Events

Biostatistics for Beginners

Biostatistics for Beginners

Save the date for the 16th Annual CHI Immunogenicity and Bioassay Summit. My one day, in-person only workshop “Biostatistics for Beginners” is scheduled for October 15, 2024. I will also chair a session Getting Down to Bioassay Brass Tacks: Measuring Potency Related Critical Quality Attributes for Cell and Gene Therapy… Read More »
High Pathogenicity Avian Influenza Vaccination Strategies to prevent and control HPAI

High Pathogenicity Avian Influenza Vaccination Strategies to prevent and control HPAI

I have been retained as the official rapporteur for this important conference to prevent and control HPAI. Also, I am happy to share the full meeting report from the IABS conference I covered in Ottawa June 2023 on vaccine quality.  The PDF of the publication is open access until May… Read More »
10th IABS Statistics Workshop

10th IABS Statistics Workshop

I have submitted an abstract.  Whether it is accepted or not, I plan to attend in person and hope to see you there! Read More »

Past Events

ASCGT Annual Meeting

ASCGT Annual Meeting

I will be attending the ASGCT Annual Meeting in person, May 7-10. If you plan to attend and would like to meet up, please contact me. Read More »
BEBPA US Bioassay 2024

BEBPA US Bioassay 2024

My talk at BEBPA US Bioassay 2024 is on Tuesday March 12: Using Equivalence Testing to Define Lot Release Limits for Product Potency Potency is a critical quality attribute for all biologics. The impact of process variability on potency levels can include changes in the safety or efficacy of the… Read More »
Gene Therapy Product Activity & Comparability & the Evaluation of T-Cells

Gene Therapy Product Activity & Comparability & the Evaluation of T-Cells

Nancy Sajjadi will attend the Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies. The Standards Coordinating Body (SCB) for Regenerative Medicine, and the U.S. Food and Drug Administration (FDA) are holding the workshop, which is co-organized… Read More »
9th Annual IABS Statistics Meeting

9th Annual IABS Statistics Meeting

Nancy Sajjadi will be attending the 9th Annual IABS Statistics Meeting in person. This workshop will provide a forum for statisticians, data scientists, development engineers, and regulators to explore approaches that serve future generations of technical and regulatory innovation in biologicals development and lifecycle management. Read More »
NIST-FDA Workshops on Measurements and Standards for Advanced Therapy

NIST-FDA Workshops on Measurements and Standards for Advanced Therapy

Nancy Sajjadi will speak about the analytical challenges for adenovirus on Day 1 of the NIST-FDA Workshops on Measurements and Standards for Advanced Therapy and will attend Days 2 and 3 in person. Day 1 will focus on identifying measurement needs, gaps and solutions for different gene delivery systems. In… Read More »
Optimizing Bioassays for Biologics

Optimizing Bioassays for Biologics

I will be co-chairing the BIOASSAY — FROM FRAMEWORK TO FAQs session as part of the “Optimizing Bioassays for Biologics” track on October 5, 2023. I will also be presenting in the same session. Title: Applying an Equivalence Model to Set Lot Release Specifications for Relative Potency Abstract: The center… Read More »
CHI's Immunogenicity & Bioassay Summit

CHI's Immunogenicity & Bioassay Summit

CHI is once again offering my one day, in-person only, biostatistics training course ahead of the Immunogenicity and Bioassay Summit. W1: Biostatistics for Beginners - IN-PERSON ONLY Biostatistics is the science of learning from biological data. Inferential statistics use data from a sample to make generalizations or predictions about a… Read More »
Maintaining the Quality of Vaccines Through the Use of References Standards

Maintaining the Quality of Vaccines Through the Use of References Standards

EVENT: Current challenges and future opportunities - An IABS Hybrid Meeting LOCATION: Ottawa, Canada I have been retained by The International Alliance for Biological Standardization (IABS), an independent, non-profit scientific alliance, with headquarters in Geneva Switzerland, to serve as the official rapporteur for this conference. I will be responsible for… Read More »
Environmental Science and Communication Studies Dyad course

Environmental Science and Communication Studies Dyad course

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. Read More »
CaSSS Bioassay

CaSSS Bioassay

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… Read More »
International Society for BioProcess Technology (ISBiotech )12th Spring Meeting

International Society for BioProcess Technology (ISBiotech )12th Spring Meeting

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."   Read More »
Cambridge Healthtech Institutes 22nd Annual Peptalk Conference

Cambridge Healthtech Institutes 22nd Annual Peptalk Conference

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… Read More »
Attending in Person: Bioassays 2022

Attending in Person: Bioassays 2022

Session Co-Chair FAQs to Facts

Session Co-Chair FAQs to Facts

Pre-Conference Workshop Presenter

Pre-Conference Workshop Presenter

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… Read More »
Panel Co-Chair: Statistics for Bioassay:  From FAQs to FACTS

Panel Co-Chair: Statistics for Bioassay: From FAQs to FACTS

American Association of Pharmaceutical Scientists PharmSci360; Bioanalytics/Biomolecular Track

American Association of Pharmaceutical Scientists PharmSci360; Bioanalytics/Biomolecular Track

AAPS 2021 PHarmSCi 360 Keynote

AAPS 2021 PHarmSCi 360 Keynote

In this presentation, Nancy describes how %CV is an often used, but poor metric for relating assay performance, reported value measurement uncertainty and fitness-for-purpose.  She presents a biomarker case study to show how assay suitability is inextricably linked to a statistical hypothesis framework and demonstrates how assay validation data can be… Read More »
“Defining Work Life Balance for the Small Business Owner”

“Defining Work Life Balance for the Small Business Owner”

Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements

Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements

In this presentation, Nancy explains that pre-clinical and clinical trials involving dose escalation assume that the assigned dose values are comparable across studies. However, dose assays for vectors often have high variability. Nancy discusses how the establishment of a dose specification is linked to the assay replication strategy and show… Read More »
Invited Session Chair and Panel Moderator INNOVATIVE STRATEGIES TO DESIGN BIOASSAYS track

Invited Session Chair and Panel Moderator INNOVATIVE STRATEGIES TO DESIGN BIOASSAYS track

“Creating a Culture of Synergy-An Evolution Inspired Approach to Achieving Optimal Outcomes for All”

“Engineering Well-Being: An Introduction to Life Quality by Design”

“Engineering Well-Being: An Introduction to Life Quality by Design”

“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”

“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”

“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”

“Understanding Critical Fold Difference and Its Application in Reporting Assay Precision”

“Achieving Success by Creating a Culture of Cooperative Adaptability”

“Achieving Success by Creating a Culture of Cooperative Adaptability”

"Design, Development and Validation of Assays to Support Advancement of Experimental Therapies"

"Design, Development and Validation of Assays to Support Advancement of Experimental Therapies"

“Applying Quality By Design Principles to Assays- Lessons From The Development of Unconventional Vaccines”

“Applying Quality By Design Principles to Assays- Lessons From The Development of Unconventional Vaccines”

“Assay Validation 101- Good Science Meets Federal Compliance”

“Assay Validation 101- Good Science Meets Federal Compliance”