Managing the Drug Discovery Process

How to Make It More Efficient and Cost-Effective

1st Edition - November 8, 2016
Authors: Susan Miller, Walter Moos, Barbara Munk, Stephen Munk
Language: English
Hardback ISBN:
9 7 8 - 0 - 0 8 - 1 0 0 6 2 5 - 2
eBook ISBN:
9 7 8 - 0 - 0 8 - 1 0 0 6 3 2 - 0

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… Read more

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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.

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
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
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
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
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
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
Index

Susan Miller

Susan M. Miller has been Professor of Pharmaceutical Chemistry in the School of Pharmacy at the University of California San Francisco (UCSF) for over 30 years. Prior to UCSF, she held positions as an Assistant Professor and Lecturer of Biological Chemistry at the University of Michigan, Ann Arbor. Her research focus and expertise lies in the areas of chemical biology and enzymology. 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 how mutations influence flux through pathways of interacting proteins, to engineering novel microbial compounds using enzymes from ribosomally-synthesized peptide precursor pathways. She has mentored over 40 students, postdocs and staff researchers who currently hold positions in academia, biotech/pharma, the FDA, data science, patent law and other entrepreneurial organizations. She has co-authored and co-edited 5 books and published ~50 peer-reviewed papers. She has served as reviewer for grants at NIH, NSF, DOE and for numerous scientific journals, and is currently a member of the Editorial Review Board at the Journal of Biological Chemistry. Recently, Dr. Miller has served a leading role in the transformative design of the UCSF professional PharmD curriculum. She has co-directed the Therapeutic Sciences portion of the Foundations course and has served as co-Director developing and implementing a novel trio of inquiry elements in the new curriculum. Susan received her B.S. with high honors in Chemistry from the University of Missouri Columbia and her Ph.D. in chemistry with Professor Judith Klinman at the University of California Berkeley.

Affiliations and expertise

Professor, Department of Pharmaceutical Chemistry, University of California San Francisco, CA, USA

Walter Moos

Walter Moos has been an adjunct Professor of Pharmaceutical Chemistry at the University of California San Francisco (UCSF) since 1992. In parallel, he has been Managing Director of Pandect Bioventures, which he co-founded in 2018. At ShangPharma Innovation, starting in 2016 as an advisor, then as CEO, and most recently as emeritus Chairman, he led development of the group's innovation ecosystem. He is past President of Biosciences at the independent nonprofit Stanford Research Institute (SRI International), where he spent more than a decade, until 2016. Moos also managed corporate IT Services at SRI. Earlier he was Chairman/CEO of MitoKor (Micrologics/Migenix) and a VP at Chiron (Novartis) and at Warner-Lambert/Parke-Davis (Pfizer). He and his teams have made significant contributions to all R&D phases from early-stage research on chemical and biological therapeutics and diagnostics to marketed pharmaceutical products. They have done this with the support of big pharma, foundations, government grants and contracts, and venture capital. Moos has served on more than 20 business and scientific boards, public and private, non-profit and for-profit, including Alnis, Amunix (Sanofi), Anterion, Aprinoia, Axiom (Sequenom), the Biotechnology Industry (Innovation) Organization (BIO), Circle, the Critical Path Institute, Global Blood (Pfizer), Keystone Symposia, Mimotopes (Fisher/Thermo), MitoKor (Micrologics/Migenix), Oncologic (Aduro/Chinook), Onyx (Amgen), Rigel, ShangPharma Innovation, Valitor, and the Virginia University Research Partnership. He has advised companies on several continents and served as a committee member for academic, government, and investor groups, including the US National Academy of Sciences. He has co-founded several scientific journals, co-authored or edited multiple books, and has around 200 patents and publications. Moos has held faculty positions at several major universities and received PhD and AB degrees in chemistry from UC Berkeley and Harvard, respectively.

Affiliations and expertise

Department of Pharmaceutical Chemistry, School of Pharmacy, University of California San Francisco, San Fransciso, CA, USA

Barbara Munk

Barbara H. Munk is currently a Clinical Assistant Professor and Associate Director for Operations in the School of Molecular Sciences at Arizona State University. Before coming back to Arizona State University, she was a Senior Lecturer in the Chemistry Department at Wayne State University (Detroit, Michigan) where she was responsible for teaching general and analytical chemistry to undergraduate chemistry majors and students in the preparatory programs for health care professions. Barbara also served as Chair of the Chemistry Department Safety Committee and was responsible for coordinating communications between various University departments 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 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 a number of publications and patents. She is co-author of a book describing the drug development process and co-editor of 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

School of Molecular Sciences, Arizona State University, Tempe, AZ, USA

Stephen Munk

Dr. Stephen Munk joined the Biodesign Institute at Arizona State University (ASU) as its Deputy Director in October of 2017 and is a Professor of Practice in the School of Molecular Sciences. Steve is involved in strategic planning for the Institute, identifying new programs, grant funding and commercialization opportunities. He was elected a Senior Member of the National Academy of Inventors in 2022. His work is summarized in a number of publications and patents. Prior to joining ASU, Steve was in the pharmaceutical industry for 25 years in a variety of scientific and managerial positions including drug design and discovery as well as drug development and manufacturing. Steve served as the CEO and President of Ash Stevens Inc., a full service Active Pharmaceutical Ingredient (API) development and manufacturing organization. Under his leadership, Ash Stevens received twelve FDA approvals to manufacture innovator drug substances. These approvals include the oncology drugs bortezomib (Velcade®), busulfan (Busulfex®), clofarabine (Clolar®), 5-azacitidine (Vidaza®), ponatinib (Iclusig®) and ixazomib (Ninlaro®). Prior to joining Ash Stevens in 1997, he worked at Allergan, Inc. as a medicinal chemist and subsequently, the co-team leader of the adrenergic drug discovery team responsible for commercializing Alphagan® to treat glaucoma. He received his B.S. in chemistry at Arizona State University, and then earned his Ph.D. in organic synthesis at The University of California at Berkeley with Henry Rapoport and subsequently completed an American Cancer Society Postdoctoral Fellowship with Dale Boger at Purdue conducting studies involved in the sequence selective interaction of small molecules with DNA using the tools of molecular biology. Dr. Munk served as an Adjunct Associate 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; Chairman, 2014), the Board of Directors of MichBio (2008 – 2014; Chairman 2010 - 2014), the Michigan Biotechnology Innovation Organization (BIO) affiliate and is currently on the Board of Directors of AZBio, the Arizona Biotechnology Innovation Organization (BIO) affiliate.

Affiliations and expertise

Biodesign Institute, Arizona State University, Tempe, AZ, USA

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Managing the Drug Discovery Process

How to Make It More Efficient and Cost-Effective

Purchase options

Institutional subscription on ScienceDirect

Susan Miller

Walter Moos

Barbara Munk

Stephen Munk