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Biological Assay Development & Validation
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May 12 - 14, 2010 · Sheraton Fisherman's Wharf · San Francisco, CA
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Event Overview
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Join us in May to find out why this is the longest running biological assay conference and most highly technical conference. This conference is a unique blend of mini-tutorial talks, hands-on workshops and case studies providing the perfect mixture to help you perform your job more efficiently.
"I found this conference extremely useful. Many of the topics covered in the talks were directly applicable to my work in analytical assay development." - Joni Castro, Senior Development Associate Process Development, OncoMed Pharmaceuticals
Keynote Presentation
Bioassays for Pharmaceutical Testing: Benefits and Limitations
Includes a not-to-be-missed film giving a cell's eye view of a potency assay
Thomas Waerner, Ph.D., Head of Cell & Molecular Biology, Quality & Compliance, Boehringer Ingelheim RCV GmbH & Co KG, Germany
2010 Conference Highlights Include:
- Selecting and maintaining critical rare reagents is difficult, our case study will help you before you get into trouble.
- Find out how to move faster during development by using quality by design - a case study and update of EU approaches.
- A case study showing how to use design of experiments (DOE) to streamline your assay development timelines.
- Avoid the common trap of poor modeling: Hear practical suggestions from Amgen and Precision Bioassay, Inc.
- Mini-tutorial on statistical approaches to comparing bioassay help you understand critical requirements before you submit your proposal to the regulators.
- See how switching assays is really done with two practical and successful case studies.
- Keep up with evolving new trends from the chair of the USP bioassay committee. Update will cover chapters to be released in May.
- Get ideas for your development plans in three case studies discussing novel approaches to developing ADCC and binding potency assays.
- The toughest assays to develop are the host-cell protein assay. Come to this session and hear how the pros get it done.
"This conference has provided a broad scope of prospective for me and has opened my eyes to a lot of 'what not to do'!" - Fouzia Farood, Research Tech/Flow Cytometrist, Malaria, Walter Reed Army Research Institute/NMRC
Plus, this year the pre-conference workshop will include tough topics other conferences can't or won't address, including:
- Outlier analyses for bioassays
- Determining limit of quantitation
- Assay monitoring using Statistical Process Control (SPC)
- Bland-Altman approaches to demonstrate assay comparability
"The best thing is the variety and the opportunity of contact with the different "sides" of this area (regulators, manufacturers) CRO" - Alicia Jiminez, Researcher, CBER/FDA, LRSP/DBPAP
Attendee Testimonials
"Each time I attend this conference, I broaden my understanding of the challenges and solutions in this industry." - L. McNeill
"The best and most directly applicable information for our industry presented by industry leaders and newcomers alike. A most valuable resource." - R. Lowe
"An interesting and entertaining interface between biologists and statisticians. I would have loved to have all this information six months ago, and I greatly appreciate having it now." - M. Woodrow
"The information presented was illuminating, entertaining and informative so that even a statistician with almost no biological background could understand it." - R. Eyben
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