Case Study No. 1
Accelerating Precision Medicine
Development in Oncology
Highline Sciences was selected by a biotechnology company for a targeted-therapy program consisting of two international trials (PhII & PhIII) to be started in parallel. The sponsor’s clinical operations team was seeking a nimble, strategic partner capable of providing a high-caliber team of oncology experts who would give their small company the attention they deserved.
These studies were to take place in a highly competitive market for an indication where the genomic target was rare and not well characterized. The sponsor required an experienced, dedicated team that could think strategically, accelerate site startup and meet aggressive enrollment milestones.
— Accrue patients in a short timeline for a rare patient population for whom genomic sequencing was not the standard of care.
Strategic Site Selection: our feasibility team performed a deep competitive analysis to identify investigators with particular interest in the drug class and history of comprehensive genomic sequencing.
PI Engagement: Highline, in collaboration with the Sponsor, initiated early, targeted outreach to key opinion leaders to engage them in development planning and leverage interest in existing data for the drug class.
Optimize the Patient Funnel: Highline implemented a strategic, modern approach to optimize patient identification and enrollment. The team combined the traditional model of core, high-volume research institutions with a distributed model to bring the trial to the patients. This combined approach along with analysis of genomic data enabled the team to zero in on target patients and accelerate enrollment.
“Highline is not a typical CRO: They are a Partner committed to executing high-quality clinical trials. While working with Highline on a global, phase 2 trial, they dissuaded me of my prior experience that CROs require ongoing (and time-consuming) oversight and management… and it is rare that I have asked a question that they have not already considered themselves. They consistently demonstrate their expertise, and their sincere investment in the success of the study.”