Loughborough, England, United Kingdom
An experienced research leader and industry influencer with demonstrated success in the biopharmaceutical industry and academia. Strong research professional skilled in Immunology, Biomarkers, Life Sciences, Vaccines, Pharmacokinetics, and Biotechnology.
I provide strategic and project level guidance for biologics and advanced medicinal product development regarding immunogenicity risk assessment, measurement and mitigation. I develop company scientists to lead their internal immunogenicity function.
Co-ordinate and apply immunogenicity risk assessment assays across the large molecule portfolio of biologics, mAbs, bispecifics, peptides and gene therapies. Drive innovation of assays, automation for continuous improvement. Alignment of strategic approach across Roche sites (Europe, US, China and Japan). Application of predictive tools across Roche therapeutic areas; Immunology, Ophthalmology, Neuroscience, Rare Disease and Oncology. Representative at the European Immunogenicity Platform. Global lead for intra-ocular inflammation investigation team.
Founded and led a multi-disciplinary ‘Immunogenicity advisory group’ to review portfolio projects at designated milestones and offer advice as needed. Leadership of in vitro safety group to deliver custom solutions for safety assessment in support of first in human submissions and subsequent clinical investigations: including target assessment, candidate selection, FIH risk assessment and dose setting. Organisational change management to optimise portfolio impact of PS and the Chapter, which consisted of 70 employees and contractors.
Implement and innovate immunosafety risk assessment and mitigation approaches portfolio wide.
Implement immunogenicity assays as acceptance criteria and safety endpoints for gene therapy trials. Design and screen biologics to avoid unwanted immune responses to biologics across Pfizer’s therapeutic areas; Oncology, Inflammation, Internal Medicine (includes Cardiovascular) and Rare Disease. Develop in vitro and in vivo tools for translating from bench to bedside. Lead the Immunogenicity Risk assessment for IND. Developed in silico/QSP model for modeling and simulation of immunogenicity outcomes (incidence and impact of ADA). Contribute to ISI development for late stage assets and defence against biosimilars. Designed and executed studies to optimise vaccine technology platform in pre-clinical species, generating key cellular and humoral data to support clinical trials with novel technology and adjuvants. Collaborated with Vaccine Research Leadership Team to gain support for plans to demonstrate platform viability, including milestone Go/No Go decisions. Led transition of pre-clinical activities following acquisition of PowderMed to identify unresolved issues with their DNA based vaccine technology.
Research Interests: ‘Interaction of Hepatitis C Virus (HCV) with entry receptors, innate and adaptive immune systems and their subsequent role in viral pathogenesis’ Designed and implemented projects to investigate Interaction of HCV with receptors and immune system components, including fund raising, staff recruitment and identification of collaborators. This resulted in three grants and contributions to seven original publications. Cloning, expression and purification of HCV glycoproteins to facilitate therapeutic mAb characterisation and HCV vaccination strategies. Resulted in identification of key mAb and the contact residues in both the mAb and the viral protein, supporting out-licensing to a leading Biotech company.
Structural studies of HIV glycoproteins