Honghui Zhou, PhD, FCP, FAAPS is currently Senior Director and Janssen Fellow, at Janssen Research & Development and US Head of Pharmacometrics in Clinical Pharmacology and Pharmacometrics. Before that, Dr. Zhou took different roles including Immunology Therapeutic Area Head in Global Clinical Pharmacology, US Head of Pharmacometrics in Model‐Based Drug Development, and Head of Biologics Pharmacokinetics and Pharmacodynamcis at the same company. Prior to joining Janssen, he was a Director of Clinical Pharmacology at Wyeth Research. He also worked for Novartis Pharmaceuticals Corp. and Johnson & Johnson Pharmaceutical Research & Development in the area of clinical pharmacology in both small molecular drugs and therapeutic proteins.

Dr. Zhou has authored and coauthored more than 200 original peer‐reviewed scientific papers, book chapters, and conference abstracts in PK/PD, drug–drug interactions, and therapeutic biologics drug development. In 2013, he coedited a book entitled, Drug–Drug Interactions for Therapeutic Biologics (Wiley), and in 2015, he coedited a book entitled ADME and Translational Pharmacokinetics/Pharmacodynamics of Therapeutic Proteins (Wiley). He has been an invited speaker in many national and international conferences. Dr. Zhou is board certified by American Board of Clinical Pharmacology (ABCP) and was elected Fellow of Clinical Pharmacology (FCP) of American College of Clinical Pharmacology (ACCP) in 1999 and Fellow of American Association of Pharmaceutical Scientists (AAPS) in 2013. He served as Section Editor for Biologics for the Journal of Clinical Pharmacology (2006–2013) and currently serves in its Editorial Board. He also serves as an Assistant Editor for mAbs. Dr. Zhou served in Board of Regents of ACCP from 2009–2013 and is currently serving another term from 2016–2020. He is a graduate of the China Pharmaceutical University, Bachelor degree in Pharmacology, and the University of Iowa, PhD in Pharmaceutics.

Diane R. Mould, PhD, FCP, FAAPS has spent 29 years as a pharmacokineticist in industry where she specialized in population pharmacokinetic/pharmacodynamic modeling and was an associate Research Professor at Georgetown University. She has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti‐cancer and anti‐viral agents, antipsychotic, cardiovascular, and sedative/hypnotic agents. Dr. Mould is involved in clinical trial simulation and optimal study design in drug development. She was a member of the Scientific Advisory Group for PharSight, where she assisted in development of clinical trial simulation software.

Currently, Dr. Mould is President of Projections Research Inc., a consulting company offering pharmacokinetic and pharmacometric services. She is also the founder of Baysient LLC, a company that develops systems to individualize doses of drugs that are difficult to manage. She has published 88 peer‐reviewed articles, 18 chapters, made 104 national and international presentations, and presented 6 podium sessions on advanced modeling and simulation approaches. Dr. Mould has authored 105 posters at both national and international meetings. She is an adjunct professor at the University of Rhode Island, OSU, and the University of Florida, and teaches an annual class on disease progression modeling at the National Institutes of Health. Dr Mould taught nine courses (OSU, URI, and SUNY Buffalo) on specialized aspects of population pharmacokinetic and dynamic modeling. She is a member of the editorial board for Journal of Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics, and Clinical Pharmacology and Therapeutics Pharmacometrics and Systems Pharmacology. Dr. Mould is a Fellow of the ACCP and of the American Association of Pharmaceutical Sciences (AAPS).