ABERDEEN PROVING GROUND ADVANCED PLANNING BRIEFING tob. 4.13 - 13_JPM-MCS (with... · PDF...

Click here to load reader

  • date post

    16-Mar-2019
  • Category

    Documents

  • view

    212
  • download

    0

Embed Size (px)

Transcript of ABERDEEN PROVING GROUND ADVANCED PLANNING BRIEFING tob. 4.13 - 13_JPM-MCS (with... · PDF...

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Management Office for

Medical Countermeasure Systems

Presented by: COL David P. Hammer 2 FEB 2017

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITIES

Joint Vaccine Acquisition Program

Marburg Vaccine

Western, Eastern, and Venezuelan Equine Encephalitis Virus Vaccine

Biological Defense Therapeutics

Antiviral Therapeutic Prototype

Anti-Alphavirus Therapeutic Prototype

Antibacterial Therapeutic Prototype

Chemical Defense Pharmaceuticals

Improved Nerve Agent Treatment System (INATS) Improved Oxime Treatment Increment

Expansion of Autoinjector Manufacturing Base Dual Drug Delivery Device (D4)

Diagnostics

Next Generation Diagnostics System Increment 2 Platform Component Development

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Joint Vaccine Acquisition Program (JVAP)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEWMedical Countermeasures Systems (MCS) mission area

is the development, production and fielding of medical solutions to counter Chemical, Biological, Radiological and Nuclear threats.

Within MCS, the Joint Vaccine Acquisition Program (JVAP) has the mission to develop, produce and field FDAlicensed biological defense vaccines.

Current JVAP portfolio includes vaccines for protection against Filoviruses, Equine Encephalitis viruses (western, eastern and Venezuelan) Botulinum Toxins (serotypes A and B), Ricin toxin and pneumonic Plague.

Future focus areas include vaccines for protection against Francisella tularensis, Coxiella burnetii (Q-Fever), and Burkholderia

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Marburg Vaccine to Protect Against Aerosolized Marburg Virus

GOAL: Development of multiple Marburg Vaccine Prototypes Against Aerosolized Marburg

Virus through a Phase 1 clinical trial

PROGRAM OFFICE CONTACT: Chris [email protected]

CONTRACT OFFICE CONTACT:Alexandra Trunzo,Contract [email protected]

JVAP intends to meet this requirement through a competitive award through the OTA Consortium.

RPP release anticipated in Feb 2017 Award anticipated April 2017 Period of performance expected to be through Phase 1 clinical trials Scope will include all manufacturing efforts, non-clinical studies and regulatory

efforts required to support execution of a phase 1 clinical trial

JVAP intends to competitively award a follow on contract for all activities leading to FDA licensure starting in early 2020

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

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

OPPORTUNITYTITLE: Western, Eastern, and Venezuelan Equine Encephalitis Virus Vaccine to Protect Against

Aerosolized exposure to above alphaviruses

GOAL: Development of an multiple-target single-vector Vaccine Prototype Against Aerosolized

Equine Encephalitic viruses including Venezuelan Equine Encephalitis Virus through a Phase 1 clinical trial

PROGRAM OFFICE CONTACT: Andrew Glenn

[email protected]

CONTRACT OFFICE CONTACT: Alexandra Trunzo,

Contract [email protected]

JVAP intends to meet this requirement through a competitive award through the OTA Consortium.

RPP release anticipated in Feb 2017 Award anticipated April 2017 Period of performance expected to be through Phase 1 clinical trials Scope will include all manufacturing efforts, non-clinical studies and regulatory efforts

required to support execution of a phase 1 clinical trial

JVAP intends to competitively award a follow on contract for activities leading to FDA licensure starting in early 2020

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

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

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Biological Defense Therapeutics (BDTX)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

JPM-MCS-BDTX has provided a broad Statement of Objectives (SOO) for a consortium Other Transactional Authority (OTA) solicitation and the MCS Broad Agency Announcement (BAA), for therapeutics against Biological Warfare Agents (BWAs)

Viral Threats: Filoviridae (Zaire ebolavirus, Sudan ebolavirus, Marburg marburgvirus, Tai Forest, and Bundibugyo); Alphaviridae (Eastern Equine Encephalitis, Western Equine Encephalitis, Venezuelan Equine Encephalitis); Bunyaviridae (Hantaan)

Bacterial Threats: Bacillus anthracis (Anthrax), Brucellaspp. (Brucellosis), Burkholderia mallei (Glanders), Burkholderia pseudomallei (Meliodosis), Francissilatularensis (Tularemia); Yersinia pestis (Plague)

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Antiviral Therapeutic Request for Prototype Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE:

OPPORTUNITYTITLE: Anti-Alphavirus Therapeutic Request for Prototype

Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE:

OPPORTUNITYTITLE: Antibacterial Therapeutic Request for Prototype Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE:

UNCLASSIFIED

UNCLASSIFIED

Dr. Erin Reichert2 February 2017

Aberdeen proving ground

advanced planning briefing to

industry

CBM Mission

Medical S&T Division is responsible for ensuring robust

pipelines of vaccine and therapeutic candidates that can be

transitioned and matured into products by our advanced

development partners. This directly supports the overall

enterprise goal of developing and delivering novel medical

technologies to address current and emerging biological

threats in order to protect the lives and maintain the battle

readiness of our warfighters.

Bio-Pretreatments Branch

Discovery and development of vaccines

for: alphaviruses, filoviruses, Bacillus

anthracis (anthrax), Burkholderia mallei

(glanders), Burkholderia pseudomallei

(meliodosis), Francisella tularensis

(tularemia), Coxiella burnetii (Q Fever),

and botulinum, ricin and SEB toxin

Bio-Therapeutics Branch

Discovery and development of

therapeutics for alphaviruses,

filoviruses, botulinum toxin, and broad-

spectrum antibiotics targeting multi-drug

resistant bacterial threat pathogens

J9 CBM Focus Areas

Supporting S&T

Investments in animal model development, novel manufacturing technologies that

exploit readily adaptable expression platforms and leverage flexible

biomanufacturing technologies, understanding host-pathogen/toxin interaction for

identification of targets and/or biomarkers, adjuvants and stabilization

technologies, drug delivery methods, and compound library compilation and

characterization

Biological Prophylaxis &

Pretreatment

Core Capability Concept

Provide the warfighter protection against biowarfare agents through the administration of pr