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.
- 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
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Section A: Introduction and Overview
1: Backgrounder: Medicinal chemistry: Research, discovery, art, science
Section B: Preprofessional Education
2: Introduction: Preprofessional education
3: Two-year certification and degree programs
4: Four-year undergraduate degree programs
5: The big decision
Section C: Graduate and Professional Education
6: Graduate and postgraduate education at a crossroads
7: Master's degree programs
8: Doctoral and professional programs
9: The big leap
Section D: Research and Discovery
10: Drug discovery: Chaos can be your friend or your enemy
11: Drug discovery: Standing on the shoulders of giants
12: Research and discovery: The difficult we do immediately-The impossible takes only a little longer
Section E: Chemical Development, Quality Requirements, and Regulatory Affairs
13: Turning a potent agent into a registered product
14: Chemical development: Synthetic studies and engineering aspects
15: Chemical development: Analytical studies
16: FDA path and process: Sponsor's regulatory tasks for drug approval
Section F: Pharmaceutical Research and Development: Concluding Remarks
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.
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.
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.
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.