Therapeutics case studies

ICON supported a randomised phase 3 study to examine the study drug in combination with nivolumab vs chemotherapy in patients with checkpoint inhibitor refractory non-squamous NSCLC.

ICON was selected by a mid-size biotech company to support a phase 1 dose escalation and cohort expansion study of an immune checkpoint inhibitor, in patients with advanced solid tumors. Mid-study, the sponsor was acquired by a large pharma company to which ICON has efficiently supported the transition to the evolving sponsor business model and operations.

A pharmaceutical client needed to better understand patient perspectives, concerns and awareness of that could impact the development of a vaccine for Human Cytomegalovirus (HCMV).

A sponsor approached ICON during an influenza pandemic in Mexico to conduct a randomised, placebo controlled vaccine study with an investigative pandemic H1N1 vaccine.

ICON was awarded a global study for Major Depressive Disease (MDD) in over 600 adult subjects. Enrollment began during the COVID pandemic and despite challenging protocol requirements, IMP expiry date and database lock requirements, ICON reached LPR and DBL closed five months early.

COA Repository, revolutionizing the management of COAs within the sponsor’s clinical trials.

ICON supported a phase 1/2/3, single-arm, open-label, multi-site, single dose in patients with transfusion-dependent ß-thalassemia. ICON overcame patient recruitment challenges due to the complexity of the study and sites with limited experience with CRISPR-Cas9 modified gene therapy. All planned milestones were met, and first patient randomised was per plan.

ICON was approached by a drug development sponsor to conduct a global, phase 3 trial in an adult patients with primary immune thrombocytopenia. The trial was part of a four-program study with challenging recruitment timelines.

ICON was approached by a large pharmaceutical company to conduct a fully decentralised placebo-controlled trial, focused
on demonstrating that the drug reduced symptom burden in patients with heart failure.

ICON assisted in the recruitment of participants for a hot flash study that had a set of complex eligibility requirements.

ICON was awarded a study in an adult patient population with Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare indication. Despite complex study logistics ICON’s proactive site and patient support strategy enabled recruitment to be completed ahead of schedule.

A small US-based biotech company was in a race to be the first to market with their lead targeted oncology product.