Politics, Policy & Law
Largely aspirational, Biden’s COVID-19 strategy hints at chance for long-term impact on drug development
The question is whether plans for expansion of data, diagnostics and health equity will come to fruition
The question is whether plans for expansion of data, diagnostics and health equity will come to fruition.
The Biden administration’s strategy for COVID-19 and long-term pandemic preparedness is in large part a plan for a plan, but it contains kernels of concepts that if fully developed could transform how drug companies conduct clinical trials, use real-world data, and reach into underserved communities.
Among the 200 pages of President Joe Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness are three areas beyond vaccine development and distribution that could present meaningful long-term change for biopharmas and patients if taken to the limit: testing and diagnostics, data collection and integration, and health equity.
The challenge will be exactly that — whether Biden’s team can create momentum around plans that are at best germinal and allow them to reach fruition. The goals can’t be achieved without engaging industry, patient groups and other critical sectors, but figuring out who should do what, and avoiding falling over each other to wrest control, will require all the stakeholders, including the administration, to use the best and not the worst behaviors of the pandemic.
Biden science adviser Eric Lander has been down this road before, albeit not with the tailwind of a pandemic behind him. He headed a President's Council of Advisors on Science and Technology committee that produced a report in 2012, “Propelling Innovation in Drug Discovery, Development, and Evaluation,” designed to launch initiatives to bring the U.S. clinical trial infrastructure into the 21st century, among other things. The project did not live up to the promises to follow through and wasn’t sustained.
The stronger parts of Biden’s plan are already under way. Those include initiatives to expedite vaccine distribution and administration and to reshape transparency and communication about COVID-19 with real-time information available at the federal, state and local level.
Its least fleshed out area is arguably for new therapeutics, where it recognizes the need for antivirals against coronavirus and other viruses for future pandemics, and calls for a partnership of scientists from government agencies, academia, industry and other sectors, but stops short of naming agencies who will anchor this or dedicating specific funds.
Industry isn’t waiting. Pharma members of the COVID R&D Alliance are creating a new organization that plans to develop a portfolio of small molecules to treat infections from coronaviruses and influenza. If successful, the organization’s work could plug an important hole in pandemic preparedness, though its scope won’t cover the need for surge manufacturing capacity, diagnostics or other gaps that have hampered the response.
A January report from the Bipartisan Commission on Biodefense calling for an “Apollo Project” could help the Biden administration make the case for a meaningful medical countermeasures budget.
The commission’s report, like the Biden administration plan, assumes that government should take the lead and has little mention of industry. The commission’s co-chairs, former Sen. Joe Lieberman and Tom Ridge, the first secretary of Homeland Security, are well respected on Capitol Hill, so even if the specific recommendations are disregarded, their call for Congress to allocate $10 billion per year for a decade to biodefense may help free up funding.
When it gets past therapeutics, the Biden plan has more details. It presents broad outlines of plans that incorporate upgrades to diagnostic testing capabilities, data collection and reporting systems, and community health centers and services.
Integrating across the initiatives, a picture might be drawn where data collected across the healthcare system could be used to drive treatment decisions as well as clinical trial design, tracks laid to reach rural and underserved patient communities for vaccine administration could be entrenched to broaden the clinical trial enterprise beyond the major medical centers, and testing and diagnostics move out of their rut to support better tracking of the next pandemic and disease monitoring in the interim.
A big question for the long-term impact of the plan will be whether it can reduce to practice its goal to modernize data collection and create an integrated data system across the healthcare system that can drive decision-making. No budget has been allocated in the plan to the goal.
The U.S. needs “improved data systems that can manage large volumes of data and connect with legacy and new data systems created in response to the current crisis,” states the plan.
Details are scant, though the plan outlines the need to strengthen software systems to streamline data reporting, and creates a cross-functional team with HHS, CDC, other federal partners and experts to guide the process.
The CDC will also maintain a public dashboard that will use de-identified data on COVID-19 cases to track performance, support forecasting, ensure transparency and promote scientific research, a template that could be duplicated for other major health priorities.
