SC12 Detailed Agenda 2017 Pegs Summit

2017 Archived Content

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Tuesday, May 2, 2017 6:00 – 8:30 PM
 SC12: Study Design and Statistical Data Analysis of Flow Cytometry Assays
Instructor: Shuguang Huang, Ph.D., Chief Scientific Officer, Stat4ward LLC
Flow cytometry assay has become a primary means of assessing T cell responses in vaccine and immunotherapy product developments. Typically, the assay is used to determine (1) if a sample shows ‘positive’ response to a treatment or a stimulation, (2) if the assay readout is correlated with clinical endpoint.
FCM assays have some unique challenges compared to other bioassays. For instance, technical replicates are rarely available, how can we design a study to evaluate the assay’s sensitivity (LOB, LOD, LOQ) and reproducibility? How can we decide whether a stimulation results in a positive response (compared to the unstimulated control) by using only one replicate? How can we develop a mathematical prediction model based on these highly correlated polyfunctions?
In this workshop, the following issues will be discussed
<ul class="Abstract">
<li>The statistical design for the analytical validation of cytometry assays</li>
<li>The gating of "positive events" – the pros and cons of FlowJo and publically available software</li>
<li>The determination assay sensitivity – Limit of blanks (LOB), lower quantification limits (LOQ), and the detection limit (LOD) of the assay</li>
<li>The identification of the "poly functions" that are associated with clinical endpoints (PK, PD, clinical outcome)</li>
<li>The development of the predictive model that serves as a Biomarker (multivariate modeling)</li>
</ul>
 Instructor Biography:
<img src="/uploadedImages/PEGS/Agenda/17/Shuguang-Huang.jpg" alt="Shuguang Huang" title="Shuguang Huang">Dr. Shuguang Huang has over 15 years of experiences in pharmaceutical and medical device companies. He has assumed technical and management positions in large pharma such as Eli Lilly, Wyeth, Pfizer, and Precision Therapeutics Inc (a cancer diagnostic company). Over the years, Dr. Huang has had many publications and presentations dedicated to assay and biomarker development and validation. He is the co-founder and the Chief Scientific Officer of the statistics consulting company Stat4ward LLC. One of the major initiatives of Stat4ward is workshop trainings that share knowledge and insights learned from real-life experiences.