Real-World Evidence in a Patient-Centric Digital Era (Chapman & Hall/CRC Biostatistics)

About the Author

Kelly H. Zou, Ph.D., PStat(R) is Head of Global Medical Analytics and Real-world Evidence, Viatris. She is an elected Fellow of the American Statistical Association and an Accredited Professional Statistician. Previously at Pfizer Inc, she was Vice President and Head of Medical Analytics & Insights; Senior Director of Real-world Evidence, Group Lead of Methods & Algorithms and Analytic Science Lead; Senior Director of Statistics. She was Associate Professor of Radiology at Harvard Medical School, as well as Director of Biostatistics at its affiliated teaching hospitals. She was Associate Director of Rates at Barclays Capital. Dr. Zou is the Vice Chair of the Methods and Data Council of AcademyHealth and Methodologies Working Group, Digital Medicine Society. She has published extensive on both clinical and methodological topics and over 160 peer-reviewed publications. She has served on the editorial board of "Significance," "Statistics in Medicine," "Academic Radiology" and "Radiology." She was the theme editor of "Mathematical and Statistical Methods for Diagnoses and Therapies" in "Philosophical Transactions of the Royal Society A." She has authored "Statistical Evaluation of Diagnostic Performance: Topics in ROC Analysis," "Patient-Reported Outcomes: Measurement, Implementation and Interpretation," and "Statistical Topics in Health Economics and Outcomes Research," published by Chapman and Hall/CRC, Taylor & Francis. She also authored a book chapter in "Leadership and Women in Statistics." Lobna Salem, MD, MBA is Head of Medical Affairs, Developed Markets, Japan, Asian and New Zealand at Viatris. Previously, she was Chief Medical Office, Developed Markets, Upjohn, a Division of Pfizer Inc. She has more than 25 years of experience in bio pharmaceutical industry working across different cultures with experience spanning global, region, and country roles. In addition, Dr. Salem has held different cross-functional roles in medical affairs, clinical development, regulatory interactions and commercial functions. She has had experience working in Asia, Emerging Markets, China, Europe and the US. Lobna has been recognized for driving innovation across Research and Development in Legacy Upjohn, a Division of Pfizer. She is a Clinical Pathologist/Hematologist by training; she received her Medical degree from Cairo University, Egypt, her MBA from Edinburgh business school UK and MSc from Hibernia College Ireland. Amrit Ray, MD, MBA is a globally-experienced industry leader, physician researcher, and biopharmaceuticals expert. Dr. Ray is Managing Partner at Principled Impact, LLC. His passion is advancing medical breakthroughs and championing healthcare access for patients. He has over 20 years of healthcare experience and has held three C-level roles of increasing responsibility at major companies, leading up to 3,500 professionals in 90 countries. Previously, Dr. Ray was Global President, Head of R&D and Medical, and Executive Leadership Team member at Pfizer Upjohn where he oversaw all aspects of research, Phases I-IV development, regulatory, safety, and medical affairs worldwide. He served as the company's most senior decision-maker and spokesperson on patient matters. Before joining Pfizer, he was the global Chief Medical Officer for pharmaceuticals at Johnson & Johnson. He earned Immunology and Medical degrees from Edinburgh Medical School, and an MBA from Dartmouth College's Tuck School of Business. Following antibody bench research at Sir Joseph Lister Labs, obesity clinical research at the Mayo Clinic, and clinical training at Edinburgh Royal Infirmary, he began his career serving as a hospital doctor delivering patient care in the UK's National Health Service. In industry, Dr. Ray has championed the development and launch of several new medicines including in Oncology, Immunology, Neuroscience, Cardio-Metabolism, and other areas. Dr. Ray has wide experience as an independent board director and private equity senior advisor. He serves as an Executive in Residence in bioethics at Columbia University, a Visiting Professor in the Faculty of Medical Sciences, Newcastle University, UK, and a board director at the EveryLife Foundation for rare diseases.