Dr. Sid Bhoopathy, President and COO of Absorption Systems has been invited to participate and speak as a panel member at the FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop by the USFDA. The workshop meeting will be held virtually on May 4th 2020.
Details on remote attendance are available at: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fy-2020-generic-drug-regulatory-science-initiatives-public-workshop-05042020-05042020.
Dr. Bhoopathy will be sharing research updates, insights, and current challenges on how to evaluate in vitro data and which in vitro studies are clinically relevant in the Breakout Session on Data Analysis and Model-Based Bioequivalence, chaired by Dr Liang Zhao of the USFDA. The overarching objectives of this session are to expand the reach and utility of model informed BE by combining this with pertinent and reproducible in vitro data. Achieving these objectives with agency supported research should further; 1) applicability of this approach to a greater number of product categories and 2) determination of the relative space within which the product CQAs can be varied without impacting in vivo outcomes, thereby expanding the QQQ tolerance for in vitro BE methodologies.
We hope you are able to join this discussion!
Absorption Systems' Dr. Benjamin Bronfin will be presenting at Hanson Wade's Gene Therapy for Immunogenicity next week!
Practical Guide for Immunogenicity Assays: A CRO Perspective
In this session you'll learn:
- Leveraging the CRO-Sponsor relationship
- What Sponsors need to provide for a successful Immunogenicity assay development
- Case study of assay development and validation process: bioanalytical parameters, timeline, and pitfalls
If you're interested in attending this talk, register for this event here.