2011-07-15 BAA Pre-Proposal Slides.pdf

Broad Agency Announcements (BAA)

Dorothy McMillan, Sr. Contracting Officer

BARDA/AMCG

Tasha McMillian, Contract Specialist

BARDA/AMCG

July 15, 2011

Background and Regulatory Basis FAR 6.102(d)(2) and 35.016

● This Broad Agency Announcement BARDA BAA-11-100-SOL-00021, is a competitive announcement to obtain proposals for the following two areas of Interest:

● Personal Protective Equipment (PPE) and Full-Featured Continuous Ventilators for Influenza Infection & All-Hazards

● Clinical Influenza Test Systems and Diagnostic Tools.

● The BAA is described in FAR 6.102(d)(2), “ Use of Competitive Procedures,” and FAR 35.016, “ Broad Agency Announcements.”

● The BAA technique shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

Benefits Streamlines the procurement process.

Provides greater transparency and open communication.

Promotes the advancement of Medical Counter Measure (MCM) technology.

Allows for competition of ideas/concepts throughout the established response period.

Provides flexibility in amending the BAA to add or subtract information or requirements.

Can remain open for up to a one year period of time.

White paper stage serves as market research.

Eligibility

This BAA is open to ALL responsible sources.

Offerors may include single entities or teams from private sector organization, Government laboratories, Federally Funded

Research and Development Centers (FFRDCs) and academic institutions.

A prospective recipients must meet certain minimum standards pertaining to financial resources, an ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.

BARDA BAA – Process

The two stage process

Stage I:

• Offerors shall submit a Quad Chart, White Paper and Addendum summarizing the proposed project. All Quad Charts shall not exceed one (1) page, White Papers shall not exceed ten (10) pages and Addendum shall not exceed two (2) pages.

• Electronic acknowledgement of receipt of white papers will be made within one week.

• Decision letters will be sent to Offerors within 90 days of submission or within 90 days after the submission deadline.

BARDA BAA – Process (cont.)

Stage II:

Offerors receiving a favorable evaluation will be asked to prepare a Full Proposal and submit to BARDA within 45 days depending on time and funding constraints.

Instructions for completing the Full Proposal are found in

Part IV of the Solicitation. A request to submit a Full

Proposal does not assure an award.

The Government intends to make an award decision within

120 days after submission of Full Proposals.

Differences between an RFP and a BAA

RFP BAA

• Sources Sought

• RFI

• Draft-RFP

• Defined Q&A Sessions

• Pre-proposal

Conference

• Proposal preparation and evaluation

• General Interest

• Post-evaluation, pre-award

• RFP close

• General Interest

• White Paper evaluation

• Proposal preparation

• Proposal evaluation

• Post decision & BAA close

Open with BARDA Facilitated by CO Closed Communication

• Before White Paper

Summary

• BAAs allow for greater flexibility in both the proposal submission and selection phases.

• BAAs have the potential to be highly effective in BARDA’s ability to respond quickly to emerging threats.

Please submit questions on notecards for written response

Development Area 1:

Personal Protective Equipments (PPEs) and

Full-Featured Continuous Ventilators

Influenza BAA Pre-Proposal Conference

Area of Interest 1: PPEs and Ventilators

Mission / Strategy

BARDA leads the advanced research and development of medical countermeasures to protect the United States from public health emergency threats, including CBRN agents and pandemic influenza.

─ 2005 HHS Pandemic Influenza Plan include:

Personal Protective Equipments such as surgical masks and N95 respirators

Ventilators and respiratory care equipments

─ Rolling Broad Agency Announcements are flexible transaction tools intended to capitalize on emerging concepts and recognized gaps in downstream development programs.

