Managing the Drug Discovery Process
1st Edition
How to Make It More Efficient and Cost-Effective
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Description
Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process.
This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry.
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
Details
- No. of pages:
- 536
- Language:
- English
- Copyright:
- © Woodhead Publishing 2016
- Published:
- 8th November 2016
- Imprint:
- Woodhead Publishing
- Hardcover ISBN:
- 9780081006252
- eBook ISBN:
- 9780081006320
About the Authors
Walter Moos
Dr. Walter H. Moos retired as President of SRI Biosciences in early 2016 after more than a decade at the independent nonprofit SRI International (Stanford Research Institute), which he joined in 2005 as Vice President and Biosciences Division Head. He also managed corporate Information Technology Services at SRI from 2011-2014. Moos and his teams have made significant contributions to all phases of R&D, from early stage research on therapeutics and diagnostics to marketed pharmaceutical products. Prior to SRI he was Chairman and Chief Executive Officer of MitoKor (Migenix) and a Vice President at Chiron (Novartis) and Warner-Lambert/Parke-Davis (Pfizer). His teams have advanced many drugs and biologics from bench to bedside, supported by Alta Partners, the Gates Foundation, NIH, Pfizer, and others. He has served on about 20 business and scientific boards, not-for-profit and for-profit, including the Biotechnology Industry Organization (BIO), the Critical Path Institute, Keystone Symposia, Oncologic (Aduro), Onyx (Amgen), and Rigel. He has advised and served as a committee member for academic, government, and investor groups, including the University of Michigan, the National Academy of Sciences, and Red Abbey Venture Partners. He has founded several scientific journals, authored or edited 6 books, and has over 160 patents and publications. Moos has held faculty positions at major universities and has been an adjunct Professor at the University of California San Francisco since 1992. He holds Ph.D. and A.B. degrees in chemistry from the University of California Berkeley and Harvard University, respectively.
Affiliations and Expertise
SRI International, Menlo Park, CA, USA and University of California–San Francisco, CA, USA
Susan Miller
Dr. Susan Miller is a professor in the Department of Pharmaceutical Chemistry at the University of California, San Francisco. Her research focus and expertise is in the areas of chemical biology and medicinal chemistry. Her team uses a variety of biochemical and biophysical tools to investigate protein structure/function questions spanning the range of elucidating novel aspects of catalysis in individual enzymes to understanding the interactions of proteins within a pathway and how mutations influence flux through the pathway. Their current work is focused on understanding how key enzymes and transport proteins of bacterial mercury detoxification pathways work individually, with each other, and with other host cell proteins to rapidly remove the toxic threat of organomercurials (such as Methyl-Hg) and mercuric ions from their environment.
Affiliations and Expertise
Department of Pharmaceutical Chemistry, University of California, San Fransisco, CA, USA
Stephen Munk
Stephen Munk, Ph.D. is the CEO and President of Ash Stevens Inc., a full service Active Pharmaceutical Ingredient (API) development and manufacturing contractor. Dr. Munk earned his Ph.D. in organic synthesis at The University of California at Berkeley under the supervision of Henry Rapoport and subsequently completed an American Cancer Society Postdoctoral Fellowship with Dale Boger at Purdue conducting studies in drug design and molecular biology. He is experienced in drug discovery, development, and manufacturing both as a scientist and as a manager. Prior to joining Ash Stevens in 1997, he worked at Allergan, Inc. initially as a medicinal chemist and subsequently, the co-team leader of the adrenergic drug discovery team responsible for the commercialization the glaucoma treatment Alphagan®. Under his leadership, Ash Stevens has received twelve FDA approvals to manufacture innovator drug substances. These approvals include the oncology drugs bortezomib (Velcade®), busulfan (Busulfex®), clofarabine (Clolar®), and 5-azacitidine (Vidaza®), ponatinib (Iclusig®) and ixazomib (Ninlaro®). Ash Stevens has won six NIH research contacts under his leadership including four competing renewals.
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
President and CEO, Ash Stevens Inc., Riverview, MI, USA
Barbara Munk
Barbara H. Munk is currently a Senior Lecturer in the Chemistry Department at Wayne State University where she is responsible for teaching classes in various areas of chemistry to undergraduate chemistry majors and students in the preparatory programs for health care professions. Barbara also serves as Chair of the Chemistry Department Safety Committee and is responsible for coordinating communications between various University departments to in order to comply with current regulations and help ensure a safe environment for undergraduate teaching and graduate student research laboratories. Prior to joining the faculty at Wayne State University, Barbara has worked as a research chemist and as a manager with a diverse set of industrial companies including Warner-Lambert/Pfizer, Allergan Pharmaceuticals, the Clorox Company, Great Lakes Chemical Corporation, the Stepan Company, and Port Systems, LLC (a start-up company in Ann Arbor, MI). During her 25 years in industry, she has been involved in research and development activities from phase I through phase III and the ultimate filing of New Drug Applications. While at the University of California at Irvine, Barbara was involved with the development of UC-ACCESS, an early online system designed to help academic scientists find industrial partners with whom to develop emerging technologies. Her chemical research efforts are summarized in 13 publications and patents. She has also co-edited a laboratory manual for undergraduate general chemistry. Barbara holds a Ph.D. in Chemistry from Wayne State University, a M.S. in Management from Purdue University and a B.S. in Chemistry from Arizona State University.
Affiliations and Expertise
Senior Lecturer, Department of Chemistry, Wayne State University, Detroit, MI, USA
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