Successful Collaboration and Preparedness in Global Governance
|
|
|
- Chad Cobb
- 5 years ago
- Views:
Transcription
1 United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Successful Collaboration and Preparedness in Global Governance ISARIC meeting London, UK November 30, 2015 Dr. Robin Robinson BARDA Director ASPR Deputy Assistant Secretary ASPR: Resilient People. Healthy Communities. A Nation Prepared. 0
2 Some Threats Are Very Large: Pandemic Influenza 1918: Spanish Flu 1957: Asian Flu 1968: Hong Kong Flu A(H1N1) A(H2N2) A(H3N2) m deaths ~500,000 in US 1-4 m deaths 60-80,000 in US 1-4 m deaths ~30,000 in US 1976 Swine Flu The No-Show Pandemic 2009 H1N1 Pandemic 1
3 Other Threats Are Ominous: High Pathogenic Avian Influenza Viruses H5N present 2013 H5N1 2
4 Ebola is both a biothreat and an emerging infectious disease MERS-CoV H5N1 3
5 Human Coronaviruses continue as emerging infectious diseases SARS-CoV MERS-CoV MERS-CoV H5N1 4
6 5 CBRN Material Threats Radiological and Nuclear agents Bacillus anthracis (anthrax) Bacillus anthracis Multi-drug resistant (MDR anthrax) Botulinum toxins (botulism) Variola virus (smallpox) Yersinia pestis (plague) Franciscella tularensis (tularemia) Hemorrhagic Fever Viruses - Ebola, Marburg Burkholderia mallei (glanders) Burkholderia pseudomallei (melioidosis) Rickettsia prowazekii (typhus) Low volatility and volatile nerve agents Hydrogen, potassium, and sodium cyanide Pillar 1 Identify and Assess CBRN Threats
7 6 Threat-Based Preparedness & Response
8 7
9 8 All-Hazards Principle Seasonal & Pandemic Influenza Preparedness All Hazards Preparedness CBRN Preparedness Emerging Diseases Preparedness
10 Medical Countermeasures 9
11 10 Medical Countermeasures Medical Devices Antimicrobials Diagnostics Vaccines Therapeutics
12 Vaccine & Drug Development is still Expensive, Risky and Lengthy 11 PHASES Preclinical Development IND NDA/BLA Discovery Phase I Phase II Phase III Licensure Production & Delivery PRODUCT PIPELINE NIH NIH & ($11.8B) DoD MERS-COV MCMs Valley of Death Ebola MCMs BARDA ARD ($540M) Project BioShield ($5.6B) Licensed Product 1-3% 5-17% 10-25% 18-35% 45-70% 90% PROBABILITY OF SUCCESS TO LICENSURE TIME PIPELINE PHASE COST 3-7 yr yr 1-2 yr yr yr 1-2 yrs $100M -130M $60-70M $70M-100M $130M-160M $190M-220M $18M-20M
13 Statutory Authorities 12
14 13 Biodefense MCM History Project BioShield Act (2004) Pandemic & All-Hazards Preparedness Act (2006) Medical Countermeasure Review (2010) Pandemic & All-Hazards Preparedness Reauthorization Act (2013) PHEMCE Strategic & Implementation Plan (2014) Mid-1950 s on: DoD bio and chem defense programs 9/11 terrorist attacks and anthrax letters Project BioShield (Jul 2004) PREP Act (Dec 2005) PAHPA (Dec 2006) BARDA (Apr 2007) 2009-H1N1 Pandemic (Apr 2009 Aug 2010) PAHPRA st Gulf War Iraqi BW, CW & nuke programs NPS founded (1999) Animal Rule (May 2002) National Strategy for Pandemic Influenza (Nov 2005) PHEMCE Strategy (Mar 2007) Integrated Portfolio (Mar 2008) PHEMCE Review (Aug 2010) PHEMCE SIP 2014
15 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Governance 14 ASPR/ NIH ASPR/ BARDA CDC/SNS CDC and CDC OPP BARDA CDC/SNS BARDA ASPR/OPEO ASPR Requirements R & D Advanced Development FDA FDA Acquisition & Stockpiling Storage/ Maintenance Deployment Evaluation PHEMCE COORDINATED PLANNING & EXECUTION Other Members:
16 15 DHS : PHEMCE CBRN Medical Countermeasure Process Pillar 1 Identify and Assess Threats BARDA Pillar 2 Evaluate Medical and Public Health Consequences ASPR/OPP Pillar 3 Establish Medical Countermeasure Requirements NIH BARDA CDC Pillar 4 Implement SIP for MCM Development & Acquisition
17 BARDA MCM Story 16 ASPR: Resilient People. Healthy Communities. A Nation Prepared.
18 BARDA s Mission Support advanced development of and make available medical countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases by transitioning MCM candidates from early development across the Valley of Death into advanced development to regulatory approval O Neil Building, Washington, DC ASPR: Resilient People. Healthy Communities. A Nation Prepared.
