DATE:April 17-19, 2023
LOCATION:Gaithersburg Marriott Washingtonian Hotel, Gaithersburg, Maryland

Engineered viral and non-viral vectors can be designed as directly administered products or as critical reagents in the manufacture of gene modified cell therapies. These vectors require some form of potency testing prior to use in pre-clinical and clinical development. In vitro cell based assays are commonly used as is the incorporation of more than one read out following a transduction or transfection event. A composite case study will be used to highlight a few questions that are frequently encountered during the design, development, and validation of these types of potency assays and how they were addressed for a dual readout test using a six-point dilution curve at both the level of transduction and readout. Specifically, issues of dilution spacing, data transformation, model selection and goodness of fit assessments will be illustrated.

DATE:October 2-5, 2023
LOCATION:Watergate Hotel, Washington, DC

My workshop “Biostatistics for Beginners” will be offered again this year at CHI’s Immunogenicity & Bioassay Summit.  I plan to expand the scope and bring on a co-instructor(s) to cover immunogenicity in addition to bioassay. Details on the session “Optimizing Bioassays for Biologics: Demonstrating Successful Bioassay Development in an Era of Emerging Modalities,” will be posted soon.  Let me know if you are interested in presenting at this session! 

DATE:April 26, 2023
LOCATION:Montgomery Community College, Germantown Maryland

Nancy Sajjadi is an invited speaker for the Environmental Science and Communication Studies Dyad course, Renaissance Scholars Honors Program, at Montgomery Community College in Germantown MD. This community service engagement is a private event.

DATE:March 20-22, 2023
LOCATION:Norfolk Virginia

Nancy Sajjadi will be a speaker at the ISBiotech session, “Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose During Pre-Clinical Studies and Early Phase Clinical Trials.”

DATE:January 16-20, 2023

Biostatistics Basics for CMC Scientists and Data Reviewers is a one-and-a-half-day training seminar designed for bench scientists and other non-statisticians who are accountable for the chemistry, manufacturing, and control sections of regulatory submissions. Specifically, it is intended for those who design, develop, and validate analytical methods used to evaluate critical quality attributes of candidate products and for others who generate and/or review assay data used to make decisions during development.

The instructors assume that participants have either no statistical training or limited experience in the application of statistical tools and techniques to CMC science. The course is structured to convey basic critical concepts that are integral to measuring, controlling, and reporting uncertainty of test results and evaluating the inherent risks in making data-driven decisions.

Biostatistics topics covered address questions the instructors have routinely encountered in 20+ years of consulting that reflect inadequate understanding of underlying fundamentals. Generous discussion time is built into the agenda so participants can feel comfortable asking questions or explaining the statistics-based challenges associated with their job responsibilities.

The primary learning objective is to elevate the conversations that non-statistician CMC scientists and reviewers have with their statistician co-workers/consultants.

Bioassay Summit 2022
DATE:October 3, 2022
LOCATION:Arlington, Virginia

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.

Workshop is offered as part of CHI 14th Annual Immunogenicity & Bioassay Summit.

Bioassay Summit 2022
DATE:October 3-6, 2022
LOCATION:Virtual and in-person in Alrington, Virginia
Cambridge Healthtech Institute Immunogenicity and Bioassay Summit
DATE:October 22, 2021
LOCATION:Virtual and In-person in Washington, DC
American Association of Pharmaceutical Scientists PharmSci360
DATE:October 20, 2021
LOCATION:108 AB, Pennsylvania Convention Center, Philadelphia, PA
Cell & Gene Therapy Analytics Conference Virtual Biotherapeutics Analytical Series
DATE:March 2021
DATE:October 18, 2020
DATE:June 2020
Conference of Minority Transportation Officials
DATE:August 2019
LOCATION:DOT, Washington, DC
Cell Therapy Working Group Forum
DATE:March 2019
LOCATION:US FDA White Oak Campus, MD
BEBPA’s 3rd Annual US Bioassay Conference
DATE:March 2019
Women and Children’s Service Quality and Education Forum
DATE:May 2018
LOCATION:Anne Arundel Medical Center, Annapolis MD
Departmental Seminar for UCLA California Institute for Regenerative Medicine
DATE:March 2018
LOCATION:Los Angeles, CA
DATE:March 2014
LOCATION:Wilmington, DE
Departmental Seminar for UCLA California Institute for Regenerative Medicine
DATE:October 2012
LOCATION:Los Angeles, CA