presol_notice2.pdf

PRESOLICITATION NOTICE

NONCLINICAL SERVICES FOR DEVELOPMENT OF INTERVENTIONAL AGENTS FOR

INFECTIOUS DISEASES

RFP-NIAID-DMID-NIHAI2017090

Note: Offerors are not required to propose to all Task Areas but may respond to a combination of two or more Task Areas. Offerors must propose to Task Area F and at least one Task Area from Task Areas B, C, D or E. The Business Proposal shall address separate costs for each proposed Task Area(s).

Type of Requirement

New Requirement Follow-on (Contract No.: HHSN272201100022I) Other (specify):________________

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location:__________________

Recompetition

SRI International.

333 Ravenswood Avenue Menlo Park, CA 94025-3493

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, Room 3B48, MSC 9821, Rockville, MD, 20852

Duration of contract: 7 year ordering period and 10 year completion

Anticipated award date: _January 30, 2018_

Presolicitation Notice Information

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 Infectious Diseases, has a requirement for a contractor to provide a suite of product development services. While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of Interventional Agents product and diagnostic candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services have helped 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 trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter a Phase I trial.

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 (https://www.niaid.nih.gov/research/microbiology-and-infectious-diseases-resources).

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 requires a nontraditional, proactive, and product development-oriented program to provide preclinical and non-clinical development support for promising therapeutic candidates that emerge from academia, the private sector, or other sources. The suite of services will encompass those activities commonly associated with the development of interventional products for infectious disease required for New Drug Application (NDA), Biologic License Applications (BLA) and/or Investigational New Drug (IND) applications. Consequently, DMID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants.

Purpose and Objectives

In order to meet the demands for interventional agent product development, NIAID awarded a single contract in 2011 to SRI International that provided a set of product development capabilities using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism (Contract Number HHSN272201100022I). Since the contract’s inception, NIAID has awarded many studies and Task Orders for specific activities that were completed to the satisfaction of the technical objectives specified in the contract. The purpose of the current solicitation is to renew this valuable NIAID resource in order to continue to offer a comprehensive array of capabilities with the intent of providing a discrete subset of product development services that will propel new products forward. This resource is intended to be applied on a case-by-case basis for a diverse collection of interventional agent product candidates rather than to carry a single product candidate through the entire preclinical development pathway. These services are intended to help a wide variety of investigators in a number of scientific areas to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements.

Since 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 https://www.niaid.nih.gov/research/microbiology-and-infectious-diseases-resources is a high priority. For that purpose, this solicitation includes services to support the development of new diagnostics for infectious disease-causing pathogens and/or toxins.

NIAID anticipates awarding one or more Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that best meet the overall qualifications for fulfilling the technical requirements of the Task Areas listed in this solicitation. Contracts may be awarded to organizations that propose the full suite of services (i.e. fulfill all Task Areas) or to organizations that propose to provide services in two or more Task Areas. The Government anticipates making awards to those organizations with the best qualifications in each Task Area. Organizations will be considered for contracts only in the Task Area(s) they include in the proposal. Sample Task Orders are provided in the RFP solely to evaluate offeror responses and capabilities. Task Orders for specific tasks will be issued after award of the Parent Contract.

Contracts are anticipated to be awarded to organizations proposing the full suite of services and also to organizations proposing one 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 drug (synthetic or natural product) or a biotechnology product (e.g., monoclonal antibody) intended for use in cure, mitigation, diagnosis or treatment of disease.

• Diagnostic – A product intended for use to determine the disease or condition causing a patient’s signs and symptoms

DMID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) Parent Contracts with an ordering period of seven years to fulfill the technical requirements of this solicitation. Sample Task Orders are provided in the RFP to evaluate offeror responses and capabilities. Task Orders for specific tasks within each of the following Task Areas will be issued after award of the Parent Contract:

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

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. Offerors must propose to Task Area F and at least one Task Area from Task Areas A-E. Contractors performing work in multiple Task Areas 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.

Any responsible Offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 28, 2017 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 via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. 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."

To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.”

http://www.fedbizopps.gov/ https://ecps.niaid.nih.gov/ http://era.nih.gov/applicants/how-to_steps.cfm#register