1. BreakthroughTherapy DesignationChuck KemmererRegulatory Intelligence02March2014 2. Topics1) What is Breakthrough Therapy Designation?1) Legislative Implementation2) How…

1. Sophisticated Portfolio Management Techniques: supporting the backbone of the industry Dr. Stefan Busch VP Strategic Planning and Portfolio-Management AstraZeneca GmbH…

Slide 1 Slide 2 Market Assessments Michael Pratt Executive Director Business Development November 1, 2011 Slide 3 Boston University Slideshow Title Goes Here Setting …

Slide 1 The role of the REB Raphael Saginur, M.D. Ottawa Hospital Research Ethics Board Slide 2 Slide 3 REB roles protection of human subjects protection of investigator,…

Slide 1 Drug Pricing in Canada Victoria Brown, Anureet Sohi, Lisa Weger SPHA 511 Slide 2 4 th fastest growing market with 8% annual growth rate Canada ranks in 8 th place…

Benefit-Transfer: Practice and Prospects Workshop 22 November 2007 Applications of Benefit–Transfer in Health Kees van Gool Centre for Health Economics Research and Evaluation…

CLINICAL TRIALS â PHASE III What are phase III trials Confirmatory phase (Therapeutic confirmatory trial) Trials are done to obtain sufficient evidence about efficacy and…

Hisotry Adjusted Marginal StructuralModels Adaptive Randomized Trial Designs Michael Rosenblum Department of Biostatistics Johns Hopkins Bloomberg School of Public Health…

Hisotry Adjusted Marginal StructuralModels Adaptive Randomized Trial Designs Michael Rosenblum Department of Biostatistics Johns Hopkins Bloomberg School of Public Health…

…Making Medicines More Affordable… Robert A. Armitage, Senior Vice President and General Counsel May 7, 2010 Creating the Best Medicines for Patients… …But Not Limiting…