1. 2018 FLC Interagency Partnership Award: Zika Virus Specimen and Material Sharing
FLC National Meeting
Philadelphia, PA
April 25, 2018
Maria Julia Marinissen, Ph.D.
Director, Division of International Health Security
Office of Policy and Planning
Office of the Assistant Secretary
for Preparedness and Response
U.S. Department of Health and Human Services
Michael R. Mowatt, Ph.D.
Director, Technology Transfer and Intellectual Property Office
National Institute of Allergy and Infectious Diseases
National Institutes of Health
U.S. Department of Health and Human Services
Kevin Brand, M.S., J.D.
Patent Advisor, Technology Transfer Office
Office of Technology and Innovation
Office of the Associate Director for Science
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

4. November 11, 2015 Brazil declares a public health emergency
December 1, 2015 PAHO issues a public health alert
February 1, 2016 WHO declares a Public Health Emergency of International Concern (PHEIC)
February 8, 2016 President Obama sends Congress $1.9B request to combat Zika outbreak
After two and a half thousand cases of microcephaly brazil declared a public health emergency. After calling a meeting of independent experts, the WHO declares.

6. Urgent Needs and Daunting Challenges
Address a rapidly evolving public health crisis involving a poorly understood pathogen
Enable rapid sharing of samples to advance research, understand the disease, and support development of diagnostics and medical countermeasures
Daunting Challenges
Limited public health response measures
Limited diagnostic capability
No vaccines or therapeutics
Reluctance of affected countries to share samples

7. Sample Sharing Challenges During Past Public Health Crises
Influenza H5N1
MERS
EBOLA
Influenza H7N9

8. HHS Interagency Partnership Approach
ASPR, CDC and NIAID collaborated to fashion a response to the Zika Public Health Emergency
These three HHS agencies led the USG effort and worked with other agencies including Departments of Defense, Commerce, and State for a whole-of-government approach

9. HHS Interagency Collaboration : ASPR
Domestically:
Created and led USG Sample Sharing Working Group (SSWG) with subject matter experts from across the USG interagency
Drafted USG framework that coordinates USG access to samples in the context of a PHEIC
With input from Legal and TTOs, develop a standard MTA for emergency use – Emergency Use Simple Letter Agreement (EUSLA)
Internationally:
Created the Sample Sharing Task Group within the Global Health Security Initiative (GHSI; G7, Mexico, European Commission, WHO as advisor)
Developed the a GHSI sample sharing framework for like-minded countries to exchange non-influenza pathogens during emergencies
Implemented by the GHSI Laboratory Network
U.S. contribution supported by the SSWG

10. Example of Original SLA

11. Zika EUSLA
3. The MATERIAL may be used for any legitimate purpose required to rapidly prevent, detect, prepare for and respond to the spread or transmission of [Zika virus].

12. Zika EUSLA
4. The MATERIAL may be further distributed to other entities for the purpose described in paragraph 3 under terms no more restrictive than this Agreement.

13. HHS Interagency Collaboration: CDC
January 22, 2016: CDC Emergency Operations Center activated
April 13, 2016: Announced Zika as the cause of microcephaly and other severe fetal brain defects
Acquired critical Zika resource materials (viral isolates and Zika+ serum samples) from Puerto Rico and Panama
Collaborated with CDC and HHS ASPR to develop EUSLA
Shared Zika resource materials with NIAID for distribution
Developed Zika diagnostic tests and received FDA
Emergency Use Authorization to send test kits to public
health labs
Zika surveillance on US mainland and territories with
on ground support in Puerto Rico, Brazil, and Columbia
Facilitated ~160 transfers of Zika resource materials with requestors (academic, government and industry) subject to the EUSLA
Leveraged Zika response efforts to establish RCAs and CRADAs with companies interested in co-development of Zika vaccines/diagnostics

14. HHS Interagency Collaboration : NIAID
Contributed Zika isolates (archival isolates as well as new ones from Mexico and from patients in the US)
Received Zika isolates from CDC
Worked with 17 institutions to acquire Zika materials
Adapted new viral isolates to in vitro culture – this was a BIG challenge but a critically important achievement
Sequenced viral isolates and made data available for further research
Collaborated with CDC and HHS ASPR to develop EUSLA
Modified NIAID contractor process for sending out and receiving samples, requiring amendment and modification of the contract
Sent materials to 124 universities, hospitals, and research institutes; 43 biotech and pharma companies; 16 federal agencies and state public health departments in 23 countries
Executed 430 agreements

15. Sample Sharing Outcomes During Zika
Recipient Countries for Zika Virus Specimens and Materials
Fulfilled 1,865 requests for Zika materials under EUSLA
Distributed materials to 35 states, Puerto Rico, and 23 countries
Completed 430 agreements, enabling distribution to 124 universities, 43 biotech and pharma, 16 USG agencies & state public health agencies, and 4 foreign governments
Facilitated development of several diagnostic tools and other medical countermeasures
Shared samples with GHSI countries
Shared serological diagnostics with state public health laboratories
The map depicts country Zika specimen and material requests fulfilled through BEI Resources. Map courtesy of Haiqing Li, NIH NIAID.
Recipient States for Zika Virus Specimens and Materials

16. Next Steps
Incorporate lessons learned from implementing the Zika EUSLA to finalize the draft USG framework for sample sharing and formally establish it as policy – tested in real life
Continue solidifying USG interagency collaboration to address the complex, multi-sectoral issues around sample sharing during an emergency
Work with public health community to develop a global collaborative solution to facilitate sample sharing for non-influenza pathogens, including consideration of a global standard MTA for use during emergency situations

17. A Total Team Effort! Brent Davidson (ASPR) Mukul Ranjan (NIAID)
Joseph Foster (OGC)
Susan Sherman (OGC)
Dale Berkley (OGC)
Dana Hsu (NIAID)
Cristina Cassetti (NIAID)
Kimberly Stemple (NIAID)
Michael Finn (NIAID)
Ruvani Chandrasekera (ASPR)
Brent Davidson (ASPR)
Wendi Kuhnert-Tallman (CDC)
Barbara Johnson (CDC)
Brandy Russell (CDC)
Juliana Cyril (CDC)
Naureen Iqbal (CDC)
Lisa Blake-DiSpigna (CDC)
Suzanne Seavello Shope (CDC)
Other key contributors: Rosemary Humes (ASPR); Michael Shaw (CDC);
Robert Fisher (FDA); Toby Merlin (CDC); Ann Powers (CDC); Walla Dempsey (NIAID);
Lauren Barna (ASPR)