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DEVELOPMENT OF THERAPEUTICS FOR BIODEFENSE

Solicitation Number: BAA-NIAID-DMID-NIHAI2010097
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DMID-NIHAI2010097
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Solicitation
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Added: Jun 10, 2010 3:01 pm Modified: Jul 09, 2010 4:23 pmTrack Changes
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (HHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Microbiology and Infectious Diseases has a requirement for advancing the development of new medical countermeasures against the biological agents that are most likely to be used in a terror attack on civilian populations.

This Broad Agency Announcement (BAA) specifically focuses on supporting the development of promising biodefense therapeutic candidates/products or lead series with broad spectrum activity. The research and development activities supported through this BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure. The eventual goal is to enable the U.S. Government to stockpile these medical countermeasures to protect the American public.


Broad spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a wide range or class of agents. There are a number of traditional threats for which effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered antibacterial and antiviral resistance. A limited number of anti-infectives with broad spectrum activity directed at common, invariable, and essential components of different classes of microbes could potentially be effective against both traditional and non-traditional threats. This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs for emergency use. Additionally, strategies to overcome bacterial and viral drug resistance could extend the clinical utility of existing broad spectrum anti-infectives and have immediate benefits. Moreover, broad spectrum treatments directed towards host targets or human immunological responses to infection have the potential to be effective against one or more diseases. For instance, targeting host receptors and cellular processes to treat infections and/or cellular intoxication can directly prevent or treat diseases. As well, targeting immune response mechanisms may be an effective way to reduce morbidity and mortality by controlling the host responses that contribute to disease or by non-specifically activating the host's natural immune defenses to induce a faster, more potent protective response. These approaches could provide clinical utility when used alone or in combination with conventional anti-infectives.


Broad spectrum therapeutics supported under this BAA are specified as the following classes:
• Broad spectrum anti-bacterial: Therapeutic with activity against more than one of the NIAID Category A, B and C bacterial threat agent AND including at least one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazeki.

• Broad spectrum anti-viral: Therapeutic with activity against more than one of the NIAID Category A, B and C viral threat agent AND including at least one of the following viral pathogens: Ebola virus, Marburg virus, Junin virus, Variola major, Dengue virus, Venezuelan encephalitis virus, Western Equine encephalitis virus, Eastern Equine encephalitis virus and human influenza virus.


• Host-directed broad spectrum therapeutic: Therapeutic directed at a host response thereby reduces morbidity and mortality from exposure/infection and is effective against more than one of the NIAID Category A, B and C bacterial or viral threat AND including at least one of the following bacterial and viral pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazeki, Ebola virus, Marburg virus, Junin virus, Variola major, Dengue virus, Venezuelan Encephalitis virus, Western Equine Encephalitis virus, Eastern Equine Encephalitis virus and human influenza virus.


• Broad spectrum anti-toxins: Therapeutics with activity against more than one of the following toxins or activity against multiple serotypes of one of these toxins: Botulinum neurotoxin, Staphylococcus enterotoxin B, Epsilon toxin of Clostridium perfringens, and ricin toxin.


Offerors shall propose a well-defined product development path that must enable and include the completion of a Phase 1 clinical trial prior to or within a 5-year contract period of performance. The performance of studies in vertebrate animals and clinical studies must be consistent with all applicable Federal regulations and the DMID, NIAID, and NIH policies and guidelines for the conduct and oversight of research in vertebrate animals and human subjects. This solicitation will also support post-Phase 1 product development activities which are enabling for a biologic license application (BLA) or a new drug application (NDA), including:
• Manufacturing scale-up leading to consistency lot manufacturing.
• Phase 2 clinical trials.
• Animal studies leading to pivotal animal efficacy studies required to support licensure under the U.S. Food and Drug Administration (FDA) "Animal Rule" (New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible: http://www.fda.gov/cber/rules/humeffic.htm).


Plans for advancing therapeutic candidates/products or lead series through the product development path shall be proposed, implemented and funded in stages with specific decision gates and well-defined criteria for determining the merit and feasibility of advancing to the next stage. Offerors may submit proposals for more than one therapeutic candidate/product or lead series; however, a separate Technical and Business Proposal is required for each therapeutic candidate/product or lead series. If a single therapeutic candidate/product or lead series is being proposed for activity against more than one of the selected pathogens within the scope of this BAA, only a single Technical and Business Proposal is required.


Offerors are encouraged to apply state-of-art and innovative technological approaches and platforms in the development of the proposed broad spectrum therapeutics. State-of-art and innovative technological approaches refer to capabilities, such as temperature stabilization or delivery method, that can be engineered into a wide array of existing and candidate products to enhance the product performance. Technological platforms, on the other hand, are standardized methods that can be used to significantly reduce the time and cost required to bring medical countermeasures to market.


It is anticipated that multiple cost reimbursement type contracts will be awarded on or about July 29, 2011. The length of the project proposed by the offeror, should be consistent with the nature and complexity of the proposed research, but should not exceed 5 years.
The NIAID estimates that one to three contracts may be issued for a total cost of up to $17 million per year. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s).


All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about June 25, 2010, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

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Solicitation 1

Type:
Solicitation
Posted Date:
July 9, 2010
Description: BAA-NIAID-DMID-NIHAI2010097
Title : Development of Therapeutics for Biodefense

Amendment 1

Type:
Mod/Amendment
Posted Date:
August 6, 2010
Description: Amendment Number: One (1)
Solicitation Number: BAA-NIAID-DMID-NIHAI2010097
Title: “Development of Therapeutics for Biodefense”

Amendment Issue Date: Friday, August 06, 2010
Proposal Due Date: Thursday November 4, 2010 4:00PM Local Time (UNCHANGED)

Issued By: Harry L. Brubaker III
Contract Specialist
Office of Acquisitions, DEA
National Institute of Allergy and Infectious Diseases
National Institute of Health
6700-B Rockledge Drive Room 3214, MSC 7612
Bethesda, Maryland 20892-7612

Point of Contact: Harry L. Brubaker III, Contract Specialist
Email: brubakerh@niaid.nih.gov
The purpose of this amendment is as follows:

Revise PART IV - REPRESENTATIONS AND INSTRUCTIONS, SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, 1. GENERAL INFORMATION, g. PRE-PROPOSAL CONFERENCE is CANCELLED and to replace with the following language:

g. PRE-PROPOSAL QUESTION AND ANSWER

The pre-proposal questions are for the purpose of providing information concerning the Government's requirements which may be helpful in the preparation of proposals and for answering any questions which you have regarding this solicitation.

Therefore, you are requested to mail or e-mail written questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, in sufficient time to be received on or before August 30, 2010 at the address specified in Block 7 of SECTION A - Solicitation/Contract Form of this solicitation or e-mail to brubakerh@niaid.nih.gov.

Your questions should be submitted to the contract specialist, Harry Brubaker, and the envelope should be marked, "Pre-proposal questions, BAA No. NIAID-DMID-NIHAI2010097." All submitted questions and answers will be posted as an Amendment.

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The date specified for receipt of proposals is unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

END OF AMENDMENT NO. 1, BAA-NIAID-DMID-NIHAI2010097

Amendment 2

Type:
Mod/Amendment
Posted Date:
October 14, 2010
Description: This Amendment provides questions submitted by potential offerors and the responses provided by the NIAID. The responses are offered for information only and do not modify or become part of this solicitation.
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
Harry L Brubaker,
Contract Specialist
Phone: 301-496-0612
Fax: 301-480-4675
:
Yvette R Brown,
Contracting Officer
Phone: 301-496-0612
Fax: 301-480-4675