IRR-SlidePresentation(SOW).pdf

INFLUENZA

DIVISION

Daniel B. Jernigan, MD MPH Deputy Director

Influenza Division National Center for Immunization and Respiratory Diseases

Coordinating Center for Infectious Diseases

Influenza Reagent Resource Statement of Work

Pre-Solicitation Conference March 14, 2008

INFLUENZA

DIVISION

Acknowledgements

• Thank you for participating

• Thank you to:

– Mark Federer

– Mary Hoelscher

– Cassandra McNeil

– CDC staff for ongoing support in development

TM

Background and NeedBackground and Need •• National Strategy for National Strategy for

Pandemic Influenza goals:Pandemic Influenza goals:

–– stopping, slowing or otherwise stopping, slowing or otherwise limiting the spread of a pandemic to limiting the spread of a pandemic to the United States; the United States;

–– limiting the domestic spread of a limiting the domestic spread of a pandemic, and mitigating disease, pandemic, and mitigating disease, suffering and death; andsuffering and death; and

–– sustaining infrastructure and sustaining infrastructure and mitigating impact to the economy mitigating impact to the economy and the functioning of society.and the functioning of society.

•• HHS leads the federal HHS leads the federal responseresponse –– CDC has primary responsibility for CDC has primary responsibility for laboratory and surveillance laboratory and surveillance nationallynationally

Major Roles & ResponsibilitiesMajor Roles & Responsibilities •• This contract is a critical component of This contract is a critical component of

CDCCDC’’s extramural efforts to ensures extramural efforts to ensure –– the availability of influenza viruses and the availability of influenza viruses and diagnostic reagents for public health responses; diagnostic reagents for public health responses;

and, and, –– the ability to provide enhanced technical the ability to provide enhanced technical assistance and materials to state and local public assistance and materials to state and local public health laboratories and commercial developers of health laboratories and commercial developers of vaccines, antiviral drugs and diagnostic tests, in vaccines, antiviral drugs and diagnostic tests, in support of our common goal to minimize the support of our common goal to minimize the impact of an influenza pandemic on the health of impact of an influenza pandemic on the health of Americans.Americans.

Project ObjectivesProject Objectives •• to ensure that adequate stocks of influenza viruses to ensure that adequate stocks of influenza viruses and reference reagents are available to the CDC on and reference reagents are available to the CDC on a routine basis (Quantity a routine basis (Quantity ““AA””); and for selected ); and for selected products, in the event of an influenza pandemic products, in the event of an influenza pandemic (Quantity (Quantity ““BB”” –– Option)Option)

•• to improve availability of these materials to qualified to improve availability of these materials to qualified public health professionals, clinicians and public health professionals, clinicians and developers of influenza vaccines, antiviral drugs developers of influenza vaccines, antiviral drugs and influenza virus diagnostic products, through an and influenza virus diagnostic products, through an electronic storefront (website); and,electronic storefront (website); and, •• to implement a proficiency testing (PT) program, to to implement a proficiency testing (PT) program, to routinely verify that public health and selected other routinely verify that public health and selected other laboratories are able to adequately characterize laboratories are able to adequately characterize circulating seasonal and other noncirculating seasonal and other non--circulating or circulating or novel influenza viruses.novel influenza viruses.

Special NoteSpecial Note

•• Throughout the SOW, all quantities with an Throughout the SOW, all quantities with an asterisk are governmentasterisk are government’’s best estimatess best estimates

•• The contract is a cost reimbursement The contract is a cost reimbursement requirements type contract with optionsrequirements type contract with options –– Quantity A Quantity A –– for routinefor routine –– Quantity B Quantity B –– for surge when needed (option)for surge when needed (option)

•• Influenza is a constantly changing virus, the Influenza is a constantly changing virus, the IRR will have frequent updates to its IRR will have frequent updates to its componentscomponents

Scope of WorkScope of Work •• The contractor will propagate, The contractor will propagate, characterize and store and distribute characterize and store and distribute (as approved) CDC(as approved) CDC--furnished viruses furnished viruses and bacterial pathogens, including and bacterial pathogens, including human influenza, low and highly human influenza, low and highly pathogenic avian influenza viruses and pathogenic avian influenza viruses and their derivatives, and other viral and their derivatives, and other viral and microbial respiratory pathogens microbial respiratory pathogens associated with influenzaassociated with influenza--like illness.like illness.

