The Future of Drug Discovery - 1st Edition - ISBN: 9780124071803, 9780124095199

The Future of Drug Discovery

1st Edition

Who Decides Which Diseases to Treat?

Authors: Tamas Bartfai Graham Lees
eBook ISBN: 9780124095199
Paperback ISBN: 9780124071803
Imprint: Academic Press
Published Date: 29th May 2013
Page Count: 376
Tax/VAT will be calculated at check-out
30% off
30% off
30% off
30% off
30% off
20% off
20% off
30% off
30% off
30% off
30% off
30% off
20% off
20% off
30% off
30% off
30% off
30% off
30% off
20% off
20% off
34.95
24.46
24.46
24.46
24.46
24.46
27.96
27.96
27.99
19.59
19.59
19.59
19.59
19.59
22.39
22.39
44.95
31.46
31.46
31.46
31.46
31.46
35.96
35.96
Unavailable
File Compatibility per Device

PDF, EPUB, VSB (Vital Source):
PC, Apple Mac, iPhone, iPad, Android mobile devices.

Mobi:
Amazon Kindle eReader.

Institutional Access


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:
Imprint:
Academic Press
eBook ISBN:
9780124095199
Paperback ISBN:
9780124071803

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