Real-world data advocates have long recognized the lack of unified data systems and interoperability as a key blockade to sharing data and utilizing the information to design more practical, real-world clinical trials. For the federal backing to make a difference, it will need to galvanize a balkanized field and engage with private and public stakeholders to iron out the issues.
Biden’s plan also invokes better data systems as one prong in the goal to address health inequities, with a mission to bolster data systems in states and localities with antiquated data systems and for HHS to optimize data collection from public and private entities including breakdown by race, ethnicity, geography and other demographic variables.
By establishing a COVID-19 Health Equity Task Force, the president is aiming to bring high-risk, rural and underserved communities into the fold for receiving vaccines and treatments for COVID-19.
Outreach to these communities, if successful, will embed new expertise and capabilities to parts of the population that have thus far had virtually no engagement in clinical research.
The plan outlines initiatives to increase funding for community health centers, strengthen home- and community-based services, expand mental healthcare, and support care and research on the effects of long COVID. It will also provide a training program for community health workers to promote vaccine operations and uptake in those areas.
There is growing recognition for the need to decentralize clinical trials and engage more community hospitals in clinical research to make trials better represent the populations their investigational agents aim to address.
There’s little reason the Health Equity Task Force should disband after the pandemic. If it can be the centralizing force to put disadvantaged and underrepresented communities on the healthcare and clinical trial map, it could create a glide-path for drug developers to broaden the reach and impact of their development programs.
Biden’s plan creates a National Pandemic Testing Board, meaning in the short term, diagnostics get their own version of Operation Warp Speed. Long term, however, it calls for onshore manufacturing and building lab capacity meant to last beyond this pandemic. It will promote innovation in testing, including at-home tests and instant tests, and make tracks for use of surveillance to identify areas at high risk for disease transmission and inform more targeted use of diagnostic tools.
Diagnostic technologies have undergone a spurt of innovation during the pandemic, with rapid molecular testing, CRISPR-based kits and functional screens for neutralizing antibodies offering capabilities that were only on the horizon a year ago. They have also given rise to a rethinking of the balance between accuracy and speed, where lateral flow technologies can provide answers faster than PCR, and the trade-off for accuracy can be achieved by making the tests cheaper and using them more frequently.
The plan’s support for asymptomatic screening, long marginalized in an ecosystem focused on diagnosing symptomatic disease, is backed up by federal government commitments to create screening protocols and make advanced purchase agreements for schools and congregate facilities.
And its inclusion of at-home tests and instant tests have clear carry-over possibilities for other infectious diseases, despite the focus on preparing for future pandemics.
In an interview for BioCentury’s 2020 Back to School collection, former FDA Commissioner Scott Gottlieb outlined the need for a rethink of the testing model in the U.S. which he said is biased towards lab-based tests over lateral-flow and point-of-care tests, ascribing the issue partly to Medicare reimbursement policies.
“We prefer the incremental margin of rigor offered by lab-based tests and don't necessarily value the access that's facilitated by an antigen-based test or other kinds of point-of-care diagnostics like lateral flow tests that might not be quite as accurate as lab-based tests, but have other attributes,” said Gottlieb.
At least three VCs have told BioCentury they believe the pandemic could be a turning point for diagnostics, based on improvements in the technology, changes in the cost structure and incentives such as the DISARM act, along with modernization of regulatory oversight through something like the VALID act, both of which could pass this session of Congress.
Crucially, the report addresses the need for increased and ongoing disease surveillance, committing to expand genomic sequencing, and citing the need to expand surveillance for hotspots and variants. The plans for this include investing in laboratory capacity, both in the short and long term.
The U.S. has not matched the level of genomic surveillance that the U.K. has achieved during the pandemic, which has allowed it to rapidly spot and track the spread of the disease and the rise of variants. To succeed in preparing for the next pandemic, a warning system with no less importance than a military surveillance system will need to be developed as a priority.