Thesis
Human immune challenge to assess proof-of-mechanism in drug development
- Abstract:
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Background: High attrition rates in immunomodulatory drug development, particularly in Phase II clinical trials, are largely driven by failure to demonstrate efficacy at this key development stage. First-principles and observational evidence indicate that establishing proof of mechanism (PoM) early is essential to support robust go/no-go decisions. Human immune challenge (HIC) models provide an experimental platform to elicit mechanism-relevant pharmacodynamic (PD) biomarkers... Expand abstract
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(Preview, Dissemination version, pdf, 14.3MB, Terms of use)
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Authors
Contributors
+ Coles, M
- Institution:
- University of Oxford
- Division:
- MSD
- Department:
- NDORMS
- Sub department:
- Kennedy Institute for Rheumatology
- Role:
- Supervisor
- ORCID:
- 0000-0001-8079-9358
+ Richards, D
- Institution:
- University of Oxford
- Division:
- MSD
- Department:
- NDORMS
- Sub department:
- Botnar Institute for Musculoskeletal Sciences
- Role:
- Supervisor
- ORCID:
- 0000-0002-8093-7084
+ Fullerton, J
- Institution:
- University of Oxford
- Division:
- MSD
- Department:
- NDORMS
- Sub department:
- Kennedy Institute for Rheumatology
- Role:
- Supervisor
- ORCID:
- 0000-0002-4855-9255
- DOI:
- Type of award:
- DPhil
- Level of award:
- Doctoral
- Awarding institution:
- University of Oxford
- Language:
-
English
- Keywords:
- Subjects:
- Pubs id:
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2407675
- Local pid:
-
pubs:2407675
- Deposit date:
-
2026-03-22
- ARK identifier:
Terms of use
- Copyright holder:
- Philip Drennan
- Copyright date:
- 2026
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