IRR-SlidePresentation.pdf

INFLUENZA

DIVISION

Daniel B. Jernigan, MD MPH Deputy Director

Influenza Division National Center for Immunization and Respiratory Diseases

Coordinating Center for Infectious Diseases

CDC Influenza Reagent Resource

Pre-Solicitation Conference March 14, 2008

Influenza Coordinating

Unit

Influenza Division

NCIRD

Beth Bell

ASSOCIATE DIRECTOR

for EPIDEMIOLOGIC SCIENCE

Kristine Sheedy

ASSOCIATE DIRECTOR

for COMMUNICATION SCIENCE

Respiratory Diseases Cynthia Whitney, CHIEF

Global Immunizations Division

Brent Burkholder

DIRECTOR

John Fitzsimmons

DEPUTY DIRECTOR

Kim Fears

PROGRAM MANAGEMENT

OFFICER

Eric Mast

ASSOCIATE DIRECTOR

for SCIENCE

Strengthening Immunization Systems (proposed) Vance Dietz, CHIEF

Disease Elimination & Eradication (proposed)

Steve Cochi*, CHIEF

Division of Viral Diseases

Larry Anderson

DIRECTOR

Jane Seward*

DEPUTY DIRECTOR

April Allman

PROGRAM MANAGEMENT

OFFICER

Sue Goldstein

ASSOCIATE DIRECTOR

for SCIENCE

Wendi Kuhnert

ASSOCIATE DIRECTOR

for LABORATORY SCIENCE

Gastroenteritis and Respiratory Viruses Jon Gentsch, CHIEF

Polio and Picornaviruses Laboratory

Mark Pallansch, CHIEF Olen Kew, Senior Science Advisor

Epidemiology Gregory Armstrong, CHIEF

MMR and Herpes Viruses William Bellini, CHIEF

Influenza Division Nancy Cox

DIRECTOR

Dan Jernigan

DEPUTY DIRECTOR

Marie Hicks*

PROGRAM

MANAGEMENT OFFICER

Carolyn Bridges

ASSOCIATE DIRECTOR

for SCIENCE

Michael Shaw

ASSOCIATE DIRECTOR

for LABORATORY SCIENCE Ann Moen

ASSOCIATE DIRECTOR

for EXTRAMURAL PROGRAMS

Epidemiology and Prevention

Joe Bresee, CHIEF

Immunology and Pathogenesis

Jacqueline Katz, CHIEF

Molecular Virology and Vaccines

Ruben Donis, CHIEF

Viral Surveillance and Diagnosis

Alexander Klimov, CHIEF

Immunization Services Division

Lance Rodewald

DIRECTOR

Jeanne Santoli

DEPUTY DIRECTOR

Julie Smith

PROGRAM

MANAGEMENT OFFICER

Abigail Shefer

ASSOCIATE DIRECTOR

for SCIENCE

Vanda Kelley

ASSOCIATE

DIRECTOR for POLICY Gina Mootrey

ASSOCIATE DIRECTOR

for ADULT IMMUNIZATION

Immunization Information Systems Support

Gary Urquhart*, CHIEF

Health Services Research and Evaluation Pascale Wortley, CHIEF

Program Operations Nancy Fasano, CHIEF

Vaccine Supply and Assurance

Greg Wallace, CHIEF

Education, Information and Partnerships

Kathy Towers-Solis, CHIEF

Assessment Jim Singleton, CHIEF

Meningitis and Vaccine Preventable Diseases

Nancy Messonnier, CHIEF

Division of Bacterial Diseases Rana Hajjeh

DIRECTOR

Vacant

DEPUTY DIRECTOR

Derrick Lake

PROGRAM

MANAGEMENT OFFICER

Trudy Murphy*

ASSOCIATE DIRECTOR

for SCIENCE Barry Fields*

ASSOCIATE DIRECTOR

for LABORATORY SCIENCE

Updated: January 18, 2008

Larry Pickering SENIOR ADVISOR and

EXECUTIVE SECRETARIAT, ACIP

Alison Mawle

ASSOCIATE DIRECTOR

for LABORATORY SCIENCE

*Acting

Olen Kew

ASSOCIATE DIRECTOR

for GLOBAL LABORATORY SCIENCE

Office of the Director

Anne Schuchat

DIRECTOR

Melinda Wharton

DEPUTY DIRECTOR

Michael Detmer

ASSOCIATE DIRECTOR

for MANAGEMENT & OPERATIONS

Kristin Pope

ASSOCIATE DIRECTOR

for HEALTH POLICY

National Center for Immunization and Respiratory Diseases (NCIRD)

