Conference Short Courses*
Short Courses Maximize Your Productivity
Maximize your educational and networking opportunities while in Lisbon by adding a short course. Continued training and education are essential for staying competitive. These interactive short courses are a great introduction for those new to a particular discipline or as a refresher for those who want to brush up on their knowledge or expand their horizons. Attendance is limited to ensure an interactive environment. Group discussions are a key component in which participants will have the opportunity to ask questions of the expert instructors and other participants. Course materials are included.
Monday, 3 November 09:00 – 12:30
SC1: Engineering of Bispecific Antibodie.
Instructors: Nicolas Fischer, Ph.D., Head, Research, Novimmune SA
Julian Bertschinger, Ph.D., CEO, Covagen
By attending this interactive workshop, you will learn about the various approaches used for the engineering of bispecific antibodies and bispecific scaffold-based binding proteins. Different technologies will be compared, and examples for applications of bispecific antibodies in drug development will be presented with a focus on candidates that are currently being evaluated in clinical trials. Opportunities and challenges in the field of bispecific antibodies will be discussed.
SC2: Mutation and Selection Strategies for Multi-Parameter Antibody Optimisatio.
Instructors: William Finlay, Ph.D., Director, Global Biotherapeutic Technologies, Pfizer, Inc.
Matthew Lambert, Ph.D., Principal Scientist, Global Biotherapeutic Technologies, Pfizer, Inc.
In therapeutic antibody discovery, few primary lead antibodies meet all of the desired product characteristics of ideal potency, expression, stability, formulation and immunogenicity. As a result, in vitro engineering is often necessary ranging from basic humanization all the way up to affinity, stability and solubility improvement. In recent times, a bewildering array of potentially useful mutagenesis, selection and screening technologies have become readily available to perform these tasks. In this course we will help attendees to critically assess their options and navigate through this complex field.
SC3: Alternate Display Technologies - (Detailed Agenda)
Instructors: John Löfblom, Ph.D., Assistant Professor, Molecular Biotechnology, AlbaNova University Center, Royal Institute of Technology (KTH)
Birgit Dreier, Ph.D., Senior Scientist, Professor Dr. A. Plückthun Laboratory, Biochemistry, University of Zurich
Phage and yeast display have become the industry standard for those looking to isolate high affinity protein ligands against nearly any receptor through directed evolution. But what happens when phage and yeast display fall short? This course will cover the development of new display systems to address shortcomings of phage and yeast display, constructing libraries and assessing library quality, and screening and selection methods for generation of new affinity proteins as well as for epitope mapping purposes.
Thursday, 6 November 17:30 – 20:30 To include Dinner
SC4: Analytical Strategies for Comparability in Bioprocess Development - (Detailed Agenda)
Instructor: Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Global Manufacturing Science & Technology, Genzyme – a Sanofi company
Bioprocess changes can impact quality attributes of biologics, and may affect efficacy and/or safety of the product. When manufacturing changes are implemented, it is essential to gather sufficient data to support the conclusion that product safety or efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development. In this short course, we will discuss the common analytical characterisation technologies used, considerations in process monitoring and controls, and the iterative process of demonstrating comparability of the product in support of process changes.
SC5: Aggregation and Immunogenicity: How Do Formulation, Process and Delivery Influence Immunogenicity of Therapeutic Proteins? - (Detailed Agenda)
Instructors: Melody Sauerborn, Ph.D., Senior Expert
Immunogenicity/Bioanalysis, TNO Triskelion
Joel Richard, Ph.D., Senior Vice President, Peptides, Head, CMC & Engineering Dreux Site, IPSEN
Formation of anti-drug antibodies (ADA) represents a risk for the patient as it possibly alters pharmaco-kinetics and compromises safety and efficacy. The course will review the immunogenicity aspects related to formulation composition, excipients, storage and in-process stability issues. The focus will be on the influence of degradation products (oxidized forms, aggregates, particulates, etc.) and process-related impurities (contaminants, particulates) on the immune system. In addition, key analytical methods for identification, characterisation and composition determination of aggregates/particulates in the formulation will be reviewed, particularly the characterisation of aggregates/particulates in the lower sub-visible size range. We will also discuss how in-depth formulation analysis can be connected to biological consequences of aggregates and particulates.
SC6: Troubleshooting and Engineering of Antibody Constructs
Instructors: Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Biochemistry, University of Zurich
Christian Kunz, Ph.D., Associate Director, Discovery Alliances & Technologies, MorphoSys AG
Recombinant antibodies vary widely in their biophysical characteristics, from stable monomers to metastable aggregation-prone oligomers. In particular, antibody variable domains differ in their intrinsic thermodynamic stability and often require labor-intensive engineering. While most antibody engineering is performed with small antibody fragments, the majority of molecules in the clinics still are of the full-length IgG format. Thus it is critical to understand how the poor stability of individual variable domains not only limits the biophysical properties of small fragments, but also affects the production yield, stability and homogeneity of full-length IgGs containing these domains.
SC7: Immunotherapy Approaches
Instructors: Andrea van Elsas, CSO, BioNovion B.V.
Sergio A. Quezada, Ph.D., Professorial Research Fellow, Research Haematology, University College London Cancer Institute
Cancer immunotherapy is distinct from other paradigms in that treatment is directed towards a patient’s immune system and not their malignant cells. During the past few years, novel approaches to immunotherapy of cancer using antibodies targeting T cell regulatory proteins produced highly encouraging clinical data. Patients responding to T cell check-point inhibitors have shown long-term benefit suggesting that, in addition to surgery, radiotherapy and (targeted) chemotherapy, immunotherapy will become a novel treatment paradigm in oncology. Besides targeting T cell checkpoint proteins other pathways and novel agents are being investigated to induce or enhance anti-tumour immunity.
SC8: Recent Advances in Antibody-Drug Conjugates
Instructor: Edmund I. Graziani, Ph.D., Associate Research Fellow, Oncology Medicinal Chemistry, Pfizer, Inc.
Antibody-drug conjugates (ADCs) consist of a monoclonal antibody (mAb) conjugated to a small molecule via a tether or linker. ADCs are an attractive therapy for cancer since the ADC provides a means to target highly potent cytotoxic small molecules to specific tumour cells that bear an antigen recognized by the mAb portion of the ADC. This short course will focus on advances in linker technology, new methods for evaluating the potential benefits of site-specific ADCs, and advances in our understanding of the fate of the ADC after in vivo exposure, with an emphasis on strategies for improving ADC pharmacokinetic (PK) exposure.
*separate registration required for short courses