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BARDA FY2016 BAA - MedicalCountermeasures.gov · ASPR ASSISTANT SECRETARY FOR PREPAREDNESS AND...

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ASPR ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE BARDA FY2016 BAA Wendell Conyers / George Keane / Sherica Teshome October 14, 2015 Resilient People. Healthy Communities. A Nation Prepared.
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  • ASPR ASSISTANT SECRETARY FOR

    PREPAREDNESS AND RESPONSE

    BARDA FY2016 BAA Wendell Conyers / George Keane /

    Sherica Teshome October 14, 2015

    Resilient People. Healthy Communities. A Nation Prepared.

  • ASPR

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    Overview Introduction

    Why use a BAA

    Benefits of a BAA

    Eligible Offerors

    Part I Application Process

    Part II Evaluation Process

    Questions

    2

  • ASPR

    1\SSISTANT SECRETARY ,O,.

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    Introduction The Biomedical Advanced Research and DevelopmentAuthority (BARDA) solicits the advanced research and development of medical countermeasures for chemical,biological, radiological, and nuclear agents that threatenthe U.S. civilian population. BARDA anticipates thatresearch and development activities awarded under thisBAA will serve to advance candidate medical countermeasures towards licensure or approval by the Food and Drug Administration (FDA).

    Under a BAA, both procurement contracts and non-procurement instruments including InteragencyAgreements (IAAs), Grants, Cooperative Agreements,and Other Transaction Agreements (OTAs) may be awarded.

    3

  • Why use a BAA? Streamlines the procurement process: Multiple submission periods possible Amend the BAA to add or subtract information or requirements Remain open for extended time Current solicitations open for two years Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

    4

  • ASPR

    1\SSISTANT SECRETARY ,O,.

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    BAA Benefits

    Opportunity to gain responses for research areasof interest

    The government may benefit from the ingenuityof our industry/ academic partners

    Offerors can provide proposals with uniquesolutions

    5

  • ASPR

    1\SSISTANT SECRETARY ,O,.

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    Eligible Offerors

    Who is eligible for award?

    Private sector organizations, Federally FundedResearch and Development Centers (FFRDCs)and Government entities (Government/Nationallaboratories, military educational institutions,etc.)

    This BAA is open to ALL responsible sources

    6

  • ASPR ASSISTANT SECRETARY FOR

    PREPAREDNESS AND RESPONSE

    Part I Application Process

    SHERICA TESHOME

    Resilient People. Healthy Communities. A Nation Prepared.

  • ASPR

    1\ SSISTANT src 1n:T1\f< Y F Oi<

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    Application Process

    The BAA Application Process consist of two stages:

    STAGE 1 Quad Chart/White Paper Instructions

    STAGE 2 Full Proposal Instructions

    8

  • Stage 1 Quad Chart/White Paper

    Quad Chart/White Paper Preparation Initial submission should not exceed 14 pages Combine all files and forms into a single searchable

    PDF file Describe the effort in sufficient detail to allow

    evaluation of the concepts technical merit and itspotential contribution to the BARDA mission

    Format Both Quad Chart and White paper format is

    explained in BAA solicitation

    9

  • Stage 1 Quad Chart/White Paper (contd)

    Review Technical merit and Program relevance is

    reviewed by panel

    An invitation letter to submit full proposal

    Do not invite letter (full proposal submissionnot recommended)

    Technical feedback provided in response letter

    No debriefing will be provided

    10

  • Stage 2 Full Proposal

    Full Proposal must be prepared in two separatevolumes:

    Volume I Technical Proposal (detailedinstructions located in solicitation)

    Volume II Cost Proposal (detailedinstructions located in solicitation)

    11

  • This is a rolling solicitation with multiple deadlines for submission:

    Submission Deadlines

    White Paper Submission Deadline Dates 30 January 2016 30 April 2016 30 July 2016 30 October 2016 30 January 2017 30 April 2017 30 July 2017 30 October 2017 Final Quad Chart/White Paper Deadline is October 30, 2017 Full Proposals are due as specified in the invitation letter

    12

  • Part II Evaluation Process George Keane

    Resilient People. Healthy Communities. A Nation Prepared.

  • Technical Evaluation Panel (TEP)

    Panel composed of Government and non-Government subject matter experts

    Three areas examined #1 Program Relevance #2 Scientific and Technical Merit #3 Offeror Capabilities

    Ratings range from Excellent (Best), Good, Fair,Poor (Worst).