Office of the Director Nancy Cox, PhD Director

Dan Jernigan, MD Deputy Director

Office of the Director Nancy Cox, PhD Director

Dan Jernigan, MD Deputy Director

Immunology and Pathogenesis Branch

Jackie Katz, Chief

Immunology and Pathogenesis Branch

Jackie Katz, Chief

Virus Surveillance and Diagnosis Branch

Alexander Klimov, Chief

Virus Surveillance and Diagnosis Branch

Alexander Klimov, Chief

Epidemiology and Prevention Branch Joe Bresee, Chief

Epidemiology and Prevention Branch Joe Bresee, Chief

Molecular Virology and Vaccines Branch

Ruben Donis, Chief

Molecular Virology and Vaccines Branch

Ruben Donis, Chief

Virus Reference TeamVirus Reference Team

Diagnostic Development Team

Diagnostic Development Team

Molecular Epidemiology Team

Molecular Epidemiology Team

Surveillance and Prevention Team Surveillance and Prevention Team

International Epidemiology and Response Team

International Epidemiology and Response Team

Molecular Virology Team

Molecular Virology Team

Vaccines and Pandemic Preparedness Team

Vaccines and Pandemic Preparedness Team

Pandemic Preparedness Team

Pandemic Preparedness Team

Immunology Laboratory Team

Immunology Laboratory Team

Pathogenesis Laboratory Team

Pathogenesis Laboratory Team

Extramural Influenza Program Ann Moen, Associate Director for

Extramural Program

Laboratory Science Michael Shaw, Assoc Dir

Communications Erin Burns, Lead

Epidemiologic Science Carolyn Bridges, Assoc Dir

Policy Bethany Anderson, Lead

Management Marie Hicks, Acting PMO

Sequencing Unit Preparedness Inzune Hwang Andy Demma

InfluenzaInfluenza DivisionDivision

Major Roles & Responsibilities for the Influenza Division

• Primary government information resource for influenza

• Influenza surveillance

– 1 of 4 Global WHO Collaborating Centers for influenza

– Also serve as a National Influenza Center

– National coordinating role

• Vaccine strain selection

• National vaccination and antiviral drug policies

• National emergencies

– Pandemic preparedness planning

– Vaccine supply shortages

• Outbreak investigations

– International

– Domestic

• Research

CDC Contributions to WHO Global Influenza Surveillance

• Help develop Global Agenda for influenza

• Help develop guidelines for pandemic planning

• Report data on isolates and ILI –FluNet

• Contribute data for vaccine strain selection

• Characterize novel viruses

• Produce WHO kits and other reagents for strain ID

(annually and for novel viruses as needed)

• Conduct international training and provide technical assistance for surveillance network development

• Assist with outbreak investigations

• Develop/evaluate vaccines

• Develop recommendations for vaccines and antivirals

Virologic Surveillance

• Requires constant monitoring of a changing virus

• Requires development of diagnostic reagents and support of public health laboratories in the US and abroad

Diagnostic PreparednessDiagnostic Preparedness

• During a pandemic, CDC and state public health laboratories will play a critical role in detection and confirmation of initial cases, virus characterization, monitoring of pandemic progression, and vaccine strain selection.

• Maintaining diagnostic preparedness is vital

• Key components of diagnostic preparedness include:

– Laboratory surge capacity

– Improving influenza diagnostic test capability

– Assuring testing proficiency and test accuracy

Influenza Triggers and Intervals

D Accel-eration

C Initiation

E Peak

Transmission

F Decel-eration

G Resolution

B Recognition

A Investigation

Influenza Triggers and Intervals

D Accel-eration

C Initiation

E Peak

Transmission

F Decel-eration

G Resolution

B Recognition

A Investigation

• What do we expect a surge in testing will look like?

