Date: Friday, 3rd March 2017
Venue: Citadines Hotel, Holborn, London
Time: 10:00 – 13:00 (including lunch)
To register email Ciaran.Flanagan@quotientclinical.com
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.
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.
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.