Case Study No. 2

Rapid Engagement for Complex Cell Therapy

I. Situation:  

Highline Sciences was selected by a Fierce Biotech – Fierce 15 company with a novel approach to cancer vaccines in combination with multiple checkpoint inhibitors for a first-in-human (FIH), dose-escalation and expansion, basket trial for advanced solid tumors. The Sponsor had previously struggled with a rigid, name-brand CRO and was looking for a true partner with the right expertise and flexibility for their highly complex program.

II. Challenges:  

A successful pre-IND meeting led to first patient in (FPI) goals months earlier than initially planned. Sponsor engaged Highline less than 2 months ahead of FPI goal.

Rapid development of study manuals and site training materials to ensure study milestones would be met with quality. Resource-constrained emerging biotech with a limited internal team.

III. Strategy:  

Highline deployed a customized team with relevant modality and sponsor-side management experience. Integrated with Sponsor team to augment their internal resources, guide vendor selection/management and develop study materials.

Developed thorough rationale and background language in anticipation of Institutional Biosafety Committee questions.

IV. Results:  

The Highline team was able to engage immediately upon project award and drive the study forward while significantly reducing the Sponsor’s workload. Through strong working relationships with the Sponsor team and active engagement of our oncology experts, the team was able to build trust quickly. Unnecessary redundancies across the combined CRO and sponsor project team were eliminated resulting in increased efficiencies and decreased costs. Within 6 weeks of contract execution, the team was able to activate the first clinical site and aggressive FPI timelines were met.

“Highline is thoughtful, detailed, organized, and efficient. They have made my life easier as I have complete trust that the study is in more-than-capable hands with the Highline team.”