Cambridge Healthtech Institute’s Ninth Annual
Immunogenicity Prediction & Control
Regulatory Perspectives, Risk Factors, and Management
October 25-26, 2017 | The Westin Alexandria | Washington, DC
Our understanding of immunology and immunogenicity is increasing all the time. Of particular interest currently are the tolerance-inducing checkpoints seen in cancer, and their control with checkpoint inhibitors. Also, there is increasing interest in the innate immune system which can be stimulated by numerous modulating impurities (IIRMIs). This has huge implications for innovators and biosimilars.
This conference will address current regulatory perspectives on immunogenicity risk assessment and the interpretation of current guidance from both Regulatory Authority and industry viewpoints, focusing on both innovators and biosimilars. We will examine risk factors that contribute to immunogenicity, particularly aggregates, SVPs and impurities, but also pay attention to component peptides, production, purification, formulation, dosing and storage. Current major concerns of the FDA are the potential of silicon oil droplets and of product dimerization to result in immunogenicity. Tools for immunogenicity risk prediction will be presented such as in silico and in vitro approaches, and examination of epitopes. We will study the predictive value of preclinical models in relation to the clinical outcome, for example, studies with cynomolgus monkeys and forms of humanized mice.
We plan to present experiences with engineering out immunogenicity or re-engineering, and progress in deimmunization and tolerance induction, together with their applicability to enzyme-replacement therapy and protein drugs in general.
Who should attend: Scientists, project managers, team leads and senior team members from departments in Product Development, Quality, Regulatory Affairs, Bioanalysis, Toxicology, R&D, PKPD, Non-Clinical and Clinical, Immunology, etc.
I am looking for case studies on the following:
- Immunogenicity risk assessment from Regulatory Authority and industry perspectives: Interpretation of current guidance, risk mitigation plans, challenges to anticipate
- The impact of sub-visible particles, aggregates and impurities on immunogenicity: Including detection and control of impurities and aggregate formation, evidence that they act as adjuvants, and immunological mechanisms
- Additional risk factors that contribute to immunogenicity: Including product characteristics, chemical modification, impurities, epitopes, and component peptides, and impact of production, purification, formulation, dosing and storage
- Current tools and approaches for immunogenicity risk prediction: Such as in silico and in vitro approaches, new tools and novel approaches
- Experiences with different models for predictive studies: Knock-in, knock-out, humanized, partially humanized, etc.
- Correlations between predictive immunogenicity and the clinical outcome
- Measures to control immunogenicity of specific products: Such as bispecifics, ADCs, enzymes, interferons, pegylated proteins, etc.
- Progress towards inducing immunological tolerance to biotherapeutics, deimmunization approaches and strategies for inducing tolerance
If you would like to submit a proposal to give a presentation at this meeting, pleaseclick here.
Deadline for submission is April 14, 2017
All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
For more details on the conference, please contact:
Nicole Lyscom, Ph.D.
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute