Welcome to NDA’s free lunch seminar on Tuesday 11th December at 12:00 -14:00 on Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind
All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should not be compromised if these risks are suitably evaluated from the earliest stages of development.
Join us to hear Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, explain how to anticipate and avoid issues for biopharmaceutical development. Grab this opportunity to benefit from his experiences and insights.
LEARNING ASPECTS:
- How to apply immunogenicity risk assessment at the lead candidate selection stage
- Minimizing incremental risks associated with manufacturing
- Understanding what and how to evaluate, at different stages of clinical development
- Integrated presentation of data to regulatory agencies
When: Tuesday 11th December 2018, 12:00 -14:00
Where: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge, UK
The Lunch seminar will be an open and interactive workshop with the opportunity to ask questions to Paul. Questions can also be sent in advance to ndaseminar@ndareg.com
Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.
Registration: RSVP by Tuesday 4th December 2018 to: ndaseminar@ndareg.com
Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623, or email ndaseminar@ndareg.com
We look forward to seeing you there!
