BioSafe Meetings

BIO’s Preclinical Safety Committee (BioSafe) will hold its BioSafe General Membership Meeting in Thousand Oaks, CA on April 28-30, 2014 at Amgen. 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.  A draft agenda including meeting start and end times can be found here.
 
For more information please contact Victoria Dohnal.
 
Mission:
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: April 28-30, 2014
  • Where: Amgen; Thousand Oaks, CA
  • Who: BIO members engaged in the conduct and reporting of preclinical safety evaluations for biopharmaceuticals.
 
Registration Information: This meeting is open to BIO member company staff engaged in the conduct and reporting of preclinical safety evaluation for biopharmaceuticals. Registration is not limited to BioSafe members, but your company must be a member of BIO. Registration is $150 to cover the cost of the meeting. Please register by Friday, April 18th, 2014 to ensure your attendance at this meeting.
 
To Register:
  1. click on the registration link http://login.bio.org/?redirectKey=product&extra=1822
  2. enter your email address, and BIO members only password
  3. click ‘continue to registration’
  4. enter payment information
  5. click ‘process my order’
  • You will need to enter your email address and password into BIO’s registration management system 'Personify'. If you cannot remember your password, you can use the 'Forgot Password' button. A link will be emailed so you may change your password.
  • If you know you do not have a BIO registration account, you will select 'Forgot Password' and then you will select 'Create Account'. You will need to provide your individual information and you will need to link yourself to a company. You may need to enter the same data twice, and we do apologize. After you have provided the individual and company data, an email will be sent so that you may complete your registration. YOU ARE NOT REGISTERED without following the link in your email and providing credit card payment at the conclusion of the registration process.
Hotel Room Block:
The hotel room block has closed. There may still be rooms available at the SHeraton Agoura Hills (http://www.starwoodhotels.com/sheraton/property/overview/index.html?propertyID=3674) located at 30100 Agoura Road Agoura Hills, CA. However, the BioSafe room rate is no longer available. There will be shuttle service between the Sheraton and the meeting site at Amgen.
 
 
Topics Include:
  • Biodistribution of mAb and mAb like products (including ADCs)
  • ADCs
  • Toxicity related to immunogenicity
  • New/Non-mAb Biologic Modalities
  • Late Stage drug development case studies
  • Combination biologics
  • Animal use/3Rs
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.