2024年度の会議プログラム

Cambridge Healthtech Institute’s 16th Annual

Immunogenicity Assessment & Clinical Relevance
( 免疫原性の評価と臨床面での関連性 )

Assay Strategy for Meaningful Evaluation

2024年10月16-17日 - IN-PERSON & ONLINE

This year's Immunogenicity Summit brings the FDA together with leading industry and academic experts to discuss the development, application and validation of immunogenicity assays. Learn how to manage drug and target interference and tolerance, understand the impact of pre-existing antibodies and interpret the clinical significance of assay data. Novel modalities including cell and gene therapies are posing new challenges to the industry, all of which will be discussed in-depth at this meeting.

Cambridge Healthtech Institute ’s 16th Annual

Immunogenicity Prediction & Control
( 免疫原性の予測と制御 )

Regulatory Perspectives, Risk Factors, and Management

2024年10月17-18日 - IN-PERSON & ONLINE

The impact of immunogenicity on safety and efficacy, and consequent cost to the industry, is well understood. Accordingly, investigators are focusing on factors that contribute to immunogenicity, as well as a number of different approaches to predict immunogenicity at the drug discovery stage. There are several major problematic areas with novel modalities. Efforts are being made to suppress immune responses to these products and to introduce tolerizing and deimmunization approaches. Attend in 2021 to hear insightful feedback from the FDA and learn from top industry and academics in this field.

Cambridge Healthtech Institute’s 12^th Annual

Optimizing Bioassays for Biologics
( 生物製剤向けバイオアッセイの最適化 )

Case Studies Demonstrating Successful Bioassay Development

2024年10月17-18日 - IN-PERSON & ONLINE

New therapeutic modalities, including cell & gene therapies, immunotherapies, and antibody therapies, continue to push the limit on bioassay development and implementation. New formats present challenges including determining what reference materials to use and how to validate the assay. Health authorities and USP have provided guidance for the design and validation of a bioassay; however, they are just starting to consider solutions to common problems springing from this revolution in technology. Cambridge Healthtech Insitute's 9th Annual Optimizing Bioassays for Biologics will bring together leaders working in bioanalytical and bioassay development to present case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and maintenance. be presented along with recommendations for implementation to ensure a steady drug development pipeline.

Training Seminar: A Guide to Statistical Methods for Bioassay
( トレーニングセミナー : バイオアッセイ向け統計学的手法の概要 )

2024年10月16-17日 - IN-PERSON ONLY

Instructor: David Lansky, PhD, President, Precision Bioassay, Inc.

This course will introduce the statistical concepts needed for bioassays (all illustrated with useful and relevant examples), review properties of bioassays, and show how the statistical methods apply to bioassay. To work with the practical constraints in the laboratory the statistical methods must adapt. Using design of experiments (DOE) for bioassay development, validation, and monitoring is powerful and effective when informed by these constraints and adaptations. Examples (mostly from cell-based bioassays; some using robotics) will illustrate strategic ways to design bioassays to make it (relatively) easy to apply DOE in early bioassay development when measuring the capability of a bioassay, when improving an existing bioassay, and when doing validation. We will cover ways that these strategic assay design considerations, when combined with good assay analysis methods, also support good assay monitoring with graphical and quantitative tools as part of a lifecycle approach.

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Cambridge Healthtech Institute’s 14th Annual

Symposium: Immunology for Biotherapeutics
( シンポジウム：バイオ治療薬向け免疫学 )

Understanding and Manipulating the Immune System for Therapeutic Advantage

2024年10月15日 - IN-PERSON & ONLINE

Many of the exciting developments in drug discovery and development today concern the immune response and its manipulation and control. Our understanding of immune involvement in therapeutic disorders and their treatment is developing rapidly. T and B lymphocyte subsets, innate lymphoid cells (ILCs), macrophages, dendritic cells and cytokines are all involved in a complex manner. There is the potential for manipulation for therapeutic advantage, yet the danger disastrous consequences if not well understood. At this virtual symposium, attendees will find out how to utilize the immune system and overcome inhibitory factors without overlooking potential safety issues.

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Workshop: Biostatistics for Beginners
( ワークショップ：初心者向け生物統計学 )

2024年10月15日 - IN-PERSON ONLY

Instructor: Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting

Biostatistics is the science of learning from biological data. Inferential statistics use data from a sample to make generalizations or predictions about a population. The process of sampling naturally incurs error and statistics are needed to measure, control, and communicate the uncertainty of reported results. This workshop is intended for people who generate or review bioassay data, but have minimal training in statistics. This slower-paced course will help participants understand the meaning of commonly encountered statistical information and expand their knowledge of fundamental concepts and tools that are applicable to their daily work.

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