Cambridge Healthtech Institute’s BioPharma Strategy Series announces its inaugural Mitigating Safety Risks in Early Clinical Development executive forum to be held November 8-9, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA.
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 program was created as a result of direct requests by leaders in drug safety and risk management, who felt that too much of today’s safety organization is siloed,” said Micah Lieberman, Executive Director of Conferences. “Though most of the discussions are focused on early clinical development and safety, we have shared sessions and breakout discussion groups with our annual Post-Approval Drug Safety audience.”
Leading the way in developing the program agenda are the featured presenters, including James Milligan of AstraZeneca; Arie Regev of Eli Lilly & Company; Phil Sager of Gilead; Stephen Furlong of AstraZeneca; Sandeep Modi of Unilever and Paul Watkins of University of North Carolina, Chapel Hill.
The main conference begins in a shared session in the Post-Approval Drug Safety conference where delegates will hear a three part, co-presentation on “Integrating Drug Safety Knowledge Across a Compound’s Lifecycle and Across a Portfolio.” The themes discussed in the co-presentation include corporate risk management by Michael Forstner M.Sc., Ph.D., Integrated Safety Risk Manager, F. Hoffmann-La Roche, Basel, Switzerland; data mining by Colette F. Saccomanno, Ph.D., MSLIS, Integrated Safety Risk Manager, F. Hoffmann-La Roche; and comparative risk benefit assessment by James Cross, MS, Ph.D., Integrated Safety Risk Manager, Genentech, San Francisco, CA
The rest of the forum features sessions and breakout discussions on Improving Early Assessment, Better Linking Preclinical Data , Clinical Studies and Post-Approval Safety, and New Technologies and Methods. The forum concludes with an interactive panel, entitled “What Predictive Safety Technologies are Being Utilized Upstream and How They May Impact Clinical and Post Approval Safety,” to be hosted by Ernie Bush, Ph.D., Vice President, Collaborative Projects, Drug Safety Executive Council (DSEC).
Advance registration discounts for both drug safety forums are available until September 17, 2010. For complete event details, visit healthtech.com/PTX
To apply for a press pass, please email Tracey Fielding, tfielding[.]healthtech.com.
To inquire about partnering or sponsoring, please contact Arnold Wolfson, awolfson[.]healthtech.com
About Cambridge Healthtech Institute (CHI)
Cambridge Healthtech Institute (healthtech.com) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Barnett International, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.
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