Email: nancy@sajjadiconsulting.com
Phone: 703-727-9195
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Privacy Policy
CaSSS Bioassay
futureEngineered 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.
CHI’s Immunogenicity & Bioassay Summit
futureMy 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!
Environmental Science and Communication Studies Dyad course
futureNancy 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.
International Society for BioProcess Technology (ISBiotech )12th Spring Meeting
futureNancy 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.”
Cambridge Healthtech Institutes 22nd Annual Peptalk Conference
pastBiostatistics 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.
Pre-Conference Workshop Presenter
pastBiostatistics 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.
Session Co-Chair FAQs to Facts
pastAttending in Person: Bioassays 2022
pastPanel Co-Chair: Statistics for Bioassay: From FAQs to FACTS
pastKeynote: Evolving Best Practices In Bioanalytics- A Backstreet View of the Fit-for Purpose Picture
past“Defining Work Life Balance for the Small Business Owner”
past“Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements”
pastInvited Session Chair and Panel Moderator INNOVATIVE STRATEGIES TO DESIGN BIOASSAYS track
past“Creating a Culture of Synergy-An Evolution Inspired Approach to Achieving Optimal Outcomes for All”
past“Engineering Well-Being: An Introduction to Life Quality by Design”
past“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”
past“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”
past“Achieving Success by Creating a Culture of Cooperative Adaptability”
past“Design, Development and Validation of Assays to Support Advancement of Experimental Therapies”
past“Applying Quality By Design Principles to Assays- Lessons From The Development of Unconventional Vaccines”
past“Assay Validation 101- Good Science Meets Federal Compliance”
past