19 BARDA Strategic Goals Goal 1: An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multipurpose and broad spectrum application, and long-term sustainability Goal 2: A capability base to provide enabling core services to medical countermeasure innovators Goal 3: Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines and other biologics against pandemic influenza and other emerging threats Goal 4: Responsive and nimble programs and capabilities to address novel and emerging threats Goal 5: A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies 18 ASPR: Resilient People. Healthy Communities. A Nation Prepared.
20 BARDA Key Element #1: Create Robust & Innovative MCM Development Pipeline ~ 200 MCM product candidates in development 250 PBS H5N1 PAHPA H1N1 BARDA ERA MCM Review PAHPRA H7N9 Ebola MERS-CoV EID FLU CBRN ASPR: Resilient People. Healthy Communities. A Nation Prepared. 19
21 BARDA Key Element #2: Stockpile CBRN MCMs under Project BioShield Smallpox Radiation Anthrax Thermal Burns 2015 Chemical Botulism ASPR: Resilient People. Healthy Communities. A Nation Prepared. 20
22 BARDA Success Key #3: Seek FDA Approval Cell-based Influenza Vaccine Influenza IV Antiviral Drug Novartis Recombinant-based Influenza Vaccine Protein Sciences Corp. Anthrax Antitoxins H1N1 & H5N1 Vaccines w/ Adjuvant Botulinum Antitoxin HGS/GSK Emergent GlaxoSmithKline Next-Generation Portable Ventilators Covidian Flu/RSV POC Diagnostic Cangene 3M/Focus Amgen ASPR: Resilient People. Healthy Communities. A Nation Prepared. 21
23 BARDA Key Element #4: Establish & Nurture Partnerships ASPR: Resilient People. Healthy Communities. A Nation Prepared
24 BARDA Key Element #5: Establish Robust Manufacturing Capacity Expanding Existing Capacity by Retrofitting Vaccine Manufacturing Infrastructure New Vaccine Mfg. Facilities 2013 ISPE Facility of the Year sanofi pasteur Swiftwater, PA Novartis Holly Springs, NC ASPR: Resilient People. Healthy Communities. A Nation Prepared. 23
25 BARDA Key Element #6: Help MCM Developers for Preparedness & Response CIADMs 2012 Regulatory & Quality Affairs 2006 Fill Finish Mfg. Network 2013 ADS Modeling Hub 2009 Nonclinical Development Network 2011 Clinical Studies Network 2014 ASPR: Resilient People. Healthy Communities. A Nation Prepared. 24
26 BARDA Key Element #7: Have the Best Technical, Clinical, & Regulatory Staff ASPR: Resilient People. Healthy Communities. A Nation Prepared. 25
27 Global Biopreparedness State of Affairs 26 ASPR: Resilient People. Healthy Communities. A Nation Prepared.
28 Key MCM R&D Challenges Ebola Licensure of vaccines(s), Rx clinical studies, & Survivor transmission Pandemic and Seasoanl Influenza Antigenic drift & and seasonal influenza vaccine mismatch Antibiotic Drug Ressitance New drug R&D: conventional & unconventional Global networks for clinical studies MERS-CoV Complete the MERS-CoV basic and translational R&D towards MCM development & approval & clinical study infrastructure in Middle East Rx & vaccine licensure pathways? Mass vaccination campaigns occur? Stockpiles? What about camel vaccines? ASPR: Resilient People. Healthy Communities. A Nation Prepared. 27
29 Global Biopreparedness Amidst Uncertainties Will emergency R&D for EIDs become the new norm? Will bioterrorism fatigue, disbelief, & denial persist? Global biopreparedness IOM, GloPID, ISARIC, Grand Convergence, & WHO consultations: Who is steering the ship and where are we going? ASPR: Resilient People. Healthy Communities. A Nation Prepared. 28
30 Contact Us BARDA: URL: BARDA Upcoming Events PHEMCE Strategy and Implementation Plan CBRN and Pan Flu Programs Business Toolkit Tech Watch program Federally-sponsored conferences Funding opportunities Resources 7 core service programs Regulatory guidance Federal strategies and reports ASPR: Resilient People. Healthy Communities. A Nation Prepared.
