Behnam Davani, PhD, has more than 25 years of experience in analytical chemistry, compendial science, QC/QA, and project management. He is currently Principal Scientific Liaison in the General Chapter Group, Science Division of the United States Pharmacopeia (USP). In this role, he coordinates the identification and scientific development of compendial (USP) courses for stakeholders worldwide. He is also active faculty for several compendial courses including method validation/verification/transfer, impurities in drug substances and products, compendial HPLC, residual solvents, stability studies for drug substances and products, spectroscopy, and others. He has taught these courses domestically and internationally, including in Canada, Europe, China, India, Russia, Korea, Latin America, Middle East, and North Africa. Prior to this position, he was Director of the Chemical Medicines Department. He provided scientific leadership and training to a team of international (India, China, and Brazil) and US-based scientific liaisons (PhD levels) responsible for the development and modernization of USP monographs and related general chapters for small-molecule drug substances and products.

Prior to this position, he was Senior Scientific Liaison in the Chemical Medicines Department (2003–2013). In this capacity, he worked with the USP Expert Committee, global pharmaceutical industry, and FDA for the development and revision of public standards for small-molecular-weight drug substances and drug products for human use. He was the Scientific Program Manager for the USP Industry Outreach Program (1999–2002). In this capacity, he managed the outreach program to enhance collaboration and communication with the major pharmaceutical companies and contract research organizations.

Prior to joining USP in 1999, he worked in various technical management positions in the industry for 12 years. He was Project Manager at Sigma-Aldrich for analytical method validation, stability studies, and method transfer in GMP Group/Pharmaceutical Division (1994–1999). He also managed the chromatography section in the Analytical Services Department, Research Division (1990–1994). Prior to that, he had management and research positions at HK Environmental Services (1988–1990) and Midwest Research Institute (1987–1988). He also held the postdoctoral research fellow position for 1 year at the US Department of Energy (1986–1987).

Dr Davani has authored numerous technical publications and reports in the areas of compendial science, pharmaceutical analysis, and trace organic analysis with emphasis on chromatography and mass spectrometry techniques.

He holds a PhD in Analytical Chemistry from New Mexico State University and MS degrees in Physical and Analytical Chemistry from Cal Poly University, Pomona, and University of Iowa, Iowa City, respectively. He also has an MBA degree from Webster University in St. Louis, Missouri. He is a member of the American Chemical Society and the American Association of Pharmaceutical Scientists.

Dr Motamed-Khorasani is a medical and scientific affairs expert and a senior scientist with a strong background in biomedical science and clinical trial/research. She obtained her PhD and MS in molecular biology from University of Toronto and British Columbia, Canada, respectively, and did her Postdoctoral Fellowship at Microbix Biosystems Inc., Mississauga, Canada. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, medical and regulatory writing, and intellectual property. Dr Motamed-Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist, and senior medical analyst at Merck, Johnson & Johnson, United States Pharmacopeia (USP) Convention, Amgen, Baxter International, Covidien (eV3), Radiant Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Samuel Lunenfeld Research Institute at Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.

She has more than 20 years of experience and many national and international certificates in GLP, GMP, ICH-GCP, and FDA regulatory compliance for clinical trials and is a member of professional associations that include the Endocrine Society, American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), and Intellectual Property Institute of Canada (IPIC). Dr Motamed-Khorasani's research has focused on high-throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein–protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts, and articles in highly regarded scientific journals and high-profile conferences and scientific meetings.

Roger Dabbah, PhD, MBA, is the Principal Consultant at Tri-Intersect Solutions, which provides consulting, training in R&D and QA in the pharmaceutical, biotechnology, and medical device industries with specialization in microbiology testing, sterilization systems, and sterility assurance and management of laboratories. He also serves as an Adjunct Associate Professor at the University of Maryland University College, teaching courses in technology management including project management and risk management in projects, and at Johns Hopkins University, Whiting School of Engineering.

Prior to his current positions, he served as Director of the Complex Actives Division of the Drug Standards Department at the US Pharmacopeia. Before joining the USP, he was a Corporate Director of the Division of Microbiology, Sterilization, and Immunology for Baxter Healthcare, Manager of R&D Administration for the Nutritional Division of Abbott Laboratories, and Manager of the Biological and Information Sciences in technical services.

Dr Dabbah has extensively published papers and articles on microbiology, biotech, and management and collaborated in a number of technical books by contributing a number of chapters. He is also the author of two books: one on project management and the other on R&D management in the pharmaceutical industry. He is also on the Editorial Board of Pharmaceutical Technology and BioProcess International and on the Board of Directors of the PDA Foundation for Pharmaceutical Sciences.

