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 Dr. Tim Hickling
Former Head of Immunosafety, Roche, & Director
Quasor
United Kingdom |
Keynote Speech:
Implementing Immunogenicity Risk Assessment: Data integration, Simulations and Mitigations for Successful Product Launch
Abstract (1):
Biologics are revolutionizing patient care across all disease areas. Optimizing a molecule’s immunogenicity risk profile contributes to the successful development and launch of biologics. Designing biologics to be of high quality requires integration of data from multiple sources. Application of in silico and in vitro immunogenicity assays in the discovery stage sets the pathway for success. Treating immunogenicity alongside other developability characteristics avoids the need for deimmunization strategies. Integrating data at each stage of development enables simulations of clinical outcomes, giving confidence for making the right decisions. If necessary, these simulations also inform the need for additional clinical mitigation steps.
Title:
Strategic investment in immunogenicity mitigation
Abstract (2):
Immunogenicity assessment and mitigation ideally results in products launched with minimal anti-drug antibody incidence and no clinical impact of those ADA. Investing in immunogenicity assessment tools at the right time to support successful discovery, development and launch requires an objective view of the return on investment. Prioritization of spending on assays should be determined by the IRA, clear expectations of what will be good enough, and the likelihood of being able to make a positive decision. For Biotechs looking to partner with established Pharma, demonstrating a complete IRA, informed by assays and demonstrated derisking activity will be viewed favourably. Investors are increasingly aware of the risks of immunogenicity and may require IRA and assays.
Biography:
Tim helps companies implement immunogenicity risk assessment and mitigation measures to develop biologics with optimal immunogenicity risk. With Quasor, Tim is working towards a quantifiable assessment of risk, building on the foundations he developed leading Immunogenicity groups in Roche and Pfizer over the past 15 years. He has held leadership roles in the ARDAT and ABIRISK international consortia and served on the board of the European Immunogenicity Platform (EIP). He holds a Biochemistry degree and Immunology Doctorate from the University of Oxford.
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