• Understanding the role of immunotherapies in modern drug development.
• Learning novel approaches clinical development of immunotherapies phase 1-4 (pathway to approval).
• Designing novel immunotherapies and identifying pitfalls in developing biologics.
• Key pharmacokinetic (PK) and pharmacodynamic (PD) concepts
·Application of PK/PD through research and development
·Basic PK characteristics of protein drugs
· Dose selection for First-in Human (FIH) clinical studies
• Understanding how to use experimental medicine to understand the human immune system & use novel statistical study designs to achieve reproducible results.
|12:00 to 13:00||Registration and Lunch|
|13:00 to 13:05||Introduction to the day
Dr Joseph Cheriyan (CUH)
|13:05 to 13:40||Journey of a biological molecule - Overview of drug development
Key Note Speaker: Dr Nic Wisniacki (GSK)
|13:40 to 13:50||Q&A|
|13:50 to 14:30||Key technologies and challenges in pre-clinical biologics drug discovery
Dr Steve Martin (GSK). Dr Andrew Buchanan (Medimmune)
|14:30 to 15:20||Biologics Interactive workshop and Q&A
Dr Steve Martin & Dr Andrew Buchanan
|15:20 to 15:50||Break|
|15:50 to 16:30||Dose Selection for First-in-Human Studies of Biologics
Dr Paolo Vicini (MedImmune)
|16:30 to 17:10||Immune Cell Responses in Participants with Type 1 Diabetes after doses of Interleukin-2 in adaptive-response clinical trials
Dr Frank Waldron-Lynch (University of Cambridge)
|17:10 to 18:00||PK/PD Interactive workshop and Q&A
Dr Frank Waldron-Lynch & Dr Paolo Vicini
|18:00 to 18:30||Immunopharmacology Group discussion, reflection and review
|18:30 to 19:00||Close of Meeting
Depart for Trinity Hall (dinner registrants only)
|19:00 to 23:00||Drinks reception followed by dinner
Trinity Hall, Cambridge
Wyng Gardens Conference Centre, Cambridge, CB5 8AQ
Paediatric Drug Development
To understand paediatric drug development in experimental medicine research and as part of clinical studies.
Gain an overview of differing disease epidemiology and regulatory considerations, understanding conditions which occur in paediatric populations & adult populations.
To understand the difficulties in ...