Ernest Parente, PhD, is currently a Principal Scientist in the Chemistry, Manufacturing, and Control Regulatory Sciences group at Cardinal Health in Overland Park, Kansas. Formerly, he was a Sr Principal Analytical Chemist at Mallinckrodt Pharmaceuticals in St. Louis and the Head of Analytical Science and the Director of Quality Control at Sanofi-Aventis in Kansas City. In addition to his experience in Quality, Dr Parente has more than 18 years of experience in research and development and was the analytical chemistry team leader for the development of several currently marketed products. Before joining Sanofi-Aventis in 1989, he held positions in analytical and pharmaceutical R&D at Wyeth Laboratories, Warner-Lambert, and Hoffmann-La Roche. He has served at the USP for over 17 years and is currently a member of the USP Council of Experts. Dr Parente holds a PhD in analytical chemistry from the University of Delaware. He is an Adjunct Assistant Professor in the Graduate School of Pharmacy at the University of Missouri-Kansas City and is an active member of the ACS, Sigma Xi, AAAS, and AAPS. He is the author of scientific papers on chemical separations and protein analysis and has presented numerous US and International lectures on topics related to pharmaceutical analysis and the pharmaceutical industry.

Oscar Liu, PhD, is currently Director at Insys Therapeutics, Inc., leading pharmaceutical research and development including formulation. Prior to that, he has had several technical management responsibilities as Director and Senior Principal Scientist at Merck, Schering-Plough, Pfizer, and Par Pharmaceutical. In this role, he led Analytical Formulation/Product, Respiratory Product Development projects for more than 15 years. Dr Liu holds PhD degree in chemistry from Duke University. He has been board member of EAS since 2005 and was EAS president in 2014.

Dr Shaligram Rane has over 23 years in quality assurance/GMP/quality control and 2 years in academics with focus on streamlining and managing operations with proactive planning, changing existing or old concepts, and introducing new concepts for top-notch companies with consistent contribution to increased performance.

He completed his PhD in applied chemistry, MSc, and MEd. He has expertise in the quality and GMP department at various renowned organizations. Currently, he is heading the Quality (QC and QA) Department of Lupin Pharmaceuticals Ltd. (Biotech Division), Pune, India. Prior to Lupin, he associated with organizations such as Intas Pharma, Dishman Pharma, Cadila Pharma, Glenmark Pharma, Sun Pharma, Aarti Drugs and with Govt. Polytechnic College. His major areas of expertise are quality system, GMP activities, SAP-ERP system, designing of quality system according to regulatory guidelines. He has successfully handled more than 200 different types of inspection, for example, regulatory, customer, business partners, organization, and conducted more than 100 inspections at various pharma industries/laboratories. He has delivered talk on GMP topics at various workshops and conferences.

Dr Rustom Mody, Sr Vice President and Head of R&D (Biotechnology Division, Lupin Ltd.).

He has 19 years of experience in the Indian biopharmaceutical industry. He was the key person behind the development and commercialization of six biosimilars in the Indian market and two biosimilars in the US and EU markets. Dr Mody is currently developing four biosimilar products targeted for regulated markets such as the United States, Japan, Europe, and Australia. He is pioneer in the development and commercial-scale manufacturing of recombinant Hepatitis B vaccine.

Dr Mody has numerous patents filed, published, and approved and has 34 publications in peer-reviewed international journals. He was Ex-Chair of the Council of Experts for Biotherapeutics for United States Pharmacopoeia (Medicines Compendium) and Ex-Advisor to Indian Pharmacopoeia.

I would like to thank Professor Gary Eiceman, my PhD advisor at New Mexico State University, for the technical review of Chapters 3–5 and 7. His support and mentorship for many years during my career have been instrumental in my professional success.

I want to acknowledge the review of Chapter 3 and helpful suggestions by Dr Oscar Liu, who also contributed to a performance test section in the same chapter. I express my appreciation to my colleagues, Dr Horacio Pappa and Dr Andrzej Wilk, who supported this project as well as for many useful discussions we have had on various compendial topics during the last several years. I also want to express my gratitude to Dr V. Srini Srinivasan, former USP Chief Science Officer, for his support and encouragement as well as recommending contributors for the analytical instrument qualification chapter.

I am indebted to my late father, Hesam Davani, who planted the first seeds of my interest in learning, love of books, and critical thinking. I am grateful to my wife Ella Davani and my daughter Kimya Davani (Gheba) for their support and patience while making this long journey. This work could not have been completed without their constant encouragement.