OPPORTUNITIES FOR HHS & DOD COLLABORATION FOR MEDICAL COUNTERMEASURES

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Ethelbert Atkins
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1 OPPORTUNITIES FOR HHS & DOD COLLABORATION FOR MEDICAL COUNTERMEASURES Dr. Robert P. Kadlec Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services 2017 Chemical and Biological Defense Science & Technology Conference November 29, 2017

2 Overview Threat Landscape ASPR Mission ASPR & BARDA History The BARDA Model Priorities for Improvement Opportunities for DOD-HHS Collaboration Q&A 2

3 21 st Century: An Increasingly Complex & Dangerous World

4 ASPR Mission Save Lives, Protect America from 21 st Century Health Security Threats 4

5 ASPR s Raison D etre: Unity of Command Public Law Pandemic & All-Hazards Preparedness Act 5

6 BARDA Created To Bridge Valley of Death Flexible, nimble authorities Cutting edge expertise Multi-year funding Facilitate partnerships Promote innovation 6

7 BARDA Has Had a Successful Decade Built in-house technical expertise Formed strong partnerships with industry, leading to 34 FDA licensed products Added 14 products to SNS under Project BioShield, ready for emergency use Significantly expanded pandemic influenza domestic vaccine production capacity Accelerated antibacterial product development 7

8 The BARDA Model Continues to Improve Core Services MCM Development MCM Stockpiling Infrastructure Dedicated & Talented Team FDA Approvals Partnerships 8

9 BARDA Invested $1.5 Billion in MCMs in FY17 Pandemic Influenza $268.1 M Zika $262.9 M Project BioShield $531.1 M Advanced Research & Development $452.0 M Ebola $42.8 M 9

10 Project BioShield Led to 14 New Stockpiled MCMs for CBRN Threats 27 products supported 14 products added to the Strategic National Stockpile 6 products taken to FDA approval/licensure/clearance 1

11 ASPR Priorities for Building Readiness for 21 st Century Threats Strong Leadership Public Health Security Capacity National Disaster Healthcare System Medical Countermeasures Enterprise 11

12 We Must Enhance ASPR s Operational Capabilities Focus on mission and response orientation Streamline processes, increase efficiencies Improve connectivity & cooperation across intraagency partners Enhance partnerships & engagements at the federal, state and local levels 12

13 ASPR Now Becoming More Operational 13

14 We Must Continue to Optimize MCM Enterprise Define threats & requirements Identify spectrum of MCM candidates Advance best candidates Procure, store, sustain Educate, train responders 14

15 Key Areas for HHS MCM Enterprise Improvement Ensure MCM enterprise is driven by current threats Streamline & simplify internal processes Promote innovation, capitalize on advances in science and biotechnology Make decisions to down-select MCM candidates Promote flexible, fast responses Sustain progress made over the last decade Engage, train first responders Ensure capability to quickly distribute & dispense MCMs 15

16 Opportunities to Build Greater Bridges Between HHS & DOD MCM Programs Identify common purpose Threats Preparedness gaps Set joint MCM requirements Leverage strengths & assets Create joint MCM pipeline Implement MCM Innovation Partner Other 16

17 Grit, Ingenuity & Perseverance 17

18 What is Our Common Purpose? What Can We Do Better Together? DOD HHS Greater Impact 18

Large Scale Production Preclinical Phase

19 Shared Interest in Flexible Rapid Response Capability MCM Development Stage Large Scale Production Preclinical Phase I Phase II Phase III Licensure Outbreak! MCM candidate based on Platform Technology New Threat Data For any outbreak: Rapid development Rapid manufacturing Rapid response New MCM candidate CIADMs Rapid response 1

20 Shared Interest in Innovative Diagnostics Infection Diagnosis Appropriate treatment + Wearable diagnostic Infection Diagnosis For any outbreak: Faster identification Faster response Real time epi data Appropriate treatment

21 Set MCM Requirements Together DOD Warfighter Needs Joint Needs HHS Civilian Needs 21

22 Leverage Diverse Strengths & Assets Build on BARDA + Industry partnership success Leverage subject matter expertise across DOD & HHS Form joint program teams to manage programs Utilize flexible contracting authorities Other? 22

23 Leverage BARDA s Core Services for DOD Needs 2012 CIADMs: Centers for Innovation in Advanced Development & Manufacturing Regulatory & Quality Affairs 2006 Fill Finish Manufacturing Network 2013 Quantitative Analytical Modeling Hub 2009 Nonclinical Development Network 2011 Clinical Studies Network

24 Create Joint MCM Pipeline Reimagine PHEMCE Coordinate BARDA CIADMs & DOD ADM Align common priorities Combine efforts to support funding requests 24

25 Implement MCM Innovation Partner Together Sec. 3084: MCM Innovation Partner Sec. 3086: MCM priority review voucher program 25

26 2018 Will Be A Big Year PAHPA Reauthorization National Biodefense Strategy National Health Security Strategy 100 year anniversary of 1918 influenza pandemic Implementation of 21 st Century Cures 2017 hurricane season after action 26

27 Together, We Can Protect America Better DOD HHS Greater Impact 27

28 We want to hear from you. Questions? What can we do better? 28

29 ASPR on the Web ASPR TRACIE: asprtracie.hhs.gov HHS empower Map: 29

30 BARDA s Partnership Model Leads to FDA Approvals and Licensures

Application of Single-Use Technologies in Medical Countermeasure Development & Manufacturing for Emerging Pathogens

Application of Single-Use Technologies in Medical Countermeasure Development & Manufacturing for Emerging Pathogens BPSA s 7 th Annual Int l Single-Use Summit July 13, 2017 Mike Angelastro Director (acting),