Last week, 1Day Sooner convened more than 80 of the nation’s top health, biosecurity, and research leaders for our third annual Operation Warp Speed 2.0 conference. This year’s theme, “Applying Pull Funding & Regulatory Capacity to Advance New Biotechnologies & Prevent Pandemics,” aimed to share proposals and activate change in replicating the elements that made Operation Warp Speed (OWS) successful and build support for vaccine development and pandemic preparedness. Read on for the top takeaways from the event.
Two interactive workshops kicked off the day, where attendees discussed current and future efforts to help solve two of our most pressing health risks. The first workshop focused on “The Hepatitis C Vaccine Development Pathway,” featuring presentations from NIH Distinguished Investigator, Liver Diseases Jake Liang; Centivax Chief Medical Officer Jerry Sadoff; PopVax Founder Soham Sankaran; and University of New Mexico Infectious Disease Epidemiologist Kimberly Page. The second workshop targeted “Opportunities, Obstacles, and Next Steps for the Pandemic All-Hazards Preparedness Act” and was moderated by Texas A&M, Associate Dean, Global One Health Gerry Parker.
A National Initiative to Eliminate Hepatitis C in the U.S.
Francis Collins, NIH Distinguished Investigator, Center for Precision Health Research, gave the keynote on the urgent need to develop a Hepatitis C vaccine. Hepatitis C affects 4 million people in the U.S., with 40% unaware of their infections.
He noted that the discovery of a cure in 2014 was one of the most important biomedical breakthroughs of the past 30 years. However, he stressed that there is a need to continue the quest for a vaccine and further education on elimination efforts, especially as treatment is still not part of routine care. In fact, despite a cure existing for the past decade, many primary care physicians are unaware of its existence, and education is needed to inform them that it will not cause undue burden on those suffering from the disease. Only one in three patients who have the disease get cured. That number diminishes even further for those without health insurance.
Hepatitis C is a cause with bipartisan support, as the diagnosis and treatment of the disease are costly. For example, doubling the number of Medicaid recipients cured will save the federal government $7 billion. That doesn’t even take into account the upcoming Congressional Budget Office report predicting cost savings based on significant reductions in liver fibrosis, cirrhosis, liver cancer, diabetes, kidney diseases, and liver transplants.
“Unless we take action, our healthcare system will be spending billions for Hepatitis C care on those already infected in the coming decades,” Collins concluded. “It’s compassionate to have a cure and a vaccine.”
Pull Funding: Using Demand Signals to Incentivize Critical Technologies
1Day Sooner Founder and President Josh Morrison opened the conference and introduced the first panel of the day. Center for Global Development Senior Fellow and Market Shaping Accelerator Director Leah Rosenzweig joined panelists Colonel Matthew G. Clark, who formerly served as the Lead Program Manager for the vaccine team in Operation Warp Speed; former Director of BARDA Division of Research, Innovation, and Ventures Sandeep Patel; and National Institute of Biomedical Imaging and Bioengineering Senior Advisor Rachael Fleurance shared the successes and lessons learned during OWS that can be applied to build critical infrastructure in the event of a medical emergency. Some highlights include:
- Develop “shovel-ready” projects that can be built using OWS methods.
- Identify which activities will generate demand and provide value.
- Pull funding can be used for infrastructure upgrades, not just medical countermeasures.
- Adaptive clinical trials are an area ripe for opportunity to utilize pull funding mechanisms.
- Subscription models can work as potential pull funding mechanisms in certain circumstances.
Regulatory Science: How Regulatory Capacity and Advance Guidance Can Accelerate Development
Politico’s FDA reporter Lauren Gardner held a lively discussion with the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, Venable Partner Jeremiah Kelly, and medical product development and regulation expert Rachel Sherman.
The ongoing H5N1 outbreak was a timely discussion point on how to apply lessons learned from OWS. Namely, an opportunity for improvement is through better surveillance. Marks emphasized the opportunity for anonymized testing, creating a no-fault environment for dairy farmers. Stressing that “perfect is the enemy of good,” empowering herd owners to provide any data to help regulatory agencies track virus spread is better than not receiving any data.
Other panelists highlighted how other past public health crises, like the HIV/AIDS crisis, were ultimately successful through different agencies putting aside egos to work alongside each other for the betterment of the U.S. population.
Other key takeaways from the panel include:
- There should be a firm apolitical pandemic preparedness plan in place that spans administrations and considers what went smoothly and what should be improved based on past public health crises.
- Develop legal infrastructure to ensure streamlined interagency cooperation. In a pandemic, multiple departments and agencies work together, each with its own rules and regulations. If one “gear in the system” jams, the whole process jams. Align legal authorities to establish adequate terms and conditions, incentivization, legal tools, and regulatory intelligence, particularly when deployed between government and industry contractors.
- Be more transparent with the public. For example, Congressional briefings can be a forum for an exchange of information. Public trust needs to be rebuilt.
- Better integrate data collection to streamline regulatory processes.
Interagency Coordination for Pandemic Preparedness and Response
Closing out the day was a panel on interagency coordination. Moderated by Venable Partner Justin Coen, he was joined by panelists Retired Colone and Co-Founder and Principal Growth Partner of BluZone Bioscience and Supply Chain Solutions Vic Suarez, Major General Paul Friedrichs, and former ASPR Assistant Secretary for Preparedness and Response Robert Kadlec.
Continuing on the theme from the previous panel, themes discussed centered around how diseases know no borders. Biological threats cannot be politicized, and the U.S. has made incredible progress in recognizing and developing the components to initiate a successful response to a public health crisis. This includes industry partnering alongside government and academia, scaling up manufacturing capabilities at risk, and prioritizing action across a flat reporting structure versus bureaucratic memos across a byzantine reporting structure.
They closed out the day with a message of optimism, reminding attendees that during OWS, they saw extraordinary efforts from CBER and FDA employees working around the clock. Dr. Friedrichs shared that the secret sauce of the U.S. is when we decide to work together–in this case, HHS and DoD–extraordinary things can happen.
Thank you to Gerald Parker and the Scowcroft Institute of International Affairs at Texas A&M for co-hosting the event with us.