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Hyatt Regency Bethesda

Feb 09, 2014 1:00 PM - Feb 09, 2014 5:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Tutorial: Making Better Benefit-Risk Decisions through the Development Life Cycle

Speakers

Richard  Hermann, DrMed, MD, MPH

Richard Hermann, DrMed, MD, MPH

Safety Science Physician, CMO Organization, AstraZeneca, United States

Ian  Hirsch, PhD

Ian Hirsch, PhD

Respiratory/Infection Biologics and Vaccine Products Biometrics Strategy Lead, Astrazeneca, United Kingdom

Ian received his PhD in modeling spatial epidemic populations at the University of Strathclyde in the UK in 1998. He then worked as a statistician at Pfizer and also worked for about 2 years as a Statistical Assessor at the UK regulators (the MHRA). Ian joined AstraZeneca in 2009. He is currently the Respiratory/Infection Biologics and Vaccine Products Strategy Lead, Late-stage Development within the Respiratory & Immunology Therapeutic Area based in the Cambridge in the UK where he is responsible for ensuring statistical, programming and information science input and support is given to late stage development programs including for the COVID area.

Bennett  Levitan, MD, PhD

Bennett Levitan, MD, PhD

Senior Director, Benefit-Risk Assessment, Global Epidemiology, Janssen Research & Development LLC, United States

Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the PhRMA BRAT Framework, the MDIC Patient-Centered B-R Framework, the IMI PREFER public-private partnership and ISPOR's Quantitative B-R Task Force. He serves on committees that inform B-R policy including MDIC's Science of Patient Input Project, the Brighton Collaboration BRAVATO Team and PhRMA's Patient-Focused Drug Development Work Group. He received a B.Sc. (Electrical Eng) from Columbia Univ and an M.D.-Ph.D. (Bioengineering) from the Univ of PA.

Zhong  Yuan, MD, PhD

Zhong Yuan, MD, PhD

Senior Director, Epidemiology, Janssen Research & Development, United States

Dr. Yuan is a physician by training and a trained epidemiologist. He has about 10 years of experience in Academic research and more than 20 years of experience in Pharmaceutical Research and Development, with nearly 70 publications in peer reviewed journals. As a Senior Director, he currently works in the Department of Epidemiology, Janssen Research & Development, LLC., providing support to the product development and post-marketing studies in the area of cardiovascular and metabolism. Dr. Yuan has also provided extensive support in the benefit-risk (B-R) analyses using a quantitative approach for the rivaroxaban development program and previously served as a working group member in PhRMA and IMI PREFER for B-R assessment.

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