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Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Considerations

Speakers

Chad  Gwaltney, PhD

Chad Gwaltney, PhD

President, Gwaltney Consulting, United States

Chad Gwaltney, Ph.D. is President and Principal Consultant at Gwaltney Consulting. Dr. Gwaltney develops innovative methods to measure patient-centered outcomes in clinical trials. His academic and industry research include the design of electronic platforms for the collection of information in real-time in the patient’s natural environment. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand medical product efficacy and safety. He has served on US NIH review committees and has co-authored ISPOR best practice guidelines on the development and use of patient-reported outcomes.

Ari  Gnanasakthy, MBA, MS, MSc

Ari Gnanasakthy, MBA, MS, MSc

Head, Patient Reported Outcomes, Novartis Pharmaceuticals Corporation, United States

Ari Gnanasakthy, MBA, MSc, is Head of Patient-Reported Outcomes at RTI HS. He has 30+years of experience in the pharmaceutical industry. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials.

Ethan  Basch, MD, MSc

Ethan Basch, MD, MSc

Director, Cancer Outcomes Research Program; Associate Professor, Medicine , University of North Carolina At Chapel Hill, United States

John H. Powers, MD, FACP

John H. Powers, MD, FACP

Professor of Clinical Medicine, George Washington University School of Medicine, United States

Dr. Powers is a physician/investigator and an internist and specialist in infectious diseases. Dr Powers has particular expertise in the design, conduct and analysis of clinical trials and has published numerous articles and book chapters in this area.

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