Advisory Board Member

Paul Chamberlain

Paul has been with NDA since 2007, focusing on the development and registration of a wide variety of biotherapeutic modalities, ranging from peptides through to genetically modified cellular therapies. He applies a multi-disciplinary, risk-based approach for building effective development strategies from lead candidate selection onwards, with a particular focus on immunogenicity-related considerations.

Paul is a member of Immunogenicity Integrated, this is a platform created by three members of the NDA Advisory Board, who combine extensive multi-disciplinary experience of assessing immunogenicity for different biotherapeutic modalities, including ATMPs. Deeper understanding of intrinsic and extrinsic factors that may influence immunogenicity enables de-risking of the product development process in a manner that is fully aligned with regulatory expectations. NDA group and Immunogenicity Integrated work in close partnership to provide documentation, including risk assessment for Clinical Trial Applications and Scientific Advice meetings, and the Integrated Summary of Immunogenicity for global registration dossiers.

Key Areas Of Expertise
  • Identification, evaluation & mitigation of immunogenicity-related risks for biotherapeutic development
  • Understanding global regulatory standards for analytical, bioanalytical, clinical methodology and data presentation to enable successful registration
  • Building commercial value incrementally via a stage-gate approach
  • Advocacy to manage unexpected results
  • High-quality dossier preparation, specializing in Immunogenicity Risk Assessment documentation and the Integrated Summary of Immunogenicity.
Before Joining The NDA Advisory Board

Paul was Senior Director, Biopharmaceutical Development Programs, at MDS Pharma Services. Previously, he held various R&D and Regulatory Affairs roles in SmithKline Beecham, Amgen, Metris Therapeutics & Sanofi-Synthélabo.

Recent Publications

Paul Chamberlain & Bonita Rup. Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates. The AAPS Journal 2020, 22: 65

Paul Chamberlain. Presentation of immunogenicity-related information in regulatory dossiers. Regulatory Rapporteur May 2020, Vol. 17, No. 5.

Salmikangas P, Chamberlain P, Silva Lima B & Toivonen M. Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures. Cell & Gene Therapy Insights 2019; 5(7), 829-857.

Wessels H, Lehnick D, Höfler J, Jankowsky R, Chamberlain P & Roth K. Pharmacodynamics, safety, and immunogenicity of Pelmeg®, a pegfilgrastim biosimilar in healthy subjects. Pharmacol Res Perspect. 2019 Oct; 7(5): e00507

Paul Chamberlain. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis 2019, 11 (17), 1581-1592.

Chamberlain P., Kurki P. (2018) Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective. In: Gutka H., Yang H., Kakar S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer

Salmikangas P, Kinsella N, Chamberlain P. Chimeric Antigen Receptor T-Cells (CAR T-Cells) for Cancer Immunotherapy - Moving Target for Industry? Pharm Res. 2018 May 31;35(8):152

Reinivuori, T, Kurki P, and Chamberlain P. Immunogenicity Assessment of Biosimilars. Pharmaceutical Medicine, 2018. 32(2): p. 103-121.

Baker, M. P., Jones, T. D. and Chamberlain, P. (2017) Immunogenicity of Biologics, in Protein Therapeutics (eds T. Vaughan, J. Osbourn and B. Jallal), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527699124.ch12

Paul Chamberlain. The role of immunogenicity evaluation for biosimilars. In: Biosimilar Drug Product Development; edited by Laszlo Endrenyi, Paul Jules Declerck & Shein Chung Chow; CRC Press 2017; Pages 361–374

Ebbers HC, Chamberlain P. Controversies in establishing biosimilarity: Extrapolation of indications and global labelling practices. BioDrugs 2016, 30 (1), 1-8

Chamberlain P. Immunogenicity: anticipating and avoiding issues for biopharmaceutical development. Drug Target Review, 2015, 2 (3), 12-15

Chamberlain PD. Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway. Biosimilars 2014, 4, 23-43.

Ebbers HC & Chamberlain P. Interchangeability: an insurmountable 5th hurdle? Generics and Biosimilars Initiative Journal 2014, 3 (2)

Chamberlain P. Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations. Bioanalysis 2013, 5 (5), 561-574.

Chamberlain P. Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies. N Biotechnol 2011, 28 (5), 481-488.

Buettel IC, Chamberlain P, Chowers Y et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 2011, 39 (2), 100-109.

Chamberlain P. Addressing immunogenicity-related risks in an integrated manner. Regulatory Affairs Pharma, Jan 2011, 10-15.

Paul Chamberlain


Speaking Engagements


European Immunogenicity Platform Symposium

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