•• the contractor will produce or the contractor will produce or otherwise acquire, characterize, store otherwise acquire, characterize, store and distribute (as approved) reagents, and distribute (as approved) reagents, which include human sera, animal which include human sera, animal sera, animal antisera, animal anti--sera, DNA plasmids, sera, DNA plasmids, RNA standards, antigens, antibodies, RNA standards, antigens, antibodies, nucleic acids and lyophilized primers nucleic acids and lyophilized primers and probes as listed in the appendicesand probes as listed in the appendices

•• Viruses and reagents will be available Viruses and reagents will be available to qualified recipients, both to qualified recipients, both individually and as parts of individually and as parts of standardized panels and kits, standardized panels and kits, –– to aid in the development, evaluation, to aid in the development, evaluation, validation and testing of influenza validation and testing of influenza diagnostic products; diagnostic products;

–– to support vaccine development; and, to support vaccine development; and, –– to assist in characterization of viruses as to assist in characterization of viruses as part of influenza surveillance activities.part of influenza surveillance activities.

•• With the exceptions of WHO Influenza Reference With the exceptions of WHO Influenza Reference

Reagent Kits, and Animal Reagent Kits, and Animal AntiseraAntisera Against Influenza Against Influenza Viruses, all viruses and reagents will be Viruses, all viruses and reagents will be manufactured (to the maximum extent practicable) manufactured (to the maximum extent practicable) in accordance with Good Manufacturing Practices in accordance with Good Manufacturing Practices (GMP) or GMP(GMP) or GMP--like processes, in a Good Laboratory like processes, in a Good Laboratory Practices (GLP) laboratory environment; see Practices (GLP) laboratory environment; see Section IV.E.6 of the Statement of Work (SOW). Section IV.E.6 of the Statement of Work (SOW).

•• The CDC Influenza Reagent Resource inventory of The CDC Influenza Reagent Resource inventory of viruses and reagents (see Appendix A) will be viruses and reagents (see Appendix A) will be regularly updated during contract performance, to regularly updated during contract performance, to ensure that current panels for development, ensure that current panels for development, validation and proficiency testing are onvalidation and proficiency testing are on--hand and hand and available for distribution. available for distribution.

Summary of WorkSummary of Work

1.1. Influenza Virus RealInfluenza Virus Real--Time Reverse Transcriptase Time Reverse Transcriptase

Polymerase Chain Reaction (RTPolymerase Chain Reaction (RT--PCR) Kits; PCR) Kits;

2.2. HemaggluttininHemaggluttinin Inhibition Assay kits for detection of Inhibition Assay kits for detection of hemagglutinatinghemagglutinating antibodies in human sera against antibodies in human sera against seasonal and animal influenza viruses, including seasonal and animal influenza viruses, including avian;avian;

3.3. Virus Virus MicroneutralizationMicroneutralization Assay kits for detection of Assay kits for detection of neutralizing antibodies in human sera against neutralizing antibodies in human sera against seasonal and animal influenza viruses, including seasonal and animal influenza viruses, including avian;avian;

4.4. live seasonal and live and betalive seasonal and live and beta--propiolactonepropiolactone (BPL)(BPL)--killed animal influenza viruses for use in Virus killed animal influenza viruses for use in Virus MicroneutralizationMicroneutralization and and HemaggluttininHemaggluttinin Inhibition Inhibition Assay kits;Assay kits;

5.5. WHO Influenza reference reagent kits for WHO Influenza reference reagent kits for identification of seasonal and animal influenza identification of seasonal and animal influenza isolates, including avian, from human cases. These isolates, including avian, from human cases. These reagents are for use at National Influenza Centers reagents are for use at National Influenza Centers (NIC) and Global Influenza (NIC) and Global Influenza SurveilanceSurveilance Network Network (GISN) and U.S. Public Health Laboratories;(GISN) and U.S. Public Health Laboratories;

