BioSafe

Started in 2003, BioSafe is the Biotechnology Innovation Organization’s preclinical safety committee within BIO’s health section, comprised of >300 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.

The mission of BioSafe is to play a key role in driving the innovation of biopharmaceuticals by identifying and addressing key regulatory and translational science issues related to preclinical safety and PKPD, expediting time to market and serving the needs of BIO.

There is a close connection with BIO’s Cell and Gene Therapy Non-Clinical Task Force which give regular updates and opportunities for collaboration at our meetings. 

To play a key role in driving the innovation of biopharmaceuticals by identifying and addressing key regulatory and translational science issues related to preclinical safety and PKPD, expediting time to market and serving the needs of BIO members and staff.

BioSafe’s signature event is the annual BioSafe General Membership Meeting (GMM). This meeting is typically a two half-day one full-day event that features presentations and networking sessions from industry and government institutions. All BioSafe members are welcome to join the BioSafe GMM planning group. BioSafe also hosts quarterly meetings for all BioSafe members to engage in dialogue with one another and listen to the presentations of other members. All BioSafe members are welcome to submit presentation ideas for each of our quarterly meetings as well as join our planning group.

There is potential for BioSafe members to start working groups to tackle hot topics. There is also potential for publishing papers related to BioSafe’s mission. The FDA/BioSafe/DruSafe meeting is an annual meeting held at FDA’s White Oak Campus. Presentation volunteers and LC members can join for this opportunity to participate in the regulatory landscape

The BioSafe Leadership Committee (LC) is the steering committee for BioSafe. All members can volunteer for candidacy for the LC, with the members being determined by a vote by the general membership.