    14

  • Technical Evaluation Report

    Documented results of the TEP

    Report is the basis of the recommendation to theSource Selection Authority (SSA)

    15

  • Cost Proposal Review

    Basic Cost/Price Information

    Documentation of Proposed Costs

    Allocable, Allowable and Reasonable

    Some areas of special consideration

    16

  • Salary Rate Limitation

    HHSAR 352.231-70

    Direct Salary cannot exceed Executive Level II

    $183,300 annually (January 2015)

    Applies to subcontractors and consultants as wellas prime contractors

    17

  • ASPR Business Toolkit Repository for business templates for submitting a

    cost proposal Documentation of Proposed Costs Salary Rate Limitation Travel Cost Proposal Attachments HHS Small Business Subcontracting Plan Total Life Cycle Costs

    Website: http://www.phe.gov/about/amcg/contracts/Pages/toolkit .aspx

    18

    http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspxhttp://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx

  • BAA Websites:

    Federal Business Opportunities:https://www.fbo.gov/

    MedicalCountermeasures:https://www.medicalcountermeasures.gov

    Public Health Emergency: Http://www.phe.gov

    Grants.gov: http://www.grants.gov/

    19

    https://www.fbo.gov/https://www.medicalcountermeasures.gov/http://www.phe.gov/http://www.phe.gov/http://www.phe.gov/http://www.grants.gov/http://www.grants.gov/http:Grants.gov

  • Submission E-mail Addresses:

    SST - [email protected]

    CBRN - [email protected]

    FLU - [email protected]

    20

    mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

  • For Future Contact:

    SST - Wendell Conyers / 202-205-8262 /[email protected]

    CBRN - George Keane / 202-260-5169 /[email protected]

    FLU - Sherica Teshome / 202-205-5919 /[email protected]

    21

    mailto:[email protected]:[email protected]:[email protected]

  • Questions?

    22

  • BARDA INDUSTRY DAY

    FY 2015 YEAR IN REVIEW Cassandra R. Freeman

    Division Director, AMCG Division of Acquisition Policy

    23

  • FY2015 Year in Review

    Actions Competed and Awarded Actions Awarded by Category

    Metrics and Efficiencies

    24

  • Actions Competed and Awarded Actions Awarded by Category

    Metrics and Efficiencies

    25

  • FY2015 A wards by Category

    Actions Competed and Awarded Actions Awarded by Category

    Metrics and Efficiencies

    26

  • Bioshield RFP 128 days Ebola 60 days I H S (PALT) 120 - 180 days VA (PALT) 180 - 215 days

    Contract Awarded Contract Awarded 60 days

    23 days

    50 100 53 days*

    98 days

    30 days 128 days

    150 180 days

    Contract Award PALT 180 - 215 days

    Contract Award PALT 120 -180 days

    Contract Awarded 180 days Evaluation / Negotiation / OGC RFP 45 days

    * Includes two outliers

    AMCG Metrics and Efficiencies Acquisition Data

    27

    Timeline

    Bioshield RFP128 days

    Ebola60 days

    I H S (PALT)120 - 180 days

    VA (PALT)180 - 215 days

    Contract AwardedContract Awarded

    30 days60 days128 days

    23 days

    50100150180days

    53 days*

    98 days

    Contract Award PALT

    180 - 215 days

    Contract AwardedContract Award PALT

    120 -180 days

    Contract Awarded

    RFP 45 daysEvaluation / Negotiation / OGC180 days

    *Includes two outliers

    OGAPA review timeline

    Projected Contract Awarded

    156 days

    Projected Contract Awarded inclusive of OGAPA review

    Contract Awarded

    128 days

    Bioshield RFP128 days

    Contract Awarded

    RFP 45 daysEvaluation / Negotiation180 days

    RFP

    Project Bioshield RFPs

    Contract NameSolicitation PublishedPosted daysProposal ReceivedEvalution daysContract Award IssuedTotal TimelineMonths

    CBRN BIOshield Herd Maintenance12/12/14321/13/151556/17/151876 months, 5 days

    HHS Innovation Lab Visualization Hub RFP3/20/15204/9/15265/4/15461 month, 14 days

    Autograft-Sparing Products for Definitive Care of Burn Injuries6/26/15327/27/15589/23/15902 months, 29 days

