An Evolving Standard for Success: Proving Product Value Through Comparative Effectiveness Data
Nayan Nanavati - Vice President and General Manager, Peri-Approval Services Americas Chuck Stevens - Vice President and General Manager, Reimbursement and Market Access
Inclusion of $1.1B in the Obama Stimulus Plan to support comparative effectiveness research of drugs, medical devices, surgical procedures and other treatments, is a clear indication of the US Government’s priority to obtain value in healthcare dollar spending. As it gains traction among policymakers, and as the Federal Government continues to increase its role as the largest direct payer for drugs, biologics, devices and diagnostics, we expect regulators to demand such data for new products demonstrating greater benefits over existing products. Our expert panel will review case studies and provide key insights as to the potential future requirements for comparative effectiveness, the opportunities and challenges they pose, and strategies to address. Webcast length: 60 minutes
Early Drug Development Strategies to Confirm Compound Viability and Increase Product Value for Promising CNS Candidates
Dr. Larry Ereshefsky - VP & Principal Consultant Dr. Stan Jhee - Sr. Director Scientific Affairs The webinar focuses on overcoming challenges in early drug development. How best practice application of the ‘CNS toolkit’ in early drug development can be used to confirm compound viability. Strategies that can increase the value of CNS compounds for divesture or improve investment potential. Webcast length: 70 minutes
Beyond Sleep Medicine: Sleep Parameters in Drug Development Polly Moore, Ph.D. - Director of Sleep Research, PAREXEL International Heidi Danker-Hopfe, Ph.D. - Head of the Laboratory for Clinical Psychophysiology (including sleep laboratory) of the Charité - University Medicine Berlin, Campus Benjamin Franklin Malek Bajbouj, M.D. - Director and Principal Consultant CNS, PAREXEL International The webinar focuses on classical and new directions in sleep physiology as well as cognitive and safety parameters in polysomnography after pharmacological interventions. New fields like indications of polysomnography beyond the central nervous system were discussed. Webcast length: 63 minutesTo view the webcast Click here
Biomarkers and Pharmacogenetics - Putting Initiative into the Critical Path Prof. Patrick Bouic, Chief Technical Officer, Synexa Life Sciences Dr. Justin Devine, Chief Medical Officer, Synexa Life Sciences Prof. Kenneth Swart, Senior Director, Bioanalytical Services, PAREXEL International The webcast addresses the roles and inter-relationships of Pharmacokinetics and Pharmacodynamics in clinical trial decision-making. Examining how biomarkers can help drive innovation. Webcast length: 60 minutes.To view the webcast Click here