This one-day workshop by the British Pharmacological Society will cover the core principles of early phase drug development from the first study in humans through to efficacy assessments in Phase 2
Bringing a potential new medicine into human clinical development for the first time is one of the most exciting, but challenging, jobs for a pharmacologist or experimental medicine physician. This workshop will cover the core principles of early phase drug development; from the first study in humans through to efficacy assessments in Phase 2.
Who should attend?
It is tailored for postgraduate students, physicians and professional scientists working in academic, clinical or industry settings who want to understand early phase drug development.
Through a mixture of practical workshops and interactive seminars, participants will learn how to:
- evaluate novel molecules at the candidate selection stage and decide which to bring forward into human development
- design first-time-in-human and other early phase studies that protect trial participant safety and understand the toxicology programmes that underpin these
- apply the key statistical principles that underpin early phase development
- appropriately implement futility analysis and quantitative decision making to enable robust development decisions from early phase data
In the morning, participants will focus on selecting a drug candidate and safety in early phase trials. The afternoon session will explore what the non-statistician needs to understand to deliver robust Phase 1 and Phase 2 trial designs that provide clear decision-making data.
Continuing Professional Development (CPD)
This event is approved by the Royal Society of Biology for purposes of CPD
and may be counted as 18 CPD credits