    Cell Based Skin Substitutes for Definitive Care of Burn Injuries6/26/15327/27/15589/23/15902 months, 29 days

    Debridement for Definitive Care of Burn Injuries6/26/15327/27/15589/23/15902 months, 29 days

    Stockpile 2015 - RFP1/12/15462/27/153081/1/1635411 months, 20 days

    Medical Countermeasure Data Analysis and Reporting Tool7/17/15168/1/15248/26/15401 month, 9 days

    Bioshield RFP

    Posted daysEvalution daysTotal Timeline

    132155187

    2202646

    3325890

    4325890

    5325890

    646308354

    7162440

    Avg3098128

    RFP

    32155187

    202646

    325890

    325890

    325890

    46308354

    162440

    Posted days

    Evalution days

    Total Timeline

    Graph

    Project Bioshield RFPs

    Bioshield RFP

    Posted daysEvalution daysTotal Timeline

    132155187

    2202646

    3325890

    4325890

    5325890

    646308354

    7162440

    Avg3098128

    Graph

    Posted days

    Evalution days

    Total Timeline

    Ebola

    Ebola Requirements

    ContractorCOR/CO/CSSolicitation PublishedPosted daysProposal ReceivedEvalution daysContract Award IssuedTotal TimelineMonths

    Mapp Biopharmaceutical, Inc.CO: Francine Hemphill CS: Nathaniel Cohen COR: Chia-Wei Tsai8/24/1499/2/149

    Profectus BioSciences, Inc.CO: RoShawn Majors COR: Amanda Zarrabian9/16/142810/14/1428

    Emergent BioSolutionsCO: Joffrey BenfordCS: Enrique ManCOR: Melissa Willis2/9/15564/6/151027/17/15158

    NanotherapeuticsCS: Quintin Hackshaw CO: Tammy McLeod COR: Arlene Joyner9/24/1411/18/1455

    BioProtection Systems Corporation (Newlink)CS: Kathy Hughes CO: Carl Newman COR: Amanda Zarrabian11/22/142712/19/1427

    GlaxoSmithKline, LLCCS: George Keane CO: Francine Hemphill COR: Ashley Cecere10/17/146812/23/1468

    Techncial Resources Inc.Jui Shah/Robert Walker/ Brooke Bernold / Matt McCord12/17/14812/24/14482/9/1556

    EMMESCO/CS: Matt McCord COR: Katina Robinson-Wright1/2/1581/9/15322/9/1540

    IIT Research InstituteCO/CS: Matt Rose COR: Kim Armstrong12/18/14201/6/15492/23/1569

    MedicagoCO: Kyle Roberts/COR: Thor Young12/22/141/13/15382/20/1533

    FraunhoferCO: Kyle Roberts/COR: Thor Young12/22/141/13/15382/20/1538

    BioCryst Pharmaceuticals, Inc.CO: Phil Hastings COR: Kimberly Sciarretta1/30/15563/27/1556

    OraSure Technologies, IncCO/CS: Carl Newman1/23/151396/11/15139

    Posted daysEvalution daysTotal Timeline

    99

    2828

    56102158

    55

    2727

    6868

    84856

    83240

    204969

    3833

    3838

    5656

    139139

    Count41213

    Avg235360

    Ebola Requirements

    The 13 requirements sampled contributed to the 2015 Ebola response.

    There were 2 outliers that skewed Ebola response times (60 Days). The outliers include Orasure (Indirect Rate calculation and Scope of Work concerns) and Emergent Biosolutions (1st award under CIADM)

    Ebola requirements Avg. 23 days to solicit under tasks orders, Under BAAs solicitation time N/A

    Ebola

    Posted days

    Evalution days

    Total Timeline

    BARDA FY2016 BAAOverviewIntroductionWhy use a BAA?BAA BenefitsEligible OfferorsPart I Application ProcessApplication ProcessStage 1Quad Chart/White Paper Stage 1 Quad Chart/White Paper (contd)Stage 2Full Proposal Slide Number 12Part II Evaluation ProcessTechnical Evaluation Panel (TEP)Technical Evaluation ReportCost Proposal ReviewSalary Rate LimitationASPR Business ToolkitBAA Websites:Submission E-mail Addresses:For Future Contact:Questions?BARDA INDUSTRY DAYFY2015 Year in Review Slide Number 25FY2015 Awards by CategoryAMCG Metrics and Efficiencies Acquisition Data


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