Training Seminars

Cambridge Healthtech Institute 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, May 4 – Tuesday, May 5
Day 1: 8:30 AM – 12:30 PM | Day 2: 8:30 AM – 5:25 PM

TS8A: Introduction to Protein and Antibody Engineering

This training seminar offers a comprehensive tutorial in the concepts, strategies, and latest tools of protein engineering applied to biotherapeutic research and development, particularly antibody and related products. 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.

Instructor: David Bramhill, PhD, Founder, Bramhill Biological Consulting, LLC

TS9A: Introduction to Structure-Based Drug Design and Development

CHI’s Introduction to Structure-Based Biologics Development and Optimization offers an introduction to the concepts, strategies, and tools of structure-based biologics 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.

Instructors: Christopher Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Traian Sulea, PhD, Principal Research Officer, Human Health Therapeutics, National Research Council Canada

TS10A: Introduction to Bispecifics: History, Engineering, and Applications

Intro 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.

Instructors: Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland

Rakesh Dixit, PhD, DABT; President & CEO, Bionavigen, LLC; CSO, Seneca Therapeutics

TS11A: Introduction to Immunology for Drug Discovery Scientists

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 readouts.

Instructor: Masha Fridkis-Hareli, MSc, PhD, Founder and President, ATR, LLC

Wednesday, May 6 – Thursday, May 7
Day 1: 8:40 AM – 6:00 PM | Day 2: 8:30 AM – 12:30 PM

TS9B: Antibody Deep Sequencing and Single-Cell Analysis

In this training seminar, participants will learn about recently developed methods for Next-Generation Sequencing (NGS) and single-cell analysis of antibody repertoires. Part 1 will provide an introduction to antibody repertoires, including genetic background, generation of diversity, and sequencing technologies. Part 2 will incorporate an introduction and hands-on session on computational tools for analyzing antibody repertoire NGS data. We will focus on pre-processing, analysis, and visualization of data, along with presentation of existing bioinformatics pipelines available. Part 3 will focus on an overview of the development of newer methods in single-cell analysis of antibody immune responses. The course will be interactive with case studies, and participants will be able to download data and examples. Please bring your computer.

Instructors: Brandon DeKosky, PhD, Assistant Professor, Department of Chemical Engineering, Department of Pharmaceutical Chemistry, Kansas Vaccine Institute, The University of Kansas

Matías Gutiérrez González, PhD, Postdoctoral Researcher, Pharmaceutical Chemistry, The University of Kansas

TS10B: Introduction to Cancer Immunotherapy Discovery and Development

This course is designed for scientists and biotechnology professionals new to the realm of cancer immunotherapy, or those interested in a broad, yet detailed, perspective of this field. The 1.5-day instruction comprises an overview of the currently used approaches, and incorporates numerous examples for technology discovery and development, with an emphasis on new trends. Immune checkpoint inhibitors and CAR T therapies have recently gained regulatory approval in the US and the EU. TILs- and TCR -based therapies, NK therapies, as well as cancer vaccines are areas of great promise, and may yield future breakthroughs. Advances in high-throughput sequencing and immunogenomics aid in identifying novel tumor antigens, building better effector molecules and vaccines, and predicting treatment outcomes, for both personalized and universal immunotherapy.

Instructor: Dina Schneider, PhD, Associate Director, Translational Research, Lentigen Technology, Inc., a Miltenyi Biotec Company

TS11B: Essentials in Bioassay Development and Validation

CHI’s Bioassay Training Seminar provides a comprehensive presentation of the most important aspect of CMC and drug development, the measurement of biological activity or potency. Learn about best practices for bioassay design, determining doses and plate layout, replicate strategy, outlier detection, and removal. The course also covers how to determine validity criteria, reference selection, and systems suitability. Case studies for a variety of cell therapy, gene therapy, and other therapeutic proteins will be presented.

Instructor: Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

TS12B: Introduction to Bioprocessing

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.

Instructors: Sheila Magil, PhD, Managing Director, Industry Specialized Services, BDO

Frank Riske, PhD, Managing Director, Industry Specialized Services, BDO

Thursday, May 7 – Friday, May 8
Day 1: 1:40 – 5:20 PM | Day 2: 8:30 AM – 3:40 PM

TS7C: Genome Editing with CRISPR: Towards Novel Research, Translational, and Clinical Applications

This rigorous 1.5-day program will comprehensively review the state-of-art information on gene editing strategies and applications in various areas, such as in vitro and in vivo disease modelling, functional genomic analyses, drug discovery and development, diagnostic and therapeutic areas. Beginning from discussion of introductory-level basic technology aspects, key molecular features, capabilities and pitfalls, strengths and shortcomings of currently available CRISPR/Cas9 systems, the instructor will advance towards sharing more specific information related to virtually all facets of present-day genome editing applications, such as constructing cell-culture-based experimental systems, engineering precision targeting disease models for in vivo research, applying CRISPR methodologies to support preclinical drug development workflows, rational design and functional screening of sgRNA libraries, application of CRISPR/Cas9 technology for clinical purposes and many others. Besides presenting theory information, the seminar will also explore practical tasks, such digital resources for designing and troubleshooting specific complex experimental scenarios.

Instructor: Serguei Kozlov, PhD, MBA, PMP, Principal Scientist/PM, Team Leader Preclinical Technology and Optimization Team, Center for Advanced Preclinical Research, Frederick National Laboratory for Cancer Research (NCI)

TS8C: Introduction to Immunogenicity

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.

Instructors: Bonnie Rup, PhD, Independent Consultant

Sofie Pattijn, CTO, ImmunXperts

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.

* The program is subject to change without notice, due to unforeseen reason.

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