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, JANUARY 9, 9:00 AM-5:30 PM –
TUESDAY, JANUARY 10, 8:30 AM-12:30 PM
TS1: 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 follow. 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 G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
TS2: Introduction to Antibody Engineering
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 provided ample opportunities to discuss technology with instructors.
Instructors:
Andrew M. Bradbury, Ph.D., MB, BS, Staff Scientist, Biosciences, Los Alamos National Laboratory
James D. Marks, M.D., Ph.D., Chief of Staff, Chief of Anesthesia, San Francisco General Hospital; Professor & Vice Chairman of Anesthesia, University of California, San Francisco
TS3: Regulatory Requirements across the Product Development Lifecycle
The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This seminar will include a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This seminar is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.
Instructor:
Christina Vessely, Ph.D., Senior Consultant, Biologics Consulting Group
TUESDAY, JANUARY 10, 2:00-5:30 PM –
WEDNESDAY, JANUARY 11, 8:30 AM-5:30 PM
TS4: Introduction to Biologics Formulation and Delivery
CHI’s Introduction to Biologics Formulation and Delivery training seminar focuses on strategies to plan and execute preformulation and formulation development studies for biologics. Such projects require co-optimization of multiple physical, chemical, and conformational stability attributes under accelerated timelines to ensure rapid delivery of a stabile product to the clinic. The seminar begins with an overview of biophysical and biochemical properties of proteins and protein structure, setting the stage for the concepts and goals at the core of protein formulation. The seminar then continues with an exploration into the theory and application of the relevant analytical and biophysical techniques that support preformulation and formulation development studies. The primary focus of the seminar is an in-depth discussion of typical formulation development workflows, including statistical analysis and use of DoE. The formulation development section of the seminar then concludes with examination of real-world case studies. Attendees of the training seminar should leave with a greater understanding of the biologics formulation field, in general, as well as with specific knowledge and strategies for setting up successful formulation development studies in their own labs.
Instructor:
Donald E. Kerkow, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma, Inc.
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.