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 programs, 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, 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 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.
To register your place, please email Ciaran Flanagan.
This event is also taking place in Cambridge on Tuesday 21 February. To go to the event page, please click here.