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8:00 am Registration and Morning Coffee
8:25 Chairpersons’ Opening Remarks
Laurent Audoly, Ph.D., Senior Director, Biologics Research, Merck Research Labs
Anne S. De Groot, M.D., CEO & CSO, EpiVax, Inc.; Professor & Director, Institute for Immunology and Informatics, University of Rhode Island
8:30 How Cells Resist Human Treg Suppression: A Role in Autoimmunity?
Clare Baecher-Allan, Ph.D., Assistant Professor of Neurology, Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School
Decreased regulatory T cell suppression has been associated with a number of human autoimmune diseases. We have found that specific sub-populations of human Tregs isolated from patients with MS exhibit kinetically distinct deficiencies suggestive of different modes of regulation. Non-regulatory CD4 T cells produce factors that can inhibit the activity of human Tregs. Modulating the production or activity of such resistance factors could be therapeutically advantageous for the treatment of autoimmunity.
9:00 The Potential for Clinical Tolerance: New Targets for Co-stimulatory Molecule Blockade
John Iacomini, Ph.D., Associate Professor of Medicine, Assistant Director, Scientific Affairs, Transplantation Research Center, Brigham and Women’s Hospital and Children’s Hospital Boston, Harvard Medical School
In this presentation I will focus on the use of co-stimulatory molecule blockade strategies in transplantation. I will also focus on targeting co-inhibitory pathways and their potential for transplantation. Lastly, I will highlight recent work from our laboratory suggesting a role for Th17 cells in transplant rejection and novel co-stimulatory molecule blockade strategies that could be used to target these cells.
9:30 Relevance of Glycosylation to Recombinant Therapeutic Proteins and Monoclonal Antibodies
Jeremy P. Kunkel, Ph.D., Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada
10:00 Coffee Break, Poster and Exhibit Viewing
10:45 A Novel Homogeneous Biotin-Digoxigenin Based Assay for the Detection of Human Anti-Therapeutic Antibodies in Autoimmune Serum
Julia Qiu, Ph.D., Scientist, Bioanalytical Research & Development, Genentech, Inc.
Homogeneous Biotin-Digoxigenin based bridging assay format was selected as an immunogenicity screening platform to replace the existing BioVeris ECL ATA assays at Genentech based on our evaluation of several available technologies. The presentation will cover the development, challenge, and qualification of a clinical Biotin-DIG ATA assay in RA matrix, as well as the investigational result of other potential interferences on the Biotin-DIG platform. The comparison of the assay performance between the homogeneous Biotin-DIG assay and the previous BioVeris ECLA will also be presented.
11:15 Molecular Determinants of T Cell Epitope Recognition in Timothy Grass Allergy
Alessandro D. Sette, Ph.D., Principal Investigator, Vaccine Discovery, La Jolla Institute for Allergy & Immunology
We have performed an in depth characterization of the epitope recognized in timothy grass, their lymphokine profile, their allergen of origin, HLA binding restriction and other immunological parameters. The results illustrate the mechanisms by which particular epitopes are recognized in the context of T cell responses directed against timothy grass allergens.
11:45 Immunization to Ameliorate Atherosclerotic Cardiovascular Diseases
Mark Carvlin, Ph.D., COO, CardioVax
Atherosclerosis involves the formation of inflammatory arterial lesions and is one of the most common causes of death globally. Recently, it has become apparent that the immune system may confer athero-protecting effects which blunt athero-promoting effects. We have shown that immunization with a formulation that selectively activates the athero-protective pathway can reduce atherosclerosis by up to 70%. In this presentation I will describe the translational work we are performing to advance CVX-210-H from the laboratory into clinical practice.
12:15 pm Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
2:00 Chairperson’s Remarks
Robert T. Woodland, Ph.D., Department of Molecular Genetics and Microbiology, University of Massachusetts Medical School
2:05 Computational Simulations of the Immune System: Applications for Vaccine Development
Vladimir Brusic, Ph.D., Director, Bioinformatics, Cancer Vaccine Center, Dana-Farber Cancer Institute
Bioinformatic applications in vaccinology focus on the analysis of pathogen diversity, profiling of human immune system, management of immunological data, and mathematical modeling of the immune system. Predictive models development requires several cycles of experimental validation and refinement. We will present examples of recent developments in computational vaccinology and discuss how these tools are combined in an integrative large-scale system, including our experience with the Human ImmunoGrid project.
2:35 A Human Lymphoid Organ Model (HuALN) for Predictive Testing of Immunogenicity, Immunotoxicity and Immune Functions in vitro
Christoph Giese, Ph.D., Director, Cell and Tissue Services, ProBiogen
Biopharmaceutical drugs such as antibodies or cytokines may bear the risk of unexpected immunogenicity in the patient. Human tissue based models which emulate immune organ function are conceived to bridge the gap between early lead optimization and the pre-clinical development stage in immunotoxicity and predictive immunogenicity. The model of the Human Artificial Lymph Node (HuALN) is designed to investigate induced immune responses in vitro. The 3D organoid model can be used for long-term culture and repeated dosing. Cytokine release, antibody secretion, cellular functionality and tissue formation are monitored.
Sponsored by
3:05 Nanoliter Scaled Immunoassay Performed on a Compact Disc: Maximizing Effectiveness in Pre-Clinical Biotherapeutic Development
Robert A. Durham, Ph.D., Manager, Field Applications Scientist, Gyros US. Inc.
Preclinical and clinical development of biotherapeutic agents is often challenged by data quality, slow turnaround time and delays due to slow assay development. Nano-liter scaled immunoassays on the Gyrolab™ workstation utilize innovative microfluidics on a compact disc that automates the assay workflow for reduced matrix interference and results in an hour. The system allows for up to 4 log dynamic range to minimize the need to dilute samples and repeat analyses. . This talk will focus on case studies highlighting the use of the Gyrolab in therapeutic protein development and immunogenicity of biotherapeutics from early discovery to clinical trials.
Sponsored by
3:20 Handling Allergenicity Risks in Clinical Development of Biologicals
Jörgen Dahlström, Ph.D., Senior Scientific Manager, Phadia
3:35 Networking Refreshment Break, Poster and Exhibit Viewing
4:15 Vaccine Development in Enhanced Hu-NSG Chimeric Mice
Robert T. Woodland, Ph.D., Department of Molecular Genetics and Microbiology, University of Massachusetts Medical School
Humanized mice present a potentially unique opportunity to model the human immune response in vivo. We show these mice when appropriately supplemented with critical human cytokines will produce de novo immune responses to challenge with both T cell dependent and T cell independent antigens. The use of these mice as a platform for vaccine development will be discussed.
4:45 End of Conference
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