Financial Mirror (Cyprus)

Biden’s health moonshot

- By Mariana Mazzucato and Travis Whitfill

Although US President Joe Biden promised to lead with “science and truth,” his administra­tion’s efforts to advance science have fallen short.

Biden only recently named a commission­er of the Food and Drug Administra­tion, and he has yet to fill many other key science-policy positions, including the office of the White House Science Adviser and the director of the National Institutes of Health.

Nonetheles­s, Biden has made up some lost ground with his proposal to create a new health agency modeled on the Defense Advanced Research Projects Agency.

Earlier in March, Congress allocated $1 billion to establish the Advanced Research Projects Agency for Health. ARPA-H will use emerging science to create new biotechnol­ogies and medicines, just as DARPA has applied basic research in defense, communicat­ions, and other sectors.

Improving clinical medicine requires bold thinking, a greater appetite for risk, and sustained commitment to goalorient­ed research. Yet America has lacked an agency devoted to radical health innovation. Instead, this task has fallen to DARPA, which has managed to punch above its weight in delivering new medicines and vaccines. DARPA has been working on pandemic countermea­sures since 2013, and in 2017 it founded the Pandemic Prevention Platform, which focused on developing RNA- and DNA-based vaccine and antibody technologi­es years before SARS-CoV-2 emerged.

The same model of innovation could pave the way for more biotechnol­ogy breakthrou­ghs. Unfortunat­ely, like DARPA, ARPA-H has been budgeted only a fraction of what it really needs – and less than one-sixth of what Biden requested. Moreover, ARPA-H’s operationa­l structure remains uncertain, because lawmakers, White House advisers, and the US Department of Health and Human Services disagree about whether it should be a standalone agency or a subsidiary of the NIH.

Given ARPA-H’s stated mission, it absolutely should be a standalone agency with the authority to fund radical, breakthrou­gh science. Pushing technologi­cal boundaries and shaping new markets is a hallmark of the DARPA model, which accelerate­s innovation by taking big risks.

DARPA relies heavily on independen­t program managers who are pursuing ambitious, clearly defined goals, and who work closely with contractor­s to ensure a project’s success and commercial viability. More to the point, the DARPA model stands in stark contrast to that of the NIH. Although the NIH plays a crucial role in funding basic research, it lacks the boldness, risk appetite, and staff of innovative program officers that have made DARPA such a success.

It takes a more conservati­ve approach, because it is subject to an independen­t review process that reduces its tolerance for risk and failure. Whereas DARPA evaluates each project according to a specific need, the NIH must score all proposals against each other.

Risky investment­s in biotechnol­ogy innovation belong in a category of their own. That is why both Biden and former NIH Director Francis Collins have argued for ARPA-H to be a standalone agency. The point of the agency is to fill major gaps in the current innovation pipeline for biotechnol­ogy: the stages from basic research through clinical trials. To succeed in accelerati­ng innovation and reducing drug costs, ARPA-H will need a much larger budget than DARPA’s Biological Technologi­es Office, and it will need to adopt establishe­d approaches to health innovation.

To that end, ARPA-H should incorporat­e an “extended pipeline” model of innovation that supports innovation all the way from research to commercial­ization, as DARPA does.

It should take a mission-oriented approach to fill gaps in biomedical innovation. It should focus on funding radical innovation. And it should ensure control over drug prices and access. At a time when Big Pharma is spending more on share buybacks (to boost share prices, stock options, and executive pay) than on research and developmen­t, such conditiona­lities are necessary to ensure that innovation serves the public good. The establishm­ent of ARPA-H will create many new opportunit­ies. The agency could reinforce an emphasis on public health, broaden access to technology, reduce prices, enhance knowledge transfer, and rationaliz­e procuremen­t at the internatio­nal level.

And with a clear DARPA-inspired design, it could ensure that taxpayer-funded drug innovation actually benefits the taxpayer, not just Big Pharma’s shareholde­rs.

In its own collaborat­ion with the private sector, the NIH has consistent­ly failed to establish conditions that would ensure benefits to the wider public. ARPA-H must follow a different model. Why fund innovation­s that people will be unable to access? The United States needs purpose-oriented agencies to address its mounting problems. The opioid crisis has highlighte­d the strong links between public-health problems and inequality, and the COVID-19 pandemic has underscore­d the need for more government-funded procuremen­t of medicines and vaccines.

Government programs should be designed to serve the needs of the public, not just private-sector profits. ARPA-H is an opportunit­y to demonstrat­e the wisdom of that approach.

Mariana Mazzucato, Professor of Innovation and Public Value at University College London, is the author of Mission Economy: A Moonshot Guide to Changing Capitalism (Penguin Books, 2022). Travis Whitfill, a health policy researcher at Yale University, is a partner at Bios Partners and a graduate researcher at University College London’s Institute for Innovation and Public Purpose.

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