- First comprehensive analysis of the failures in curing cancer, Alzheimer’s, and cardiovascular disease with solutions proposed
- Defines deficiencies in academic life science research, including conflicting incentives, QA/QC issues, and how to fix them
- Provides a rationale for FDA reform especially as it relates to terminal disease drugs
- Details how a reformed NIH, regulators, and industry can partner to form a NASA-type effort to speed cures of terminal diseases
- Provides the first detailed roadmap for life science researchers to conquer terminal disease
Table of Contents
Part A. The Reasons for Failure
Chapter 1. The Medical R&D Fiasco
- The Most Serious Humanitarian Crisis
- The Magnitude of the Problem
- My Journey Through the Quagmire
- Where to Begin
- Cancer: Fifty Years of the Same Toxic Drugs
- Neurodegenerative Disease: Criminal Negligence
- Cardiovascular Disease: Treating the Symptoms
- Time to Get Serious
Chapter 2. Academia Is Marching to the Wrong Drummer
- Science for Its Own Sake
- Chaotic Poor-Quality Science
- Universities: Where Is the Accountability?
- Technology Transfer, Why Bother?
- The Collaboration Myth
- Thought Leaders: Blessing or Curse?
- The National Institutes of Health: Where Is the Beef?
- Strategy, Accountability, and Urgency: The Missing Links
Chapter 3. Mavericks Versus the Establishment
- Medical Research 101
- Established Science Is Being Wasted
- Maverick Science, Our Best Hope?
- Old Drugs for New Uses and Mavericks
- Getting Physicians Back in the Game
- Natural Agents Are Being Overlooked
- Charities: An Insult to the Cure Quest
- The Bottom Line on the Research Enterprise
Chapter 4. The Strangled Unincentivized Drug Industry
- Biotechnology Versus Pharmaceuticals, Macro Versus Micro
- Biologics: Great Targets but Terrible Drugs
- Biologicals: Super Expense for Marginal Benefit
- Gene Therapy and Stem Cell Therapy: Hype Versus Substance?
- The Biotechnology Report Card
- Start-Up Companies and Why They Fail
- Venture Capital: Selling Science for Profit
- Pharmaceuticals: Where Is the Beef?
- Corporate Partnering, Oil, and Water
Chapter 5. The FDA Roadblock to Cures
- Evolution of a Monster
- The Rocky Road to Drug Approval
- Clinical Trials: A Very Inexact Science
- Phase III: The Mother of All Clinical Trials
- Must We Be so Timid for All Drugs?
- Terminal Disease Patients Condemned to Death
- The Mistake That Created the Monster
- Surgery, an Example of What Fewer Regulations Can Produce
- Regulation and the Patient–Physician Relationship
Chapter 6. The Liability Barrier
- Everyone Responds to Drugs Differently
- Where Does Liability Begin?
- Medical Class Action Lawsuits: A Litigator’s Dream
- Should We Trust the Drug Companies?
- Malpractice Madness; Who Wins?
- The Risk–Benefit Conundrum
- Liability for Failed Clinical Trials
Part B. Towards Solutions
Chapter 7. Cleaning Up the Academic Research Quagmire
- Rebuilding the National Institutes of Health: NASA for Cures
- What to Do With Academia and Indirect Costs?
- Charities: You Have to Be Kidding!
- Quality Control in Research
- Injecting Strategy and Management Into Medical Research
- Fewer Thought Leaders and More Mavericks
- The Public Rip Off
Chapter 8. Reforming the FDA
- The Evolution of Drug Regulation
- Rethinking the FDA
- Some Common FDA Horror Stories
- Academic Purism Versus Right to Life
- Placebo-Controlled Trials for Terminal Disease Drugs
- A Regulatory–Industry–Research Partnership
Chapter 9. Enabling the Drug Industry
- Treating Is More Profitable Than Curing
- Ending Me-Too Drugs
- Mavericks Are Needed in the Industry Too
- The Venture Capital Fiasco
- Do Start-Ups Make Sense?
- Corporate Partnerships, Why Bother?
- Incentivizing Industry to Focus on Cures
- Where Is the Consumer?
Chapter 10. Patent and Liability Reform
- Speeding Up Patents
- Opening the Floodgates: Patenting Existing Science
- Born Again Patents and the Terminal Disease Exclusivity Act
- Immunity and Indemnification
- Reigning in the Medical Tort System
Chapter 11. The Public Will Make It Happen
- Taking Back Control of Our Lives With Health Savings Account
- Knowledge Is Power
- The AIDS Strategy
- The Roadmap
- No. of pages: 160
- Language: English
- Copyright: © Elsevier 2017
- Published: April 25, 2017
- Imprint: Elsevier
- eBook ISBN: 9780128127971
- Paperback ISBN: 9780128127964
About the Author
Paul J. Marangos
Dr. Marangos is author of 252 peer-reviewed research papers on neurobiology, and 4 books – three by Academic Press (the Neurobiological Research series of volumes) and a fourth titled “Emerging Strategies in Neuroprotection”. He is a founding editor of “The Journal of Molecular Neuroscience” and inventor on 14 issued patents. He spent 13 years at the NIMH and was adjunct professor of neurochemistry at GW School of Medicine during that time. He is co-Founder of five Biotech firms with over 20 years of experience as CEO of both public and private life science companies. He has had extensive experience in all aspects of the pharmaceutical and biotechnology industries from bench to product. This coupled with his academic experience has provided a global perspective on the entire medical R&D enterprise, in particular its faults, and remedies to speed the quest for cures.
Affiliations and Expertise
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