HOW WE

PREPARE for the Next Pandemic

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 key-note 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 video-conference from CDC headquarters in Atlanta, stressed the importance of public/private partner-ships when addressing pandemic risk.

“We need the speed, flexibility and sup-port 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 physi-cians 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 anti-polio infrastructure was quickly redirected to fight the more immediate threat.

Dr. Frieden noted that emerging genomic technologies are also making a significant dif-ference in how we fight pandemics. During a recent yellow fever outbreak, sequenc-ing 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 ge-nome sequences in a couple of hours.”

Learning from EbolaAccording to Dr. Frieden, the Ebola out-break offered major lessons to public health officials and policymakers. First, every coun-

try must have the capacity to detect, stop and prevent health threats. However, in severe emergencies, the international community must have the capac-ity to “surge” in to help over-whelmed 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 addi-tion, 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, govern-ments, 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.”

KeynoteThomas R. Frieden, MDDirector, Centers for Disease Control and Prevention

Panel ModeratorPenny Heaton, MDDirector of Vaccine Development, Bill and Melinda Gates Foundation

PanelDavid Ecker, PhDDivisional Vice President, Carlsbad Site General Manager, Abbott

Rekha Murthy, MDVice President, Medical Affairs, Associate Chief Medical Officer, Professor

of Medicine, Cedars-Sinai

Quita HighsmithFranchise Head, Tamiflu, Genentech

Bill Lee, PhDExecutive Vice President, Research, Gilead Sciences

Thomas Frieden, MDDirector, Centers for Disease

Control and Prevention

Embracing PreparednessFollowing 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 any-thing, 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, prepared-ness 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 DiagnosticsDavid 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 valid-ity 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 tech-nologies that detect potential new threats, whether we are looking for them or not.

“Once you know what something is, you make a targeted diagnostic, such as a PCR [polymerase chain reaction] test or an im-munological 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 col-lected and de-identified so we can watch what’s happening on a macro scale.”

FundingOne of the main challenges with pan-demic 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 strat-egy 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 stockpil-ing. 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 bipar-tisan support.

The challenges of relying on an annual appropriations cycle to successfully de-velop 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 pub-lic health and medical preparedness and re-sponse capabilities for emergencies, whether deliberate, accidental or natural. Today, the U.S. is far better equipped to anticipate, de-tect and respond to threats than most coun-tries, 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 respond-ing to SARS, H1N1, Ebola and Zika, there remain critical gaps that must be filled.

Public/Private PartnershipsThe panel was unanimous on the need for increased collaboration between indus-try and various government agencies.

“There’s a lot of competition between agencies,” said Dr. Lee. “When we in-teract 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.”

“The paradox of preparedness is that we are both better prepared than ever before and at greater risk.”

—Thomas R. Frieden, MD, Director, Centers for Disease Control and Prevention

CLSA Bay Area250 East Grand Ave.,

Suite 26, South San Francisco, CA

94080

CLSA Sacramento1201 K St. Suite 1840,

Sacramento, CA 95814

CLSA San Diego9191 Towne Centre

Drive, Suite 450, San Diego, CA 92122

Phone: (858) 551-6677

CLSA Los Angeles605 East Huntington

Drive, Suite 103, Monrovia, CA

91016

CLSA Washington D.C.1350 I Street, NW,

Suite 830, Washington, DC

20005

Learn more at www.califesciences.org

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 innova-tive 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 TeamSara 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

Recommended Policy ChangesThe 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 eliminat-ing the Office of Management and Budget (OMB) review of BioShield procurements.

© 2016 California Life Sciences Association (CLSA)