Our Enabled-First-in-Human® (Enabled-FIH) programs integrate real-time drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. With a wealth of experience and state-of-the-art manufacturing and clinical facilities on site, our team will work closely with you to:
Enabled-FIH programs are applicable to all molecules (small and large), all formulation types (from simple to complex) and all routes of dose administration. Our programs are proven to reduce development timelines and costs.
As part of the development program, our multidisciplinary team of experts can help you to interpret biopharmaceutical data, and design your formulation for FIH and beyond. We can also undertake:
Real-time manufacturing in response to emerging clinical data, during single and ascending dose studies, allows us to adjust drug dose and formulation between each group without slowing timelines. This enables flexible study designs incorporating:
With our network of key opinion leaders and access to several patient groups, we can deliver integrated programs, whether that’s on-site dosing in our fully-equipped 85-bed clinic, or through real-time product supply to specialist clinical sites.
The benefits of this approach include: