Federal contract opportunity RFIFY2013 for research and development in biotechnology at Office of the Secretary Acquisitions Management, Contracts, & Grants (AMCG), response was due Jun 19, 2013.

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Solicitation Number
RFIFY2013
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Request for Information (RFI) Number: RFIFY2013
 
Subject: Agents and/or Approaches for Treatment of New and Emerging Infectious Threats.

Key Dates:
Release date: 18 March 2013
Submission of Information date: 18 June 2013
 


Issued by:
Biological Advanced Research and Development Authority


The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases. Under the leadership of HHS, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. The first version of the strategy and implementation plan formed by the Government in 2007 provided a framework for product development successes that were made possible through funding authorized under the Project BioShield Act of 2004. An updated (2012) Strategy and Implementation plan accounts for gains made and further expands the efforts needed to improve national capability and capacity to respond to major public health threats.

The 2012 HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE. The companion 2012 HHS PHEMCE Implementation Plan describes the activities and programs that HHS, in collaboration with its interagency partners, is undertaking over the next five years to increase MCM preparedness for national health security threats. This Strategy and the Implementation Plans together provide the blueprints the PHEMCE will follow in the near-, mid-, and long-terms to make the best use of available resources to enhance national health security.


This Notice seeks declarations of technical capabilities and various information, data, and materials from the public on their interest and ability to develop new or currently marketed therapeutics or prophylactics for mitigation of illness caused by new and/ or emerging chemical and/or biological threats (NETs). Of particular interest are agents that modulate the host innate immune or inflammatory response or otherwise target host factors facilitating pathogenesis.


Description

This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the Government to issue a solicitation, make any contract award, nor pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned.

To date, the focus of the PHEMCE has been on developing, acquiring and stockpiling medical countermeasures (MCMs) to manage potential exposure of the civilian population to specified CBRN threats and pandemic influenza. Key assumptions of this approach are that potential threats will be known or quickly diagnosed, therapeutic agents exist and have been FDA approved for the specific threat, and that it is the function of the Strategic National Stockpile (SNS) to maintain such agents for deployment as needed. Truly novel or emerging threats (NETs) would present significant challenges, particularly if currently marketed and stockpiled MCMs lack efficacy in the treatment or prophylaxis of pathogen associated disease and/ or if rapid diagnosis of the threat was unavailable. The development of MCMs based on augmentation or modification of the host response or other novel mechanisms of action could enhance our Nation's preparedness to respond to NETs and potentially help address the increasing problem of antimicrobial resistance while reducing the total cost of maintaining the SNS.

Novel therapeutics that augment or modulate the host immune system and/ or specific host inflammatory components may provide benefit in treating a wide array of pathogens. Agents functioning as immunomodulators that reduce the morbidity associated with pathogen-induced inflammation are also of interest. Such treatments or prophylactic agents may have value in treating individuals exposed to a pathogen for which definitive medical countermeasures do not exist. Host-directed therapeutics that lend themselves to empiric treatment in the absence of firm microbiologic diagnosis would offer significant operational advantages.

Potential mechanisms may involve approaches focusing on:

• Innate defense regulators e.g. defensins and defensin mimetics: host defense polypeptides which are active against fungi, bacteria and many viruses
• T-cell control (CTLA-4/ IDO antagonists/ CD28): down regulation of T-cell suppression or up-regulation of T-cell stimulatory factors
• Cell surface modification: reducing ability of pathogens to bind to target cells
• Vaccine adjuvants: increasing immunogenicity and/ or reducing required antigen levels
• Pattern recognition agonists, e.g. TLRs: either as adjuvants or agents up-regulating the immune response
• Interferons and other cytokines: as T, B cell stimulatory factors and up-regulation of adaptive immunity and Mx system agonists
• Immunomodulators: reduction of cytokines linked to morbidity and extreme inflammation
• NK cell agonists that may stimulate innate NK or other null cell activities that result in better and sooner recovery to infectious pathogens in an emergency

Compounds that are approved for other indications but which can be repurposed/repositioned as a MCM are of considerable interest as well.

