2023 Archived Content
OVERVIEW | DOWNLOAD BROCHURE | TRAINING SEMINARS | BUZZ SESSIONS | KEYNOTES | PARTICIPANT LIST | TOP PHARMA | EVENT FEATURES
Training-Seminars

Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.  They will be held IN-PERSON ONLY.  

Monday, January 16, 2023  9:00 - 6:00 pm | Tuesday, January 17, 2023  8:45 - 12:40 pm

TS2A: Introduction to Bispecific Antibodies

Detailed Agenda
Introduction to Bispecific Antibodies will be organized as an informative and practical guide to getting 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 the ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.
G. Jonah Rainey, PhD, Senior Director, Protein Engineering, Eli Lilly and Company

ROOM LOCATION: Indigo 202A

Topics to be Covered:

  • A brief history of bispecific antibodies: 60 years of progress with critical advances and key pioneers
  • Bispecific applications and powerful mechanisms of action
  • Engineering bispecific antibodies: 100 formats and counting
  • Bispecific-specific considerations in preclinical development and regulatory landscape
  • Developability, manufacturing, and analytical considerations
  • Clinical experience, translation, and regulatory approval
  • Current trends and future opportunities in regulating immune checkpoints, cell-based therapies, and personalized approaches​​

INSTRUCTOR BIOGRAPHIES:

G. Jonah Rainey, PhD, Senior Director, Protein Engineering, Eli Lilly and Company

Jonah Rainey holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute. He has engaged in discovery, research, and development of bispecific antibodies for more than 15 years. He is an inventor on several patents describing novel bispecific platforms and current clinical candidates that exploit these platforms as well as an author on almost 30 publications. Jonah contributed to research and early development leading to multiple clinical candidates from Phase I and through approved products and led many advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Previous industry experience includes MacroGenics, MedImmune/AZ, Oriole Biotech, Gritstone Oncology, and Alivamab Discovery Services. Currently, Jonah is a Senior Director in Protein Science at Eli Lilly & Co.

 

TS7A: Introduction to Antibody Engineering

Detailed Agenda
In this training seminar, students will learn about antibody basics, including structure, genetics, and the generation of diversity, as well as the generation of potential therapeutic antibodies. This latter part will include antibody humanization, affinity and specificity maturation, display technologies, creation of naïve libraries, and antibody characterization. The seminar will be fully interactive with students providing ample opportunities to discuss technology with instructors.​
Andrew R.M. Bradbury, PhD, CSO, Specifica, Inc.
James D. Marks, MD, PhD, Professor and Vice Chairman, Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF); Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

Antibody Background

  • Structure 
  • Genes 
  • Generation of diversity (recombination, somatic hypermutations) 

Antibody Humanization

  • Closest human gene approach 
  • Minimal modification approach
  • Veneering
Display Technologies Overview 
  • Phage
  • Yeast 
  • Combining phage and yeast display
  • Ribosome 
  • Others 

Generation of Naïve Antibody Libraries 

  • Natural libraries (methods, quality control)
  • Synthetic libraries (including strategies for generation diversity) 

Affinity Maturation 

  • Error-prone PCR 
  • Chain shuffling 
  • CDR targeted mutations 

Next-Generation Sequencing in Antibody Engineering 

  • Platforms: advantages and disadvantages
  • Error rates and why they’re important 
  • Naïve library diversity analysis 
  • Selection analysis 

Antibody Characterization and Developability 

  • Expression 
  • Specificity 
  • Aggregation 
  • Solubility

INSTRUCTOR BIOGRAPHIES:

Andrew R.M. Bradbury, PhD, CSO, Specifica, Inc.

Andrew Bradbury is Chief Scientific Officer of Specifica. He trained in medicine at the universities of Oxford and London and received his PhD from the university of Cambridge at the MRC Laboratory of Molecular Biology under the guidance of Nobel Laureate, Cesar Milstein. He has worked in the fields of phage and yeast display, library generation, antibody engineering and Next Generation Sequencing for over thirty years. He was a Group Leader at Los Alamos National Laboratory before founding Specifica. Specifica's mission is to enable companies developing therapeutic antibodies with the world’s best antibody discovery platform.

James D. Marks, MD, PhD, Professor and Vice Chairman, Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF); Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

Dr. Marks is Professor and Vice-Chairman of the Department of Anesthesia and Perioperative Care at the University of California, San Francisco (UCSF) and Chief of Performance Excellence at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG). Dr. Marks received his medical degree from UCSF where he also completed residencies in Internal Medicine and Anesthesia and a fellowship in Critical Care Medicine. He received his Ph.D. in molecular biology from the Medical Research Council Laboratory of Molecular Biology in Cambridge, England. Dr. Marks is an internationally recognized pioneer in the field of antibody engineering, has had constant federal funding for 27 years and has authored more than 200 publications and 100 patents. In recognition of these scholarly achievements, he was elected to the National Academy of Medicine. As an entrepreneur, he has co-founded four biotechnology companies and currently serves on three biotechnology corporate boards.

