importance of research and development partnerships for ...barda’s use of novel partnering...
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Importance of Research and
Development Partnerships
for Innovation
Joe Larsen, Ph.D.Director
BARDA Division of CBRN Medical Countermeasures
June 2017
Resilient People. Healthy Communities. A Nation Prepared
Support the advanced development and procurementof medical countermeasures for CBRN threats,pandemic
influenza, and emerging infectiousdiseases
BARDA’s mission
R&D Partnerships
• Critical to success
• Infectious disease preparedness is a global
affair-no one group can go it alone
• BARDA has successfully formed
public:private partnerships with industry
• Collaborate/leverage where you can to make
you investment more impactful
Characteristics of Successful
Partnerships
• Shared vision
• Flexible, nimble partnerships
• Resource sharing where possible
R&D Partnerships
Examples
BARDA’s use of novel partnering
mechanisms
• BARDA has established 4 partnerships
using Other Transactional Agreements
• Used with GSK, AstraZeneca (Pfizer), Roche,
and the Medicines Co to form stable
strategic commitments to those companies
• Maximizes flexibility, allows for collaborative
decision making, cost sharing
AZ:BARDA:IMI partnership
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DTRA: BARDA: JPEO Collaboration
• Collaborate on the development of
geptotidacin, a novel antibiotic
• DTRA discovered the chemical series,
conducted biodefense testing
• BARDA supported the CMC, clinical
development
• JPEO plans to support clinical trials to
support biodefense indications
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International Collaboration
BARDA & Taiwan
Background:• On June 27, 2015 a color festival
celebration turned in to a burn mass casualty.
• At a concert held at a water park, where many gathered in drained pools.
• Color powder dust ignited and caused a massive explosion.
• About 470 people had varying degrees of burns. To date, 15 victims died while many remained hospitalized with severe burns.
Formosa Fun Coast
in New Taipei City
Taiwan
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International Collaboration
BARDA and Taiwan
Collaboration Goals:
Lessons to Learn for Burn Care Preparedness
• BARDA and TECRO (Taipei Economic and Cultural Representative Office in the United States) are in active collaboration
• BARDA with burn experts from ABA and Taiwan will study various aspects of the burn casualty response in an urban environment.
1. Impact assessment of new burn MCMs under development
2. Identify critical factors in burn response to address in a national context
CARB-X
A portfolio of ~20 antibacterial candidates
Private sector approach to funding/portfolio management
A minimum of 2 candidates progress to clinical development
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• BARDA is a member of the Trans-Atlantic Task
Force on Antimicrobial Resistance (TATFAR)
• Joint US:EU/Canada Norway partnership to
coordinate efforts on AMR
• BARDA is working towards building consensus
internationally on economic incentives for
antibacterial drug development
• See Sciarretta et al., 2016 CID
• See Ardal et al., in press CID
TATFAR