PHEMCE Review 2010

Known Concerns with PPEs

• Availability / Ease of Stockpiling and Inventory Management

• Influenza transmission not well understood

• Minimal research available to verify safety and effectiveness in healthcare environment

• Need for innovative and strengthened PPE design, testing and certification

• Performance requirements of consideration: Functionality, Usability, Comfort & Wearability, Maintenance & Reuse, Cost, Aesthetics, and Durability

2007 IOM Report – Preparing for an Influenza Pandemic: PPE for Healthcare Workers

2010 IOM Report – Preventing Transmission of Pandemic Influenza and Other Viral

Respiratory Diseases, PPE for Healthcare Personnel

Known Concerns with Full-Featured Ventilators

• 2007 HHS pandemic influenza medical countermeasures gap analysis revealed a national need for large numbers of portable ventilators for emergencies.

• Known factors to consider include:

─ Ease of use by an untrained care provider

─ Flexible patient population considerations

─ Portability and environmental considerations

─ Standard of care

─ Stockpiling and maintenance ease

─ Low cost

─ Surge production

Area of Interest 1.1: Improving PPE

1.1Development and characterization of improved personal protective equipment such as masks or N95 respirators to prevent influenza infections or harmful effects from all-hazard events.

Product Development and Technical Objectives include:

• Design and validate performance test protocols and acceptance criteria (e.g., bench, animal and/or clinical studies) to enable standardized safety and effectiveness measures.

• Field evaluations of PPEs to filter influenza viruses and other respiratory pathogens.

• Provide equipments and/or necessary materials along with technical support to programs evaluating the safety and effectiveness of these devices in relevant environments.

Area of Interest 1.2: Improved Ventilator

1.2 Development of improved full-featured continuous ventilators.

Advanced development of new or improved ventilator to include:

─ support for neonate to adult populations

─ capability of operation by unskilled or minimally trained care providers

─ considerations for ease of stockpiling/maintenance

─ accommodation/provision of accessories typically used in ventilatory standard of care

─ low cost per unit

─ domestic surge capacity

Product Development and Technical Objectives include:

• Design and coordinate conduct of clinical evaluations including device performance and usability by non-skilled or minimally trained care providers in collaboration with institutional or public health programs.

Technological Maturity

• “Offerors for Area of Interest #1 should propose activities for products which can currently be described as having a maturity level equal to or greater than Technology

Readiness Level (TRL) 6. A product can be described as achieving a TRL if it has completed all activities identified in that TRL.“

• Department of Defense Technology Readiness

Assessment Deskbook available at:

http://www.dod.mil/ddre/doc/DoD_TRA_July_2009_Read_

Version.pdf

Points of Contact

• Contracting Point of Contact

─ Dorothy McMillan

─ Email address: FLU-BAA@HHS.GOV

─ For all contractual and process questions

─ For all white paper, quad chart and full proposal submissions

• Technical Point of Contact: PPEs and Ventilators

─ Melanie Choe, PhD, Interdisciplinary Scientist

─ Email address: FLU-BAA-MITIGATE@HHS.GOV mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA-MITIGATE@HHS.GOV mailto:FLU-BAA-MITIGATE@HHS.GOV mailto:FLU-BAA-MITIGATE@HHS.GOV mailto:FLU-BAA-MITIGATE@HHS.GOV mailto:FLU-BAA-MITIGATE@HHS.GOV

BARDA Influenza BAA Pre-Proposal Conference

Development Area 2:

Clinical Influenza Test Systems

And Diagnostic Tools

Roadmap

• HHS/BARDA/CDC “diagnostic” strategic goals

─ H1N1 experience

─ PHEMCE strategies

• Influenza Diagnostic Test Systems

• Influenza Diagnostic Tools

• TRLs

• Areas of Interest

2009 H1N1 Pandemic Diagnostic

Preparedness Legacy

2009H1N1 highlighted recognized gaps:

• Reliable, accurate point-of-care tests in outpatient settings

• Timely, accurate influenza tests in hospital settings

• Capability to detect multiple respiratory pathogens

• Guidance and resources for clinicians (and labs)

(Clinical algorithms and tools for maximizing testing practice and test performance, better specimen collection, improved reporting and electronic data management)

• Resource support for manufacturers, developers, PHLs

(reagents, specimens, and standards)

• Field assessments in practice settings

• Point-of-care and high throughput testing for immunity/exposure assessments

(to assess disease severity)

• Rapid characterization of reassortant influenza viruses and antiviral resistance

Note: preparedness includes use for traditional seasonal testing, outbreaks, and having capabilities in place readily adaptable to specific pandemic requirements across settings and intervals.