PROMOTING AN EFFECTIVE MEDICAL COUNTERMEASURES ENTERPRISE
PROMOTING AN EFFECTIVE MEDICAL COUNTERMEASURES ENTERPRISE Gerald R. Kovacs, PhD Director, Division of Chem/Bio/Rad/Nuc Medical Countermeasures Biomedical Advanced Research and Development Authority Assistant
Advancements in CBRN Medical Countermeasures
Advancements in CBRN Medical Countermeasures Gerald R. Kovacs, Ph.D. Division of CBRN Countermeasures Biomedical Advanced Research and Development Authority Presentation at the MARCE Public Health Emergency
8/3/2016 THE BARDA CHEMICAL/RADIOLOGICAL/NUCLEAR COUNTERMEASURES EFFORT. Biodefense MCM History
THE BARDA CHEMICAL/RADIOLOGICAL/NUCLEAR COUNTERMEASURES EFFORT Tom C.-C. Hu, Ph.D. MBA DABMP Interdisciplinary Scientist/Project Officer US Department of Health and Human Services Office of the Assistant
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),
OPPORTUNITIES FOR HHS & DOD COLLABORATION FOR MEDICAL COUNTERMEASURES
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
Financing Influenza Vaccine R&D
Financing Influenza Vaccine R&D WHO GAP-II Geneve, Switzerland July 13, 2011 Robin Robinson, Ph.D. Deputy Assistant Secretary & Director HHS/ASPR/BARDA 0 Vaccine Development is Risky, Lengthy, & Expensive
BARDA s Division of Chemical, Biological, Radiological and Nuclear Medical Countermeasures
BARDA s Division of Chemical, Biological, Radiological and Nuclear Medical Countermeasures Joe Larsen, Ph.D. Director (Acting) BARDA Division of CBRN Medical Countermeasures January 2018 ASPR: Saving Lives
U.S. Readiness for Pandemics
0 U.S. Readiness for Pandemics 5 th National Emergency Management Summit Brooklyn, NY September 15, 2011 Robin Robinson, Ph.D. Deputy Assistant Secretary for Preparedness & Response (HHS/ASPR) Director
TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) SENATE HELP COMMITTEE May 17, 2011 Good morning Chairman
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20117 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY: Department of Health and Human
OPTIMIZING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE DEVELOPMENT: Washington, DC February 22, 2010
OPTIMIZING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE DEVELOPMENT: A REPORT OF THE NATIONAL BIODEFENSE SCIENCE BOARD www.hhs.gov/aspr/omsph/nbsb/ Washington, DC February 22, 2010 The National Biodefense
NIAID Biodefense Research Agenda
NIAID Biodefense Research Agenda Deborah G. Katz, M.S., R.N. Deputy Director Office of Biodefense Research Affairs National Institute of Allergy and Infectious Diseases Princeton University September 8,
Public Health Emergencies: Mass Dispensing in the Community
Public Health Emergencies: Mass Dispensing in the Community Chrissy Gamboa - Pinal County Public Health Chris Lyons, RN - Maricopa County Public Health Role of Public Health in an Disease prevention Emergency
Emergency Use Authorizations
Emergency Use Authorizations May 26, 2016 Quality Improvement Forum Call Celia Hagan, MPH Senior Specialist, Public Policy Overview Emergency Use Authorization (EUA) authority EUA issuance process Zika
MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR FUTURE THREATS?
FEBRUARY 26, 2015 MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR FUTURE THREATS? U.S. SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS ONE HUNDRED FOURTEENTH CONGRESS,
MEDICAL PRODUCTS FOR PUBLIC HEALTH EMERGENCIES GEORGE W. KORCH, JR. PHD ACTING ASSISTANT SECRETARY
MEDICAL PRODUCTS FOR PUBLIC HEALTH EMERGENCIES GEORGE W. KORCH, JR. PHD ACTING ASSISTANT SECRETARY National defense industry association CBRN Conference 15 August 2017 ASPR brings together policy, science,
Product Development for Public Health & Emerging Infections
Product Development for Public Health & Emerging Infections Michael G Kurilla, MD-PhD Director, Office of BioDefense Research Affairs Division of Microbiology & Infectious Diseases Associate Director,
5/8/ Introduction to DEPR. 2. Types of Disasters. 3. State and National Resources. 4. Pharmacy Partners. 5.
Dianne Malburg, Chief Operations Officer Michigan Pharmacists Association Ferris Spring Seminar May 15, 2017 1. Identify key risk hazards, thereby providing the impetus to plan a coordinated response now.
