Pre-conference  Workshop - Technical Advice on Assay Development, Validation and Sample Analysis

Course Leaders:

Boris Gorovits, Ph.D., Director, Bioanalytical R&D, Wyeth

Ana Menendez, Ph.D., Senior Director of Biotechnology, Catalent Pharma Solutions

Current concerns regarding immunogenicity are focused on accurate pre-clinical assessment and the clinical significance.  White papers offering advice have been produced by the experts but despite the obvious help they provide, difficulties and uncertainties remain. Key amongst these are the challenges of dealing with free drug in the assay, the difficulties of obtaining true positive results, and the constant dilemma of how to satisfy the regulatory authorities while the guidance remains undefined. These issues will be dealt with in great depth and presented with pre-clinical and clinical case studies from leaders in the field.  There will also be a half-day pre-conference workshop for those needing advice in setting up an immunogenicity testing protocol.

This conference will report on current progress in developing drugs with reduced or absent immunogenicity. It examines factors contributing to immunogenicity such as excipients, aggregation, impurities, the route of administration, and T and B cell epitopes. For minimisation of immunogenicity, the role of immunosuppressive agents such as methotrexate and the advantages of PEG-like sequences are evaluated and discussed. In a series of case studies, investigators present technologies for identifying and removing immunogenic determinants ranging from proteins showing harmful misfolding to T or B cell epitopes. Results are expressed in terms of the impact on product activity and stability and in clinical case studies. The technologies are further evaluated in terms of their application to the successful development of non-immunogenic biologics.

Keynote Speakers:

Clinical Impact of Anti-Drug Antibodies

Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec, Inc.

Priorities for EU Guidance on Immunogenicity Risk Assessment for Therapeutic Monoclonal Antibodies

Paul Chamberlain, NDA Advisory Board

 Pre-clinical Studies and Clinical Plans for Tolerance Induction

Richard Garman Ph.D., Scientific Director, Immunology R&D, Genzyme Corp.

Featured Presentations:

• Gopi Shankar Ph.D., Director, Clinical Pharmacology Sciences, Centocor R&D Inc.
• Bonnie Rup, Ph.D., Assistant Vice President, Protein Bioanalytics, Drug Safety and Metabolism, Wyeth Research
• Michael G. Tovey, Ph.D., Director of Research, Laboratory of Viral Oncology, Institute Andre Lwoff, CNRS
• Susan Kirshner, Associate Chief, Laboratory of Immunology, Office of Biotechnology, FDA
• Boris Gorovits, Ph.D., Director, Drug Safety Metabolism, Bioanalytical R&D, Wyeth
• Matthew Baker, Ph.D., Chief Scientific Officer, Antitope Ltd.

Distinguished Faculty List:

• Michele Fiscella, Ph.D., Associate Director, Clinical Immunology Department, Human Genome Sciences
• Dong Geng, Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb Co.
• Bonnie Wu Ph.D., Senior Research Scientist, Clinical Pharmacology Sciences, Centocor Research & Development Inc.
• Meina Liang, Ph.D., Associate Director, PKPD & Bioanalysis, MedImmune, Inc.
• Joy Cavagnaro, Ph.D., D.A.B.T., R.A.C., President, Access BIO, LC
• Nadja S. Prang-Richard, Ph.D., M.B.A., Program Director Monoclonal Antibodies, LFB S.A.
• Jochem Gokemeijer, Principal Scientist, Pharmacology, Adnexus Therapeutics, a Bristol-Myers Squibb R&D Company
• Claire Dobson, Ph.D., Head of Display Technology - Neuroscience & CVGI, Lead Generation, MedImmune, Inc.
• Sally Fischer Ph.D., Senior Scientist / Group Leader, Bioanalytical Research and Development (BARD), Genentech, Inc.
• Erik D. Foehr, Ph.D., Director, BioAnalytical Research and Development, BioMarin Pharmaceuticals, Inc.
• Albert Torri, Ph.D., Senior Director, Pre-clinical Development, Regeneron Pharmaceuticals Inc.
• Steve Keller, Director, Pre-clinical and Clinical Development Sciences, Facet Biotech, Inc.
• Joël Richard Ph.D., Senior Director, Head of Drug Product Development, Pharmaceutical Development, IPSEN - Beaufour Ipsen Industrie
• Jack A. Ragheb, M.D., Ph.D., Senior Regulatory Research Officer, Laboratory of Immunology, Department of Therapeutic Proteins, CDER, FDA. (Tentative)
• Richard Garman Ph.D., Scientific Director, Immunology R&D, Genzyme
• Barend Bouma Ph.D., Chief Operating Officer, Head Research & Development, Crossbeta Biosciences BV
• Volker Schellenberger, Ph.D., Vice President, Drug Discovery, Amunix, Inc.
• Paul W.H.I. Parren Ph.D., Vice President, Research & Pre-clinical Development, Genmab
• Philippe Stas, MBA, CEO, Algonomics
• Fiona A. Harding, Ph.D., Associate Director, New Technologies, Facet Biotech, Inc.
• David Estell, Vice President, Innovation, Genencor International
• Erika Gustafsson, Project Manager, Alligator Bioscience AB