
Managing the Drug Discovery Process
How to Make It More Efficient and Cost-Effective
Description
Key Features
- Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes
- Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work
- Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable
Readership
Researchers and postgraduate students in academia and the pharmaceutical industry
Table of Contents
- Foreword
- Preface
- List of abbreviations
- Section A: Introduction and Overview
- 1: Backgrounder: Medicinal chemistry: Research, discovery, art, science
- Abstract
- 1.1 The landscape of biotechnology and pharmaceutical research and development
- 1.2 Understanding the pharmaceutical industry and its challenging environment
- 1.3 Organizing the chaos of biotechnology and pharmaceutical R&D
- 1.4 To in-house or outsource biotechnology and pharmaceutical R&D?
- 1.5 Innovation and intellectual capital in drug discovery and the business of science and technology
- 1.6 Drug targets
- 1.7 Afterword
- 1: Backgrounder: Medicinal chemistry: Research, discovery, art, science
- Section B: Preprofessional Education
- 2: Introduction: Preprofessional education
- Abstract
- 2.1 It truly takes a village
- 2.2 Discovery and Development team structure
- 2.3 Opportunities for staff who have completed 2-year certificate programs
- 2.4 Opportunities for staff with 4-year undergraduate degrees
- 2.5 Experience—Scientific research: The external stamp of approval
- 2.6 Experience—Soft skills
- 2.7 Choosing the path forward
- 2.8 Afterword
- 3: Two-year certification and degree programs
- Abstract
- 3.1 Overview—Two-year certification/degree programs
- 3.2 Laboratory technicians
- 3.3 Pharmacy technician
- 3.4 Veterinary technicians
- 3.5 Other
- 3.6 Afterword
- 4: Four-year undergraduate degree programs
- Abstract
- 4.1 Overview—Four-year undergraduate degree programs
- 4.2 General requirements for a Bachelor’s degree
- 4.3 Four-year undergraduate degrees—Myth or misnomer?
- 4.4 Four-year undergraduate degrees in STEM fields
- 4.5 Four-year undergraduate degrees in non-STEM fields
- 4.6 Afterword
- 5: The big decision
- Abstract
- 5.1 The big decision—Now what?
- 5.2 Factors influencing the big decision
- 5.3 Finding immediate employment
- 5.4 Choosing graduate or professional school
- 5.5 Afterword
- 2: Introduction: Preprofessional education
- Section C: Graduate and Professional Education
- 6: Graduate and postgraduate education at a crossroads
- Abstract
- 6.1 At the proverbial crossroads with graduate and postgraduate education and jobs
- 6.2 Core drug discovery disciplines including medicinal and organic chemistry
- 6.3 Enhancing science and technology—How to rise above the gathering storm
- 6.4 Jobs!
- 6.5 Afterword
- 7: Master’s degree programs
- Abstract
- 7.1 Introduction
- 7.2 Congratulations on graduating with a Bachelor’s degree—What’s next?
- 7.3 Deciding on the next step—Master’s or Doctoral (PhD/professional) levels
- 7.4 Selected examples of Master’s programs relevant to biotech/pharma R&D
- 7.5 Afterword
- 8: Doctoral and professional programs
- Abstract
- 8.1 Introduction
- 8.2 Where to apply, and why?
- 8.3 With whom should you work?
- 8.4 What should you do to be successful?
- 8.5 To postdoc or not—and further context
- 8.6 Does success in graduate school or a postdoctoral fellowship require different skills than undergraduate degrees?
- 8.7 Different strokes for different folks
- 8.8 Afterword
- 9: The big leap
- Abstract
- 9.1 It is time for the big leap—or is it?
- 9.2 Yes, I am in fact ready for the big leap!
- 9.3 Afterword
- 6: Graduate and postgraduate education at a crossroads
- Section D: Research and Discovery
- 10: Drug discovery: Chaos can be your friend or your enemy
- Abstract
- 10.1 Introduction to selected aspects of biotechnology and pharmaceutical discovery R&D
