BIO’s Preclinical Safety Committee (BioSafe) will hold its annual general membership meeting at Boehringer Ingelheim in Ridgefield, CT on May 6-8, 2013. The meeting’s goal is to provide industry experience and perspectives gained to help ensure common understanding and continued application of scientific principles with respect to key issues in preclinical safety evaluation of biopharmaceuticals.
For more information please contact Victoria Dohnal
The mission of BioSafe is to serve as a resource for BIO members and BIO staff by identifying and responding to key scientific and regulatory issues related to the preclinical safety evaluation of biopharmaceutical products.
The General Membership consists of over 30 companies who work on white papers, responses to regulatory guidance, and expert topic meetings. These companies also make up various ad hoc subcommittees including the Specialty Biologics Expert Working Group, the PK/PD Working Group, and the Comparability Task Force.
About the Meeting:
• When: May 6-8, 2013
• Where: Boehringer Ingelheim, Ridgefield, CT
• Who: BIO members engaged in the conduct and reporting of preclinical safety evaluations for biopharmaceuticals.
Registration for this meeting is now CLOSED. Thank you to all who registered, I look forward to a great meeting!
• ePPND Survey Results
• Concordance Survey Results
• When does pharmacology become adverse? Determining safe staring doses/NOAELs
• Just how immunosuppressive is my immunodulatory mAb and how can I better understand the relative risk of infection and cancer?
• PEGylated biotherapeutics-is there a safety issue?
• Impact of pre-existing antibodies against “novel” biological scaffolds on PK, PD and safety of biologics in animals and man
• Impact of activation of the complement system by biotherapeutic modalities
• New directions in advanced medicines
BioSafe is a committee within BIO's Health Section, comprised of BIO members working to identify key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products and recommending appropriate science-based responses.