Biotech case studies

A leading biotech company developing a groundbreaking non-opioid treatment for moderate-to-severe acute pain partnered with ICON to conduct a series of early-phase trials.

ICON conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.

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

ICON’s proactivity in risk mitigation, commitment to the study, project planning and communication contributed significantly to the ultimate success of the study.

ICON developed flexible, cost-effective CRF designs for a cell therapy immuno-oncology study, harmonising RECIST and iRECIST criteria while addressing re-treatment requirements and supporting sponsors in meeting study timelines.

ICON assisted a US-based oncology biotech in overcoming timeline, data uncertainty, budget constraints, and pressure for publishable results by offering a cost-effective phase 3 trial design with interim analysis, enabling early efficacy and regulatory approval with minimal upfront investment.

A newly formed company needed expertise to support asset due diligence and strategic development planning to build their portfolio. ICON was asked to verify the company’s own due diligence assessments and requested ICON’s experience in designing and executing a more efficient clinical development programme.

A sponsor needed to recruit nearly 500 patients for a pivotal study in an ultra rare disease. The study's demanding protocol posed significant difficulties for patients. ICON was able to revise the protocol, reducing patient burden, and implemented a global recruitment strategy and additional support that allowed recruitment to be completed ahead of schedule, saving the sponsor an estimated $700,000.

ICON provided a comprehensive DMC solution for a phase 2 NASH trial, overcoming challenges like coordinating data across multiple vendors and adjusting to rapid enrollment.

ICON provided a tailored quantitative risk assessment solution to help a sponsor anonymize clinical study data and documents for regulatory submission and private data-sharing.

A small US based biotechnology company sought ICON’s assistance for a high-risk immunology study with heavy investment and limited resources. The study was a phase 3 Lupus SLE study with a complex protocol governing 90 sites.

For this client, ICON has performed technical evaluations of more than sixty assets across a range of therapeutic areas and modalities, including assessing the development risks and probability of achieving registration and commercial success.