Geneva Seminar

Accelerating Clinical Development from First-In-Human to Proof-Of-Concept

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Date: Tuesday, 28th February 2017

Venue: Novotel Genève Centre, Rue de Zurich 19 1201

Time: 10:00 – 13:00 (including lunch)

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Presentation titles and summary

This seminar will describe how Quotient Clinical’s unique Enabled-First-In-Human® programs significantly reduce the time and cost required to transition to Proof-Of-Concept. The integration of real-time GMP manufacture and clinical testing minimises CMC investments and simplifies supply chains. By enhancing the design and speed of early phase clinical programmes, the pressure on R&D budgets is reduced and critical decisions are made sooner.


Presentation 1: First-In-Human to Proof-Of-Concept – there is a better way!Alyson Connor

Alyson Connor, Executive Director Exploratory Clinical Pharmacology

A current perspective on the conduct of First-In-Human (FIH) programs in the UK will be shared, highlighting the benefits of Quotient’s innovative approach. Case studies will illustrate successes across a range of molecule classes and indications.


Presentation 2: Adaptive CMC strategies for First-In-Human programs.

Nikki Whitfield, Vice President, Pharmaceutical SciencesNikki Whitfield Vice-President, Pharmaceutical Sciences

Insights into novel approaches for the development of fit-for-purpose FIH drug products to allow rapid entry into clinic will be described. Proven strategies for a time- and cost-efficient transition, within the FIH programme, to a product suitable for downstream development will be presented.