Influenza Diagnostic Dilemma

D ia g n o s is

L a b

-C o n fi rm e d a t

P u b li c H e a lt h L a b o r C

D C

RIDTs (CLIA-waived)

RIDTs DFA PCR Viral Culture

C li n ic a l a s s e s s m e n t p re li m in a ry c li n ic a l d ia g n o s is

CDC

Outpatient

& Clinic Hospital

Lab

Referral

Lab

Public

Health

Lab

T E

S T

E

T T

IN

G

S

Definitive Results

Time to Results

PHEMCE Review, August 2010

Findings/Recommendations influencing next steps:

─ Shift from focusing on developing and stockpiling highly pathogen/ threat-specific countermeasures toward a multiuse platform approach

─ New tools, standards and approaches to more efficiently develop products and to facilitate the evaluation of product safety, efficacy (effectiveness), and quality.

─ Enhanced ability and capacity to collect data during emergencies

– A focused solicitation program for more targeted research, using flexible transaction tools, such as rolling Broad Agency Announcements, to capitalize on emerging concepts and recognized gaps in downstream development programs.

Influenza Diagnostic Test Systems

Applications

Clinical Diagnosis → Treatment, Management, Infection Control

Public Health Monitoring → Prevention, Control, Mitigation

Clinical Diagnostic IVDs

Viral Characterization

Viral Disease Properties

• Presence of influenza A or B virus in clinical specimen

• Presence of other respiratory pathogen

• Other (tests for assessing signs/symptoms)

• Antiviral Susceptibility (functional)

• Subtype determination

• Antigenic analysis (to inform annual vaccine strain selection)

• Genetic analysis for viral changes

• Transmissibility

• Severity

• Define risk populations

CDC

Outpatient

& Clinic

Hospital

Clin Lab

Referral

Lab

Public

Health

Lab

T E

T

E

T T

IN

G

S

Immunoassays

Antigenic Characterization

Serology

Immunofluorescence

CURRENT

TESTS (2010)

Influenza & multi-respiratory NAATs

High Throughput

Rapid Influenza Immunity Test

Development reflecting changing setting practices

(2011)

Antiviral Resistance Influenza Test

Multi-respiratory Pathogen Tests

Rapid Virus Characterization Tests

POC InfluenzaTest Laboratory Influenza

Tests (mod complexity)

Viral Culture

CDC multi-target PCR

LDTs – Influenza, multi-respiratory PCR Tests/antiviral functional testing

Sequencing/pyrosequencing

Influenza Test Systems - Settings

Advancing Development of Influenza

Diagnostic Test Systems and Tools

• PHLs, USG, States, Territories

• Reference Labs

• Hosp. Clinical labs

• EDs, Clinics

• Physician Offices

• IVD Industry

• Clinical Investigators

• Distributors

• Suppliers, Biotech

• Research funding

• CDC, ASM, APHL,

JCHAO, CMS

• AAP, AEP, AFP,

IDSA, others

• Research funding

• 510(k)

• ASR/LDT

• PMA

• CLIA-waiver

• RUO

FDA

IVD

Guidance (Reimbursement)

PracticeNew Lab or POC

Test

Data &

Standards

(Lab&Clinical)

Assistant Secretary for

Preparedness & Response

Biomedical Advanced Research

& Development Authority

Preparedness & Emergency Operations

Policy and Planning

CBRN Influenza

Office of the Secretary

SSTD

Acquisition Management

Contracts &

Grants

RQA Req. Modeling Clinical

Studies

Mfg. &

Eng.

