Time for a 21st Century Manhattan Project

Only science can defeat COVID-19

Politics, incompetence and disorganization got us into this mess. Science, solidarity and discipline can get us out of it.

There’s already a blueprint for organizing science and industry to overcome an existential threat. It was drawn in the high desert of New Mexico during World War II.

What is needed is a 21st century version of the Manhattan Project, with a similar level of resource commitment and urgency. The key now, as it was then, is aligning the focused intelligence of some of the world’s leading scientists with the immense capabilities of industry and the almost unlimited resources of government.

The contemporary version of the Manhattan Project must be led by individuals who can command the trust and respect of scientists, politicians and the public.

There will be time when the pandemic has faded to catalog the blunders and missed opportunities that turned a manageable problem into a global catastrophe.

History will not smile on the actions, and inaction, of President Donald Trump, HHS Secretary Alex Azar, FDA Commissioner Stephen Hahn, and CDC Director Robert Redfield in January 2020, or of their counterparts in Italy and other countries (see “Coronavirus Crisis Calls for Competence, Clarity and Courage at the Top”).

The only reason for retrospection at this moment is to identify policies and attitudes that must be changed immediately because they are impeding progress.

What is needed is a 21st century version of the Manhattan Project, with a similar level of resource commitment and urgency.

More important is determining what must be done and how societies should organize to get it done.

The United States, home to the world’s preeminent biomedical researchers and life sciences companies, must take the lead. But solutions can come from anywhere, and the effort will require collaboration with the public and private sectors in Europe, China, Japan and elsewhere.

To make this work, clear lines of authority are needed. Real scientists and medical experts must make the decisions and have power to spend whatever funds are required. They must be in control of public communications as well.

There can and will be rigorous debate about the details, but the general outline of the project is clear: develop, validate and deploy testing technologies; screen and test repurposed therapies; develop new therapies; and create and test vaccines.

The most important tools in this enterprise are techniques for separating truth from hope, for distinguishing what might be from what is.

Scientists with experience in drug development are better placed than anyone to do that.

Good news

The good news is that the necessary technologies exist or can be extrapolated from products and processes that are already in hand.

Despite hopeful rhetoric from government officials, the U.S. is still far behind the curve on testing. The first step is to create the infrastructure and logistics for testing almost every citizen multiple times.

South Korea has demonstrated that large populations can be tested with existing technologies if government and healthcare institutions think creatively and act with appropriate urgency and commitment.

Containment and mitigation require broad disease surveillance and testing of anyone with symptoms at the point of care or at home.

Every patient’s experience should be put to work to improve the outcomes of future patients.

Blood tests that can detect antibodies are also under development. If they can be accelerated and used widely in a coordinated manner, they’ll enable scientists to chart the virus’ path and better plot strategies to defeat it.

A lot of ideas for repurposing drugs and for rapidly developing new therapies have been suggested and many more will emerge as the learning increases about COVID-19.

Controlled clinical trials are essential. It is imperative that trials be coordinated and that precious resources -- time, patients and medical professionals -- be allocated in a rational and transparent manner.

An ad hoc approach in which individual investigators pursue whatever treatments can pass muster with an institutional review board will lead to large numbers of uncontrolled, underpowered studies. That would create little data about what works or doesn’t work. Already, too many underpowered, uncontrolled trials are being conducted that will not produce actionable data.

Master protocols should be established immediately that automatically enroll every person who is hospitalized with COVID-19 anywhere in the world. Every patient’s experience should be put to work to improve the outcomes of future patients.

The standard-of-care arm that new interventions will be measured against should be modified as therapies are proved to be effective, so no one is exposed to anything less than the best available treatment.

Prepare for success

Just as the Manhattan Project started building immense factories before there was any certainty of success, one of the keys to defeating COVID-19 quickly will be to begin large-scale manufacturing of any medicines that seem promising before testing is completed. That would make it possible to get them into the field quickly once proven effective.

One of the top bets looks like antibody therapies that are fine-tuned to treat and protect against infection by the SARS-CoV-2 virus that causes COVID-19.

Antibodies that could provide immediate, short-term protection, as well as treatment for infected patients, are being developed now by AbCellera Biologics Inc., Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Vir Biotechnology Inc. (NASDAQ:VIR) and other companies and academic groups (see “COVID-19: A Growing List of New Vaccines and Therapies in Development”).

Even as therapies and medicines that could provide short-term protection are in progress, the development of vaccines must proceed at the fastest pace safely possible.

Scores of vaccine candidates are being developed using a wide range of scientific and technological approaches.

Now is the time to apply that knowledge to counter a wily and remorseless enemy.

When Phase I results are available, Manhattan Project leaders will have to make the hard call about which vaccines will be advanced to Phase II trials. They will have to decide on critical aspects of the product profile, such as the number of doses and requirements for a cold chain, the speed and reliability of mass manufacturing, as well as trial endpoints and the amount of data that must be collected to support wide-scale vaccination campaigns.

Governments must plan for success, ensuring that there is sufficient capacity to manufacture vaccines and to administer them. That might mean clearing the path for filling vials or syringes, establishing distribution systems, and especially for postmarket surveillance of safety and efficacy.

As with the development of therapies, these critical decisions need to be coordinated, and made by individuals who are guided by science, who are acting in the public interest -- and who are perceived as such.

The public and private sectors have invested hundreds of billions of dollars over the past decade to improve the ways medicines are discovered, developed and tested. Now is the time to apply that knowledge to counter a wily and remorseless enemy.

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