DISCOVERY STREAM May 11-12
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WEDNESDAY, MAY 11
7:00 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
8:40 Multidimensional Glycan Arrays for Selection and Characterization of Carbohydrate-Binding Antibodies
Jeffrey C. Gildersleeve, Ph.D., Chemical Biology Laboratory, Center for Cancer Research, National Cancer Institute-Frederick
Carbohydrate-binding antibodies are used extensively for basic research and have clinical applications as therapeutic agents and diagnostics. We have developed a carbohydrate microarray or “glycan array” containing hundreds of carbohydrate antigens immobilized on a glass microscope slide. To enhance diversity, the array contains variations in both carbohydrate structure and presentation. The array provides a high-throughput tool for evaluating antibody-antigen interactions.
9:10 Elicitation of Structure-Specific Antibodies by Epitope Scaffolds: Application to HIV-1 Vaccine Design
Gilad Ofek, Ph.D., Senior Scientist, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
A key challenge for vaccine design has been the elicitation of antibodies against epitopes that are immunorecessive, cryptic, or transient in their native context. We employ computational techniques to transplant a vulnerable neutralizing HIV-1 determinant into acceptor protein scaffolds - epitope scaffolds - and demonstrate that epitope scaffolds readily elicit antibodies that recognize the pre-determined shape of the epitope. Epitope scaffolds thus provide a means for eliciting structure-specific antibodies against HIV-1 and against other pathogens for which vaccines are sought.
9:40 Tools for the Evaluation of Disulfide-Mediated Heterogeneity Characteristic to IgG2 Monoclonal Antibodies
Nathan A. Lacher, Ph.D., Analytical R&D, Pfizer BioTherapeutics R&D
The development of analytical methodologies to study disulfide-mediated isoforms that are present in IgG2 antibodies as a result of differences in the disulfide connectivity within the hinge region will be reviewed. The application of these tools for comparability, bioprocess development, and in vivo assessment will also be discussed.
10:10 Refreshment Break in the Exhibit Hall with Poster Viewing
11:10 Exploiting Potent Chromatin Remodelling Elements to Rapidly Identify Relevant Monoclonal Antibody Variants in Stable CHO Cell Lines
Armelle Gaussin, Ph.D., Chief Technology Officer, SELEXIS SADNA vectors incorporating versatile epigenetic regulatory elements such as the Selexis Genetic Elements (SGEs)providehigh transcription rates and prevent transgene silencing, yielding cell clones with increased and stable expression. Thus, combined with optimized gene transfer methods, these vectors can be used to generate high-producer stable cell lines in short time frames and with little screening efforts.This unique feature opens up the possibility of relying on a single stable expression system throughout the drug development process, allowing the identification of relevant monoclonal antibody variants and high expressing clones at the same time. This novel set up allows considerable time and labour saving by screening top lead candidates in a production ready platform.
11:40 Harnessing the Human Immune Response to Fight Infectious Disease
Roger Beerli, Ph.D., Head, Human mAb Discovery, Intercell AG
Sophisticated in vivo processes that shape the immune repertoire afford endogenous human antibodies with high affinity, minimal immunogenicity and minimal off-target reactivity. Natural human mAbs are therefore an attractive alternative to antibodies developed by other means. We isolate human mAbs directly from the B lymphocytes of naturally exposed or immunized human subjects using a proprietary platform technology involving mammalian cell display. Here, the mammalian cell display platform will be discussed and several pre-clinically validated natural human mAbs against infectious disease targets will be described.
12:10 pm De-risking Strategies of Therapeutic Antibodies
Philippe Stas, MBA, Head Applied Protein Services, Lonza
In order to reduce the high attrition rate of therapeutic antibodies in clinical development, rational design strategies will be presented, including avoidance of immunogenicity and the optimization of aggregate propensity and other drug characteristics.
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30 Chairperson’s Remarks
1:35 A Novel Integrated Data Management Platform for Biologics R&DChristoph Freiberg, Ph.D., Senior Scientist, Head of Biologics Data Platform Project, Biologics Research, Bayer HealthCare Pharmaceuticals, Wuppertal/GermanyWe have implemented an enterprise-level software solution together with our partner Genedata to comprehensively support biologics R&D activities. We show how we have integrated all steps from HT biologics screening to cell line development into one workflow.
