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October 29-30, 2018 | Grand Hyatt • Washington, D.C.
Influenza and Emerging Infectious Diseases (IEID) Vaccine
Development
Armen Donabedian, PhDBranch Chief, Vaccine Development
October 29, 2018
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2Saving Lives. Protecting Americans.
Public Health Impact of Influenza
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3Saving Lives. Protecting Americans.
Influenza Pandemic Preparedness AccomplishmentsH7N9
stockpile
2013-2018Goal Goal
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4Saving Lives. Protecting Americans.
One develops disease
Domestic CapacityGaps
Speed/Flexibility
Adjuvantsupply
Ongoing Influenza Countermeasure Initiatives
Antigensupply
Better, Faster, Flu Vaccines
Efficacy
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5Saving Lives. Protecting Americans.
Domestic Capacity Gaps
diseases
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6Saving Lives. Protecting Americans.
Speed
diseases
Modernized release testing Break Though Vaccine!
Multi-target
e.g. CMIAdministration technologies
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7Saving Lives. Protecting Americans.
Effectiveness
diseases
Multiple immune pathways Vaccine Targets HA stem
Mucosal Immunity
Improved vaccine formulationsAdjuvants
Single Dose
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8Saving Lives. Protecting Americans.
Speed >> Efficacy
Infectious
diseases
Later Vaccine with Higher Efficacy Earlier Vaccine with Lower
Efficacy
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9Saving Lives. Protecting Americans.
Partnership Requirements The vaccine candidate must offer a
substantial improvement in
pandemic response
Evidence of substantial improvement
Phase 1 IND
clinical trial
Manufacturingfeasibility at scale
Regulatory + Commercialization
plans
TONS!HIGH CAPACITY
PresenterPresentation Notes
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10Saving Lives. Protecting Americans.
The ‘End-to-End’ Solution
Product Approval Information -Licensing ActionDEPARTMENT OF
HEALTH AND HUMAN SERVICESCenter for Biologics Evaluation and
ResearchFood and Drug Administration
Dear Development Innovator,
Your biologics license application for Awesome is approved
effective this date…
Sustainability
Licensure
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11Saving Lives. Protecting Americans.
CollaborationSolicitation Number: BAA-18-100-SOL-00003
Area of Interest #8: Influenza and Emerging Infectious Diseases
(IEID) Vaccines
• 8.1 Advanced development of more effective influenza vaccine
candidates
• 8.2 Innovative vaccine production enhancements.
Technical Point of Contact: Armen Donabedian;
[email protected]
PresenterPresentation Notes.
mailto:[email protected]
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12Saving Lives. Protecting Americans.
https://www.phe.gov/about/BARDA/Pages/default.aspxProgram
description, information,
news, announcements
www.fbo.gov/(“FedBizOpps”)
Official announcements and info for all government contract
solicitations
www.drive.hhs.govDRIVe questions
https://www.usajobs.gov/Join the team!
medicalcountermeasures.gov/home.aspx
Portal to BARDA: Register to request a TechWatch meeting!
How to contact BARDA
https://www.phe.gov/about/BARDA/Pages/default.aspxhttp://www.fbo.gov/http://www.drive.hhs.gov/https://www.usajobs.gov/https://www.medicalcountermeasures.gov/home.aspx
Influenza and Emerging Infectious Diseases (IEID) Vaccine
DevelopmentPublic Health Impact of InfluenzaInfluenza Pandemic
Preparedness AccomplishmentsSlide Number 4Domestic Capacity
GapsSpeedEffectivenessSpeed >> Efficacy Partnership
Requirements The ‘End-to-End’ Solution CollaborationHow to contact
BARDA
