Pre-Sol_Notice.pdf

PRESOLICITATION NOTICE

PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT

DEVELOPMENT

RFP-NIAID-DMID-NIHAI2015036

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-D. The Business Proposal shall address separate costs for each proposed Task Area(s).

Type of Requirement

New Requirement Follow-on (Contract No.: HHSN272201100023I) Other (specify):________________

Place of Performance

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

Recompetition

Leidos, Inc.

11951 Freedom Drive Reston, VA 20190 571-526-6000

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: _July 29, 2016_

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 biopharmaceutical 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 (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 a nontraditional, proactive, and product development-oriented program to provide preclinical product development support for promising biopharmaceutical 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.

Purpose and Objectives

The suite of services included in this contract will encompass those activities commonly associated with the development of biopharmaceutical products 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 biopharmaceutical 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 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:

http://www3.niaid.nih.gov/research/resources/dmid

• Task Area A - Product Development Planning and Evaluation

• Task Area B - Analytical Assay Development and Product Characterization

• Task Area C - Process Development and Related Activities

• Task Area D - CGMP Manufacture and Related Activities

• Task Area E - Regulatory Activities and Documentation

• Task Area F – Parent Contract Management Support Activities

Contracts are anticipated 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:

• Biopharmaceutical Products – Materials that are derived from biotechnology processes including, but not limited to, monoclonal antibodies and derivatives of monoclonal antibodies;

recombinant proteins derived from traditional and non-traditional expression systems; natural products and derivatives; peptides; nucleic acid based materials (such as siRNA and plasmids);

and live, modified-live and/or attenuated entities.

• 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

DMID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) 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 Basic Contract:

• Task Area A - Product Development Planning and Evaluation

• Task Area B - Analytical Assay Development and Product Characterization

• Task Area C - Process Development and Related Activities

• Task Area D - CGMP Manufacture and Related Activities

• Task Area E - Regulatory Activities and Documentation

• 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 B-D. 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 July 31, 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.

http://www.fedbizopps.gov/

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.”

https://ecps.niaid.nih.gov/ http://era.nih.gov/applicants/how-to_steps.cfm%23register