研討會 | 16th Annual Immunogenicity & Bioassay Summit 2024 官方網站

2024年研討會

2024年10月15日（二） 9:00 - 5:00 pm

W1: Biostatistics for Beginners

Statistical analysis is an integral part of designing, developing, validating, and implementing a bioassay. Statistical tools and techniques are required for experimental design, selecting an appropriate model for the dose response curve, evaluating system and sample suitability, and to measure, control, and communicate the uncertainty of reported potency results. Fundamental concepts are also integral to developing product specifications and making decisions for lot release. 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 in context and expand their knowledge of fundamental concepts and tools that are applicable to their daily work. Sufficient time is allocated at the end of the day to review specific topics by request and further discuss participant questions.

9:00 am

Biostatistics for Beginners

Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting

Topics to be Covered Include:

Statistics: Definition and its application to assay development
The arithmetic mean, the standard deviation, and how to prove differences
Assay intended use, hypothesis testing, and evaluating fitness-for-purpose
Inferential statistics: terminology and symbols explained
Standard error of the mean, t values, and p values
Reported mean values, margin of error, and confidence interval of a mean
Statistical Significance: Difference vs. Equivalence Testing
Type I and Type II Errors and Statistical Power
Dose-response curve- model selection, system, and sample suitability evaluation
Log transformation of response readouts and relative potency values
Calculating relative potency values: parallel line vs. 4 PL
Quality by Design (QbD): Assays as processes to be optimized and evaluated against target performance requirements
Overview of available guidance: FDA, USP, and ICH documents

The Commitment to Participants:

Each participant is likely to arrive at the course with the expectation of examples or explanations to address issues that are specific to them or their organization. To ensure that participants are satisfied, the instructor is open to receiving non-confidential questions in advance for consideration in customizing the course material. The instructor will assess each question to ensure it matches the scope of the workshop. If you have any questions you would like the instructor to address at the workshop, please email them to Iris Goldman: igoldman@cambridgeinnovationinstitute.com

Who Should Attend:

Laboratory scientists, technicians, and others with limited statistical knowledge who are involved in generating and reporting data
Managers in QA, QC, and Regulatory functions who review data and statistical analyses
Non-statisticians who engage with statisticians in the design and interpretation of studies
Technicians involved in the design, execution, or review of assay qualification protocols
Anyone interested in increasing their understanding of basic statistical concepts and improving their comprehension of conference presentations that include statistical analyses

Workshop Agenda:

9:00 am Start of Workshop

11:10 Networking Coffee Break

1:00 pm Lunch on Your Own

2:15 Workshop Resumes

4:00 Networking Refreshment Break

5:00 Close of Workshop

INSTRUCTOR BIOGRAPHIES:

Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting

Nancy Sajjadi, M.Sc. is Founder and Principal Consultant of Sajjadi Consulting. She has over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research then joined a start-up company developing cell and gene-using therapies for infectious disease, cancer, and cell therapy applications. Her responsibilities included research, assay development, and quality control. In 2000, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start her own consulting business. For over 20 years, Ms. Sajjadi has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of cutting-edge products and provides technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy and has served on 5 advisory panels for the United States Pharmacopeia (USP). She enjoys teaching introductory courses in bioassay design, development, and validation for non-statisticians. Her company has recently expanded services to include leadership development and executive coaching to guide organizations toward sustaining a culture of quality.

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