Program

Mang.

Emerging

Diseases

Diagnostics Functions within these groups

Diagnostic Programs within BARDA

CDC NIH PHEMCE

NIH: Influenza Diagnostic Test Research & Development

Maureen Beanan, Ph.D.

Program Officer

Division of Microbiology and Infectious Diseases National Institute of Allergy & Infectious Diseases NIH/DHHS

NIAID “Omics” Program

Genome Sequencing

Centers

Genomics

ProteomicsStructural Genomics

Systems Biology

Clinical Proteomics

Centers Structural Genomics

Centers Immune Epitope

Discovery Program

Database: Bioinformatics Resource Centers

Systems Biology Centers

Microbiology and Infectious Diseases Biological Resource Repository (BEI)

DMID DAIT

Database: Immunology Database and Analysis Portal (ImmPort) http://www.fludb.org/brc/home.do?decorator=influenza

Emerging

Technologies

Early Stage

Development

Later Stage

Development

NIAID Diagnostic Program

NIAID Diagnostic Funding Opportunities

NIH Investigator Initiated Grants (R01) http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html (R03) http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html (R21) http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html

NIH Small Business Program Grants Small Business Innovation Research (SBIR) (R443/R44) grant http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html Small Business Technology Transfer (STTR) (R41/R42) grant http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html

NIAID Advanced Technology SBIR (NIAID-AT-SBIR [R43/R44]) http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html

NIAID Proposed Initiatives for FY11 http://funding.niaid.nih.gov/researchfunding/council/concepts/pages/default.aspx http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-096.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-11-097.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://grants.nih.gov/grants/guide/pa-files/PA-10-123.html http://funding.niaid.nih.gov/researchfunding/council/concepts/pages/default.aspx

NIAID Flu Diagnostics Example of Current Activities – Multiplex Diagnostics Project

Goal: To develop and validate 2 multiplex diagnostic products

1) A multiplex POC lateral flow antigen assay to detect common respiratory viruses, including influenza A subtypes and influenza B

2) A multiplex PCR-based assay to detect the same viruses to be used as a confirmatory molecular test

Project Description:

• Building on lateral flow technology and multiplex PCR assays developed and validated in earlier awards

• Optimizing Process Development methods to ensure manufacturability of the lateral flow instrument components, and the antigen and multiplex PCR assay components

• Perform validation studies and assessments of both multiplex diagnostic products to determine if these products have improved clinical sensitivity, specificity and cost effectiveness compared to currently available standard diagnostic tests for these viruses

NIAID Diagnostics Examples of Small Business Awards

• Optimizing multiplex PCR assay for Influenza A subtypes and Influenza B; HPLC detection

• Developing new detection platform capable of amplifying a signal emitted after capture probe binds to target influenza nucleic acid

• Developing detection assay based on light emission released after influenza neuraminidase cleavage of synthetic substrate

Example of Diagnostic Platform Transitioned to BARDA:

Highly Multiplexed Pathogen Detection Using Mass-Tag PCR

Platform Technologies and Applications

Reagent Stabilization

Analytical Assays

Methods & Platforms for Diagnostic Tests

Molecular Tools

Biomanufacturing

SSTD Platform Technologies – Process Oriented

BARDA BAA-11-100-SOL-00001

Pandemic Influenza (Influenza Division)

BARDA BAA-11-100-SOL-00021

Applied to Late Stage Products – Integrated Development Activities

Product Specific Applications & Research

Also: BARDA CBRN BAA-11-100-SOL-00009

“Offerors for Area of Interest #2 should propose activities for products with currently described maturity level equal to or great than Technology Readiness Level (TRL) 6-8.”

Note: A product (or its critical technology component) achieves a TRL if it has completed all activities identified in that TRL.

Why 2 TRL references?