6.6. live influenza seed stocks;live influenza seed stocks;

•• Further clarification on intended use of vaccine seed Further clarification on intended use of vaccine seed stocks will be providedstocks will be provided

7.7. purified influenza virus stocks;purified influenza virus stocks;

8.8. Specific panels of viruses and/or bacteria:Specific panels of viruses and/or bacteria:

a.a. Seasonal Panels;Seasonal Panels;

b.b. Development Panels;Development Panels;

c.c. Specificity Panels; Specificity Panels;

d.d. Independent Evaluation Panels;Independent Evaluation Panels;

e.e. Proficiency Panels;Proficiency Panels;

f.f. AntiviralAntiviral--Resistance Panels;Resistance Panels;

9.9. nucleic acids from influenza and other respiratory nucleic acids from influenza and other respiratory agents, to use as viral test standards;agents, to use as viral test standards;

10.10.Other kits as availableOther kits as available 11.11.Other reagents/kits: available individually or as Other reagents/kits: available individually or as kit/panel components:kit/panel components:

a.a. lyophilized primers and probes for diagnostic testing for lyophilized primers and probes for diagnostic testing for other respiratory viral and bacterial agents; See Appendix other respiratory viral and bacterial agents; See Appendix

BB

b.b. plasmid DNA with relevant influenza gene sequences;plasmid DNA with relevant influenza gene sequences;

c.c. RNA Standards for controls for RNA based detection RNA Standards for controls for RNA based detection systemssystems d.d. recombinant expressed influenza viral antigens; See recombinant expressed influenza viral antigens; See

Appendix CAppendix C e.e. monoclonal and polyclonal antibodies to influenza monoclonal and polyclonal antibodies to influenza viral antigens;viral antigens;

f.f. Animal Animal antiseraantisera against influenza viruses (rabbit, against influenza viruses (rabbit, ferret, sheep, etc.); ferret, sheep, etc.);

g.g. normal human sera; normal human sera;

h.h. cell lines required for virus growth and antigenic cell lines required for virus growth and antigenic determination of influenza viruses;determination of influenza viruses;

i.i. realreal--time one step RTtime one step RT--PCR reagent kits, Nucleic acid PCR reagent kits, Nucleic acid extraction kits and other reagents for use with extraction kits and other reagents for use with influenza real time RTinfluenza real time RT--PCR testing (see Appendix D; PCR testing (see Appendix D;

and,and, j.j. lyophilized or otherwise modified enzymes for lyophilized or otherwise modified enzymes for diagnostic testing for influenza and other respiratory diagnostic testing for influenza and other respiratory viral and bacterial agents.viral and bacterial agents.

QualityQuality •• Maintain inventory of influenza reagentsMaintain inventory of influenza reagents •• Maintain quality controlMaintain quality control •• Quality GradeQuality Grade

–– ““With the exceptions of WHO Influenza Reference Reagent With the exceptions of WHO Influenza Reference Reagent Kits (see Section III, Item 8 of the SOW), and Animal Kits (see Section III, Item 8 of the SOW), and Animal AntiseraAntisera Against Influenza Viruses (Section III, Item 15 of Against Influenza Viruses (Section III, Item 15 of the SOW), all viruses, reagents, panels and kits that are the SOW), all viruses, reagents, panels and kits that are produced or otherwise acquired, stored and distributed produced or otherwise acquired, stored and distributed under this contract shall be manufactured (to the maximum under this contract shall be manufactured (to the maximum extent extent practicablepracticable) in compliance with Good Manufacturing ) in compliance with Good Manufacturing Practices (GMP) or GMPPractices (GMP) or GMP--like processes, in a Good like processes, in a Good Laboratory Practices (GLP) laboratory environment; see: Laboratory Practices (GLP) laboratory environment; see:

http://www.fda.gov/cdrh/devadvice/32.htmlhttp://www.fda.gov/cdrh/devadvice/32.html..””

