Interface Between Regulation and Statistics in Drug Development (Hardcover) (ISBN-13: 9780367490485)

Demissie Alemayehu, PhD, is Vice President and Head of the Statistical Research and Data Science Center at Pfizer Inc. He is a Fellow of the American Statistical Association, has published widely, and has served on the editorial boards of major journals, including the "Journal of the American Statistical Association" and the "Journal of Nonparametric Statistics." Additionally, he has been on the faculties of both Columbia University and Western Michigan University. He has co-authored a monograph entitled, "Patient-Reported Outcomes: Measurement, Implementation and Interpretation," and co-edited another, "Statistical Topics in Health Economics and Outcome Research" both published by Chapman & Hall/CRC Press.

Birol Emir, PhD, is Senior Director and Statistics Lead of Real-World Evidence (RWE) at Pfizer Inc. In addition, Dr. Emir has served as Adjunct Professor of Statistics and Lecturer at Columbia University in New York and as an External PhD Committee Member, Graduate School of Arts and Sciences, Rutgers, The State University of New Jersey. Recently, his primary focuses have been on big data, predictive modelling and genomic data analysis. He has numerous publications in refereed journals, and he has co-edited "Statistical Topics in Health Economics and Outcome Research" published by Chapman & Hall/CRC Press. He has taught many short courses and has given several invited presentations.

Michael Gaffney, PhD, is Vice President, Statistics at Pfizer, and received his Ph.D. from New York University School of Environmental Medicine with his dissertation in the area of multistage model of cancer induction. Dr. Gaffney has spent his 43-year career in pharmaceutical research concentrating in the areas of design and analysis of clinical trials and regulatory interaction for drug approval and product defense. He has interacted with FDA, EMA, MHRA and regulators in Canada and Japan on over 25 distinct regulatory approvals and product issues in many therapeutic areas. Dr. Gaffney has published 40 peer-reviewed articles and presented at numerous scientific meetings in diverse areas of modelling cancer induction, variance components, harmonic regression, factor analysis, propensity scores, meta-analysis, large safety trials and sample size re-estimation. Dr. Gaffney was recently a member of the Council for International Organizations of Medical Sciences (CIOMS) X committee and was a co-author of, CIOMS X: Evidence Synthesis and Meta-Analysis for Drug Safety.