Target Profile

The BARDA mission is primarily to focus on supporting advanced stages of MCM development. However, novel treatments and/ or prophylactics at an advanced stage of development for an alternative indication but at an early phase of development as a medical countermeasure will be of considerable interest as well. Agents that can demonstrate a spectrum of use beyond that of the traditional broad spectrum antibiotics and act without overstimulation of cytokine production and are otherwise generally well tolerated are preferred. While the product profile of a drug or biologic in early phases of development may not be known early in the development process, a fully developed, licensable product should:

• Have an onset of action within 24 hours of an initial administration
• Be indicated for use in adults, pediatrics, geriatrics and in special populations
• Have minimal metabolic interactions with commonly prescribed drugs for the general population
• Have a stable shelf life of 4-5 years

Commercial utility outside of use as a medical countermeasure is also preferred.

Data to be provided:

Data from this RFI will assist BARDA in assessing the viability of research and development of antimicrobial agents not focused on specific pathogens and thereby enhancing the nation's biodefense efforts.

In Vitro data are acceptable as demonstration of the viability of an approach though results from animal models would be preferred. Data obtained from human clinical trials are welcomed though not required. All in vitro and in vivo data submitted in response to this RFI should be accompanied by a brief summary of findings as well as the description of the model(s) used. Additional data including chemical or immunological characteristics, mechanism of action, proposed formulation and dosage as well as scale of manufacture are welcome.

Responders to this RFI may also describe institutional expertise and experience.

This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to make any contract award on the basis of responses nor otherwise pay for the preparation of any information submitted or for the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. All responses will be treated as confidential. Any proprietary information should be so marked.

Inquiries

Information must be received by no later than the close of business 18 June 2013. Responses should be limited to 10 pages and marked with RFI Number: RFIFY2013. Responses are to be electronic only and shall be emailed to the following Point of Contact:

Ethan J. Mueller, Contracting Officer, HHS/OS/ASPR/AMCG
Office: 301-696-7289, Cell: 202-450-9878
Email: Ethan.Mueller@HHS.gov

In addition, please electronically submit any questions that you have regarding this RFI to the Point of Contact above by no later than 10 calendar days after the posting date of this RFI. If the due date falls on a non-business day then the due date shall be the close of business the next business day.

The Government will plan on posting all questions and answers on a non-attribution basis as quickly as possible after the question due date.


 


 


 


 


 


 


 

