Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided.
- Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries
- Case study detailing the discovery of the anti-cancer drug, lorlatinib
- Venture capitalist commentary on trends and best practices in drug discovery and development
- Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding
- Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research
- Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business
Table of Contents
Introduction to the First Edition (1992)
Introduction to the Second Edition (2006)
Chapter 1: Introduction to Drug Discovery and Development
James J. O’Donnell III, John C. Somberg, and James T. O’Donnell
SECTION I Overview
Chapter 2: Current Opinions on the Trajectory of the Pharmaceutical Development
John C. Somberg
Chapter 3: Innovation in Drug Development: Perspectives of a Venture Capitalist
SECTION II Drug Discovery
Chapter 4: High-Throughput Screening
Olivia Perez, J. Pena, Virneliz Fernandez-Vega, Louis Scampavia, and Timothy Spicer
Chapter 5: DNA-Encoded Compound Libraries: An Emerging Paradigm in Drug Hit Discovery
Raphael M. Franzini
Chapter 6: Bio-Targeted Nanomaterials for Theranostic Applications
Sabyasachi Maiti and Kalyan Kumar Sen
Chapter 7: The Development of Adoptive T-Cell Immunotherapies for Cancer: Challenges and Prospects
David J. Dow, Steven J. Howe, Mala K. Talekar, and Laura A. Johnson
Chapter 8: CRISPR in Drug Discovery
Chih-Shia Lee and Ji Luo
Chapter 9: Probiotics in the World: “Bugs-as-Drugs”
Thomas Kuntz, Madeline Kim, Elle Simone Hill, Mariana C. Salas Garcia, and Jack A. Gilbert
Chapter 10: Discovery and Early Development of the Next-Generation ALK Inhibitor, Lorlatinib (18): Agent for Non・Small-Cell Lung Cancer
Paul F. Richardson
SECTION III Drug Development
Chapter 11: Integrated Drug Product Development: From Lead Candidate Selection to Life-Cycle Management
Madhu Pudipeddi, Abu T.M. Serajuddin, Ankita V. Shah, and Daniel Mufson
Chapter 12: New Trends in Pharmacological and Pharmaceutical Profiling
Lyn Rosenbrier Ribeiro, Duncan Armstrong, Thierry Jean, and Jean-Pierre Valentin
Chapter 13: Pharmacokinetics・Pharmacodynamics in New Drug Development
Sarfaraz K. Niazi
Chapter 14: The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms
Jibin Li and Ismael J. Hidalgo
Chapter 15: Preclinical Toxicology
Chapter 16: Safety Pharmacology: Past, Present, and Future
Jean-Pierre Valentin, Annie Delaunois, Marie-Luce Rosseels, Vitalina Gryshkova, and Tim G. Hammond
Chapter 17: Ethical Concerns in Clinical Research
Jonathan C. Young and Lori Nesbitt
Chapter 18: Clinical Trials Methodology
Chapter 19: The Academic Research Enterprise
Crista Brawley, Mary Jane Welch, Jeff Oswald, Erin Kampschmidt, Jennifer Garcia, Allecia Harley, Shrijay Vijayan, John McClatchy, Stephanie Guzik, and Stephanie Tedford
Chapter 20: Clinical Testing Challenges in HIV/AIDS Research
Chapter 21: The Evolving Role of the Pharmacist in Clinical, Academic, and Industry Sectors
Gourang Patel and Stephanie Tedford
Chapter 22: Intellectual Property in the Drug Discovery Process
Martha M. Rumore and William Schmidt
Chapter 23: Drug Repurposing: Academic Clinician Research Endeavors
Kathleen Heneghan and Stephanie E. Tedford
SECTION IV Regulations
Chapter 24: The Role of the Regulatory Affairs Professional in Guiding New Drug Research, Development, and Approval
S. Albert Edwards
Chapter 25: Orphan Drug Development and Regulations
Chapter 26: Development of Drug Products for Older Adults: Challenges, Solutions, and Regulatory Considerations
S.W. Johnny Lau, Darrell R. Abernethy, and Chandrahas Sahajwalla
Chapter 27: Clinical Pharmacology and Regulatory Concerns for Developing Drug Products for Pediatric Patients
Janelle M. Burnham and Gilbert J. Burckart
Chapter 28: Pharmacy Compounding Regulations
Loyd V. Allen, Jr. and Willis C. Triplett
James John O’Donnell III, MS, PhD is a chemist and research pharmacologist in Chicago. He is Assistant Professor / Pharmacology, Colleges of Medicine and Pharmacology at the Rosalind Franklin University, North Chicago, IL, as well as the Co-Editor of O’Donnell’s Drug Injury, Fourth Edition (2016).
