The Future of Drug Discovery
1st Edition
Who Decides Which Diseases to Treat?
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Description
The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease.
Key Features
- Provides an in-depth, broad perspective on the crisis in drug industry
- Exposes the disconnect between what society needs and what the drug companies are working on
- Analyses and projects over 10 years into the future
- Explains what it means for scientists and society
- Determines what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat
Readership
Biomedical researchers involved in drug discovery in industry and academic settings, physicians, patient advocacy groups, health economists and regulatory officials
Table of Contents
Expert Reviews for The Future of Drug Discovery: Who Decides Which Diseases to Treat?
Dedication
Preface
Foreword by Graeme Bilbe PhD
Foreword by James H Eberwine PhD
Foreword by Eduard Enrico Holdener MD
Chapter 00: Introduction
What medicines you will need & why you might not ever have them
Aging is the major risk factor for disease
Painful truth & AD
More government action required
The decisiveness & divisiveness of market access
Government can change the future
Not all is doom & gloom
What can society do?
Chapter 01. Why there will be new drugs despite the ongoing “crisis” of drug development in Big Pharma
Pharmaceutical industry in crisis & consolidation
Why is there a strong belief that new future medicines will come?
Safe drugs in new indications: one does not always need new drugs for new therapies
Preventive drugs: large, long, expensive, convincing trials
Age as a risk factor & keeping costs in check
Newly orphaned diseases: more government needed
Chapter 02. The need for medicines grows
Small molecules & biologicals
The aging population
Rare or “orphan” diseases
Drug development: adding biologicals
Treatment of MS
Treatment of RA
Recombinant proteins as treatments
Future recombinant proteins as treatments
Pharma, governments, & nongovernmental organizations
Chapter 03. Medicines are becoming better: some of the breakthrough medicines of the past decades
Significant progress since WW II
The great beginning & the feared end of extremely profitable drug discovery
Drug discovery recovery, phase 1
Drug discovery arrested?
Meta-analysis matters: new twist on old information
New uses for safe drugs
Off-label use in other indications
Life cycle extension by repositioning
Inter- & intra-company competition to replace approved drugs in financially attractive indications
Pricing policies
Greater emphasis on long-term drug safety & benefit–risk ratio
Moving the goalposts
Weight loss drugs kept waiting
Evidence-based medicine requires large & long public-funded trials
Gains of & from EBM
Numbers of annually approved drugs
Chapter 04. Which diseases do we want to treat?
How many diseases are there?
How pharma companies have selected which diseases to treat
The funding & direction of biomedical research
The scientific basis of disease treatment
New avenues of research & the emergence of biosimilars
Generic drug makers
Biosimilars
“Firsts in class,” “me–toos,” & “best in class”: marketers’ dreams
Rescuing successful phase 2 candidates from oblivion
Una¢¢ounted u$e$ of $afe drug$
NGOs
Creating indications in the clinic or at the FDA?
Off-label use definitely enables approved drugs to treat additional diseases, but is it a desired tactic?
How can society affect the selection of indications by Big Pharma & by biotech?
Chapter 05. Therapeutic areas: Strategically important diseases of the future
Diverging views of society & industry
The human & economic cost of major diseases
AD: the most loomingly threatening disease
Early diagnostic imperatives
Translational research
Obesity & type 2 diabetes
Surgical versus drug interventions
Neuropathic pain
Cancer
Effective governmental & societal intervention
Chapter 06. Blockbuster proprietary drugs versus generic drugs
What happened to the blockbuster drug pipeline?
Where can the industry find new blockbusters?
More science here, please
The new blockbusters
Double-digit growth becomes an unreasonable expectation
Big Pharma attaches a generic arm
Generics attach an R&D arm
Will all drugs become generic?
Regulating biosimilars
The future of R&D
There are still huge, unmet medical needs
Chapter 07. Why is pharma a special industry?
Drug discovery is the most regulated human activity
History & mergers
Basic & translational research
Economic & social contribution
Governmental nonintervention & intervention
Crisis, what crisis? Tail wagging the dog?
Academia–industry collaborations
Gaps in Big Pharma’s research revisited
Plugging the gaps in Big Pharma’s research
Regulation & politics
Clinical trials
Chapter 08. Diagnosing toward personalized medicine
“Without diagnostics there can be no treatment; without available treatment, we need not diagnose”
Growth of diagnostics
Why is the diagnostics industry becoming so important for the pharmaceutical industry?
Biomarkers
Targeted cancer therapies
Companion diagnostics
Tougher regulation of diagnostics
What makes a diagnostic test good?
Chapter 09. Personalized medicine
Personalized medicine basics
ENCODE
Emerging personalized medicine
Adverse drug reactions may rank as high as the fifth leading cause of death
The “hair-dryer” & “toaster” drugs
The future of personalized medicine
Knowledge management
What does this mean for drug treatments?
Knowledge mining & learning algorithms
Chapter 10. How much can drugs cost?
Will the sums spent on medical care and new medicines grow?
The “number to treat”
The price of the most expensive drugs
Eroding the high-priced drugs
Quality adjusted life year costs: the QALY
How is the QALY calculated in the UK?
What about cost effectiveness?
Chapter 11. Modeling drug discovery until 2025
Early twenty-first century realities
Long-term safety (gets) in the face of short-term pharma
The path away from innovation
Evidence-based medicine
Risk of failure leads to risk aversion
Filling the strategic vacuum
VCs: less capital leads to less venture
Society-funded safety net
The history of the future
How will we then make new drugs in these areas of medical need abandoned by pharma?
What would be the best way to dispense governmental support?
Which diseases are international, urgent priorities?
Step 1: intensify research
Step 2: new results, new targets, new biotechs
Step 3: government-backed initiatives
Outsourcing & what parts of the drug discovery process are scalable?
