First-in-Human to Proof-of-Concept

Enabled-FIH®

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:

  • Reduce time to Proof-of-Concept
  • Minimize up-front investment
  • Simplify supply chains

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.

Download our Fact sheet, Case Studies and Scientific Publications

Transition into clinical development

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:

  •        Non-clinical formulation development and supply
  •        in-silico modelling and simulation to predict human dose and pharmacokinetics
  •        Production and compilation of all documentation to support regulatory submission

Dose escalation phase

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:

  •      Assessment of drug safety and pharmacokinetics
  •      Selection of precise dose strengths
  •      Screening of alternative formulations
  •      Inclusion of biomarker assessments

Proof-of-Concept phase

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:

  •      Smooth transition from healthy volunteers to patients
  •      Continuity of drug product supply on a global basis
  •      The option to incorporate biomarkers and clinical pharmacodynamic assessments