Immunogenicity and Bioassay Summit – REM Software Demo and Presentations

Immunogenicity and Bioassay Summit – REM Software Demo and Presentations
August 14, 2022 Ariadne Solutions

Immunogenicity and Bioassay Summit – REM Software Demo and Presentations

Join us for the demonstration of the prototype of an automated software tool for determining cut point using Random Effects Model. Additionally, Dr. Stephanie Pasas-Farmer will be presenting at Bioassay Summit as well as co-presenting with Dr. Cheikh Kane from KCAS at Immunogenicity Summit.

October 3-6, 2022 | Washington, D.C.
(In person or virtual)
Visit Us at Booth #11

Join us at booth #11 to demo our prototype for a more accurate Cut Point determination using Random Effects Model to address the variance in population without the need to remove outliers.

Presentation 1: Using Random and Fixed Effects Modeling for a More Accurate Cut Point Determination
Speakers: Dr. Cheikh Kane, KCAS and Dr. Stephanie Pasas-Farmer, Ariadne Software
Date and Time: October 4, 2022, 10 am ET
Artificial Intelligence (AI) is increasing efficiencies in drug discovery and development by automating human tasks that are repetitive, demand accuracy and/or require immense resources. Using some case studies, we will highlight the benefits of AI solutions, as well as discuss challenges that the industry faces in the adoption of AI solutions, such as inadequate regulations, inaccessibility to quality development data, limited understanding of AI, cognitive biases, and implementation challenges.

Presentation 2: Current State of Artificial Intelligence in Drug Discovery and Development
Speakers: Dr. Stephanie Pasas-Farmer, Ariadne Software
Date and Time: October 6, 2022, 12 pm ET
The goal of ADA cut point (CP) calculation is to understand the biological variance of a drug naïve population and apply this CP to confirm the presence of ADA after treatment in the clinic. There are multiple approaches to CP calculation that deal with expected outliers. The traditional approach removes outliers while a modeled approach (e.g. random effect models (REM)) retains all population data while modeling random and known sources of variance. Using case studies, we present an analysis of REM and propose when to use REM and how to choose amongst the various modeled outcomes.

Panel Discussion:  Immunogenicity Assessment Challenges in Bioanalytical Development of Cell and Gene Therapy Products
Speakers: Dr. Stephanie Pasas-Farmer, Ariadne Software (Moderator); Dr. Boris Gorovits, VP of Bioanalytical and non-clinical biomarkers at Sana Biotechnology; Dr. Priya Chockalingam, Vice President, Head of Clinical Bioanalytics & Translational Sciences at Beam Therapeutics; Dr. Cheikh Kane, Senior Director, Biopharma Services, KCAS; Dr. John Farmer, Director of Immunology and Large Molecule Bioanalysis, Lovelace Biomedical; Rich Snyder, Senior Medical & Scientific Advisor, Q2 Solutions
Date and Time: October 5, 2022, 2:20 pm ET

We will discuss:

  1. Unwanted Immunogenicity Assessment for classical modalities vs ATMPs
  2. Immunogenicity assessment strategies for autologous vs. allogenic cell therapies
  3. Innate immunity and its impact on cell and gene therapy products
  4. NAb vs. Tab response or cellular response to capsid proteins
  5. Importance of biomarkers/PD for programs with expected complex immunogenicity profile