2:05 Design, Production and Efficacy of Antibody-Peptide Fusions for Oral Treatment of Neonatal Cryptosporidium spp. Infection
Michael Imboden, Ph.D., Director, Research and Development, ioGenetics LLC
Effective drugs are needed to treat Cryptosporidium parvum and C. hominis infections in livestock and humans. Specific targeting of the parasite in vivo is achieved through genetically engineered fusions comprising monoclonal antibodies linked to innate immunity peptides toxic to the parasite while well-tolerated by the mammalian host. Efficacy of oral treatment against neonatal cryptosporidiosis in mice is presented.
Sponsored by2:35 In-silico Protein Engineering: Computational Methods used in the Design and Study of Macromolecular SystemsFrancisco Hernandez-Guzman, Product Manager, Life Sciences, AccelrysAs new biologics based therapies or diagnostics continue to gain interest, there is an increased need for computational tools that can assist researchers characterize, model and predict the behavior of their molecules. So, whether you're interested in generating a structure in absentia of experimentally determined structures, or are looking to understand protein stability and the effect of site-directed mutagenesis, or you want to study molecular motion as a function of time, or are looking to accelerate your development and reduce the experimental burden, modern computational algorithms can be used effectively to make rational decisions for the design of novel biological based molecules. In this presentation, we will present a short overview of some of these computational methods commonly used in the study of biologics.
Sponsored by 2:50 Novel Biosensor Technologies and Analysis Approaches Mimicking Natural EnvironmentsIan A. Nicholls, Linnaeus University, Sweden
3:05 Refreshment Break in the Exhibit Hall with Poster Viewing
3:50 Problem Solving Breakout Sessions
Concurrent Problem Solving Breakouts are interactive sessions hosted by a moderator to discuss a topic in depth. They are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. Please pick a topic of your choice and join in.
TABLE 1: The Role of Computations in Engineering Antibodies
Moderator: Robert Pantazes, Department of Chemical Engineering, The Pennsylvania State University
• What are the open challenges in antibody engineering that could benefit from modeling and computations?
• What are the key recent advances that may change the current landscape?
• Lessons learned from successes/failures?
TABLE 2: Finding Antibodies for Infectious Diseases, Discussion of Strategies and Problems
Moderator: Michael Imboden, Ph.D., Director, Research and Development, IoGenetics
TABLE 3: New Analytical Technologies for BioTherapeutic Development
Moderator: Nathan A. Lacher, Ph.D., Senior Principal Scientist, Pfizer Inc., Biotherapeutics Pharmaceutical Sciences, Analytical R&D
• What new technologies are available for enhanced analytical acuity and throughput?
• How are these technologies being utilized to advance biomolecular candidates?
• What are the regulatory hurdles to implementing new analytical technologies?
TABLE 4: Strategies for Predictive Immunogenicity Screening: Sense and Nonsense
Moderator: Philippe Stas, Head, Applied Protein Services, Lonza Biologics Pl
• What are the elements to take into account when evaluating potential immunogenicity?
• Which drug classes benefit from early stage screening and which don't?
• What are the potential pitfalls from unexpected results in pre-clinical immunogenicity?
TABLE 5: Use of Monoclonal Antibodies as Tools to Interrogate Receptor Signaling
Moderator: Estelle Leclerc, Ph.D., North Dakota State University
• What are the receptors that are most suitable for these studies?
• What can we learn from IgG and Fab fragments?
• Limitations and Problems
TABLE 6: The Promise of Single-Domain Antibodies (VHHs, VHs, VLs, VNARs)
Moderator: Jamshid Tanha, Ph.D., Research Officer, Institute for Biological Sciences, National Research Council Canada
• It has been more than 2 decades since the introduction of the single-chain Fv, and we have yet to see its debut as a therapeutic drug. Being recombinant antibody fragments like scFvs, what do you think are the prospects of sdAbs as therapeutics?
• What would successful forms/formats for therapy look like?
•What are their strengths/areas of strength and what challenges do sdAbs need to overcome to be credible/better alternatives to monoclonal Ab therapeutics?
4:50 Reception in the Exhibit Hall with Poster Viewing
6:00 End of Day
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