January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

Dinner Short Courses*


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

SC1: How to Set Up Collaborations between Academia and Industrial Biotech Companies

Not all academic and industrial organizations and scientists are aware of the possibilities and pitfalls of industrial-academic collaboration. By sharing our opinions and experiences, we hope to contribute to successful interactions between the biotech industry and the knowledge base of academic science. Any academic-industrial collaboration should start by acknowledging the different primary objectives of the partners. We discuss four different modes of collaboration between academia and industry: consulting, contract research, bilateral partnerships and public-private partnerships (PPPs).

Instructors:

  • Bernhard O. Palsson, Ph.D., Galletti Professor of Bioengineering, Professor of Pediatrics, and the Principal Investigator, Systems Biology Research Group, Bioengineering, University of California, San Diego
  • Andrew Fosberry, Ph.D., Manager, Expression and Fermentation Sciences, GlaxoSmithKline

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

Next-generation sequencing 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 are emphasized. Experimental sample preparation strategies that ensure the acquisition of high-quality NGS datasets are highlighted. Bioinformatics processing considerations and examples are also presented.

Instructor:

  • 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 on how to develop sound formulations for biologic drugs. Case studies are presented to demonstrate how to incorporate QbD concepts to assess critical material attributes, design multivariate experiments, how to obtain representative data and how to analyze data in order to propose robust formulation for bulk drug substance or final drug product in the context of designated container closure systems. The course utilizes real-world examples and interactive discussion.

Instructor:

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

SC4: Insect Cell Expression Systems: Cutting-Edge Advances for Enhancing Protein Production

We first introduce the baculovirus-insect cell system and share an overview of our experience expressing many proteins in it, together with information on high throughput. We include practical tips that facilitate your setup and use of this system for recombinant protein production. Finally, we present our latest research on host protein processing and efforts to engineer host pathways in insect cell systems. We will adjust the level of this course to participants’ experience.

Instructors:

  • Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.
  • Donald Jarvis, Ph.D., Professor, Molecular Biology, University of Wyoming; President, GlycoBac, LLC

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.

Instructors:

  • 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, so does the ability to design and improve genes, pathways, genomes and organisms using synthetic biology techniques. This revolution in biology demands large quantities of custom, high-quality, synthetic DNA constructs and rationally designed libraries produced through high-throughput, high-capacity manufacturing processes. We present innovative technologies allowing high-throughput production of long, clonal, sequence-perfect DNA, and discuss diverse applications for synthetic DNA and rationally designed libraries across industry and academia.

Instructors:

  • 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 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 covered include: antibody discovery, including methods to generate antibodies and antigen preparation; assays to measure antibody binding; in vitro assays to measure functional activity of the antibody; and review of promising GPCR targets and antibodies in the clinic.

Instructor:

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

SC8: Designing Antibodies for Function and Low Risk of Immunogenicity

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.

Instructor:

  • Matthew Baker, Ph.D., CSO, Abzena

SC9: Lyophilization Formulation Development and Process Optimization

This short course will focus on the most common challenges faced by scientists and engineers working in lyophilization. The challenges of developing a scientifically sound formulation will be discussed as will process optimization for biologics and vaccines. Lastly, strategies for scale-up from Research & Development scale to full production level, and selection of container closure systems will be covered.

Instructor:

  • Mark Manning, Ph.D., CSO, Legacy BioDesign LLC

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.

Instructors:

  • Richard Altman, MS, Research Scientist, Molecular Sciences, 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 industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients. This in-depth workshop reviews origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying it. It benefits scientists engaged in development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of aggregation.

Instructors:

  • 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

SC12: Improved Methods for Binder Screening and Validation

A robust pipeline for the high-throughput generation of affinity reagents enables many scientific projects and novel applications. To optimize the pipeline’s throughput, we have developed a streamlined process, consisting of parallel Ribosome Display selections and various semi-automated high-throughput screenings. Also including aspects of target acquisition to binder validation while decreasing its time and cost requirements, we perform simultaneous selections against 94 targets and screen and validate several thousand binders in parallel for their characteristics.

Instructors:

  • Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Biochemistry, University of Zurich
  • Fridtjof Lund-Johansen, Ph.D., Group Leader, Immunology, Oslo University Hospital


 *Separate registration required