This article first appeared in BioCentury.com. It is co-authored with David Beier.
The U.S. is not ready for the next pandemic. Our public health infrastructure and planning process are not up to the challenge, our capacity to treat at-risk citizens is insufficient, and we are not making enough of a new category of antiviral that can treat emerging viruses: mAbs derived from patients.
The bottom line is this — we are poised to make the same mistakes again unless we act now. Five measures would help the U.S. scale up testing, therapeutics and vaccine development. The goal must be to create policies, financial structures and new capabilities that enable innovation, provide the necessary manufacturing capabilities, and protect the supply chain before the next pandemic hits.
Years before the COVID crisis struck, prior presidents (Bush and Obama) focused on pandemic planning, for example by setting standards for a national stockpile of personal protective equipment (PPE). But the Trump administration failed to build up our reserves or secure our supply, shutting down the unit of the National Security Council tasked with global health security. Fortunately, one of Biden’s first acts as president was to restore this office.
Our health system has struggled to deliver mAbs targeting the virus, which can prevent infections from becoming severe, because these therapies require IV administration and access to infusion centers is primarily at the same hospitals that are overburdened and trying to avoid serving early-stage patients. If health systems figure out how to administer mAbs to all the patients who would benefit, we will quickly experience shortages since there are not enough doses being manufactured.
The Biden administration is faced with fixing this fact and has created a temporary White House office led by Jeff Zients to develop a national plan and assist states in operationalizing it.
The industrial landscape should include alliances and agreements to cooperate to serve the supply chain as a matter of routine.
The one bright spot has been vaccine development. The dedication of modern science to truth and the hard work of testing biological hypotheses has resulted in multiple highly effective vaccines. The commitment of more than $20 billion has been well worth it. But as former FDA Commissioner Scott Gottlieb notes, the underinvestment in shorter term treatments such as biologics — about $1 billion — has been disappointing.
The two paths to effective medical intervention for COVID-19 and future pandemic threats are vaccines and new medicines. So, how are we doing? Brilliantly on the science but not so well on manufacturing or delivering doses to patients. We can do better and here is how:
1. Antitrust carve-outs to permit companies to share information about manufacturing limitations and future plans to construct U.S.-based mAb manufacturing capacity. The industrial landscape should include alliances and agreements to cooperate to serve the supply chain as a matter of routine.
2. A biotech infrastructure bank or lending facility. We should create a credit facility that permits low-cost lending, guaranteed by the government, to finance the construction of new biotech manufacturing facilities. The government should be creative in structuring financial terms, including securing modest equity stakes for government.
3. Commitment of research and development funds in the form of grants, advanced purchase commitments or use of “prize” authority under existing federal law to advance new engineering and technological solutions to improve, speed or increase product yields for new biotechnologies manufacturing, especially mAbs. This program could be administered by NIH with technical assistance from NIST, and the National Academy of Engineering.
4. Creation of standby pandemic manufacturing facilities. These would serve a similar purpose to the national stockpile for PPE, diagnostics tests (imagine if we had enough low cost self-administered COVID-19 antigen tests, ventilators and the like). The concept is to create government funded backup capacity. These could be run like National Labs as Government Owned, Contractor Operated (GOCO) facilities.
5. Short- and medium-term access to vital pandemic and other medicines. The supply chains for these medicines very frequently involve sourcing from non-American players. The first step is to exclude from any national security review normal commercial supply contracts with companies located in countries with whom the United States has a military alliance, such as NATO countries, Japan and South Korea. Other contracts involving routine, commodity-like supplies should be permitted to continue for as long as the medical need for the final medical product continues and until U.S. capacity is sufficient. Any national security rules or reviews should be fair, prompt and governed by clear and consistent rules.
We must use the shock of the COVID pandemic to plan ahead.
Testing must also be a priority. There have never been adequate incentives for the development of point-of-care diagnostic tools, despite years of warnings. We continue to remain behind the rapid testing eight ball today as we struggle to put in place the screening testing needed to safely re-open schools, businesses and travel.
The next pandemic, or even COVID-22 or COVID-23, may be in waiting, so we need to take these lessons seriously. Infectious diseases can be prevented or treated using mAbs. Any plan to use this cutting-edge medical arsenal must accelerate the manufacturing and distribution of these medicines. Anything less ignores the tragic lessons from this once-in-a-century public health crisis.
David Beier is managing director at Bay City Capital and a board member of the California Life Sciences Association; he previously served as chief domestic policy adviser for Vice President Al Gore and has been a senior executive at Amgen Inc. (NASDAQ:AMGN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).
Bob Kocher is a partner at Venrock, adjunct professor at Stanford University and a senior fellow at University of Southern California’s Schaeffer Center for Health Policy.
Signed commentaries do not necessarily reflect the views of BioCentury.