 

TS8A: Introduction to Machine Learning for Biologics Design

Detailed Agenda
This course offers an introduction to the concepts, strategies, and machine learning methods used for biologics design. It consists of presentations and demonstrations of the methods used in the field, covering techniques such as triaging sequences, modulating affinity, and designing antibody libraries, along with increasing manufacturability. The course is directed at scientists new to the field and protein engineers wanting an introduction to how machine learning can aid in guiding biologics design.
Christopher R. Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada
Francis Gaudreault, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Seminar Highlights:

  • Basics of machine learning and where it fits into drug discovery
  • Machine learning: a historical view of its application in the field of drug discovery
  • How machine learning revolutionized homology modeling
  • Applying machine learning to structure-based biologics design
  • Guiding the design of display libraries using machine learning
  • Developability Assessment

INSTRUCTOR BIOGRAPHIES:

Christopher R. Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Dr. Christopher Corbeil is a research officer at the National Research Council Canada (NRC) who specializes in the development and application of computational tools for biotherapeutic design and optimization. He is also an associate member of the McGill Biochemistry Department and teaches classes in Structure-Based Drug Design at McGill University. After receiving his PhD from McGill University, he joined the NRC as a Research Associate investigating the basics of protein-binding affinity. Following his time at the NRC he joined Chemical Computing Group as a research scientist developing tools for protein design, structure prediction, and binding affinity prediction. He then decided to leave private industry and rejoin NRC with a focus on antibody engineering. Dr. Corbeil has authored over 30 scientific articles and is the main developer of multiple software programs.

Francis Gaudreault, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Francis obtained his PhD in Biochemistry from University of Sherbrooke in 2015, during which he developed a molecular docking program for docking small molecules to flexible protein or RNA targets. While doing his PhD studies, Francis co-founded a successful IT company for automating the management of scientific conferences. Francis joined the National Research Council (NRC) of Canada in 2016, where he has taken part in and led various efforts in the discovery and engineering of antibodies or other biologics. In such efforts are included the structure prediction of antibodies alone or in complex, the affinity assessment of antibody-antigen complexes, and the detection of antibody developability issues. Francis is leading the technical efforts in using artificial intelligence for antibody discovery.

Tuesday, January 17, 2023  1:30 - 5:30 pm | Wednesday, January 18, 2023  9:00 - 5:45 pm

TS6B: Biomanufacturing 101: An Overview on Animal Cell Culture Technology from Cell Line Development to Scale-Up Strategies

Detailed Agenda
In this seminar, we will take an in-depth look at modern cell culture techniques from a frozen stock to bioreactor design and operations. Cell line development, characterization, and scale-up strategies will be discussed in detail. Special emphasis will be placed on media design and optimization for specific clones to be utilized in production of biologics. We will highlight the significance of proper handling of cells in culture to avoid contamination and batch failure. Upstream processing of therapeutic proteins, monoclonal antibodies, and vaccines will be presented. After the completion of this seminar, the participants will have a clear understanding of the principles and techniques utilized in culturing animal cells for production of biologics, quality control of a cell culture laboratory, and types of contaminants of cells in culture with special emphasis on mycoplasma detection. They will learn scale-up strategies for suspension and anchorage-dependent cells utilizing stirred-tank bioreactors, hollow fiber bioreactors, and microcarrier cell culture technology.
Kamal A. Rashid, PhD, President, International Biotechnology Associates
Benjamin Madsen, PhD, Staff Engineer, R&D, Thermo Fisher Scientific, Inc.
Natalie McAdams, PhD, Manager Cell Biology, BioProduction R&D, Thermo Fisher Scientific

ROOM LOCATION: Indigo 202A

Seminar Outline:​

  • Historical development of animal cell culture technology.
  • Animal cells as factories for production of biologics.
  • The importance of understanding the cell cycle for optimal productivity.
  • Expression systems, transformation, and transfection assays.
  • Cell line characterization and cell banking and cryopreservation.
  • The importance of nutrients and media design for specific cells.
  • Scale-up of cell culture and bioprocessing.
  • Monoclonal antibody production.
  • Viral vaccine production.
  • Hollow fiber cell culture technology.
  • Microcarrier cell culture technology.
  • Stirred-tank bioreactors: Stainless steel and single-use systems.
  • Case studies with CHO and Vero Cell lines.

