4月30日 (月)、5月1日 (火)
1日目：8:30 - 19:15｜2日目：8:30 - 17:25
8:30 - 12:30 研修セミナー
14:20 - 19:15 分科会、全体基調セッション、歓迎レセプション
8:30 - 17:25 研修セミナー
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. The class is directed at scientists new to the industry or working in support roles, academic scientists and career protein scientists wanting a detailed update on the current state of the field.
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, 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
CHI's Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today's complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. The seminar also explores 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. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
Sheila G. Magil, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
This 1.5-day lecture-based seminar is an introduction course to the concept of Design of Experiments (DoE) for bioassay lifecycle management. First, trainees will learn, using a simple example, the value of DoE and how it can drastically increase the amount of information provided by each experiment. Then, we'll discuss how to choose the appropriate design for different assay development situations. Trainees will have an overview of the DoE catalog, including the advantage of each type of design (Screening designs, Factorial designs, Response-surface designs, Optimal designs). Finally, attendees will gain an appreciation for the many ways output can be used to better understand and optimize processes.
Perceval Sondag, Senior Manager, Statistics, PharmaLex
5月2日 (水)、5月3日 (木)
1日目：8:30 - 19:00｜2日目8:30 - 12:30
8:30 - 17:45 研修セミナー
12:25 - 14:10 主催者提供の昼食
17:45 - 19:00 レセプション
8:30 - 12:30研修セミナー
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 hands-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 platforms of R and Python, 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.
Simon Friedensohn, MSc, Research Assistant; Biosystems Science and Engineering, ETH Zurich, Switzerland
Enkelejda Miho, Ph.D., Research Assistant II, Biosystems Science and Engineering; Pioneer Innovation & Entrepreneurship Lab, 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 immuno-therapy. 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
5月3日 (木) - 5月4日 (金)
1日目: 13:40 - 17:20 | 2日目: 8:30 - 15:40
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.
Arno Kromminga, PhD, Member, European Immunogenicity Platform, Senior Vice President and European CSO, BioAgilytix
Training Seminar Information
Each CHI 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 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 engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.