How can we best reduce the risk of severe adverse reactions to marketed drugs? The program will focus on clinical risk assessment and bridging the gap between preclinical data and clinical studies and offer strategies to better assess, predict and mitigate safety risks. Preclinical safety and clinical safety participants and presenters will share challenges with their counterparts on the ‘other side’ in order to educate each other and better understand safety in a context that goes beyond one’s immediate purview.
The special, two-day conference entitled “Mitigating Safety Risks in Early Clinical Development” will address the pressing issues that drug safety experts are facing today. Safety issues can arise throughout the life-history of a drug, from preclinical screening through to the clinic and after launch. Thus, the conference is co-located with our annual “Post-Approval Drug Safety” meeting and will offer shared sessions and networking in order to facilitate inter-disciplinary sharing of ideas in an informal setting. Our hope is that everyone, no matter their role at their company or institute, can learn from those working earlier or later in drug development and that industry can better bridge the gap between preclinical, clinical and post-approval drug safety.
I hope you can join us on November 8-9, 2010 in Philadelphia, PA.