Supporting innovation in Alzheimer’s treatment

Thursday, November 14, 2019


Governments around the world need to change the math for medical innovators to provide the certainty that drug developers need to take on Alzheimer’s, write Eli Lilly CEO David Ricks and Medical Director Brandy Matthews in the Global Innovation Index 2019. This article is part of a series about the power of innovation to solve social and economic challenges. Stories and statistics are drawn from the World Intellectual Property Organization’s Global Innovation Index 2019 – your guide to world-changing ideas.


Alzheimer’s is one of the most feared diseases in the world, for good reason. No other illness among the top 10 causes of death lacks a treatment to slow it down.


Drug development failure rates have been higher in Alzheimer’s than in almost any other disease—99.6% from 2002 to 2012, compared with 81% in cancer. And there have been many late-stage failures since then, including two—crenezumab and aducanumab—this year alone.


Attempting to alter the trajectory of a chronic and slowly progressive disease is inherently time-consuming. It involves a commitment of nearly 10 years from bench to bedside—plus around four years of preclinical discovery and testing.


Overcoming the length and complexity of Alzheimer’s clinical trials requires innovative policy responses. In the past, breakthroughs in therapy have almost always been coupled with breakthroughs in regulatory standards. That was true when developing medicines for oncology, AIDS, and other diseases. It is needed now in Alzheimer’s.


The need for policy innovation


Currently, the extra time and high failure rate for Alzheimer’s medicines mean that the costs of bringing a drug through the regulatory process is more than double the highest estimate for overall drug development.


Various solutions have been put forward to address the problematic math of Alzheimer’s drug development. Below are five categories of policies that could make a difference.


1) Research. Because publicly funded research often produces insights that create the conditions for new medicines, governments should maintain or increase funding for Alzheimer’s research.


Start-ups, private investors and large pharmaceutical companies are also critical, with most new drugs developed by private efforts. Governments should nurture private efforts to advance drug development.


2) Innovative funding. We need innovative funding approaches—especially in the earliest and riskiest phases of drug research. Public-private partnerships, crowd-funding and prizes all help. Governments could also integrate disparate funding sources—perhaps creating mega-funds to advance research.


Since biopharmaceutical companies sponsor more than 70% of Alzheimer’s trials, the biggest thing governments can do is change the math for these companies. The next three categories aim at that goal.


3) Faster testing. In response to the challenge of low patient enrolment in Alzheimer’s trials, governments could organize registries of suitable candidates.


In cancer, regulators have long accepted progression-free survival as a surrogate endpoint for new drugs. Alzheimer’s trials need similar flexibility, which would encourage innovators to keep working on slow-progressing diseases.


4) Intellectual property. Patents provide 20 years of protection for a new medicine, But the clock starts ticking years before a medicine is approved for sale. Every extra year of clinical testing means one less ?in patent-protected sales. The single best thing governments can do to incentivize development of a drug to slow Alzheimer’s is to create sufficiently long periods of data exclusivity.


5) Reimbursement. An analysis of 15 developed countries found that those that introduced the newest medicines soonest, saved the most on hospital costs—US$2.50 saved for every US$1.00 extra spent on the latest pharmaceuticals.


Yet few health programs reward a pharmaceutical that enables reduced spending in other healthcare areas. To prepare for the arrival of a therapy for Alzheimer’s, governments should create mechanisms to connect disparate funding streams.


The Global Innovation Index 2019 is the result of a collaboration between Cornell University, INSEAD, and the World Intellectual Property Organization (WIPO) as co-publishers, and their Knowledge Partners, Confederation of Indian Industry, Dassault Systèmes, SEBRAE, Brazilian Micro and Small Industry Support Services, and Brazilian Confederation of Industry.


Published under Creative Commons Attribution-NoDerivatives 4.0 International (CC BY-ND 4.0) licence. That means you can copy and redistribute the material in any medium or format for any purpose, even commercially, but you cannot change it in any way.

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