Prepared for Members and Committees of Congress
Prepared for Members and Committees of Congress Œ œ Ÿ Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available countermeasures. In 2003, President Bush proposed
Towards a Sustainable Global Infrastructure for Medical Countermeasures
Towards a Sustainable Global Infrastructure for Medical Countermeasures Institute of Medicine The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from
Approaches to Pandemic Influenza Vaccine Preparedness
United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Approaches to Pandemic Influenza Vaccine Preparedness Julie Schafer, MPH, MS Influenza
BARDA INDUSTRY DAYS 10 th Anniversary November 7-8, 2017
BARDA INDUSTRY DAYS 10 th Anniversary November 7-8, 2017 Below is a summary of the BARDA Industry Days Conference in D.C. November 7-8, 2017. Each year this conference is organized by the Biomedical Advanced
Federal Select Agent Program Overview
Centers for Disease Control and Prevention Center for Preparedness and Response Federal Select Agent Program Overview Samuel S. Edwin, Ph.D. Director, Division of Select Agents and Toxins Boston Public
Occupational Health Program Guidance Document for Working with Tier 1 Select Agents and Toxins
Occupational Health Program Guidance Document for Working with Tier 1 Select Agents and Toxins 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73 05 July 2013 Centers for Disease Control and Prevention (CDC)
President's FY 2009 Budget Request for R&D and Public Health Programs
Request for R&D and Public Health Programs (in millions) : http://www.whitehouse.gov/omb/budget/fy2007/ FY Final Appropriations: http://thomas.loc.gov/home/approp/app08.html FY Levels based on Documents
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS APRIL 2017 Infectious viruses are a global health threat Since the approval of the first antiviral drug
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS MAY 2017 1 Infectious viral pathogens are a significant global health threat to mankind 2 Since the approval
Opportunities for the Future of Healthcare and Public Health Preparedness, Response, and Recovery
Opportunities for the Future of Healthcare and Public Health Preparedness, Response, and Recovery National Academy of Medicine Workshop March 8-9, 2017 Tom Inglesby Healthcare system that can care for
2013 NEHA AEC July 9 11, One Health and All-Hazards: the New Environmental Health. Want this on you?
One Health and All-Hazards: the New Environmental Health Christopher Eddy, MPH, REHS, RS, M.B.A. (candidate) Erik Balster, MPH, REHS, RS July 11, 2013 Next best thing to the Cover of the Rolling Stone?
Influenza Pandemic Preparedness for Clinicians on the Frontline
Influenza Pandemic Preparedness for Clinicians on the Frontline CAPT HA C. TANG, DO US Public Health Service Adjunct Associate Clinical Professor of Dartmouth Medical School, Community/Family Medicine
Agents of Bioterrorism: Argument for and Against a List That Needs Cropping
Agents of Bioterrorism: Argument for and Against a List That Needs Cropping Bioterrorism Preparedness: A Conference for Senior Practitioners and Professionals Dr. Arnold N. Weinberg Professor of Medicine
Pandemic Influenza Preparedness Subpanel
Defense Health Board Pandemic Influenza Preparedness Subpanel Gregory A. Poland, MD Vice-President, Defense Health Board Chair, Select Subcommittee on PI Planning and Response Purpose Brief Background
Global Challenges of Pandemic and Avian Influenza. 19 December 2006 Keiji Fukuda Global influenza Programme
Global Challenges of Pandemic and Avian Influenza 19 December 2006 Keiji Fukuda Global influenza Programme Summary of Current H5N1 Situation 1997 First known outbreak infecting humans 18 people hospitalized
Development and Procurement of Biotechnology for Emerging Disease and Engineered Threats in the Public Health Preparedness Sector
Development and Procurement of Biotechnology for Emerging Disease and Engineered Threats in the Public Health Preparedness Sector John M. Clerici john@tibercreekpartners.com Public Health Preparedness
Dr. Jim LeDuc Director Galveston National Laboratory University of Texas Medical Branch. 29 October 2015
National Academy of Sciences Committee on Federal Regulations and Reporting Requirements: A new framework for research universities in the 21 st Century Select Agents Dr. Jim LeDuc Director Galveston National
CDC Strategies to Strengthen Public Health Emergency Management Programs
CDC Strategies to Strengthen Public Health Emergency Management Programs Christine Kosmos, R.N., B.S.N., M.S. Director, CDC Division of State and Local Readiness ASTHO Eleventh Annual DPHP Meeting October
