trial.
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Triple negative breast cancer

A large, multinational pharmaceutical company needed to better understand patient perspectives to optimize protocol and study design and operationalise a study for TNBC.
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