On-label reporting of health effects of biologics is a very contentious issue; industry competitors are not supposed to compare data with one another, but it is a rather open secret that this does go on regardless. During the session Gauging the Utility of Reporting Low-Titer Antibodies, we focus on the importance of setting firm, consistent, meaningful criteria for the reporting of low-titer borderline antibodies, in order to present the clearest possible picture of potential health impacts. Immunogenicity for Biotherapeutics will take place March 18-20, 2013 in Baltimore Maryland. For more information on this session and the rest of the agenda, download the brochure. If you'd like to join us, as a reader of this blog, register today and mention code XP1838BLOG to save 15% off the standard rate!
 |
| Speaker Swati Gupta |
Featured Speaker: Swati Gupta, Principal Scientist, Bioanalytical Sciences, ALLERGAN
About the session: Despite regulatory recommendations, it is a simple fact that competitors within the industry compare their own immunogenicity reports to those of other companies as provided in the pack-in material. This makes it all the more important to set firm, consistent and meaningful criteria for the reporting of low-titer borderline antibodies. Especially in the biosimilar era with its increased focus on the results of older programs, the presence or absence of necessary historical performance data can lead to drastic overreporting of every single positive result, regardless of titer level.
- • Prepare clinical and bioanalytical colleagues for disputes over what goes on-label
- • Determine in advance your preferred action if clinical sequelae are not present
- • Adapt your minimum dilution levels to those most likely to yield significant results
|
Share this article with your social network, just click below to share now!
|
|
|
No comments :
Post a Comment