Conversation with Tom Inglesby on October 2, 2013
Participants Conversation with Tom Inglesby on October 2, 2013 Tom Inglesby, M.D., Chief Executive Officer and Director, University of Pittsburgh Medical Center (UPMC) Center for Health Security Alexander
Centers for Disease Control and Prevention (CDC) FY 2009 Budget Request Summary
Centers for Disease Control and Prevention (CDC) FY 2009 Budget Request Summary The President s FY 2009 Budget Request for the Centers for Disease Control and Prevention (CDC) discretionary funding is
Science. Systems Policy Process Programs People
Expectations Bioterrorism - a real and present danger Anthrax attacks in the United States, 2001 Time Where to Implement Are Changes We and? Unexpected Consequences f Science Systems Policy Process Programs
Approximately 6 years ago, then-president
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 11, Number 2, 2013 ª Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2013.0042 Commentary The Pandemic and All-Hazards Preparedness
Biopharma's Flexible Imperative. Robert Dream Principal, HDR COMPANY LLC April 24, 2013
Biopharma's Flexible Imperative Robert Dream Principal, HDR COMPANY LLC April 24, 2013 Biopharma's Flexible Imperative Introduction Can history help us see the future Comparing 1918 and today Pandemic
Public Safety and Health Cooperation from the Canadian Perspective
1 2 Public Safety and Health Cooperation from the Canadian Perspective Presentation by: Dr. Rainer Engelhardt Assistant Deputy Minister Infectious Disease Prevention and Control Public Health Agency of
Preparing for the Unexpected
Centers for Disease Control and Prevention Center for Preparedness and Response Preparing for the Unexpected Stephen C. Redd, MD Rear Admiral, US Public Health Service Director, Center for Preparedness
An Affordable Pandemic Influenza Vaccine Solution for Developing Countries (and Developed Countries Too)
An Affordable Pandemic Influenza Vaccine Solution for Developing Countries (and Developed Countries Too) James M. Robinson, PE VP Technical and Quality Operations Novavax, Inc. New Cells for New Vaccines
Development of Recombinant MERS-CoV Spike (S) Nanoparticle Vaccine
Development of Recombinant MERS-CoV Spike (S) Nanoparticle Vaccine Russell P. Wilson Senior Vice President, Business Development Vaccine World MENA & CIS 2014 Istanbul, Turkey November 19, 2014 1 www.novavax.com
FY 2008 Appropriations for R&D and Public Health Programs (in millions)
FY 2008 Appropriations for R&D and Public Health Programs (in millions) AGENCY PROGRAM FY 2008 Appropriations Status: http://thomas.loc.gov/home/approp/app08.html FY 2008 : http://www.whitehouse.gov/omb/budget/fy2007/
USG Policy Perspectives on Global Influenza
USG Policy Perspectives on Global Influenza IOM Committee for the Assessment of DoD-GEIS Influenza Surveillance & Response Programs Ms. Ellen P. Embrey Deputy Assistant Secretary of Defense Force Health
Public Health Emergency Preparedness: Looking Back, Moving Forward U.S. Efforts and International Dimensions
United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Public Health Emergency Preparedness: Looking Back, Moving Forward U.S. Efforts and International
Promoting Public Health Security Addressing Avian Influenza A Viruses and Other Emerging Diseases
Promoting Public Health Security Addressing Avian Influenza A Viruses and Other Emerging Diseases Masaya Kato, WHO Viet Nam OIE Regional Workshop on Enhancing Influenza A viruses National Surveillance
EC research and innovation strategy and actions
EC research and innovation strategy and actions for preparedness and response to outbreaks IMI Stakeholder Forum 28-29 September 2016 Line Matthiessen Head of Unit E.3 Health Directorate DG Research &
COMMUNICATING IN A CRISIS
NEWS &TERRORISM COMMUNICATING IN A CRISIS A fact sheet from the National Academies and the U.S.Department of Homeland Security BIOLOGICAL ATTACK HUMAN PATHOGENS, BIOTOXINS, AND AGRICULTURAL THREATS Communication
EPIDEMICS AND PANDEMICS: PREDICTION, PREVENTION, CONTROL?
8 th International Conference GLOBAL HEALTH CONSORTIUM Building Alliances in Global Health Miami, May 22-25, 2018 EPIDEMICS AND PANDEMICS: PREDICTION, PREVENTION, CONTROL? José Esparza MD, PhD - Adjunct
Bioterrorism. Environmental Encyclopedia, 2011 Updated: August 30, 2017 From Opposing Viewpoints in Context
Bioterrorism Environmental Encyclopedia, 2011 Updated: August 30, 2017 From Opposing Viewpoints in Context Bioterrorism refers to the use of lethal biological agents to wage terror against a civilian population.