He served as an NIH T32 Training Grant Postdoctoral Fellow in Respiratory Biology at the University of Chicago. He also held a postdoctoral appointment at the Indiana University School of Medicine at South Bend. His medical research principally focused on inflammatory diseases. Additionally, he conducted organometallic chemistry research at the University of Wisconsin-Madison and at Northwestern University in Evanston, IL.
Dr. O’Donnell is a member of the American Society for Pharmacology and Experimental Therapeutics, American College of Clinical Pharmacology, and the American Academy of Clinical Toxicology. He has particular interests in the microbiome research, computational research in pharmacology, pharmacokinetics, and analytical toxicology. He received his Bachelor’s Degree in Electrical Engineering and Computer Sciences from the Massachusetts Institute of Technology (MIT), a Masters Degree in Chemistry from the University of Wisconsin-Madison, and a Doctor of Philosophy in Pharmacology from Rush University Medical Center-Chicago. He recently joined the Pharmaconsultant Inc. firm, and consults in drug injury, analytical toxicology, and other related matters.
John Somberg MD is Professor of Medicine and Pharmacology and Director of Clinical Pharmacology at the Rush University Medical Center in Chicago. Dr. Somberg is the former editor of the Journal of Clinical Pharmacology and the Founding Editor of the Journal of Therapeutics. A consultant and reviewer for the FDA, Dr. Somberg also holds patents on new uses for drugs, and operates Academic Pharmaceuticals, a company specializing in the development of new dosage forms and new indications for drugs.
Vincent Idemyor PharmD is a Clinical Professor of Pharmacology with a special interest in Infectious Diseases and HIV Therapy. He is also a Visiting Professor at the Port Hartcourt University in Nigeria, and has extensive international public Health Experiences. Dr. Idemyor received his Doctor of Pharmacy degree from the University of Minnesota.
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. is a pharmacologist, pharmacist and nutritionist in Barrington Hills, Illinois.
His career has included pharmacy practice in a variety of settings, as well as teaching, research, publications, and consultations in pharmacology, pharmacy, and nutrition to industry, government, health care, publishing and legal fields. He is Associate Professor of Pharmacology at the Rush University Medical Center in Chicago, where he served as the Course Director for the Medical Pharmacology program. He also held Faculty appointments at the University of Illinois Colleges of Medicine and Pharmacy.
Dr. O’Donnell is a Diplomate of the American Board of Clinical Pharmacology, a fellow of the American College of Clinical Pharmacology, a fellow of the American College of Nutrition, Founding Editor-in-Chief of the Journal of Pharmacy Practice, and Editor of Drug Injury: Liability, Analysis, and Prevention, First Edition (2001), Second Edition (2005), and Third Edition (2012); and a Co-Editor Pharmacy Law: Litigating Pharmaceutical Cases (1995), and The Process of New Drug Discovery and Development, Second Edition (CRC Press 2005).
He consults and testifies in matters involving pharmaceuticals, medication errors, nutritionals, dietary supplements, alcohol and recreational drug toxicity, and drug injuries throughout the United States, for defense and plaintiffs’ counsel. Dr. O’Donnell received a Bachelor of Science in Pharmacy from the University of Illinois, a Doctor of Pharmacy from the University of Michigan, and a Master of Science in Clinical Nutrition from Rush University.