Request for Information (RFI) Number: RFIFY2013 Subject: Agents and/or Approaches for Treatment of New and Emerging Infectious Threats.Key Dates:Release date: 18 March 2013Submission of Information date: Close of business 45 calendar days after the posting date of this RFIIssued by:Biological Advanced Research and Development Authority The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases. Under the leadership of HHS, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. The first version of the strategy and implementation plan formed by the Government in 2007 provided a framework for product development successes that were made possible through funding authorized under the Project BioShield Act of 2004. An updated (2012) Strategy and Implementation plan accounts for gains made and further expands the efforts needed to improve national capability and capacity to respond to major public health threats.The 2012 HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE. The companion 2012 HHS PHEMCE Implementation Plan describes the activities and programs that HHS, in collaboration with its interagency partners, is undertaking over the next five years to increase MCM preparedness for national health security threats. This Strategy and the Implementation Plans together provide the blueprints the PHEMCE will follow in the near-, mid-, and long-terms to make the best use of available resources to enhance national health security. This Notice seeks declarations of technical capabilities and various information, data, and materials from the public on their interest and ability to develop new or currently marketed therapeutics or prophylactics for mitigation of illness caused by new and/ or emerging chemical and/or biological threats (NETs). Of particular interest are agents that modulate the host innate immune or inflammatory response or otherwise target host factors facilitating pathogenesis. DescriptionThis is a Request for Information (RFI) only. It is not a request for proposals and does not commit the Government to issue a solicitation, make any contract award, nor pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned.To date, the focus of the PHEMCE has been on developing, acquiring and stockpiling medical countermeasures (MCMs) to manage potential exposure of the civilian population to specified CBRN threats and pandemic influenza. Key assumptions of this approach are that potential threats will be known or quickly diagnosed, therapeutic agents exist and have been FDA approved for the specific threat, and that it is the function of the Strategic National Stockpile (SNS) to maintain such agents for deployment as needed. Truly novel or emerging threats (NETs) would present significant challenges, particularly if currently marketed and stockpiled MCMs lack efficacy in the treatment or prophylaxis of pathogen associated disease and/ or if rapid diagnosis of the threat was unavailable. The development of MCMs based on augmentation or modification of the host response or other novel mechanisms of action could enhance our Nation's preparedness to respond to NETs and potentially help address the increasing problem of antimicrobial resistance while reducing the total cost of maintaining the SNS. Novel therapeutics that augment or modulate the host immune system and/ or specific host inflammatory components may provide benefit in treating a wide array of pathogens. Agents functioning as immunomodulators that reduce the morbidity associated with pathogen-induced inflammation are also of interest. Such treatments or prophylactic agents may have value in treating individuals exposed to a pathogen for which definitive medical countermeasures do not exist. Host-directed therapeutics that lend themselves to empiric treatment in the absence of firm microbiologic diagnosis would offer significant operational advantages.Potential mechanisms may involve approaches focusing on:• Innate defense regulators e.g. defensins and defensin mimetics: host defense polypeptides which are active against fungi, bacteria and many viruses• T-cell control (CTLA-4/ IDO antagonists/ CD28): down regulation of T-cell suppression or up-regulation of T-cell stimulatory factors• Cell surface modification: reducing ability of pathogens to bind to target cells• Vaccine adjuvants: increasing immunogenicity and/ or reducing required antigen levels• Pattern recognition agonists, e.g. TLRs: either as adjuvants or agents up-regulating the immune response• Interferons and other cytokines: as T, B cell stimulatory factors and up-regulation of adaptive immunity and Mx system agonists• Immunomodulators: reduction of cytokines linked to morbidity and extreme inflammation• NK cell agonists that may stimulate innate NK or other null cell activities that result in better and sooner recovery to infectious pathogens in an emergencyCompounds that are approved for other indications but which can be repurposed/repositioned as a MCM are of considerable interest as well. Target ProfileThe BARDA mission is primarily to focus on supporting advanced stages of MCM development. However, novel treatments and/ or prophylactics at an advanced stage of development for an alternative indication but at an early phase of development as a medical countermeasure will be of considerable interest as well. Agents that can demonstrate a spectrum of use beyond that of the traditional broad spectrum antibiotics and act without overstimulation of cytokine production and are otherwise generally well tolerated are preferred. While the product profile of a drug or biologic in early phases of development may not be known early in the development process, a fully developed, licensable product should:• Have an onset of action within 24 hours of an initial administration• Be indicated for use in adults, pediatrics, geriatrics and in special populations• Have minimal metabolic interactions with commonly prescribed drugs for the general population• Have a stable shelf life of 4-5 yearsCommercial utility outside of use as a medical countermeasure is also preferred. Data to be provided:Data from this RFI will assist BARDA in assessing the viability of research and development of antimicrobial agents not focused on specific pathogens and thereby enhancing the nation's biodefense efforts.In Vitro data are acceptable as demonstration of the viability of an approach though results from animal models would be preferred. Data obtained from human clinical trials are welcomed though not required. All in vitro and in vivo data submitted in response to this RFI should be accompanied by a brief summary of findings as well as the description of the model(s) used. Additional data including chemical or immunological characteristics, mechanism of action, proposed formulation and dosage as well as scale of manufacture are welcome. Responders to this RFI may also describe institutional expertise and experience.This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to make any contract award on the basis of responses nor otherwise pay for the preparation of any information submitted or for the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. All responses will be treated as confidential. Any proprietary information should be so marked.InquiriesInformation must be received by no later than the close of business 45 calendar days after the posting date of this RFI. If the due date falls on a non-business day then the due date shall be the close of business the next business day. Responses should be limited to 10 pages and marked with RFI Number: RFIFY2013. Responses are to be electronic only and shall be emailed to the following Point of Contact:Ethan J. Mueller, Contracting Officer, HHS/OS/ASPR/AMCGOffice: 301-696-7289, Cell: 202-450-9878 Email: Ethan.Mueller@HHS.govIn addition, please electronically submit any questions that you have regarding this RFI to the Point of Contact above by no later than 10 calendar days after the posting date of this RFI. If the due date falls on a non-business day then the due date shall be the close of business the next business day.The Government will plan on posting all questions and answers on a non-attribution basis as quickly as possible after the question due date.              

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Unspecified Amendment_1.docx Amendment 1 to Request for Information (RFI) Number: RFIFY2013 Agents and/o...
Unspecified Amendment_1.docx Amendment 1 to Request for Information (RFI) Number: RFIFY2013 Agents and/o...