Case Study No. 2
Rapid Engagement for Complex Cell Therapy
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.
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.
Developed thorough rationale and background language in anticipation of Institutional Biosafety Committee questions.
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.”