PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

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. Background 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/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 product development support for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused by infectious agents. 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) and/or other FDA submissions including 510(k) application and Investigational Device Exemption (IDE) application. These services are available for therapeutic candidates arising from academia, the private sector or other sources. Purpose and Objectives This resource is intended to be applied to any/multiple product(s) at any/multiple stage(s) requiring access to services in support of a diverse collection of biopharmaceutical 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 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. This IDIQ will be administered and used primarily to support DMID initiatives as necessary to help the Division accomplish its mission. However, other NIAID programs may initiate Task Orders under this IDIQ as necessary to accomplish their mission. NIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that best meet the overall qualifications needed to fulfill the technical requirements of the Task Areas of this solicitation. In the last few years of the current contract, the Biopharmaceutical Product Development Services were underutilized and in the cases where a request was made only one or two out of four participating Contractors sent proposals. Root cause analysis based on Contractor feedback and our own experience suggested that the number of Contractors in the Contractor pool is too small and the Contractors may not have time and resources to identify subcontractors to support the requested studies. For this solicitation, we aim to reach out to many potential offerors including large, multidisciplinary companies with government contract experience as well as smaller companies with specialized technologies. It is anticipated that the resulting Contractor pool will include organizations proposing the full suite of services (all Task Areas) and smaller ones only proposing to provide services in one or more of the Task Areas. This strategy will create a larger pool of Contractors that could offer diverse expertise and services, increasing the probability for the Government to receive competitive offers. The Government anticipates awards to those organizations with the best qualifications whether in all task areas or a subset. Organizations will be considered for contracts only in the Task Area(s) included in their 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 Basic Contract. Specific Task Orders will depend on the status of the candidate(s) as part of an overall product development plan and/or regulatory submission plan to the FDA. Tasks shall be conducted in accordance with quality oversight that is appropriate to the phase of the specific task and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Task Areas and the scope of each are as follows: Task Area A - Product Development Planning and Evaluation Task Area A will support the assessment of products with respect to feasibility of design, development, manufacture, assay development and stability for the preparation of Phase I and II clinical trial materials and materials for diagnostic purposes; developing and writing Preclinical and/or Product Development Plans for specified products; and conducting, reviewing and evaluating technical and/or facility audits of potential vendors. Task Area B - Analytical Assay Development and Product Characterization Task Area B will support activities required for the design, development, qualification and validation of assays as needed for the characterization of a biopharmaceutical product or diagnostic product to demonstrate safety, identity, potency, purity, and quality; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials. Other activities under this Task Area include method comparability studies; redevelopment or improvement of existing assays; technology transfer of assays between the Contractor and facilities. Task Area C - Process Development and Related Activities Task Area C will support the development and performance of production and purification processes amendable to scale-up for the manufacture of biopharmaceutical products or diagnostic reagents; the development of reagents supporting the development of biopharmaceutical products or diagnostic reagents; the production of research-grade products and reagents; performance of CGMP banking (cell/viral) activities; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials. Activities may also include technology transfer of processes between the Contractor and other facilities. Task Area D - CGMP Manufacture and Related Activities Task Area D will support the production of CGMP biopharmaceutical products in accordance with relevant FDA guidelines and the performance and documentation of all other related activities including product release assays required for human clinical use. The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of the activities. The needs, funding, product maturity and timelines of the product as specified in the Task Order establishes requirements for compliance with Current Good Manufacturing Practices (CGMP) [21 CFR Parts -11, -210, -211, -600]. Task Area E - Regulatory Activities and Documentation Task Area E will support developing a Manufacturing Report; Chemistry, Manufacturing and Controls (CMC) Information; a Master File; and other regulatory documents appropriate for submission to the U.S. Food and Drug Administration (FDA). Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber). The Contractor shall obtain and compile, in consultation with the COR, product sponsors, subcontractors and/or consultants, the nonclinical data, CMC, and other appropriate documentation for submission to either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), FDA, Center for Devices and Radiological Health (CDRH), or non-domestic regulatory authorities, as applicable. 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, oligonucleotides and plasmids); bacteriophages, 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 Project requirements 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 one 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 January 05, 2023. Other important consideration None 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, Sixth Edition 2007 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm); Federal Guidelines for Research involving Recombinant DNA molecules at https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities/; 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 System for Award Management (SAM) at https://www.sam.gov/SAM/pages/public/index.jsf. 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 Tasha Lee, Contract Specialist, at tasha.lee@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify NIH-AI-75N93022R00004. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00pm EST on November 30, 2021. 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).