Linking Pandemic Influenza Preparedness with Bioterrorism Vaccination Planning
Linking Pandemic Influenza Preparedness with Bioterrorism Vaccination Planning APHA Annual Meeting San Francisco, California Lara Misegades, MS Director of Infectious Disease Policy November 18, 2003 Overview
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL INTERIM REPORT 02_2013
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL EXECUTIVE AGENCY FOR HEALTH AND CONSUMERS Health unit Contract number: 2010 21 02 Acronym: QUANDHIP INTERIM REPORT 02_2013 Proposal title: Quality
10/11/2011. H1N1 Influenza Pandemic: Lessons Learned for Today and Tomorrow. H1N1 Influenza Pandemic: Lessons Learned for Today and Tomorrow
H1N1 Influenza Pandemic: Lessons Learned for Today and Tomorrow Michael T. Osterholm, PhD, MPH Director, Center for Infectious Disease Research & Policy Director, Minnesota Center of Excellence for Influenza
Global Health Security: Preparedness and Response: can we do better and stay safe?
Global Health Security: Preparedness and Response: can we do better and stay safe? John Watson Health Protection Directorate, Public Health England Formerly Deputy Chief Medical Officer, Department of
University of Colorado Denver. Pandemic Preparedness and Response Plan. April 30, 2009
University of Colorado Denver Pandemic Preparedness and Response Plan April 30, 2009 UCD Pandemic Preparedness and Response Plan Executive Summary The World Health Organization (WHO) and the Centers for
Synthetic Genomics and Its Application to Viral Infectious Diseases. Timothy Stockwell (JCVI) David Wentworth (JCVI)
Synthetic Genomics and Its Application to Viral Infectious Diseases Timothy Stockwell (JCVI) David Wentworth (JCVI) Outline Using informatics to predict drift (strain selection) Synthetic Genomics: Preparedness
Vaccine Innovation and Adult Immunization Landscape
Vaccine Innovation and Adult Immunization Landscape National Adult and Influenza Immunization Summit, May 12-14, 2015 Phyllis Arthur Senior Director Vaccines, Immunotherapeutics & Diagnostics Policy parthur@bio.org
An Overview of Bioterrorism. SAEMS January 30, Charles A. Schable, M.S. Institutional Biosafety Committee University of Arizona
An Overview of Bioterrorism SAEMS January 30, 2008 Charles A. Schable, M.S. Institutional Biosafety Committee University of Arizona Bioterrorism Intentional or threatened use of viruses, bacteria, fungi,
INFLUENZA PANDEMIC CONTINUED FOCUS ON THE NATION S PLANNING AND PREPAREDNESS EFFORTS REMAINS ESSENTIAL
INFLUENZA PANDEMIC CONTINUED FOCUS ON THE NATION S PLANNING AND PREPAREDNESS EFFORTS REMAINS ESSENTIAL page 1 / 5 page 2 / 5 influenza pandemic continued focus pdf The 2009 flu pandemic or swine flu was
Bioterrorism: Public Health Challenges (Module 1: Bioterrorism Overview and History of Biological Warfare)
Biological Terrorism and Public Health Bioterrorism: Public Health Challenges (Module 1: Bioterrorism Overview and History of Biological Warfare) re) Chemical Terrorism HAZMAT EVENT-----------------------------------PUBLIC
Prof. Dr. Reinhard Burger Robert Koch-Institut
Berlin-Marienfelde, 25. März 2004 Fortbildungsveranstaltung für den Öffentlichen Gesundheitsdienst 2004 Aktuelle Entwicklungen in Infektionsschutz- und Bioterrorismus- Prävention Prof. Dr. Reinhard Burger
Transforming The Approach to Vaccines and Protein- Based Therapeutics. Alain Doucet, Ph.D. Manager, Process Development, Medicago
