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, August 31 – Tuesday, September 1
Day 1: 8:30 AM – 12:30 PM | Day 2: 8:30 AM – 5:25 PM
TS8A: Introduction to Protein and Antibody Engineering - Detailed Agenda
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
TS10A: Introduction to Bispecifics: History, Engineering, and Applications - Detailed Agenda
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
Brian H. Santich, PhD, Research Fellow, Department of Pediatrics Memorial Sloan Kettering Cancer Center
Mahiuddin Ahmed, PhD, Chief Scientific Officer, Y-mAbs Therapeutics
G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology, Inc.
TS11A: Introduction to Immunology for Drug Discovery Scientists - Detailed Agenda
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, September 2 – Thursday, September 3
Day 1: 8:40 AM – 6:00 PM | Day 2: 8:30 AM – 12:30 PM
TS10B: Introduction to Cancer Immunotherapy Discovery and Development - Detailed Agenda
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 - Detailed Agenda
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
Thursday, September 3 – Friday, September 4
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 - Detailed Agenda
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 - Detailed Agenda
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.