Drug Discovery and Development, Third Edition

The Process of New 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. Features: 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:
1 Current Opinions on Pharmaceutical Development John Somberg 2 Innovation in Drug Discovery: A Venture Capitalist Perspective on Trends and Best Practices Krishna Yeshwant 3 High-Throughput Screening Timothy Spicer, Louis Scampavia 4 DNA-Encoded Libraries Raphael Franzini 5 Biotargeted Nanomaterials for Theranostic Applications Sabyasachi Maiti, Kalyan Kumar Sen 6 T-Cell Cancer Immunotherapies David Dow 7 Role of CRISPR/Cas9 in Drug Discovery Ji Luo 8 Microbiome--Frontier of New Drug Discovery Jack Gilbert and Tom Kuntz, University of Chicago 9 Discovery and Synthesis of the Macrocyclic EML4-ALK Inhibitor PF-06463922 Paul Richardson, Pfizer 10 Integrated DOSAGE FORM Development: From Lead Candidate Selection to Life-Cycle Management Abu T.M. Serajuddin, Madhu Pudipeddi, Ankita Shah, and Daniel Mufson 11 Pharmacological and Pharmaceutical Profiling: New Trends Jean-Pierre Valentin, Duncan Armstrong, Lyn Rosenbrier Ribeiro, Thierry Jean 12 Pharmacokinetics – pharmacodynamics in new drug development Sarfaraz Niazi 13 The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms Jibin Li and Ismael J. Hidalgo 14 Parran Pre-Clinical Toxicology Damani Parran 15 Valentin Safety Pharmacology Jean-Pierre Valentin, Tim G. Hammond, Marie-Luce Rosseels, Annie Delaunois 16. Young Clinical Research Industry Jonathan Young 17. Somberg Clinical Trial Methodology John Somberg 18. Brawley University (Academic) Research Enterprise Crista Brawley, Mary Jane Welch, Stephanie Tedford 19. Allen Pharmaceutics and Compounding Issues in New Drug Development and Marketing Loyd Allen, Willis C. Triplett, 20. Idemyor Clinical Testing Challenges in HIV/AIDS Vincent Idemyor 21. Patel Pharmacists' Role in Clinical Research Gourang Patel Stephanie Tedford 22. Rumore Patents in the Pharmaceutical and Biotechnology Industries Martha Rumore PharmD JD, William Schmidt 23. Edwards Important Regulations in Drug Development S. Albert Edwards 24. Lynch Orphan Drug Development Angela Malin Lynch 25. Lau Regulatory Concerns for Developing Drug Products for Geriatric Patients S.W. Johnny Lau, Chandrahas Sahajwalla, Darrell R. Abernethy 26. Burckart Clinical Pharmacology and Regulatory Concerns for Developing Drug Products for Pediatric Patients Gilbert Burckart, Janelle Burnham 27. Heneghan Repurposing Old Drugs: NDA development for topical Loperamide Kathleen Heneghan

About the Author :
James 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. 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 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.