- 10.2 Major issues including attrition, cost, financing, ROI, and timelines
- 10.3 Champions, teams, and project management
- 10.4 Recruiting, developing, compensating, and retaining valuable human resources
- 10.5 Multiple sites and outsourcing
- 10.6 Comparing and contrasting centers and sectors of innovation
- 10.7 BD including IP
- 10.8 Afterword
- 11: Drug discovery: Standing on the shoulders of giants
- Abstract
- 11.1 Introduction
- 11.2 Getting the basics right
- 11.3 Combinatorial chemistry
- 11.4 Peptoids
- 11.5 Mitochondria
- 11.6 Genomics +
- 11.7 Chemical biology +
- 11.8 Macromolecules
- 11.9 Computational technologies
- 11.10 Easy to forget
- 11.11 Alzheimer disease
- 11.12 Targets
- 11.13 Afterword
- 12: Research and discovery: The difficult we do immediately—The impossible takes only a little longer
- Abstract
- 12.1 Recapping our journey
- 12.2 The end of the beginning
- 12.3 Afterword
- 10: Drug discovery: Chaos can be your friend or your enemy
- Section E: Chemical Development, Quality Requirements, and Regulatory Affairs
- 13: Turning a potent agent into a registered product
- Abstract
- 13.1 Drug discovery versus chemical development—An overview
- 13.2 Careers in chemical development
- 13.3 The active pharmaceutical ingredient
- 13.4 Regulations governing chemical development
- 13.5 The chemical process for producing the API
- 13.6 Afterword
- 14: Chemical development: Synthetic studies and engineering aspects
- Abstract
- 14.1 Lab feasible is not plant feasible
- 14.2 Monitoring reaction progress
- 14.3 Solid-state chemistry
- 14.4 Reprocess and rework of materials
- 14.5 Cleaning
- 14.6 Afterword
- 15: Chemical development: Analytical studies
- Abstract
- 15.1 Analytical method validation
- 15.2 Impurities
- 15.3 Solid-state chemistry and polymorphism
- 15.4 Reference standard of the drug substance
- 15.5 Stability of the API
- 15.6 Packaging
- 15.7 Afterword
- 16: FDA path and process: Sponsor‘s regulatory tasks for drug approval
- Abstract
- 16.1 Drug substance physical and chemical properties
- 16.2 Statistical evaluation of process variables
- 16.3 Current pathways to a process approval—Parametric studies using a QbD approach
- 16.4 Process performance qualification (validation) activities
- 16.5 Accelerated pathways to approval
- 16.6 Timeline from concept to approval
- 16.7 Afterword
- 13: Turning a potent agent into a registered product
- Section F: Pharmaceutical Research and Development: Concluding Remarks
- 17: Epilogue
- Abstract
- 17.1 Somewhere!
- 17.2 Models for drug discovery are changing—They must
- 17.3 Final word
- 17: Epilogue
- Index
Product details
- No. of pages: 536
- Language: English
- Copyright: © Woodhead Publishing 2016
- Published: November 8, 2016
- Imprint: Woodhead Publishing
- Hardcover ISBN: 9780081006252
- eBook ISBN: 9780081006320
About the Authors
Walter Moos

Affiliations and Expertise
Susan Miller
Affiliations and Expertise
Stephen Munk

Dr. Munk’s work has been summarized in a number of publications and patents; a book chapter in “Comprehensive Medicinal Chemistry II” (Elsevier Ltd.), as well as presentations at Scientific Conferences and Universities. Dr. Munk serves as an Adjunct Professor of Chemistry at Wayne State University and on the Henry Ford Community College Biotechnology Advisory Board. He served on the Steering Committee of the Chemistry in Cancer Research Working Group of the American Association for Cancer Research (CICR-AACR; 2008-2010; 2011-2013; Chair, 2014), the Board of Directors of MichBio (2008 - 2014; Chairman 2010 - 2014). He also serves on various grant review committees for the Federal Government.
Affiliations and Expertise
Barbara Munk

Affiliations and Expertise
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