SOURCES_SOUGHT_NOTICE.pdf

SOURCES SOUGHT 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).

Sources Sought Reference Number: RFP-NIAID-DMID-NIHAI2015036

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 (if applicable)

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

Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this 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 Biopharmaceutical Product Development Services Program, 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.

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:

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 two 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

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.

Anticipated period of performance

This is an IDIQ Contract with a seven year ordering period. The anticipated start date is on/or about July 29, 2016.

Capability Statement/Information Sought: Capability Statements should clearly convey information regarding the respondent’s capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; (4) corporate experience and management capability;

and (5) examples of prior completed Government contracts, references, and other related information.

Interested contractors must submit a capability statement describing their company’s experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) demonstrated ability to carry out the work;

(6) adequacy of the documented experience with, and appropriateness of plans for: (a) receiving, formatting, storing and shipping compounds and biological agents; (b) technology transfer processes; (c) shipping, handling and storing compounds and formulated drugs; (d) providing and evaluating preclinical and/or product development plans; (e) experience working with potential biohazards, toxic chemicals, and radioisotopes; and (f) adequacy of the plan for training, implementation, and monitoring of safety procedures; (7) availability of adequate facilities, equipment, and resources with sufficient capacity necessary to safely and efficiently accomplish the work described in the Statement of Work in a timely manner, to include documented access to BSL-2 and BSL-3 facilities; (8) perform work in accordance with the following guidelines: “Biosafety in Microbiological and Biomedical Laboratories”, Centers for Disease Control and Prevention and the National Institutes of Health, Fifth Edition 2007 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm); Federal Guidelines for Research involving Recombinant DNA molecules at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html);and Recommendations for the Safe Handling of Cytotoxic Drugs, NIH Publication No. 92-2621 and the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 3 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points.

Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.

Required Business Information:

DUNS.

Company Name.

Company Address.

Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.

Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR) located at http://www.ccr.gov/index.asp. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electronic copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Ms. Emily Edler, Contracting Specialist, at emily.edler@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify RFP- NIAID-DMID-NIHAI2015036. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 12:00 PM (Eastern Prevailing Time) on 05/05/2015. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE

AND TIME WILL NOT BE CONSIDERED.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”