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Agenda

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November 7-8, 2017

8:00 AM to 5:00 PM Daily
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Washington, D.C.

1300 Pennsylvania Avenue NW
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Innovation in products and partnerships for flexible, dynamic response capabilities

Exhibitors located in Amphitheater Foyer: BARDA TechWatch, DoD, NASA, ASPR/AMCG and NIH

Day 1: Tuesday, November 7th, Plenary Session - Amphitheatre

8:30 - 9:30

Presentation

BARDA Welcome

Dr. Rick Bright

Deputy Assistant Secretary for Preparedness and Response
Director, Biomedical Advanced Research and Development Authority
Department of Health and Human Services

Presentation

Keynote Address (PDF - 1MB)

Dr. Robert Kadlec

Assistant Secretary for Preparedness and Response
Director Department of Health and Human Services

9:30-9:45 BREAK
9:50-11:00 Medical Countermeasures for the 21st Century: BARDA Strategy
11:05-11:40 Innovative Technologies, Products, and Platforms
11:40-12:00 Questions and Answers
12:00-12:20 Reflections from the FDA: Ms. Anna Abram, Deputy Commissioner for Policy, Planning, Legislations and Analysis, Food and Drug Administration
12:30-1:30 LUNCH
  Breakout Sessions
Amphitheatre
Breakout Sessions
Polaris AB
Breakout Sessions
Oceanic AB
1:30-2:30 Chemical, Biological, Radiological and Nuclear Programs Design and Development Of Next Generation Pandemic Influenza Vaccines

Chris Roberts, NIH
Michelle Crank, NIH
Jerry Weir, FDA/Division of Viral Products/Office CBER
Armen Donabedian, BARDA
Jonathan Seals, BARDA

Modeling: Using Data to Predict Infectious Diseases

Jessica Appler, BARDA
Jason Asher, Leidos
Melissa Willis, BARDA
Mary Homer, BARDA
Mary Beth Hill, BARDA

2:30-3:45 Chemical, Biological, Radiological and Nuclear Programs Rapid Response Manufacturing Platforms

Nicole Kilgore, DoD
Colleen Sico, NIH
Robert Fisher, ASPR
Melissa Willis, BARDA
Eric Espeland, BARDA
Jonathan Seals, BARDA

Innovations in Clinical Trial Design for Emergency MCMs

Scott Berry, Berry Consultants
Michael Merchlinsky, BARDA
Tom Moench, Mapp Bio
Barbara Styrt, FDA
George Risi, BARDA

3:45-3:55 BREAK
3:55-5:00 Pandemic Influenza and Emerging Infectious Disease Programs Repurposing MCMs to Address Chemical Threat Pulmonary Injury

Judy Laney, BARDA
Efrain Garcia, BARDA
Kristen Herring, BARDA
Tom Hu, BARDA
Robert Raulli, BARDA

Developing Nonclinical Models with Partners

Gabriel T. Meister, Battelle Biomedical Research Center (BBRC)
Isabel L. Jackson, University of Maryland School of Medicine
Matthew D Reed, Lovelace Biomedical and Environmental Research Institute
Claiborne Hughes, BARDA
James Little, BARDA
Michael Merchlinsky, BARDA

Day 2: Wednesday, November 8th, Plenary Session - Amphitheatre

8:30 - 8:50

Presentation

Keynote Address

Senator Tom Daschle

Founder and CEO, The Daschle Group

8:55 - 9:15

Presentation

Partner Perspective (PDF - 770KB)

Dr. Lee Swem

Chief Scientific Officer, Achaogen, Inc.

9:20 - 9:40

Presentation

Partner Perspective (PDF - 1.7MB)

Dr. Paul Stoffels

Chief Scientific Officer, Johnson & Johnson

9:45 - 10:00

Presentation

NASA Perspective

Dr. Craig Kundrot

Director, Space Life and Physical Sciences Research & Applications Division, National Aeronautics and Space Administration

10:00-10:15 BREAK
10:15-10:30 Perspectivies on Contracting/Acquisition (PDF - 140KB): Mr. Jess Scarbrough, Director, Acquisition Management, Contracts & Grants (AMCG)/ASPR Head of the Contracting Activity
10:35-10:50 BARDA Broad Agency Announcement (PDF - 340KB): Dr. Gary Disbrow, BARDA Acting Deputy Director and Ms. Brooke Bernold, Section Chief, AMCG
10:55-11:10 Other Transaction Agreements (OTA) (PDF - 790KB): Dr. Francine Hemphill, Section Chief, AMCG
11:15-11:30 CARB-X (PDF - 2.4MB): Mr. Tyler Merkeley, CARB-X Manager, BARDA
11:35-11:50 DoD Perspective: Mr. Doug Bryce, Joint Program Executive Officer for Chemical and Biological Defense, Department of Defense
11:50-12:00 Questions and Answers
12:00-1:15 LUNCH
  Breakout Sessions
Amphitheatre
Breakout Sessions
Polaris AB
Breakout Sessions
Oceanic AB
1:15-2:15 BARDA BAA: An Introduction

Efrain Garcia, BARDA
Ruben Donis, BARDA
Gary Disbrow, BARDA
Joe Larsen, BARDA
Oke Obi, AMCG

DoD/Collaborating on MCM Priorities

Matt Hepburn, DARPA
Julie Boylan, DTRA
Tim Belski, JPEO
Renae Malek, CDM-JPdMO
Dan Wolfe, BARDA
David Simon, BARDA
Judy Laney, BARDA
Mary Homer, BARDA
Chris Houchens, BARDA

Emergency Use Authorizations and Pre-Authorizations for MCMs

Brooke Courtney, FDA
Kimberly Grantham, BARDA
Silvija Tresnjak-Smith, BARDA
Susan Hollingsworth, BARDA
Nina El-Badry, BARDA

2:20-3:20 The CARB-X Model

Tyler Merkeley, BARDA
Heather Shane, California Life Sciences Institute
Zachary Zimmerman, Forge Therapeutics
John Mueller, Entasis Therapeutics

Other Transaction Agreements with BARDA: Concept and Experiences

Mark Armitage, Janssen
Ramon Polo, Janssen
Michelle Linfesty, The Medicines Company
Melissa Willis, BARDA
Chris Houchens, BARDA
Kyle Roberts, AMCG
Francine Hemphill, AMCG

BARDA/Success in Developing MCMs: Case study

Liz Morgan, The Medicines Company
Phil Gomez, SIGA Technologies, Inc.
Andrew Albright, BARDA
Kimberly Armstrong, BARDA

3:20-3:30 BREAK
3:30-5:00 Next Generation Economic Incentives for MCM Development

Jane Ennis, MAPP Bio
Nicole Mahoney, Merck
Phil Gomez, SIGA Technologies
Barrett Thornhill, AIA
Amesh Adalja, Johns Hopkins University
Joe Larsen, BARDA
Marina Kozak, BARDA
Kim Sciarretta, BARDA

FDA/Regulatory Considerations for MCM Development

Heather Agler, FDA CDR
Qiao Bobo, FDA
Nina El-Badry, BARDA
Wylie McVay, BARDA
Danielle Turley, BARDA

CIADMs: Capabilities and How to Access Services

Ian Henderson, Emergent BioSolutions
Jay Treat, Texas A&M University System
Robert House, Ology Bioservices
Tim Belski, DoD
Michael Angelastro, BARDA


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