• What support is needed for laboratories at CDC, state public health departments, National Influenza Centers to be prepared for and to be maintained during a pandemic response?

Laboratory Processes Laboratory Processes for Pandemic Responsefor Pandemic Response

• Pyrosequencing

• Chemiluminescence

• Microneutralization

• Hemagglutination Inhibition

• RT-PCR

• Gene Sequencing

• Virus isolation in eggs, MDCK cells

• Vaccine candidate development www.pandemicflu.gov www.cdc.gov/flu

Evaluation of Surge Capacity and Needs

• Developed process models for determining surge requirements at CDC and state PHLs

• Utilized “FluLabSurge” model to estimate number of specimens

• Determined: staffing, space, equipment, supplies, prophylaxis, training

• Estimates serve to guide development of surge planning and “stockpile”

CDC Influenza Diagnostic ResourceCDC Influenza Diagnostic Resource

• In order to adequately prepare for a pandemic influenza response, an Influenza Diagnostic Resource is needed to support:

– Virologic Surveillance

– Diagnostic Test Development and Improvement

– Proficiency Testing

– Surge Preparedness and Capacity

• Development of the Resource will be achieved through contracts and other extramural agreements

– Transition selected internal CDC activities to contractors

– Support some maintenance “rapid test” activities

– Increase access to CDC reagents/viruses

Support Support VirologicVirologic SurveillanceSurveillance

• Produce annual WHO kits for virus characterization at public health laboratories in US and at NICs

• Produce and update PCR primers and probes for seasonal and novel influenza virus detection

• *Maintain training materials and courses

• *Assist state public health laboratories with

– Equipment

– Supplies

• *Assist sentinel providers with testing supplies

*not in SOW for IRR Contract*not in SOW for IRR Contract

Support Diagnostic Test Support Diagnostic Test Development and ImprovementDevelopment and Improvement

• Produce influenza reagent panels

– Initial test development panels (H1, H3, H5)

– Test evaluation and validation panels

• Up to 100 human seasonal strains

• Up to 20 human and/or avian H5 strains

• Up to 20 other non-contemporary human and animal strains

– Specificity panels

• Up to 40 non-influenza respiratory virus and bacteria Develop panels

• Produce Challenge Panels

– Most recent circulating strains for test manufacturers to assure adequate detection

• Produce Selected Reagents

– mAbs

– Recombinant HA

• Improve Access to Panels and Reagents through a Web “Storefront”

Support Diagnostic Test Support Diagnostic Test Development and ImprovementDevelopment and Improvement

• *Current HHS-supported advanced development

– CDC 5-Target RT-PCR intramural development

– Point of care influenza IVD contract

– Laboratory Influenza Test contract

• *Possible HHS-supported advanced development

– Rapid immunity tests

– Antiviral resistance tests

– Simplified specimen collection

– Improved rapid antigen detection tests

– Additional point of care tests

Support Proficiency TestingSupport Proficiency Testing

• Produce blinded panels to test proficiency with using:

– Reference antigen detection methods

– PCR methods

• Maintain a distribution and proficiency testing program for laboratories participating in:

– U.S. virologic surveillance

– Global Influenza Surveillance Network

Support Surge Preparedness Support Surge Preparedness and Capacityand Capacity

• Maintain stocks of critical testing reagents and supplies

• *Maintain an updated list of manufacturers for critical reagents

• *Develop purchasing agreements for access to test reagents for current use with options for increases anticipated in a surge

• *Train and exercise laboratorians at CDC, PHLs, and other laboratories for critical processes needed during surge

SummarySummary

• CDC seeks to support diagnostic preparedness activities through development of an influenza reagent resource

– To fulfill preparedness tasks from HHS secretary

– To support diagnostic test development and improvement

– To support virologic surveillance

– To provide surge capabilities

– To assure that critical laboratories are performing testing proficiently

Thank youThank you