"Members of BIO's preclinical development expert committee, BioSafe, are participating in the current ICH expert working groups that are developing new guidances on preclinical safety requirements. The current guidances under development include 1) a new guidance (ICH S9) for preclinical requirements governing oncology drug development for small molecules and biologics; and 2) the revision of an existing guidance (ICH M3) that addresses the timing of preclinical studies in relation to clinical studies. In addition, scientific issues related to
carcinogenicity assessment of biopharmaceuticals are being reviewed. BioSafe expert working group members will present new developments in each of these areas that are under discussion by the EWG groups. A panel of current BioSafe
committee members will discuss these guidances and new developments and their potential impact in preclinical safety evaluation programs."

Objective1: Provide latest information regarding new ICH initiatives that will affect preclinical safety evaluation programs.

Objective2: Provide expert commentary and perspective on global preclinical development issues.

Objective3: Provide expert discussion and perspective on future ICH preclinical safety evaluation topics.