BioSafe Meetings

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BIO’s Preclinical Safety Committee (BioSafe) will hold its annual general membership meeting at Pfizer in La Jolla, CA,on April 16 – 18, 2012. 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: April 16-18, 2012
  • Where: Pfizer Facility in La Jolla, CA (10777 Science Center Drive, San Diego CA 92121)
  • Who: BIO members engaged in the conduct and reporting of preclinical safety evaluations for biopharmaceuticals.

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. Registration will close on Friday, April 6th.

 

To Register:

  1.  click on the registration link http://login.bio.org/?redirectKey=product&extra=1493
  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.

 

If you have trouble registering, please contact me at vdohnal@bio.org.

We have secured a limited number of rooms in a room block at the Estancia Hotel and Spa (http://www.estancialajolla.com/) located at 9700 N. Torrey Pines Rd, La Jolla, CA 92037. Please book early to ensure you obtain a room before they run out!

To book a room:

  • Please call 1-877-437-8262 or 858-550-1000
  • The group name for this block is “Biotechnology Industry Organization” and the group number is “1TM8IK”.
  • Please note as the meeting is quickly approaching, reservations are due to the hotel by Monday, March 19th. Any reservations requested after this date will be based upon hotel availability, so please be sure to reserve your room prior to March 19th to ensure you receive one of the reserved rooms at our guaranteed rate of $189 per night.
  • We have reserved rooms for the nights of Sunday April 15th, Monday April 16th, and Tuesday April 17th.
     

Agenda items include:

  • Cancer Risk Assessment
  • Ocular and Non-parenteral Routes of Administration
  • Biologics/Advanced Medicines
  • Defining Maturity in Non-human Primates for Fertility Assessment
  • Immunogenicity Assessment for Biologic Development
  • Cytokine Release Safety Assessment
  • PK/PD

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.

Download the Draft Agenda