Events

BEBPA US Bioassay 2024

BEBPA US Bioassay 2024

I have plans to submit an abstract for BEBPA US Bioassay 2024. The meeting will be held in March on the West Coast. Details will be forthcoming. Read More »

Past Events

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 »