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CLSA Report: How We Prepare for the Next Pandemic
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Viral pandemics are growing in both frequency and virulence. SARS, H1N1, Ebola and Zika are just a few examples. These growing public health threats are being driven by urbanization, global travel and other factors. They are here to stay.

As deadly pathogens continue to emerge, what can the world do to combat them? Recently, the California Life Sciences Association hosted an Afternoon with Thought Leaders to discuss these issues. The event featured a live, remote keynote from Centers for Disease Control and Prevention (CDC) director Thomas Frieden, MD, and a panel of academic, industry and provider experts.

While improving our ability to respond to pandemics is a complex, multifaceted issue, there are a number of measures, large and small, that can help move the needle.

Leveraging Collaboration and Technology

Keynote speaker Thomas Frieden, MD, who participated via live panelists-p2pandemicbrochure-sept29-2video-conference from CDC eadquarters in Atlanta, stressed the importance of public/private partnerships when addressing pandemic risk.

“We need the speed, flexibility and support from both private and philanthropic sectors, and every partner has an important role to play with specific expertise, access and assets,” said Dr. Frieden. “We also need to leverage partnerships with physicians and healthcare organizations.”

These partnerships can have a dramatic impact on the course of a pandemic. African nations with pre-existing polio eradication programs, such as Nigeria and Liberia, were better prepared to handle Ebola. The antipolio infrastructure was quickly redirected to fight the more immediate threat.

Dr. Frieden noted that emerging genomic technologies are also making a significant difference in how we fight pandemics. During a recent yellow fever outbreak, sequencing confirmed that outbreaks in different countries were caused by different strains.

“When I was an epidemic intelligence service officer 25 years ago, we were able to analyze small fragments of the genome and it took us several months,” said Dr. Frieden. “Now we can get entire genome sequences in a couple of hours.”

Learning from Ebola

p2-frieden-pandemicbrochure-sept29-2According to Dr. Frieden, the Ebola outbreak offered major lessons to public health officials and policymakers. First, every country must have the capacity to detect, stop and prevent health threats. However, in severe emergencies, the international community must have the capacity to “surge” in to help overwhelmed nations.

Second, both the United States and the international community must develop rapid response capabilities, which would be analogous to the Federal Emergency Management Agency (FEMA). In addition, mechanisms must be in place to cut red tape and accelerate critical processes.

“We’re currently challenged with Zika because it takes two months to get a contract out,” said Dr. Frieden. “Two months is an eternity.”

Third, to manage viral threats, governments, nonprofits and industry must bolster their investment in diagnostics, therapeutics and vaccines. Still, there are many challenges that must be addressed.

“The paradox of preparedness is that we are both better prepared than ever before and at greater risk,” said Dr. Frieden. “We need to take advantage of this opportunity to establish systems in the U.S., and around the world, to hold ourselves collectively accountable for protection and to commit to working collaboratively to achieve it.”

Embracing Preparedness 

Rekha Murthy, MD Vice President, Medical Affairs, Associate Chief Medical Officer, Professor of Medicine, Cedars-Sinai
Rekha Murthy, MD
Vice President, Medical Affairs, Associate Chief Medical Officer, Professor of Medicine, Cedars-Sinai

Following Dr. Frieden’s keynote, an expert panel (see sidebar) addressed many of the challenges the world faces when dealing with pandemic threats and offered a number of ways to move forward. More than anything, the panel focused on preparedness.

“There’s always going to be a next pathogen,” said Rekha Murthy, MD. “It’s not a question of if; it’s a question of when. Rather than waiting for it, we need to be prepared, now.”

From Dr. Murthy’s perspective, preparedness means hospitals need systems in place to protect both patients and staff. This includes ongoing education and drills to help staff internalize what they must do when dealing with highly communicable diseases. The annual flu epidemics could be a valuable opportunity to test preparedness.

“We have an opportunity with each year’s influenza season to practice for an unpredictable and potentially novel emerging disease,” said Dr. Murthy.

Advanced Diagnostics

David Ecker, PhD Divisional Vice President, Carlsbad Site General Manager, Abbott
David Ecker, PhD
Divisional Vice President, Carlsbad Site General
Manager, Abbott

David Ecker, PhD, believes we need to “hammer away at bureaucracy,” listing a variety of barriers that make it challenging to develop a diagnostic test, including in particular, access to critical raw materials.

