SOLICITATION NOTICE
A -- Development of Therapeutic Products for Biodefense & Emerging Infectious Diseases
- Notice Date
- 6/17/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- BAA-NIAID-DMID-NIH-AI-2015037
- Point of Contact
- Alexandra Buck, Phone: 240-669-5174, George Kennedy, Phone: 240-669-5170
- E-Mail Address
-
alexandra.buck@nih.gov, kennedyg@mail.nih.gov
(alexandra.buck@nih.gov, kennedyg@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- DEVELOPMENT OF THERAPEUTIC PRODUCTS FOR BIODEFENSE AND EMERGING INFECTIOUS DISEASES BAA NUMBER: BAA-NIAID-DMID-NIH-AI-2015037 Presolicitation Notice Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) 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 Infectiou s Diseases has a requirement for th e development of therapeutic products for use in post-event settings following the intentional release of a NIAID Category A, B, or C Priority Pathogen or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A, B, and C Priority Pathogens. Description Organizations responding to this BAA must have documented expertise in drug discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against biological threats identified as NIAID Category A, B and C Priority Pathogens or 2012 HHS PHEMCE Strategy and Implementation Plan ( http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx ) and shall complete and submit the Summary of Related Activities form from the following website: http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf. This BAA solicitation focuses on the development of promising lead therapeutic candidates/products. For the purposes of this BAA, a lead candidate has demonstrated feasibility of manufacturing, in vitro and in vivo evidence of efficacy, and sufficient characterization to allow the development of a draft target product profile. One category of products being solicited are those with broad spectrum therapeutic activity against viruses or bacterial pathogens. This solicitation also focuses on supporting development of promising anti-toxins as therapeutic candidates/products, particularly small molecule therapeutics with anti-toxin activity. The research and development activities supported through this BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure by the FDA. Broad spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a 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, or directed at host functions that are required by 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 have the potential to be effective against one or more diseases. For these reasons, non-traditional therapeutics are encouraged provided they have demonstrated therapeutic activity when used alone or in combination with an existing licensed product. Therapeutic activity is defined as the cure or mitigation of disease once signs and symptoms of infection are evident. For the purposes of this BAA, the ideal broad spectrum therapeutic candidate is defined as a single agent that meets all three of the following criteria: 1) A drug (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant protein) intended for use in the cure, mitigation, or treatment of two or more bacterial or viral pathogens; AND 2) An agent with demonstrated in vivo activity in an appropriate therapeutic model of disease; AND 3) An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3( http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf ). Toxins are poisonous substances produced by living cells or organisms that are capable of causing or exacerbating disease when introduced into the body tissues. While bacteria that produce toxins may often be eliminated by the use of antibiotics during an infection, disease may still occur or may progress because of the presence of toxins produced by the pathogen. In addition, toxins may be isolated and themselves be introduced into body tissues and thereby cause disease and death, as in the case of ricin. Treatments are needed to target specific toxins in order to cure or mitigate disease caused by those toxins. For the purposes of this BAA, the ideal anti-toxin therapeutic candidate is a single agent, preferably a small molecule, meeting the following criteria/definitions: 1) An agent intended for use in the cure, mitigation or treatment of intoxication; AND 2) An agent that has demonstrated activity against a specific toxin in an in vivo model of disease; AND 3) An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3 ( http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf ). Therapeutics targeted under this BAA are specified as the following: B ro ad s p e ct r u m a nt i -b a ct er i a l : · T h er a p e ut i c w i t h a c t i v i t y a g a i n st o n e o f t h e f o l l o w i n g b act er i al pa th o g e n s: B aci l l u s a nth r aci s, F r a n cis e lla t u la r e n si s, Y e r si n ia p e st i s, B u r k h o l de r ia p s e ud o m a l l e i, B. ma l l e i A N D i n ad d i t i o n, act i v i t y a g a in st o n e o th e r N I A I D Ca t e g o r y A, B or C b act e r i al t h re at age nt. · Antibacterial therapeutic with activity against two or more of the urgent, serious and concerning drug-resistant bacterial threats listed in the 2013 CDC Antibiotic Resistance Threats in the United States report ( http://www.cdc.gov/drugresistance/biggest_threats.html ). B ro ad s p e ct r u m a nt i - v i r a l : · T h er a p e ut i c w i t h a c t iv i t y a g a in st o n e o f t h e f o l l o w i n g v i r al p a th o g e n s: E b o l a v i r u s, Ma r bu r g v i r u s, Orthopoxviruses representative of V a r i o la m aj o r, D e ng u e v i r u s, MERS-CoV, Chikungunya virus AN D, i n ad d i t i o n, act i v i t y a g a i n st o n e o the r N I A I D Ca t e go r y A, B or C v i r al t h re at age n t including activity against discrete strains, species or serotypes within a virus genus. · T he r a p e ut i c a ct i ve a g a i n st m u l t i p l e i n f l u en z a s ubt yp e s d i re ct e d at e i th e r v i r al o r h o st ta r g e t s. A n t i -t o x i n s: · A t h er a p e ut i c a g e nt, preferably a s m a ll m o l e c u l e, w i t h a c t i v i t y a g a i n st o n e o f th e f o ll o w i n g t o x i n s: Botulinum neurotoxin, Staphylococcus enterotoxin B, Bacillus anthracis Protective Antigen, Lethal Factor or Edema Factor, and ricin toxin. Contracts awarded under this BAA will not target : · Basic research and discovery of new candidates/products · Refinement of a lead series to identify a candidate · Development of devices, topical products, prophylactic products, or diagnostics · Development of candidates/products that have not demonstrated therapeutic activity in a relevant animal model of disease · Development of serum-derived products · Development of licensed products as new formulations or for additional clinical indications It is anticipated that multiple cost reimbursement, completion type contracts will be awarded on or about June 1, 2016. The total period of performance comprised of a base period and options shall not exceed five years. NIAID estimates that two to five contracts may be issued for a total cost (direct and indirect costs combined) of up to $15.3 million in Fiscal Year 2016 for all awards. 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). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about July 1, 2015 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. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (“eCPS”) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/BAA-NIAID-DMID-NIH-AI-2015037/listing.html)
- Record
- SN03767896-W 20150619/150617235702-40be9ab247dc9ab080acd3c18cc1b646 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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