Introduction
A biotech company developing a treatment for cancer and immune disorders planned to conduct their Phase 1b clinical trial in the United States (US). They approached Venn Life Sciences seeking a partner to provide comprehensive support for their pre-Investigational New Drug (IND) meeting and IND application to the US Food and Drug Administration (FDA).
The Challenge
The project’s complexity required expertise across multiple disciplines including chemistry, manufacturing, and control (CMC), nonclinical, clinical, and project management. The client needed a partner who could not only understand the intricacies of each discipline but also seamlessly integrate them into a cohesive strategy.
Solution
Venn Life Sciences, with its multi-disciplinary expertise and with a commitment to high-quality deliverables, provided the following services:
- Project Management: Including the collaboration with the client’s US partner/contract research
organization (CRO) who submitted the regulatory documentation to the US FDA. - Regulatory Affairs Support: Assisting with regulatory compliance & collaborating with the client to develop the pre-IND briefing package and prepare for meetings.
hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