• Similar perspectives; similar assessment parameters

• DoD version emphasizes “critical technology element” for device systems (including IVDs) that may integrate components with multiple technology elements

• MCM/PHEMCE version is draft, not widely available, and IVD-specific

• Neither is all-inclusive as FDA milestones are not universally applicable to all IVD products

Research Area of Interest 2: Diagnostics Maturity levels (TRLs)

Advanced

High

Low

S ta g e o f P ro d u c t

D e v e lo p m e n t

BARDA Interest: Stage of Platform

Technology and Product Development

TRL-9

Advanced

Research

TRL-3

Integrated Regulatory Pathway

Basic/Applied

TRL-5

Basic/Applied

TRL-6

BARDA Interest

Low

High

S ta g e o f M a tu ri ty

Critical Technology/Platform Component

Notes:

• TRL evolution may not be sequential, especially when FDA anchors are undefined.

• TRL examples are neither mandatory nor all inclusive

T R

L -3

T R

L -9

High

To include: Advanced development of new or improved rapid tests, including point of care (POC) ………. that could enable home use, or use in minimally resourced settings with beneficial clinical and public health impact.

Critical technology component should be at a maturity level equal to or greater than TRL 6.

2.1 Development of better rapid influenza

diagnostic tests.

Medicare reimbursement claims from 2004-2009 for virus culture, fluorescent antibody, and antigen detection assays. Jernigan et

al. Clin Infect Dis. 2011 Jan 1;52 Suppl 1:S36-43

Performance limitations with rapid antigen tests:

⁻ Sensitivities generally 40-70%

⁻ Range of 10-80% reported compared to viral culture or RT-PCR.

RATs used by 60% of primary care providers in the U.S.

(Rothberg CID 2006;42:95-99 & MMWR 2008;57:61-65)

Rapid increase in use since 2007 (in physician office and outpatient settings as well as clinical laboratories)

Approaches should enable direct testing ……..and evaluation in on-site laboratories…. Materials and methods can enable reliable and consistent self-collection or collection by non-expert personnel.

2.2 Development of improved respiratory specimen

collection materials and methods

Part II: Product development and Technical Objectives

b. Internal and External Validation Studies:

• Assessments of specimen processing methods and specimen target stability using modified or new collection and transport materials.

• Collaborate with clinical entities to assess feasibility for use of specific specimen collection methods.

Kaiser, et al. Journal of Clinical Virology 14 (1999) 191–197 http://www.nasalaspirationkit.com/Video/mpro8revise.wmv

Transfer and validation of established molecular, or other target signatures for influenza and other respiratory pathogens, to existing platforms.

Critical technology component should be at a maturity level equal to or greater than TRL 8.

2.3 Development of expanded respiratory pathogen tests

on existing test platforms

0%

10%

20%

30%

40%

50%

60%

70%

80%

0%

20%

40%

60%

80%

100%

120%

1 2 3 4 5 6 7 8 9 10 11

4,000

8,000

12,000

16,000

20,000

24,000

28,000

32,000

36,000

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A(H1) A(H3)

A(2009 H1N1) Total ILI Specimens Tested*

Percent Positive (Y3 Axis)‡

N u m b er o f Sp ec im en s

Y3 A xi s

Pe rc en t Po si ti ve

New Device Approval by FDA†

*n= 607,344

Assessment of 2009H1N1 spread in the U.S.

(Respiratory specimen testing from ~150 laboratories participating in

CDC’s virus surveillance system)

From: Jernigan et al. Clin Infect Dis. 2011 Jan 1;52 Suppl 1:S36-43

Advanced development and implementation of methods applying targeted or whole genome sequencing for known influenza reassortant genes to enable more rapid identification of human-animal reassortant influenza viruses with the goal of diagnosis of unusual influenza infections.

Critical technology component should be at a maturity level equal to or greater than

TRL 6.

