2025 Training Seminar (In-Person Only)

*Separate registration is required.

The Training Seminar Will Be Offered In-Person Only
To ensure a cohesive and focused learning environment, moving between conference sessions and the training seminar is not allowed.

Wednesday, October 8, 2025 8:30 AM – 5:30 PM | Thursday, October 9, 2025 8:00 AM – 12:00 PM

TS2B TS2B: Biostatistics for Beginners

Statistical analysis is an integral part of designing, developing, validating, and monitoring performance of a bioassay after it is implemented. 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 training seminar is intended for people who generate or review bioassay data but have minimal training in statistics. A slower-paced interactive course helps 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. Time is built into the agenda to allow for review of specific topics and open discussion in response to participant questions.

TS2B:Â Biostatistics for Beginners - IN-PERSON ONLY

Nancy Sajjadi, Founder and Principal Consultant, Sajjadi Consulting

Topics to be Covered:

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 training seminar. If you have any questions you would like the instructor to address at the training seminar, please email them to Gemma Smith: gsmith@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 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

INSTRUCTOR BIOGRAPHY:

Photo of Nancy Sajjadi, Founder and Principal Consultant, Sajjadi Consulting — **Nancy Sajjadi, Founder and Principal 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.

CONFERENCE PROGRAMS