–– Manufactured products will not be used as a Manufactured products will not be used as a pharmaceutical, or as a pharmaceutical raw materialpharmaceutical, or as a pharmaceutical raw material

–– FDA licensed facility will be required for only a specified FDA licensed facility will be required for only a specified few reagents.few reagents.

–– Clarification in subsequent SOW will be provided.Clarification in subsequent SOW will be provided.

http://www.fda.gov/cdrh/devadvice/32.html

FacilitiesFacilities •• Laboratory safety levels, certifications, and Laboratory safety levels, certifications, and approvals are required for those performing the approvals are required for those performing the required work as determined by the agents being required work as determined by the agents being handledhandled –– http://bmbl.od.nih.gov/contents.htmhttp://bmbl.od.nih.gov/contents.htm, , http://www.cdc.gov.od.ohs.biosfty/bmbl4/bmbl4oc.htmhttp://www.cdc.gov.od.ohs.biosfty/bmbl4/bmbl4oc.htm

•• BSLBSL--2, BSL3+2, BSL3+

•• USDA Select agent approval requiredUSDA Select agent approval required •• Storage and maintenance requirementsStorage and maintenance requirements

–– Clarification on these requirements will be provided in Clarification on these requirements will be provided in subsequent SOWsubsequent SOW

•• Since only certain work requirements must be performed in Since only certain work requirements must be performed in BSL3+, those requirements could be performed by a qualified BSL3+, those requirements could be performed by a qualified subcontractor or teaming partner at no detriment to evaluation subcontractor or teaming partner at no detriment to evaluation of the prime contractorof the prime contractor’’s proposals proposal

•• ““Working facilities shall be available for inspection at the timeWorking facilities shall be available for inspection at the time of contract awardof contract award”” http://bmbl.od.nih.gov/contents.htm http://www.cdc.gov.od.ohs.biosfty/bmbl4/bmbl4oc.htm

Processing RequestsProcessing Requests •• Develop processes for handling requests including Develop processes for handling requests including management of all required:management of all required:

–– MTAMTA

–– Licenses Licenses –– PermitsPermits –– Transport/Shipping criteriaTransport/Shipping criteria

•• All requests will be approved by the project officerAll requests will be approved by the project officer

Proficiency Testing ProgramProficiency Testing Program •• Annual testing of approximately 140 WHO Annual testing of approximately 140 WHO collaborating laboratories in participating in CDC collaborating laboratories in participating in CDC virologicvirologic surveillance in the USsurveillance in the US

•• Annual testing of approximately 118 National Annual testing of approximately 118 National Influenza Center laboratories participating in the Influenza Center laboratories participating in the WHO Global Influenza Surveillance Network in 89 WHO Global Influenza Surveillance Network in 89 countriescountries

•• Distribute blinded panels of 9 reagents annually Distribute blinded panels of 9 reagents annually with scenarios, instructions, and COAwith scenarios, instructions, and COA

Database and Inventory Database and Inventory ManagementManagement

•• Computerized management of data, accounting for Computerized management of data, accounting for BSL3+ and select agent requirementsBSL3+ and select agent requirements

•• Sample tracking requirementsSample tracking requirements

•• Online ordering portalOnline ordering portal •• Bulletin board for information and instructionsBulletin board for information and instructions •• Maintain user supportMaintain user support •• Reagents will be provided to qualified recipients at Reagents will be provided to qualified recipients at minimal cost minimal cost –– further clarification on this will be further clarification on this will be providedprovided

Web StorefrontWeb Storefront

Period of PerformancePeriod of Performance •• Twelve months from the time of the awardTwelve months from the time of the award •• Contract contains nine Contract contains nine –– 12 month option periods12 month option periods

Other ConsiderationsOther Considerations •• Funds for year one have been provided to the Funds for year one have been provided to the

Influenza DivisionInfluenza Division •• An anticipated release date is in April/May; An anticipated release date is in April/May;

however, a final date has not been establishedhowever, a final date has not been established