Cambridge Healthtech Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields – and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.
Monday, April 8: 8:30 am - 12:30 pm - Tuesday, April 9: 8:30 am - 5:25 pm
CHI’s Introduction to Protein Engineering training seminar offers a comprehensive tutorial in the concepts, strategies and tools of protein engineering and explains the role of this discipline in the progression of biotherapeutic research and development. Learn about the selection of functional assays to monitor changes in desired properties, traditional and emerging display technologies and library design strategies. Also explore the engineering and enhancement of traditional antibodies and discuss the roles of protein engineering in the discovery, design and development of new therapeutic modalities. The class includes briefings on the expression platforms used for producing proteins for testing and for manufacture, and the rapidly emerging role of protein engineering in optimizing antibody and other protein therapeutics.
Instructor: David Bramhill, PhD, Founder, Bramhill Biological Consulting, LLC
CHI’s Introduction to Structure-Based Drug Design and Development offers an introduction to the concepts, strategies and tools of structure-based drug design, optimization and development. The seminar consists of presentations and live demonstrations of some of the common computational tools used in the field. We will cover techniques to triage therapeutics sequences, modulate affinity, create novel constructs (such as Fc-fusions, bispecifics, and protein traps) along with increasing the manufacturability of a biologic. The class is directed at scientists new to the industry, academic scientists and career protein engineers wanting an introduction into how structure can aid in guiding experimental design.
Christopher Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada
Traian Sulea, PhD, Senior Research Officer, Human Health Therapeutics, National Research Council Canada
Introduction to Bispecifics will be organized as an informative and practical guide to get up to speed on critical aspects of bispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction will span mechanisms of action, engineering, developability, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.
Instructor: G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology
CHI’s Introduction to Bioprocessing training seminar offers a detailed survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with an introduction to biologic drugs and the aspects of protein science that drive the progression of analytical and process steps that follow. Then, step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. Also explore emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments in developing and gaining approval for a biopharmaceutical are also examined.
Sheila G. Magil, PhD, Principal Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
wednesday, April 10: 8:30 am - 5:45 pm - Thursday, April 11: 8:30 am - 12:30 pm
In this training seminar, participants will learn about Next-Generation Sequencing (NGS) of antibody repertoires. Part 1 will provide an introduction to the antibody repertoires, consisting of genetic background, generation of diversity, sequencing technologies and a hand-on session on the computational tools available for the analysis antibody repertoire NGS data. Part 2 will focus on the preprocessing and analysis of data. Each step of the preprocessing will be elucidated using the programming language R along with existing bioinformatics pipelines available. Repertoire analysis content will provide statistical quantification and visualization of high-dimensional data. The course will be fully interactive with case studies, participants will be able to download data and example scripts. Please bring your computer.
Sai Reddy, PhD, Assistant Professor, Biosystems Science and Engineering, ETH Zurich, Switzerland
Simon Friedensohn, MSc, Research Assistant, Biosystems Science and Engineering, ETH Zurich, Switzerland
This 1.5-day seminar will cover the fundamentals of human immunology for an audience of scientists across different backgrounds working in pharmaceutical and biotech organizations in programs related to immunotherapy. The course will cover a historical perspective, basic mechanisms, fundamental concepts and practical approaches to developing therapeutics and their combinations to modulate the immune system. Additionally, the class will offer perspectives on how immune responses can be monitored by assessment of biomarkers and modulated through biopharmaceutical intervention. Through group activities, attendees will actively review immunological concepts as well as design functional immunological assays and read-outs.
Masha Fridkis-Hareli, MSc, PhD, Founder and President, ATR, LLC
Tatiana Novobrantseva, PhD, Co-Founder, Head of Research and Development, Verseau Therapeutics
This training first covers all the basic statistical concepts that are required to perform a successful assay validation, such as (non)linear models for calibration, variance component analysis, and design of experiments. We will then discuss some regulatory requirements for assay validation and discuss how to ensure regulatory compliance while also guaranteeing that the assay is fit for its intended purpose. Finally, we will combine those statistical and regulatory concepts in a case study.
Instructor: Perceval Sondag, Senior Manager, Statistics, PharmaLex
Thursday, April 11: 1:40 - 5:20 pm - Friday, April 12: 8:30 am - 3:40 pm
All protein drugs generate an immunogenic response. This 1.5-day training seminar provides a practical, comprehensive overview of immunogenicity – the causes, how to assess, predict and prevent, and what to do if you observe immunogenicity during preclinical, clinical and post-market approval. The seminar begins by detailing the science behind immunogenicity, the latest international guidances, followed by assay and bioanalytical assessment strategies for traditional and emerging biologics. Other topics include predictive models and how to report immunogenicity incidents both internally and externally.
Bonnie Rup, PhD, Independent Consultant
Sofie Pattijn, CTO, ImmunXperts
This rigorous day and a half program compiled for specialists interested in applying genome editing technologies for both basic and translational research will comprehensively review the state-of-art information on gene editing strategies and applications in various areas, such as disease modelling, drug discovery and development. Beginning from introductory level basic technology aspects, key molecular features, strengths and shortcomings of CRISPR/Cas9 systems, the instructor will advance towards sharing in-depth knowledge related to virtually all facets of present day genome editing applications, such as constructing of cell culture-based experimental platforms, engineering disease models for in vivo research supporting preclinical drug development workflows, rational design and functional screening of sgRNA libraries, application of CRISPR/Cas9 technology for diagnostic and therapeutic purposes and many others.
Serguei V. Kozlov, PhD, MBA, PMP, Principal Scientist/PM, Team Leader PTO, Center for Advanced Preclinical Research, Frederick National Laboratory for Cancer Research (NCI)
What is a Training Seminar?
Each Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.
Though CHI encourages track and symposia hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.