BioSafe Meetings

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

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: May 6-8, 2013
• Where: Boehringer Ingelheim, Ridgefield, CT 
• Who: BIO members engaged in the conduct and reporting of preclinical safety evaluations for biopharmaceuticals.

Hotel Room Block:

We have also reserved a limited number of rooms in a room block at the Ethan Allen Hotel (www.ethanallenhotel.com) located at 21 Lake Avenue Extension Danbury, CT. The room block will close on Sunday, April 21^st. There will be a shuttle between the Ethan Allen and the meeting site. In addition, the meeting reception will be held at the Ethan Allen on Monday evening.

To book a room in this hotel block:

• Please call 203-744-1776 or 800-742-1776
• The group name for this block is “BIO Group"
• We have reserved rooms for the nights of Sunday May 5^th, Monday May 6^th, and Tuesday May 7^th.

Registration:
The 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. 

To Register:

1. click on the registration link http://login.bio.org/?redirectKey=product&extra=1665
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.

Sessions include:

•  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