Paul Chamberlain has been directly involved in the development of biopharmaceutical products since 1983, occupying analytical, bioanalytical, product quality control, monoclonal antibody production and regulatory roles. His interest in immunogenicity risk assessment was triggered by experience gained at Amgen in 1998 with PEG-MGDF and then extended through his role as a Development Programs Director at MDS Pharma Services (2001-2007). Paul started submitting the Immunogenicity Risk Assessment module in Clinical Trial Applications from 2004 and then focused on creating an Integrated Summary of Immunogenicity (ISI) to provide a self-standing section of the CTD format that incorporates the multi-disciplinary information required for a balanced regulatory assessment. His first ISI was submitted in 2009 to support the approval of XIAFLEX™, a clostridial collagenase for treatment of Dupuytren’s contracture. The ISI format was subsequently refined and then adopted into EU (2017) and FDA (2019) guidance.

Paul has worked closely with EU and FDA regulators to understand the priorities for regulatory submissions at different stages of the product life cycle, supporting companies directly at Scientific Advice, pre-CTA/IND, End-of-Phase 2, Pre-MAA/BLA submission, Oral Hearings and FDA Advisory Committee meetings.

Find me on LinkedIn

Selected publications...

• Paul Chamberlain. Presentation of immunogenicity-related information in regulatory dossiers. Regulatory Rapporteur May 2020, Vol. 17, No. 5.
• Paul Chamberlain. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis 2019, 11 (17), 1581-1592.
• Chamberlain P. Addressing immunogenicity-related risks in an integrated manner. Regulatory Affairs Pharma, Jan 2011, 10-15.
• Paul Chamberlain & Bonita Rup. Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates. The AAPS Journal 2020, 22: 65
• 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
• 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
• 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

Laura began her regulatory affairs career in 2009 as Immunogenicity Program Coordinator and immunogenicity expert at the FDA, while holding a Chemistry, Manufacturing and Controls (CMC) reviewer position. She evaluated the CMC and immunogenicity of multiple therapeutic proteins INDs, license applications (BLAs) and post-approval supplements. She was responsible for the review and Advisory Committee presentation of the immunogenicity of metreleptin (MYALEPT®), currently approved for the treatment of pediatric and adult lipodystrophy.

After 5 years at the FDA, Laura moved to the private sector to broaden her clinical development knowledge acting as Immunology and Biomarkers expert for Sanofi-Genzyme. In this role, she provided strategic support for analytical bioassay development and immunogenicity risk assessment for Enzyme Replacement Therapies (Avalglucosidase alfa – Pompe’s disease), monoclonal antibodies (Sarilumab – KEVZARA® – Rheumatoid Arthritis, and Alirocumab – PRALUENT® - familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease), and gene therapies (Leber’s Congenital Amaurosis), while developing an expertise in biomarker qualification.

Laura then consolidated her CMC expertise acting as regulatory lead for several US and EU regulatory submissions for Sanofi-Genzyme (PRALUENT®), Fresenius Kabi SwissBiosim (Biosimilars), ZioPharm Oncology (autologous CAR-T cell and gene therapies), PokeACell (autologous tumor infiltrating lymphocytes, TILs) and cBio (cell therapy manufacturing).

Laura holds a PhD in Biochemistry and Molecular Biology and has authored various publications in multiple peer-reviewed journals. She is now based in Lausanne, Switzerland, where she works as independent regulatory consultant.

Find me on LinkedIn

Selected publications...

• Salazar-Fontana LI, Desai DD, Khan TA, et al. Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development. AAPS Journal 2017; 19(2):377-385
• Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS Journal, 2016, 18(2): 311-20.
• Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, et al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 — LBA, biomarkers and immunogenicity). Bioanalysis. 2015 Dec;7(24):3107-24
• Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, et al. White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 — LBA and immunogenicity), Bioanalysis, 2014; 6 (24): 3355-68