SOURCES SOUGHT
A -- NONCLINICAL SERVICES FOR DEVELOPMENT OF INTERVENTIONAL AGENTS FOR INFECTIOUS DISEASES - Sources Sought
- Notice Date
- 11/17/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in 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
- SBSS-HHS-NIH-NIAID-AI-2017090
- Archive Date
- 12/17/2016
- Point of Contact
- Courtney A. Markey, Phone: 3017615141, Edward Shane Ryan, Phone: 301-451-3692
- E-Mail Address
-
courtney.markey@nih.gov, ryanes@niaid.nih.gov
(courtney.markey@nih.gov, ryanes@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Description Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services (http://www3.niaid.nih.gov/research/resources/dmid). The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID established the Preclinical Development of Interventional Agents program, a nontraditional, proactive, and product development-oriented program to provide preclinical product development support for promising therapeutic candidates for human infectious diseases or diseases caused by infectious agents. The purpose of this solicitation is to recompete this program and include services supportive of new diagnostics for infectious disease-causing pathogens and/or toxins. The suite of services included in this contract will encompass those activities commonly associated with the development of interventional agents for treating or diagnosing infectious disease that are required for Investigational New Drug (IND) application and/or Biologic License Application (BLA). These services are available for therapeutic candidates arising from academia, the private sector or other sources. While the overall suite of services provided is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of therapeutic product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter a Phase I trial. Furthermore, the rapid diagnosis of infectious disease-causing pathogens and/or toxins is crucial for implementing proper treatment and patient management. The commercial development of new diagnostics is a high priority. For that purpose, this solicitation includes services supportive of new diagnostics for infectious disease-causing pathogens and/or toxins. DMID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to the organizations that best meet the overall qualifications needed to fulfill the technical requirements of the Task Areas of this solicitation, which include: • Task Area A - Product Development Planning and Evaluation Task Area B- Lead Identification Development, Chemistry and Synthesis Services Task Area C- Chemistry and Manufacturing Services Task Area D- Pre-Clinical Microbiological, Safety, Toxicology, and Pharmacokinetics Services Task Area E- Lead Optimization Screening Assays for ADME, Safety and PK Properties • Task Area F - Parent Contract Management Support Activities Contracts are anticipated to organizations proposing the full suite of services and also to organizations proposing two or more of the Task Areas. For the purposes of this contract, the following definitions apply: • Interventional Agent or Product - Therapeutic or diagnostic for the treatment or diagnosis of an infectious disease caused by a pathogen or certain toxins (e.g., botulinum toxin). • Therapeutic - A product intended for use in the cure, mitigation or treatment of disease caused by a pathogen or certain toxins, e.g., botulinum toxin. • Diagnostic - A product intended for use to determine the disease or condition causing a patient's signs and symptoms The NIAID recognizes that a single organization or institution may not have the full spectrum of expertise or facilities required to perform all activities set forth in the Statement of Work. Contractors shall perform the work described in two or more Task Areas. Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. However, contractors shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/SBSS-HHS-NIH-NIAID-AI-2017090/listing.html)
- Record
- SN04330683-W 20161119/161117234205-ce48bc6f8d8ec0ab5143c7bcf97a1aab (fbodaily.com)
- Source
-
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