Enhancing Global Health Security and Preparing for the Next Pandemic: An Interview with Margaret A. Hamburg, M.D., of the Nuclear Threat Initiative

Enhancing Global Health Security and Preparing for the Next Pandemic: An Interview with Margaret A. Hamburg, M.D., of the Nuclear Threat Initiative

March 7, 2022 – By Jared Mueller, Director – Mayo Clinic Innovation Exchange

Dr. Margaret A. Hamburg is a Board member and currently also serves as the Interim Vice President of Global Biological Policy and Programs at the Nuclear Threat Initiative (NTI), where she also serves as chair of the NTI | bio Advisory Group. NTI is a nonprofit, nonpartisan global security organization focused on reducing both nuclear and biological threats imperiling humanity.

The millions of lives lost to the COVID-19 pandemic over the last two years have brought new attention and urgency to the biosecurity work of NTI and its partners, work that aims to reduce the threats associated with global catastrophic biological risks — whether those risks emerge from naturally occurring pandemic threats, the deliberate use of biological agents to do harm as biological weapons/terrorism, or inadvertent misuse (including laboratory accidents).

Before re-joining NTI, where she earlier served as a founding vice president and senior scientist, Dr. Hamburg spent nearly six years as Commissioner of the U.S. Food and Drug Administration (FDA) and then served as foreign secretary of the National Academy of Medicine, as well as President/Chair of the American Association for the Advancement of Science (AAAS). Her previous government positions include Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services; Health Commissioner for New York City; and Assistant Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

An alumna of Harvard College, Dr. Hamburg later earned her M.D. from Harvard Medical School and completed her medical residency at Weill Cornell Medical Center.

Q: A major thread of NTI’s biosecurity work is advocating for stronger global systems to respond to pandemics and other catastrophic risks to human health. NTI has worked with the Munich Security Conference to organize tabletop exercises for senior government and civil society leaders to discuss their responses to simulated pandemics, for example. How would you grade international and national systems’ current readiness to respond to pandemics?

MH: The loss of life, and trillions of dollars of economic losses, that society has experienced due to COVID-19 has shown that both national governments and the international community are woefully unprepared to confront pandemics. This shared vulnerability to biological threats has implications not just for COVID-19, but for future pandemics, which could be far deadlier than even COVID-19 has been.

Strengthening each nation’s ability to respond to future biological risks is both a humanitarian imperative, and essential to our own self-interest as individuals and residents in a highly developed economy. We also need to bolster regional and global mechanisms and strategic approaches, as no individual country can solve these problems alone, especially given the rapid pace of globalization, interconnectedness, and technological innovation.

Q: What are some of the lessons from NTI’s tabletop exercises, and the organization’s other recent work in the biosecurity field?

MH: The list of vulnerabilities, gaps, and opportunities is long. Two that I can describe here have to do with international systems and mechanisms that merit further development. One is establishing a governance regime appropriate for the fast-evolving field of biological research and biotechnology capabilities, including the establishment of an international entity with a specific mandate to engage relevant stakeholders to strengthen biosecurity and the responsible stewardship of bioscience. The second is to develop a network of early warning and detection systems that can evaluate (and provide actionable guidance about) emerging pandemic risks, including a new mechanism to investigate the source of high-consequence biological events.

Advances in bioscience and biotechnology are vital to fighting disease, protecting the environment, and promoting economic development — but these innovations also can increase the risks of accidents or deliberate misuse. A deliberate or accidental biotechnology catastrophe would significantly undermine progress toward achieving health and economic goals. Governments play critical roles in providing oversight to prevent abuse and misuse, but their governance mechanisms have struggled to keep pace with these rapidly evolving and increasingly complex fields.

According to the Global Health Security Index — a project led by NTI in partnership with the Johns Hopkins Center for Health Security — fewer than 5% of countries provide oversight for “dual-use” bioscience research in which laboratories undertaking infectious disease research work with, create or store pathogens that, if released, could lead to deadly pandemics. At the same time, no international entity has a specific mandate to strengthen biosecurity and bioscience governance.

To address this global vulnerability, we at NTI seek to establish a new global entity, the International Biosecurity and Biosafety Initiative for Science (IBBIS). IBBIS will be an independent organization dedicated to strengthening global biosecurity norms and developing innovative tools to uphold them. Our vision is a world in which bioscience and biotechnology can advance and flourish, safely and responsibly.

Longstanding shortcomings in the national and international systems for detecting, investigating, and tracking pandemics have been starkly revealed during COVID-19. We need to support the United Nations and World Health Organization to develop new mechanisms for these activities that are commensurate to the global scale of the health security challenge. Better systems will help us understand, in fine-grained detail, how quickly a virus is emerging, in which regions it is spreading at any given moment — and the virus’s likely origins.

In an effort to explore the prospect of a new, internationally credible “Joint Assessment Mechanism” to rapidly investigate high-consequence biological events of unknown origin, NTI | bio is convening international experts encompassing a broad range of expertise — including public health, biosecurity, bioscience and biotechnology, non-proliferation, and international diplomacy. The goal is to establish a rapid-reaction multinational team to determine the source of a high-consequence biological event of unknown origin. This mechanism would address cases where there is ambiguity about the source of a biological event — specifically, whether it emerged naturally or was deliberately or accidentally released from an academic, commercial, or government laboratory.

Q: NTI has collaborated with the World Economic Forum to convene actors at the intersection of the bioeconomy and global health security. Can you share more context on NTI’s work on the economic implications of biosecurity, and industries directly relevant to the field?

MH: The bioeconomy offers great promise to improve human health and the quality of life across many domains of activity. At the same time, cutting-edge research taking place in labs around the world may generate risks for humanity. It is vital that all sectors work together to ensure global health security and realize the potential of modern biotechnology. NTI | bio and the World Economic Forum have pursued such efforts through the convening of an international Technical Consortium — which includes extensive industry representation — to advise on the development and testing of a prototype for the international Common Mechanism for DNA synthesis screening.

The Consortium focuses on three main goals — identifying baseline DNA sequences and algorithms for screening; developing customer screening guidance; and integrating the Common Mechanism into benchtop synthesis devices. NTI | bio is currently moving forward with initial development of a software prototype for a Common Mechanism that includes a set of reference databases and a screening algorithm. Novel databases of “benign” and “biorisk” sequences have been developed, informed by publicly available literature and industry expertise and inputs. We look forward to launching this prototype as part of the initial scope for IBBIS in late 2022.

Q: Thirteen years ago, you were nominated (and confirmed) as the 21st Commissioner of the FDA. Few positions in government offer a better vantage point, when it comes to emerging technologies in healthcare and the life sciences. What breakthrough innovations in healthcare delivery or technology excite you most?

MH: This is an incredibly exciting time for medical product innovation, in the therapeutics and devices areas, as well as for vaccines. The COVID-19 experience has, of course, been a powerful reminder of what we can achieve when we apply great science to unmet public healthcare and medical care needs, as well as the value of working in partnership across sectors to achieve critical goals.

As for specific emerging technologies and breakthrough innovations, there are too many to list here, but a few examples would include our increasing understanding of the genetic and molecular basis of disease — and life itself — which gives us so many new targets and tools to develop new, more effective interventions.

In addition, advances in information technology provide exciting new strategies for unlocking important information from large data sets to better analyze and monitor medical therapies, as well as to develop new ones. And the explosion of digital technologies is ushering in a new generation of medical devices and systems for monitoring health in non-clinical settings.

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