“We need a virus, patient antisera and clinical specimens to test the validity of the technology,” said Dr. Ecker.

Bill Lee, PhD, concurred. “It can be hard to find animal models to test molecules for Zika.”

While diagnostics can determine if a patient has a specific infection—something we already know is out there—the panel noted these efforts can also be limiting. The health community must embrace emerging technologies that detect potential new threats, whether we are looking for them or not.

p3-frieden-quote-pandemicbrochure-sept29-3

“Once you know what something is, you make a targeted diagnostic, such as a PCR [polymerase chain reaction] test or an immunological test,” said Dr. Ecker.

There is also a need for new computing solutions that have the capability to pool health information without jeopardizing patient privacy.

“Diagnostic technologies need to be linked together without violating HIPAA [Health Insurance Portability and Accountability Act],” said Dr. Ecker. “The information needs to be collected and de-identified so we can watch what’s happening on a macro scale.”

Funding

One of the main challenges with pandemic preparedness and response is funding. Moderator Penny Heaton, MD, pointed to Zika-resistant mosquitos, created by infecting them with a naturally occurring bacterium, as a potentially helpful strategy to help stunt the outbreak. However, this solution will take time to scale up, as mosquitoes don’t travel far, and many eggs must be distributed to cover the necessary ground. While it is highly cost-effective, communities need to better understand the benefits of distributing these “good” mosquitos as a permanent solution to Zika and other mosquito-borne diseases and that it does not offer a treatment solution for those already infected with the virus.

In 2004, Congress created a ten-year Special Reserve Fund (SRF) to support medical countermeasure development and stockpiling. This funding helped produce important medical countermeasures to protect the public and cultivate a development pipeline with more than 160 candidate products. However, the funds expired at the end of 2013, and the continued development of these national security products, as well as new ones, is now dependent on the annual appropriations process and continued bipartisan support.

The challenges of relying on an annual appropriations cycle to successfully develop needed products for all populations, plan ahead, maintain vigilance and sustain research and development are best illustrated by the months-long Congressional effort to allocate emergency funding to combat Zika. A strong, stable and well-funded public health infrastructure is essential to biosecurity and public health preparedness.

In December 2006, Congress enacted the Pandemic and All-Hazards Preparedness Act, which has vastly improved the nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental or natural. Today, the U.S. is far better equipped to anticipate, detect and respond to threats than most countries, with dedicated funding for agencies like the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Biomedical Advanced Research and Development Authority (BARDA), Department of Defense (DOD), United States Agency for International Development (USAID), and others. But as we have witnessed with the challenge in responding to SARS, H1N1, Ebola and Zika, there remain critical gaps that must be filled.

Public/Private Partnerships

The panel was unanimous on the need for increased collaboration between industry and various government agencies.

“There’s a lot of competition between agencies,” said Dr. Lee. “When we interact with one of these groups, we are actually able to bring them together.”

Quita Highsmith echoed this sentiment. “We need to have serious discussions with all stakeholders on a regular basis to solve small problems before they become big.”

Recommended Policy Changesstock-dc-capitoltrst

The Blue Ribbon Study Panel on Biodefense—comprised of key bipartisan leaders in past administrations and Congresses—published a comprehensive analysis of our nation’s preparedness and response enterprise and proposed specific policy reforms that will help bolster our nation’s efforts to anticipate, respond to and recover from chemical, biological, radiological and nuclear threats and pandemics.

Key Recommendations Include:

  • Fully prioritize, fund and incentivize medical countermeasures
    (MCM), including funding the countermeasures to authorized
    levels, and re-establish multi-year biodefense funding for
    countermeasure procurement.
  • Reform Biomedical Advanced Research and Development Authority (BARDA) to enable nimble and efficient contracting and accelerate the availability of MCM, including returning contracting authority to BARDA and eliminating the Office of Management and Budget (OMB) review of BioShield procurements.

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 About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at www.califesciences.org and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

Project Team

Sara Radcliffe
President & CEO
California Life Sciences Association

Todd Gillenwater
EVP, Advocacy & External Relations
California Life Sciences Association

Will Zasadny
Associate Director, Communications
California Life Sciences Association

Josh Baxt
Baxt Communications

Dave Meyer
Dave Meyer Design

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