One of ICON’s top five clients, a small US-based biotechnology company that primarily targets oncology mutations, was in a race to be first-to-market with their lead targeted oncology product. ICON’s close relationship with the sponsor, experience partnering with small biotech firms, and clear understanding that biotech companies require a different approach than larger pharmaceutical sponsors made us the perfect partner for this study. Applying a flexible, creative, customised solution allowed ICON to meet the client’s unique needs for hands-on oversight, strategic advice, and detailed reporting.

ICON’s partnership with a small, US-based biotechnology company began with a single Phase 2 study. As the result of our innovative approach, operational excellence, and quality outcomes on their first trial, the sponsor entrusted ICON with more studies in the challenging space of precision medicine for cancer treatment. Based on trust, transparency, collaboration, and respect, the growing partnership evolved into a sole provider arrangement to take the sponsor through their ambitious oncology drug development program.

When this biotech sponsor found themselves in a tight race to be first-to-market with their lead targeted oncology product to treat one of the most commonly mutated genes in oncology (specifically in tumors with a high unmet need), they once again partnered with ICON. Today, we are running 14 ongoing studies for this sponsor, with four more in development. There are close to 500 ICON colleagues working on the account globally, with this number set to significantly increase in the coming months.

Bringing therapies to market that target rare genetic mutations is a heavy lift for a small biotech company. When the sponsor’s lead compound was ready for Phase 2 and 3 studies, they needed a CRO partner with ICON’s depth of biotech experience to initiate four large studies within four months of each other. ICON was also entrusted with crafting a strategy to make this the program of choice for sites and patients in a highly competitive research landscape where patients can be challenging to recruit and retain. Operating a study in the midst of a global pandemic also added logistical challenges and concerns about safety for our team, sites, and patients. ICON understood that partnering with high-performing sites would increase enrollment and, therefore, accelerate time to market.

Together, ICON and the sponsor assembled teams, conducted research, and adopted a vision and mission statement for the program centered around ICON’s patient-centred approachto innovation, collaboration, and operational efficiency. We also established three key goals for the program:

• Leverage available technologies to ensure participation is as convenient as possible for patients and sites.
• Wherever possible, streamline technologies into a seamless ecosystem for trial management.
• Ensure the simplest, most efficient approach is taken for every step in the clinical trial process.

Identifying our shared vision, mission, and goals enabled ICON to design and implement a multi-focused approach that would differentiate this innovative biotech company from its competitors. We assigned cross-functional teams who could embrace the challenges of innovating and thinking outside the box, pressure-test every process and remain flexible, and apply the experience of prior study teams. ICON also leveraged our global infrastructure of technologies and vendors to provide the tools and services that sites needed to meet the unique challenges of conducting cancer clinical trials during a pandemic.

ICON implemented digital health technologies that brought the study to patients, increasing compliance and patient engagement while also giving sites real-time access into patient data. These technologies also allowed for better integration across all aspects of the trial, increasing the efficiency of enrollment and operating procedures for study sites and solving our ultimate goal of simplicity. ICON also ensured the sponsor attracted high-performing sites by offering them a steady stream of work with a complete portfolio of studies. This, combined with a variety of simplified start-up innovations and increased awareness and education efforts for sites and patients, supported study recruitment and accelerated start-up timelines.

The resulting package of trial delivery and program process optimisations—combined with our technology strategy—positioned the studies for success even in uncertain times and further strengthened the client’s trust in ICON and our partnership.

ICON and the sponsor cultivated our relationship by meeting the challenges of identifying “needle-in-a-haystack” patients for precision medicine studies. The results:

• Over the years, the sponsor has come to depend on ICON’s strategic advice and ability to conduct trials efficiently and maintain quality standards.
• The ICON teams who work for this biotech company are motivated to work smarter and devise creative solutions, as they value and respect the experience and power of our people and resources.
• Based on the client’s comfort working with ICON, the number of studies and scope of services have increased. Our studies are now all full service and include portfolio-level initiatives and support from every functional group from start-up to stats.

ICON created a mutually beneficial culture to support the sponsor’s unique needs. Our client realised the benefits of predictability among project teams and processes, as well as efficiency and cost savings. In turn, ICON gained visibility into the pipeline of future development, and we can develop and grow employees that align well with the relationship that has been formed.