Transforming The Approach to Vaccines and Protein- Based Therapeutics Alain Doucet, Ph.D. Manager, Process Development, Medicago 2018-08-15 1 Medicago Overview 2 Novel Technologies 3 Robust Pipeline 2
Appendix 3: Federal Government Agencies Involved in Immunization
Appendix 3: Federal Government Agencies Involved in Immunization Department of Health and Human Services (HHS) Secretary of Health and Human Services Directs all HHS activities. Office of the Assistant
BARDA INFLUENZA PROGRAM OVERVIEW
BARDA INFLUENZA PROGRAM OVERVIEW Drs. Armen Donabedian and Michael Wathen Vaccines and Therapeutics Resilient People. Healthy Communities. A Nation Prepared. 0 BARDA Overview 1 Perpetual challenge of responding
Children s Preparedness: An Overview
Children s Preparedness: An Overview Michael Bartenfeld, MA CDC Children s Preparedness Team, NCBDDD Emergency Coordinator NPHIC Call 8/14/2014 National Center on Birth Defects and Developmental Disabilities
100 Years since the 1918 Spanish Flu Pandemic. Current Standards for Flu Pandemic Preparedness
100 Years since the 1918 Spanish Flu Pandemic. Current Standards for Flu Pandemic Preparedness OCTOBER 16, 2018 SALLY A. HOJVAT M.Sc., Ph.D. Retired as Director of FDA Division of Microbiology Devices,
Pandemic Influenza Preparedness and Response
Pandemic Influenza Preparedness and Response US Department of Health and Human Services Bruce Gellin, MD, MPH Director, National Vaccine Program Office The pandemic influenza clock is ticking. We just
Association of Public Health Laboratories
STATEMENT BY DR. Peter A. Shult ON BEHALF OF THE ASSOCIATION OF PUBLIC HEALTH LABORATORIES DIRECTOR OF THE COMMUNICABLE DISEASES DIVISION OF THE WISCONSIN STATE LABORATORY OF HYGIENE ON Beyond the Checklist:
Vaccines: Reaching for higher branches after the low hanging fruit has been picked
Engineering Conferences International ECI Digital Archives Vaccine Technology VI Proceedings 6-12-2016 Vaccines: Reaching for higher branches after the low hanging fruit has been picked Michael G. Kurilla
Anti-Viral Prophylaxis Target Product Profile Guidelines
Anti-Viral Prophylaxis Target Product Profile Guidelines February 24, 2009 Report Documentation Page Form Approved OMB No. 0704-0188 Public reporting burden for the collection of information is estimated
Scientific and Medical Differences of Category A Pathogens
Scientific and Medical Differences of Category A Pathogens Richard Gorman, M.D. Chair, Pediatric and Obstetrics Integrated Program Team HHS Office of the Assistant Secretary for Preparedness and Response
GSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine
GSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine Regulatory Pathway for Licensure VRBPAC, February 29, 2012 Katalin Abraham, Director, US Regulatory Affairs GSK Biologicals GSK s Influenza Vaccines
Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine. since 2006
Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine use from high to low income countries since 2006 Dr. Michael Watson, sanofi-pasteur on behalf of WHO GAP
7th Mena Influenza Stakeholders Meeting. WHO Influenza Strategy Development and Vaccine-related Research Priorities
7th Mena Influenza Stakeholders Meeting WHO Influenza Strategy Development and Vaccine-related Research Priorities Wenqing Zhang 9 10 September 2017 Riga, Latvia 1 Seasonal influenza 1 billion cases yearly
Biological Warfare & Terrorism
Biological Warfare & Terrorism COL Ted Cieslak, MC, USA Director, Clinical Services Division U.S. Army Medical Command Ft Sam Houston TX USAMRIID: A Unique National Resource Page 1 Page 2 USAMRIID 9/15/2011
