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

7

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

9

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

10

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

12

• 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

Thank you joseph.larsen@hhs.gov

202-260-0050

Questions?