Workshops

Post conference workshops, Wednesday 29th February

09:00 - 12:00 Workshop A: Latest Advances in Reducing the Risk of Immunogenicity: Deimmunisation and Tolerance Induction

Induction of T cell response is one of the root causes of the immunogenicity problem associated with protein therapeutics. Preclinical engineering efforts are therefore directed towards modulating the presence of T cell epitopes in protein therapeutics prior to further development of the protein for clinical use.

Deimmunisation is one method currently practiced by protein engineers that renders biologics less immunogenic in the clinic; two case studies will be described here (FVIII and Botox). The recent discovery of Tregitopes, natural regulatory T cell epitopes in the sequence of therapeutic mAbs, has also had a profound impact on the design of biologics. Tregitopes and the number of potential effector epitopes in a protein therapeutic has now been clearly associated with its potential for immunogenicity. As a result, a number of companies have now integrated both Treg epitope and T effector epitope screening into their approach to biologics.

During this workshop attendees will discuss:

• Factors that contribute to immunogenicity
• Methods for screening biologics in vitro and in silico
• Identification of Tregs by FACS, cytokine profiling and expression of FoxP3
• Expansion of antigen-specific regulatory T cells (adaptive Tregs)

Experienced users will describe the application of web-based immunoinformatics tools to their preclinical pipeline. An online demonstration of the ISPRI system will be provided for workshop participants.

Workshop leader

Anne DeGroot, CEO, EpiVax

After receiving her M.D, Anne earned a research fellowship in tropical medicine and vaccinology and underwent specialty training in infectious disease. In 1993 she moved to Brown University and established a productive vaccine research laboratory, developing new tools for vaccine design (EpiMatrix toolkit). She co-founded EpiVax with Bill Martin in 1998 and has been CEO/CSO of the company since.

Although De Groot is known for her contributions to the fields of immunoinformatics and vaccinology, the discovery of Tregitopes by the EpiVax research team in 2008 resulted in a shift in her research efforts, adding new explorations in autoimmunity and tolerance.

13:00 - 16:00 Workshop B: Developing a Biosimilar Monoclonal Antibody in the EU – CMC Considerations

This workshop will focus on the challenges faced in the development of biosimilar medicines and particularly monoclonal antibodies.

Key challenges that will be considered include:

• Sourcing of reference product
• When to go for national and CHMP scientific advice
• Establishing a comprehensive physicochemical and biological comparability program
• Comparative stability requirements
• Manufacturing process change
• Formulation development
• Defining product related substances and impurities

The EU biosimilar marketing authorisation (MA) approval process allows similarity to be demonstrated to the original product based on a combination of physico-chemical and biological data, supplemented by limited relevant non clinical and clinical data, which generally is far less than would be required for a new stand-alone MA application.

Attend this workshop to leave with all the information you need to sail through development, manufacturing and market authorisation of biosimilar drug products.

Workshop leader

Keith Watson, Principal Consultant, Parexel

Keith is a PhD biochemist with extensive experience in academia, industry and the regulatory environment. Keith is now a principal consultant at PAREXEL and prior to this was a senior quality assessor in the medicines and health products regulatory agency, responsible for all aspects of biological product licensing and scientific advice at national and European level.

Keith has extensive knowledge of regulatory guidelines and procedures at a national and European level and has offered quality and strategic advice to companies regarding recombinant proteins, biosimilar products, monoclonal antibody and plasma derived medicinal product license applications.