Dinner Short Courses*

Sunday, January 17 | 5:00-8:00 pm

    SC2: Next-Generation Sequencing of Antibody Libraries: Bridging Experimental and Bioinformatic Methods

    Next-generation sequencing (NGS) of antibody repertoires provides a quantitative approach to measuring the diversity and distribution of antibody libraries. This course enables researchers to design, perform and analyze antibody NGS studies. Practical details of antibody NGS with an emphasis on in vivo libraries and the Illumina MiSeq platform will be emphasized. Experimental sample preparation strategies that ensure the acquisition of high-quality NGS datasets will be highlighted. Bioinformatics processing considerations and examples will also be presented, providing a complete overview of NGS antibody repertoire generation and analysis. This course evolves from one co-taught with Professor Sai Reddy (ETH Zurich) at PEGS 2015.


    • Tarik Khan, Ph.D., Postdoctoral Fellow, Department of Biosystems Science and Engineering, ETH Zurich

    SC3: A Rational Approach to Formulation Development of Biologic Therapeutics

    The course offers a forum discussing how to develop sound formulations for biologic drugs. A number of case studies will be presented to demonstrate how to incorporate Quality-by-Design (QbD) concepts to assess critical material attributes (CMA), design multivariate experiments (DOE), how to obtain representative data, and how to analyze data (JMP) in order to propose robust formulation for bulk drug substance (BDS) or final drug product (FDP) in the context of designated container closure systems. The course utilizes real-world examples in an interactive discussion.


    • Kevin Zen, Ph.D., Senior Director, Biologics Development, Allgenesis Biotherapeutics


    SC5: Accelerated Stability Testing of Biologics

    This short course aims to guide the researcher in designing studies for accelerated stability testing of biologics. The course begins with basic underlying concepts governing protein drug product stability, and focuses on design principles for measuring stress and accelerated stability testing of not only the protein of interest, but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.


    • Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.
    • Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.

    SC6: DNA Matters: Applications for High-Throughput Rational Design

    As our understanding of gene sequence data increases, the ability to design and improve genes, pathways, genomes and organisms using synthetic biology techniques is also increasing. This revolution in biology demands large quantities of custom, high quality, synthetic DNA constructs and rationally designed libraries which are produced through high-throughput, high-capacity manufacturing processes. In this workshop, we will present innovative technologies that allow for the high-throughput production of long, clonal, sequence-perfect DNA, and we will discuss the many different applications for synthetic DNA and rationally designed libraries across industry and academia.


    • Devin Leake, Ph.D., Vice President, R&D and Operations, Gen9, Inc.
    • William Finlay, Ph.D., Director, Global Biotherapeutic Technologies, Pfizer, Inc.

    Tuesday, January 19 | 5:45-8:45 pm

    SC7: Targeting of GPCRs with Monoclonal Antibodies

    While GPCRs (G protein-coupled receptors) are important therapeutic targets, it has been challenging to discover therapeutically relevant antibodies against them. This course examines different steps along the anti-GPCR antibody discovery pathway and highlights various approaches to accomplishing each step. The topics to be covered include: 1) antibody discovery, including methods to generate antibodies and antigen preparation; 2) assays to measure antibody binding, such as an EC50 using cells expressing the GPCR; 3) in vitro assays to measure functional activity of the antibody, including antagonism (IC50) or agonism using chemotaxis, calcium, cAMP or other cell-based assays; and 4) review of promising GPCR targets and antibodies in the clinic.


    • Barbara Swanson, Ph.D., Director, Research, Sorrento Therapeutics, Inc.

    SC8: Designing Antibodies for Function and Low Risk of Immunogenicity

    Increased knowledge of elements that contribute to enhancing the immunogenicity of protein therapeutics has enabled the development of a preclinical “toolkit” that can be used to assess and mitigate against the risk of immunogenicity during the early stages of drug development. For antibody therapeutics, a variety of in silico, in vitro and in vivo immunogenicity selection/testing technologies are available and these can be used at various stages during antibody development from discovery through to lead optimization. This workshop provides an introduction to antibody immunogenicity, assessment of the technologies available for lead selection, rational sequence design through engineering and how these tools can be integrated with optimizing antibodies for desired function.


    • Tim D. Jones, Ph.D., Vice President, Biology, Abzena plc
    • Christopher Thanos, Ph.D., Senior Director, Biotherapeutics Discovery Research, Halozyme Therapeutics, Inc.


    SC10: Transient Protein Production in Mammalian Cells

    This short course introduces both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells. This allows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional and structural studies. The course combines instruction and case studies in an interactive environment.


    • Richard Altman, MS, Research Scientist, Discovery Research, Alexion Pharmaceuticals
    • Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
    • Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.

    SC11: Protein Aggregation: Mechanism, Characterization and Consequences

    Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.


    • Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
    • David F. Nicoli, Ph.D., Vice President, R&D, Particle Sizing Systems, LLC


     *Separate registration required