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7:00 am Registration and Morning Coffee

How Do You Begin?

8:30 Chairperson’s Opening Remarks

Joy Cavagnaro, Ph.D., President, Access BIO

8:40 Keynote Presentation

Thinking about Product Immunogenicity: From Tolls to Packaging

Daniela VerthelyiDaniela Verthelyi, Ph.D., Chief, Laboratory of Immunology, DTP/FDA

9:10 Immunogenicity Issues With Biosimilars: The Need for Comparability Assessment

Joy Cavagnaro, Ph.D., President, Access BIO

Assessment of unwanted immunogenicity is important for ensuring the safety of biotherapeutics including biosimilar products. A comparative evaluation of relative immunogenicity of the biosimilar and the innovator product using an appropriate testing strategy and methods for antibody detection is a requirement for approval of a biosimilar product. Some examples of the immunogenicity issues with biosimilars and the current guidance available will be presented.

9:40 Importance of T cells to Antibody Response

Sara J. Brett, Ph.D., Department of Immunology, GlaxoSmithKline

This presentation will give an overview about the role of CD4+ T cells in regulation B cell and antibody responses. It will focus on the cellular and molecular interactions required to induce an antibody response to foreign antigens. The mechanisms of regulation of the antibody response to self antigens will be summarised and the potential mechanisms which result in breaking of self tolerance and the generation of auto-antibody responses will be discussed. The relevance of basic immunology of T cell regulation to the generation of an antibody response will be discussed in the context of clinical anti-drug antibody responses observed during therapy with protein agents such as monoclonal antibodies with examples from some case studies.   

10:10 Grand Opening Coffee Break, Poster and Exhibit Viewing

11:10 Development of Point-of-Care Assay for Detection of Anti-Drug Antibodies 

Tatiana Plavina, Ph.D., Scientist, Clinical Science & Technology, Biogen Idec

Given the speed and growing flexibility required to support drug development and increasing emphasis on individualized medicine, deployment to the point of patient care of a rapid and simple-to-perform test detecting the presence of anti-drug antibodies (ADA) may be desirable both in the clinical development and commercial settings. The feasibility of developing point-of-care ADA assay using a lateral flow platform was established. Materials and custom reagents were evaluated against desired specifications for ADA detection, and key areas requiring optimization were defined and will be discussed.

11:40 Protein Structures Responsible for Immunogenicity of Biologics   

Barend Bouma, Ph.D., COO & Head, R&D, Crossbeta Biosciences

This presentation will report on the immune response and breaking of tolerance against interferon-alpha with conformational changes, accompanied by adoption of amyloid-like crossbeta structure and misfolding. For several biologics the level of crossbeta structure increases upon prescribed storage, and results indicate that misfolding of therapeutic proteins is a risk factor for immunogenicity. Methods for detecting potentially harmful misfolded protein entities with crossbeta structures will be described together with affinity matrices under development to remove harmful entities with crossbeta structures from biopharmaceutical preparations.

12:10 pm Potential Clinical Adverse Consequences Related to the Immunogenicity of Therapeutic Biologics

Jacques Descotes, M.D., Pharm.D., Ph.D., Fellow ATS, Professor and Head, Poison Center and Pharmacovigilance Department, Lyon University Hospitals

This presentation will report on the potential adverse consequences related to the immunogenicity of therapeutic biologics in treated patients. These include alterations in biopharmacokinetics or declining efficacy due to the development of neutralizing anti-drug antibodies as well as acute or delayed immune-mediated hypersensitivity reactions. Examples of therapeutic biologics for which a sufficient amount of nonclinical, clinical and post-marketing data is available will be used to illustrate the incidence, clinical outcome, pathogenesis and management of these adverse events.

12:40 Luncheon Presentation I Meso Scale
Immunogenicity: Detection and Characterization on the Meso Scale Discovery® (MSD®) Platform
Neeta Shenoy, Ph.D., Scientist, Meso Scale Discovery®
Key factors in immunogenicity assays are high sensitivity and free drug tolerance. The MSD® platform provides significant advantages in meeting these criteria in clinical and pre-clinical settings and also offers broad dynamic range, reduced matrix effects, easy workflow, and multiplexing capabilities. MSD®’s electrochemiluminescence-based technology provides a robust platform not only for detection of immune responses but also their characterization. This includes isotyping, NAb assays, quantification of secreted biomarkers (cytokines), and modulation of membrane-bound and intracellular proteins (receptor internalization and phosphorylation)  

1:10 Luncheon Presentation II (Sponsorship Opportunity Available) or Lunch on Your Own


2:30 Chairperson’s Remarks

Sara J. Brett, Ph.D., Department of Immunology, GlaxoSmithKline

2:35 Selected Poster Presentations

3:05 Networking Refreshment Break, Poster and Exhibit Viewing

3:45 Non-Clinical Case Studies of the Interplay of Pharmacokinetics, Pharmacodynamics and Immunogenicity

Holly W. Smith, Ph.D., Senior Research Scientist, Investigative Toxicology, Eli Lilly & Company

Demonstrating adequate exposure to active drug in the presence of anti-drug antibodies is a complex formula of evaluating the format of the PK assay, the quantitative nature of the PD marker, and/or the interpretation of the immune-relatedness of the adverse event. We present examples of “complicated” immunogenicity assessments.

4:15 Review of the Immunogenicity of Therapeutic Insulins

S.Edwin Fineberg, M.D., Professor Emeritus Indiana University, School of Medicine and Clinical Professor of Medicine, UAB (Birmingham) School of Medicine

The factors affecting insulin antibody formation will be discussed including molecular structure, site of delivery and characteristics of recipients will be reviewed. Clinical trial data regarding insulin analogs and native insulins will be presented with special attention to data from inhaled insulin trials. Lastly, data will be presented regarding impact of insulin antibodies on clinical efficacy, insulin resistance and hypoglycemia.

4:45 Problem Solving Break-Out Sessions - ASK THE EXPERTS

Table 10: Current Practices in Clinical Immunogenicity Assessment

Moderator: Catherine Wang, Ph.D., Department of Immunology, GlaxoSmithKline

Table 11: What is the Best Way to Manage the Clinical Program When Significant Immunogenicity/Immunotoxicity is Observed in Preclinical Studies?

Moderator: Joy Cavagnaro, Ph.D., DABT, RAC, President, Access BIO LC

Table 12: Preclinical Screening for Immunogenicity Using in silico, in vitro and in vivo Techniques

Moderator: Anne S. De Groot, M.D., CEO & CSO, EpiVax, Inc.; Professor and Director, Institute for Immunology and Informatics, University of Rhode Island

Table 13: Role of Product Impurities and Innate Immunity in Product Immunogenicity

Moderator: Daniela Verthelyi, Ph.D., Chief, Laboratory of Immunology, DTP/FDA

5:45 Networking Cocktail Reception in the Exhibit Hall

6:45 End of Day

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Program Navigation

Phage and Yeast Display of Antibodies and Proteins Engineering Antibodies Antibody Optimization Difficult to Express Proteins Pre-Clinical/Clinical Development Revival of Bispecific Antibodies Immunogenicity of Therapeutic Biologics Protein Aggregation in Biopharmaceutical Products Biotherapeutic Targets

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