Timothy Hickling: Immunogenicity of biotherapeutics: why do we care and where do we stand

Описание: Immune responses to biotherapeutics are increasingly recognized as a risk to the success of projects and products in the Biopharmaceutical industry. These risks have various consequences ranging from project delays in the preclinical phase, to increased regulatory burden following clinical anti-drug antibody (ADA) observations, and in extreme cases to project termination. Many factors contribute to the overall risk of inducing ADA, for example route of administration, protein aggregates, T cell responses, drug pharmacology, impurities and patient status. Regulatory authorities offer guidance as to the assessments of immunogenicity risk they expect sponsors to undertake prior to commencement of clinical trials. In addition, appreciating the risks associated with projects can add confidence for an organization to commit funds to a clinical trial. Applying recently developed and improved tools can generate more confidence and hopefully allow for a better chance of success. The knowledge gained across a range of Biotherapeutic projects will allow general and product specific risks to be recognized and addressed. At the frontier of this effort we are investigating a systems biology and mechanistic modeling approach to predicting immune responses. Broader understanding of the immune system offers hope for safer and more efficacious products. I will give an overview of the issues and the tools to investigate immune responses for immunogenicity.

Dr Tim Hickling is currently investigating the immunogenicity of Biotherapeutics at Pfizer. He obtained his Biochemistry degree (1995) and D. Phil (1998) from the University of Oxford. He carried out post-doctoral training at Glaxo and the MRC’s National Institute for Medical Research before taking up a lectureship at the University of Nottingham. Tim has worked on various aspects of innate and adaptive immunology in infectious and inflammatory diseases. Tim joined Pfizer in 2007 and has worked on early stage vaccines and from early discovery to late stage development of biotherapeutics.