100 Years Since 1918: Are We Ready for the Next Pandemic?
100 Years Since 1918: Are We Ready for the Next Pandemic? Daniel B. Jernigan, MD MPH Director, Centers for Disease Control and Prevention January 9, 2018 Today s Agenda Remembering the 1918 pandemic Reviewing
CBER Regulates Complex (MCM) Products
Tissues Cell & Gene Therapies CBER Regulates Complex (MCM) Products Mesenchymal Stem Cells Skin, tissues Pathogen-specific Immunoglobulins Blood, Blood Components and Derivatives Anthrax, Botulinum, Smallpox,
Medicago: transforming the approach to vaccines and protein-based therapeutics. Bruce D. Clark PhD President & CEO September 27, 2017
Medicago: transforming the approach to vaccines and protein-based therapeutics Bruce D. Clark PhD President & CEO September 27, 2017 Medicago Overview Focus Manufacturing technology Vaccine technology
Center for Biologics Evaluation and Research
Center for Biologics Evaluation and Research Current Activities Future Directions Washington, DC January 25, 2010 Karen Midthun, MD Acting Director, CBER CBER Our Mission To ensure the safety, purity,
A conversation with Michael Osterholm on July 30, 2013 about pandemics
A conversation with Michael Osterholm on July 30, 2013 about pandemics Participants Michael Osterholm Director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota Alexander
Infrastructure and Methods to Support Real Time Biosurveillance. Kenneth D. Mandl, MD, MPH Children s Hospital Boston Harvard Medical School
Infrastructure and Methods to Support Real Time Biosurveillance Kenneth D. Mandl, MD, MPH Children s Hospital Boston Harvard Medical School Category A agents Anthrax (Bacillus anthracis) Botulism (Clostridium
Bioterrorism: Assessing the Threat
.United States House of Representatives Committee on Homeland Security Subcommittee on Emergency Preparedness, Response, and Communications Bioterrorism: Assessing the Threat Testimony of Tom Inglesby,
Management Presentation. January 2019
Management Presentation January 2019 Forward Looking Statements The statements made in this presentation may include forward-looking statements regarding the treatment of smallpox and other orthopoxvirusinfections,
Introduction to Influenza Pandemic Planning
Introduction to Influenza Pandemic Planning Dr. Wan Noraini bt. Wan Mohamed Noor Head of Surveillance Sector Disease Control Division, MOH Malaysia 3 May 2018 Negative single stranded RNA virus, part of
Acquisition of Novartis Influenza Vaccines Business. 27 th October 2014
1 Acquisition of Novartis Influenza Vaccines Business 27 th October 2014 2 Legal Notice Forward looking statements The materials in this presentation speak only as of the date of these materials, and include
Biorisk reduction: A WHO approach
ESRC Seminar, 8-9 January 2007 University of Sussex, Brighton Biorisk reduction: A WHO approach Emmanuelle Tuerlings Biorisk reduction for dangerous pathogens Department of Epidemic and Pandemic Alert
Planning for Pandemic Influenza in York County: Considerations for Healthcare and Medical Response
Planning for Pandemic Influenza in York County: Considerations for Healthcare and Medical Response York County Pandemic Influenza Stakeholders Village by the Sea, Wells, Maine 8 August 2006 Steven J Trockman,
Influenza: The Threat of a Pandemic
April, 2009 Definitions Epidemic: An increase in disease above what you what would normally expect. Pandemic: A worldwide epidemic 2 What is Influenza? Also called Flu, it is a contagious respiratory illness
Bioterrorism Capabilities in Rural Texas Hospitals and Laboratories by
Bioterrorism Capabilities in Rural Texas Hospitals and Laboratories by Taylor M. Johnson Public Health Internship Program School of Biological Sciences The University of Texas at Austin Mentor: Dr. Grace
Confronting infectious diseases and the role of vaccination: A global perspective KATE ANTEYI. MD, MPH, MBA
Confronting infectious diseases and the role of vaccination: A global perspective KATE ANTEYI. MD, MPH, MBA Technical Advisor, United States Agency for International Development (USAID) Chair, WONCA Working
Business Continuity and Crisis Management. Cardinal Health s Approach
Business Continuity and Crisis Management Cardinal Health s Approach Welcome We don t have ALL the answers Opportunity to share ideas Discussion around how we can work together to help prepare our communities,
Institutional Laboratory Biosafety Manual
Appendix B. Select Agents and Toxins The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) oversee the possession, use and transfer of select agents
B-NICE Overview. Types of WMD Agents. Types of WMD Agents. Types of WMD Agents. Job Aid Version 1.0 and 2.0. CDC & Prevention
B-NICE Overview Types of WMD Agents Biological Nuclear Incendiary Chemical Explosive Types of WMD Agents Job Aid Version 1.0 and 2.0 Chemical Biological Radiological Nuclear Explosive Types of WMD Agents
Page 1 of 5 For Immediate Release Office of the Press Secretary July 17, 2007 Fact Sheet: Implementation of the National Strategy for Pandemic Influenza A One-Year Summary Of Efforts To Better Protect
Alternative models for influenza vaccine R&D financing
Alternative models for influenza vaccine R&D financing Third WHO consultation on Global Action Plan on Influenza Vaccines (GAPIII) Nov 15-16 2016 John-Arne Røttingen, interim CEO of CEPI Influenza the
2009 H1N1 Accomplishments and Critical Lessons Learned
2009 H1N1 Accomplishments and Critical Lessons Learned Defense Health Board November 2, 2010 COL Wayne Hachey DO, MPH Director Preventive Medicine Office of Deputy Assistant Secretary of Defense for Force
Avian Influenza A(H7N9) Overview
Avian Influenza A(H7N9) Overview Side event organized by China and WHO 21 May 2013 1 Avian Influenza A(H7N9) Novel Coronavirus (ncov) World experiencing emergence of 2 exceptional new virus infections