2.4 Development of advanced sequence detection

methods for identifying novel influenza strains

First cases in Mexico: 24 February 2009 (sequences posted April 24)

First cases in S Calif: 1 April (sequences posted April 25)

Advanced development of reagents for reference methods to identify antiviral resistance and standardize functional resistance testing; adaptation of these methods for use in clinical hospital laboratories with interpretive criteria correlating to clinical outcomes in patients with antiviral resistant infections

2.5 Rapid identification of antiviral resistant

influenza strains

From: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Recommendations and Reports: January 21, 2011 / 60(RR01);1-24

Advanced development and evaluation of methods to rapidly determine presence/absence of significant circulating antibodies specific for influenza viruses, or adaptation of such methods, procedures, standards and controls to an OTS platform for use in clinical and research laboratory settings.

Critical technology component should be at a maturity level equal to or greater than

TRL 6

2.6 Rapid identification of influenza

immunological response

Seroepidemiology studies can provide information on:

• Pre-existing cross-reactive immunity in the population

• Age specific cumulative incidence as infection spreads

• Attack rates & case severity IDSA 2011: What is the value of serosurveillance? Maria Zambon, Health

Protection Agency, London

For applications with existing diagnostic test systems on established platforms. Capability should be available for maintaining inventories and assuring stability sufficient to enable rapid distribution on-demand

(including to remote locations), and capability for rapid surge production.

Critical technology component should be at a maturity level equal to or greater than

TRL 8

2.7 Development and characterization of stable

diagnostic reagents or reference material and controls www.cdc.gov/H1N1flu

The Influenza Reagent Resource (IRR):

A global CDC resource for public health laboratories

Joe Miller, MBA PHD

Chief laboratory preparedness Officer

Centers for Disease Control and Prevention

Atlanta, GA

September 29, 2010 http://www.influenzareagentresource.org/Default.aspx?base

The Influenza Reagent Resource was developed through a contract between CDC and ATCC to provide influenza reagents

1 year contract with 9 option years

Awarded September, 2008

Year 3 began October, 2010

Prime contractor is American Type Culture Collection (ATCC) Manassas, VA, USA

ATCC is a non-profit organization

ATCC follows all CDC regulations and applicable WHO requirements

CDC directs ATCC, who manages multiple subcontractors

The annual IRR budget is $14M

The purpose of the IRR is to support public health by enhancing the detection, surveillance, and control of influenza

Goals:

Support global influenza surveillance by supplying high quality test kits for the detection and characterization of influenza

Ensure high quality reagents are the standard for influenza research and the development of new influenza diagnostics, vaccines, and therapeutics

IRR

Virus

Surveillance

Research and

The IRR stocks many influenza specific reagents rRT-PCR primers, probes, and enzymes

WHO hemagglutination inhibition and DFA reagent kits

Influenza viruses available in panels and ala carte

Polyclonal and monoclonal antibodies

Cell Lines

Virus MN assay reagents

Pyrosequencing reagents

RNA standards for RNA based detection assays http://www.influenzareagentresource.org/Default.aspx?base

Quality of Products

All products manufactured under the contract undergo strict quality testing by CDC

For example, viruses undergo QC testing for

RT-PCR subtype confirmation

HA confirmation

TCID50/CEID50 confirmation

Sterility

Sequencing confirmation

RT-PCR kits and controls

Internal controls fall within a set cT range

Kit as a whole meets set criteria

Antisera

Limited cross-reactivity with other subtypes

Titers must meet an minimally acceptable titer

WHO kit

Antigens tested for sterility, RT-PCR subtype, and HA confirmation

Antisera must meet an acceptable titer by HI, limited cross reactivity

Kit as a whole meets set criteria

IDR

IMMUNE DIAGNOSTIC & RESEARCH

Prime Contractor

Subcontractors

The CDC oversees a diverse group of IRR contractors

Monitors Project, Provides Technical Guidance

Flu Viruses, Cell Lines, Kit Assembly, Panels, Ancillary Reagent Purchase, Hemagglutination Inhibition Reagents, Subcontract Management, Storage, Distribution, RNA standards, Antisera, PCR Primers and Probes, mAb, MN reagents, pyrosequencing reagents

Contract Issuer http://www.biosearchtech.com/

Who can receive IRR reagents?