Real really beats virtual
Manufacturing in the near future
Clinical trials in the near future
Positive outcome of the near future
Negative outcome of the near future
Perfect is not perfect
Room, & time, for optimism?
Faster, longer regulatory practices
Chapter 12. Drug development models between 2010 & 2025
Why the pharma industry is where it is
Emerging economies & pharma
Intellectual property & quality
Switzerland’s opportunity
Drug development is moving, but not completely
But where does this leave us when we ask who will develop new drugs?
Medical need motivates
Past & future trends
Rescue of phase 2 drugs
The fourth idea for a big incentive: rewrite patent guidelines
A “Biotech Projects Stock Market”
Safeguarding the future of safe medicines
Index
Details
- No. of pages:
- 376
- Language:
- English
- Copyright:
- © Academic Press 2013
- Published:
- 29th May 2013
- Imprint:
- Academic Press
- Paperback ISBN:
- 9780124071803
- eBook ISBN:
- 9780124095199
About the Author
Tamas Bartfai
Tamas Bartfai was a student of mathematics, physics, and chemistry before translating his skills into biochemistry, pharmacology and neuroscience. Trained in Stockholm University, Yale University, and The Rockefeller University, he is presently a professor at The Scripps Research Institute, the University Oxford, and the University of Pennsylvania, and an expert in medicinal chemistry and the neurological sciences. He has been working in the development of new medicines and vaccines for many years as a former Sr.VP of Hoffmann La Roche, and long-term consultant at Astra, Novartis and, presently, Pfizer. Eight of the drugs Dr. Bartfai developed are in clinical use and three are in trials. He has trained and collaborated with many scientists throughout his scientific work on the topics of fever, neuropeptides, and prostaglandins, while publishing over 400 articles in over 80 journals.
Dr. Bartfai has held many prestigious academic positions. He is a member of Academia Europae and the Hungarian Academy of Sciences, a fellow of AAAS for pioneering work on neuropeptides, and a member of the Royal Swedish Academy of Sciences, which awards the Nobel Prizes in Chemistry and Physics. He was professor of the Karolinska Institute, which awards the Nobel Prize in Medicine or Physiology. He has been awarded a number of prestigious prizes including Eötvös Medal for mathematics in 1966, Budapest, Hungary; Royal Swedish Academy’s Svedberg Prize for biochemistry in 1985 and Ericsson Prize in 1996; and the Ellison Medical Foundation Senior Scholar Award 2002.
Affiliations and Expertise
PhD, The Scripps Research Institute, La Jolla, CA Harold L. Dorris Neurological Research Center and Scripps Research Institute, La Jolla, California, USA
Graham Lees
Graham V Lees acquired his BA, MA and PhD degrees at the University of Cambridge. His postdoctoral work on the biophysics of ion channels was followed by a lengthy career in scientific, technical and medical publishing with Elsevier (Amsterdam), Raven Press (New York), Academic Press (San Diego & London) and TheScientificWorld (San Diego, Boynton Beach, Newbury & Helsinki). His scientific writing has been actively increasing, including contributions to the textbook Fundamental Neuroscience; co-editing with Edward G. Jones and Lorne Mendell, and contributing to Neuroscience to Neurological Recovery for the Society for Neuroscience (SfN); and co-authoring The Future of Drug Discovery: Who Decides Which Diseases to Treat and Drug Discovery: From Bedside to Wall Street with Tamas Bartfai. He is interested in politics and social aspects of drug discovery. He has a profound ability to translate complex processes and ideas into more simple English that can be widely read.
The authors’ previous book Drug Discovery: from Bedside to Wall Street, Elsevier/Academic Press, 2006, has been published in Japanese (Chem-Bio Informatics Society) and Mandarin (Science Press). Their later book’s Japanese and Mandarin editions are in preparation.
Affiliations and Expertise
PhD, Publishing Consultant, Corpus Alienum Oy, Finland
Reviews
"This book reviews in exquisite detail the drug development process from the initial inception of an idea through the life cycle of a new drug entity. The authors also spend an appropriate amount of time on the role of government-funded research programs along with the role of medium and small biotechnology companies in the drug treatment of diseases…Summing Up: Highly recommended." --CHOICE Reviews Online, December 2013
"Bartfai and Lees describe the looming crisis in health care…They target society in general as their audience, because of the need for the public to understand what is happening and why they should be concerned. The book is a compendium of data and analysis and there are many tables and figures supporting the text." --Reference and Research Book News, August 2013
"A remarkable compendium of hard data and wise prescription for the pharmaceutical industry." --Michael S. Brown, 1985 Novel Laureate in Medicine or Physiology, UT Southwestern Medical Center
"This is an extraordinary, insightful and provocative book that should be read by all those concerned by the progress of biomedicine, from scientists to politicians." --Jean-Pierre Changeux, Collège de France and l’Institut Pasteur
"Bartfai and Lees raise critical issues confronting the search for new medicines. Their analysis is cogent, and their proposals thoughtful and thought provoking. For anyone curious about where new medicines come from, and what it will take for the BioPharma industry to bring new treatments to patients with Alzheimer's disease, diabetes, depression, cancer, and more, this is a must read." --Michael D. Ehlers, Senior VP Pfizer and CSO Neuroscience, former Howard Hughes Investigator, Duke University
"This book is a must read for students, prescribing physicians, academic and industry researchers, analysts, patient groups, business and science journalists, and importantly, Policy Makers. More than ever before, drug development is a complex scientific, industrial and societal endeavour that needs the combined attention of Governments, Academics and Big Pharma; it cannot be left to Wall Street alone." --Daniel Hoyer, Chair, Department of Pharmacology, University of Melbourne, former Novartis Leading Scientist