Immunogenicity Workshop Part 1.
IMMUNOGENICITY INTEGRATED (Part I.)- Interactive workshop to apply risk assessment tools in practice
15 - 16 October 2012, Munich, Germany
- Current regulatory environment, including biosimilars
- Mechanisms involved in immune responses to therapeutic proteins
- Bioanalytical method selection for immunogenicity testing
- Identification of product-specific risk factors
- Multi-disciplinary evaluation of risks
- Integrated data interpretation
- Interactive expert panel discussions & case study
The aim of this 1½ -day workshop was to provide biopharmaceutical development professionals – who could be analytical, bioanalytical, non-clinical, clinical or regulatory specialists – with the interrogative tools to plan a strategy for evaluating (and managing) immunogenicity-related risks that is appropriate for the stage of development of their particular product, be it new therapeutic protein or biosimilar.
Faced with an expanding number of technical platforms, which often generate signals of equivocal clinical significance, even those scientists who are familiar with the bioanalytical state-of-the-art can find it difficult to provide clear advice to their project teams about the most suitable technical strategy for immunogenicity evaluation. Interpretation of bioanalytical signals relative to clinical significance should involve correlation with relevant PK and PD parameters as well as an assessment of the impact on clinical efficacy and safety in the target population. For biosimilars a product-specific package addressing clinically significant signals will need to be complemented by post-approval monitoring. This workshop illustrated the application of an integrated approach to data interpretation that addresses this challenge in a manner that meets the regulatory priorities.
The starting point should always be to understand the intrinsic immunogenicity of the therapeutic protein followed by consideration of how extrinsic factors might moderate the intrinsic immunogenic potential. Accordingly biopharmaceutical development scientists who do not have an immunology background need to be aware of the underlying mechanisms by which therapeutic proteins invariably generate treatment-emergent immune responses and the nature of the tools available to mitigate risks during product development. These aspects were discussed in the opening part of the programme.
The workshop seeked to reinforce the learning exercise via an interactive case study in the final part of the programme as well as by interactive panel discussions during each session.
The workshop presenters were chosen for their specialist knowledge as well as their experience of immunogenicity evaluation for biopharmaceutical development.