First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines

12 July 2016 - 29 January 2022

Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success. The traditional staged approach to drug development has involved discrete clinical studies in Phase I and Phase II, separated by decision steps. However, increasingly protocols are being combined or interleaved to accelerate the pathway to POC.

In addition to optimizing the clinical plan, pharmaceutical project teams now also demand more data than ever before to answer key “developability” questions in Phase I. Can we assess the impact of formulation and formulation performance? How can we rapidly manufacture GMP product for Phase I? What drug product will we use for Phase II? Is there a valid biomarker to establish an early pharmacodynamics response? Are there any metabolism or bioavailability issues that need to be addressed?

During this webinar, the speakers will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. The effect is to significantly reduce time to proof-of-concept, minimize up-front investment and simplify supply chains.

This webinar will present a set of case studies on:

  • Integrated single and multiple ascending dose studies combining healthy volunteer and POC investigations
  • Real-time adaptive GMP manufacturing to enable dose, formulation and product changes within a clinical protocol in response to emerging clinical data
  • Continuous supply of clinical trial material (CTM) to global clinical sites post-Phase I, avoiding the need for tech transfer and scale up prior to Phase II

Dr Ofir Moreno, MEI Pharma, Inc will present the design and results of an early development program of a new molecule ME-401, which is in development for the treatment of lymphoid malignancies.

Dr Alyson Connor, Quotient Clinical, will present further cases studies illustrating the applications and benefits of Enabled-FIH.