INSTRUCTOR BIOGRAPHIES:

Kamal A. Rashid, PhD, President, International Biotechnology Associates

Dr. Kamal Rashid has over forty years of academic experience in research, teaching, and workforce development efforts. He has developed, directed, and implemented biotechnology/biomanufacturing training programs at Albany College of Pharmacy and Health Sciences, Worcester Polytechnic Institute, Utah State University, Penn State University, and internationally. He is an expert in animal cell culture technology and has developed and taught graduate courses in cell culture techniques and scale-up strategies for more than thirty-five years. He realized early on the importance of animal cell systems in bioprocessing and biomanufacturing as he developed the first hands-on cell culture training program for the bio-based industry in 1989, as part of a comprehensive bioprocessing training program at Penn State University. While on the faculty at Penn State, Dr. Rashid established International Biotechnology Associates as a strategic consulting partner for companies, institutions, and government agencies, helping them bring life-changing biotechnologies to people around the world. Operating on a model of collaboration, Dr. Rashid assembles and leads multidisciplinary teams to support specific client initiatives. Dr. Rashid received his undergraduate degree from University of Baghdad, Iraq, with distinction, and PhD from Penn State University with superior ranking. His major areas of research interests are in bioprocessing and genetic toxicology.

Benjamin Madsen, PhD, Staff Engineer, R&D, Thermo Fisher Scientific, Inc.

Ben Madsen leads the cell culture application team for Thermo Fisher Scientific’s single-use technologies division in Logan, Utah, evaluating new and existing technologies and systems including bioreactors, mixers, controllers, sensors, and filters. He has 12 years of cell culture and process development experience mainly working in mammalian cell culture with specific emphasis on perfusion workflows. He works daily with customers of single-use equipment to troubleshoot and optimize processes to achieve ideal outcomes. He obtained his Ph.D. in Biological Engineering from Utah State University in 2010.

Natalie McAdams, PhD, Manager Cell Biology, BioProduction R&D, Thermo Fisher Scientific

Natalie McAdams joined Thermo Fisher Scientific in 2018 as an R&D scientist for the BioProduction Group supporting and leading custom cell culture media development service projects for CHO protein therapeutics. She currently leads a team as an R&D manager for the Gibco PD-Express Services group in Grand Island, NY. Natalie received her PhD in Biological Sciences at the University at Buffalo, The State University of New York studying transcriptional regulation in B. subtilis by the RNA-binding TRAP protein. She then examined mitochondrial RNA editing in the eukaryotic parasite Trypanosoma brucei for her postdoctoral research in the Department of Microbiology and Immunology at SUNY Buffalo.

Thursday, January 19, 2023  8:30 - 5:00 pm | Friday, January 20, 2023  9:00 - 12:30 pm

TS4C: Introduction to CMC for Biotech, Cell & Gene Therapy Products

Detailed Agenda
The chemistry manufacturing and controls (CMC) of biologics is a multidiscipline technical operation of bioprocess, analytics, dosage formulation and cGMP manufacturing/testing for DS/DP release and stability to treat human diseases. This interactive training course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, monoclonal antibodies (Mab), and cell and gene therapy (CGT) in the context of IMPD and IND regulatory filing. Attendees will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirement. The instructor will present common pitfalls and share the best industry practices. Numerous real-world regulatory queries/comments from health authorities worldwide will be exemplified as case studies during the training course.
Kevin Zen, PhD, Executive Director, Chemistry Manufacturing and Controls, AnaptysBio, Inc.

ROOM LOCATION: Indigo 202A

TOPICS TO BE COVERED:

1. Diverse modality of therapeutic biological products 

2. Biologics CMC activities for regulatory filing (IMPD/IND)

3. Quality by design (QbD) concept, quality target product profile (QTPP), and critical quality attributes (CQA) 

4. Cell line development, process development, and manufacture of biologics, CGT DS and DP

5. Current analytical technologies to characterize product variants/impurities, process impurities (e. g. HCP), and contaminants

6. Formulation development and compatibility with container closures and injection devices 

7. Reference material characterization/qualification and justification of specifications for DS/DP release and ICH stability for product expiry

8. Process validation, analytical validation, and control strategy of cGMP manufacturing 

9. Manufacturing process changes during product development lifecycle: CMC comparability exercise

WHO SHOULD ATTEND: The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Executive Director, Chemistry Manufacturing and Controls, AnaptysBio, Inc.

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining AnaptysBio, he held various positions in biologics CMC disciplines at Allergan, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.