Qualified public health laboratories and National Influenza Centers

Commercial companies are considered on a case by case basis

Priority is given to companies that collaborate with federal government agencies

Licensing is available for IRR reagents

Most reagents in the IRR are available without an MTA or are available for licensing

CDC owned intellectual property: CDC Technology Transfer Office, phone 770-488-8600 or email to tto@cdc.gov

Non-CDC intellectual property: contact specific contributor

Many viruses are distributed without an MTA. New viruses may be subject to World Health Assembly regulations.

http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64 _8-en.pdf

The IRR can guide you to the right licensing resource:Contact@InfluenzaReagentResource.org mailto:tto@cdc.gov mailto:tto@cdc.gov http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf mailto:Contact@InfluenzaReagentResource.org

How are IRR reagents distributed to users?

All products are provided free of charge, the IRR does not cover customs fees

International shipments are delivered within 2 weeks to most locations

Door to door is the default shipping method, door to customs is used when door to door shipping is not available

Customer support is available at Contact@InfluenzaReagentResource.org Customer support is managed by CDC and ATCC

Technical support for rRT-PCR diagnostics is available at FluSupport@CDC.gov Technical support is managed by CDC

Technical support for other reagents is available by contacting CDC subject matter experts mailto:Contact@InfluenzaReagentResource.org mailto:FluSupport@CDC.gov

To date, the IRR has distributed over 16,000 reagents to 517 laboratories in 146 countries

IRR Challenges

30% Budget Cut

Can optimized processes and technologies help decrease costs?

Proteins, RT-CR controls, Primer/Probes, ancillary reagents

Developing new IRR resources

Monoclonal antibodies against emerging influenza strains

Rapid Influenza Immunity Test reagents

Human specimens

Antiviral Resistance test reagents

Virus panels

DecelAccel ResolutionPeakInitiationRecognitionInvestigation

- Low prevalence

- Low test PPV*

- Need high sens/spec tests

- Rapid response needed

- “Crisis” level low

- Negative implications for false “+”s

- High prevalence

- High test PPV

- Focus on clinical diagnosis and management

- Use broad approaches to surveillance and interventions

- Low prevalence

- Low test PPV*

- Early detection critical

- Detection initiates community interventions

- “Crisis” level high

Diagnostic Assumptions

(2007)

* Laboratory confirmation of first cases required

Alert Event(s)

Notification of a potential PHEIC to WHO

On-going HHS Planning

(CDC, FDA, NIH, ASPR/BARDA)

Identification of activities at each interval of a pandemic curve

Before the Pandemic During the Pandemic

Test

Requests

Assumptions post 2009

• Contracting Point of Contact (Email address: FLU-BAA@HHS.GOV)

─ For all contractual and process questions

─ For all white paper, quad chart, and full proposal submissions

• Technical Point of Contact: Influenza Test Systems and Diagnostic Tools

─ Roxanne Shively, Interdisciplinary Scientist/Branch Chief

Influenza Division (HHS/ASPR/BARDA)

─ Email address: FLU-BAA-DIAGNOSTIC@HHS.GOV

• Why a BAA?

─ BAA’s may be used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution (FAR Part 35.016).

─ The primary basis for selecting proposals for acceptance shall be technical, importance to pandemic preparedness programs and fund availability. Beneficial clinical and public health impact is a priority.

─ A mechanism for funding advanced development activities.

─ capitalize on emerging concepts and recognized gaps in downstream development programs.

Research Area of Interest 2: Influenza Diagnostics Last Words mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA@HHS.GOV mailto:FLU-BAA-DIAGNOSTIC@HHS.GOV mailto:FLU-BAA-DIAGNOSTIC@HHS.GOV mailto:FLU-BAA-DIAGNOSTIC@HHS.GOV mailto:FLU-BAA-DIAGNOSTIC@HHS.GOV mailto:FLU-BAA-DIAGNOSTIC@HHS.GOV