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 London on Friday 3 March. To go to the event page, please click here.