Case Study No. 1

Accelerating Precision Medicine
Development in Oncology

I. Situation:  

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.

II. Challenges:  

— Rapid site ID and startup for two clinical trials in parallel to secure high-volume centers ahead of the 3 large-pharma competitors.

— Accrue patients in a short timeline for a rare patient population for whom genomic sequencing was not the standard of care.

III. Strategy:  

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.

IV. Results:  

The strategies implemented on this trial along with the strong site relationships established by Highline’s expert monitoring team enabled our Sponsor to accrue this trial faster than expected and progress from their data cut-off to new drug application (NDA) filing two months ahead of the corporate stretch goal and before their large-pharma competitors. Subsequent health authority inspections of multiple clinical sites were completed with no 483s issued.

“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.”