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Visit the Cell Based Assays & Bioanalyitical Method Development agenda here.
First of all, can you tell us a little bit about your background?
Xu-Rong: I started cell based assay development back to 1998 at Geron for the early drug discovery. I have further developed cell based potency assays at Amgen since 2002. I was leading a group of scientists responsible for the development, qualification, validation of potency assays used for clinical and commercial biologic development. During the past 3 years, I have increasing responsibilities leading a large bioassay group responsible for development of cell based assays for low release biological characterization of biologics at MedImmune, a Biologic Subdivision of AstraZeneca. It has been my great pleasure working with Anne Reel, your program director, to present and co-chair at the Cell Based Assay Development conferences during the past 4 years. It is a very enriching experience for me.
Can you give us a preview of the case study you’ll be presenting this year? Xu-Rong: I have observed an increased level of interests and attendants of the conference during the past few years. Attendance of this conference really covers a great deal from the biopharmaceutical industry, especially for scientists the industrial leaders such as Genentech, Amgen, Biogen Idec, as well as for scientists from new emerging companies who wish to learn more from the industrial leaders and discuss their concerns. The case study I will present at this conference focuses more on a platform technology approach that will facilitate the development of homogeneous, fast and robust bioassays more effectively and efficiently. Specifically, this case study concerning the utilization of engineered cells for the development of cell based assays that could assess both Fab and Fc functionalities in a development- and QC-friendly manner.
What are you looking forward to at this year’s event?
Xu-Rong: I think this year there are a couple of aspects that really have advanced from the past few years. Firstly, this year’s Cell Based Assays will be combined with Bioanalytical Method Development. So they are going to cover a broader range of topics, from cell based assays for potency, Fc effector function assessment, Nabs assays for immunogenicity, and assays utilized for PK/PD purpose.
Secondly, while I am serving on the advisory panel for the meeting organizers that we realized it would be great to attract regulators to present at the conference. This year,
2 Cell Based Assays & Bioanalytical Method Development Podcast: Xu-Rong Jiang, PhD
the conference has indeed attracted broader attendance, especially speakers from the FDA.
Last but not least, this year will held a Fc effector function session and a strategy white paper for the assessment of effector functions of therapeutic antibodies will be presented by An Song, PhD, Senior Scientist, Associate Director, BioAnalytical R&D, GENENTECH. I worked closely with her to co-author the manuscript that was submitted one month ago. All these aspects I believe will make this combined conference very unique.
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