SOURCES SOUGHT
A -- NIAID Preclinical Development Support
- Notice Date
- 1/9/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- HHS-NIH-NIAID-RDSS-NIHAI2015035
- Archive Date
- 2/10/2015
- Point of Contact
- Kishan Patel, Phone: 240-669-5157, Michelle L Scala, Phone: 240-669-5156
- E-Mail Address
-
patelki@niaid.nih.gov, mscala@niaid.nih.gov
(patelki@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction/Synopsis This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential R&D requirement. Background This Division of DAIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has an existing requirement for a project entitled "NIAID Preclinical Development Support," with Advanced BioScience Laboratory, Inc. under contract number HHSN2722001100021I. This Indefinite Delivery Indefinite Quantity (IDIQ) contract was awarded on a competitive basis for a seven year period from August 29, 2011 through August 28, 2018. The purpose of the contract is to provide preclinical development support for promising candidates when such candidates emerge from investigator-Initiated research studies. The total value of the IDIQ contract is a maximum of $102,500,000. The development of vaccines and any other mucosally/systemically deliverable entities to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity to move promising concepts through the development process. In order to supplement limited industry involvement in developing vaccines, the NIAID sponsors a nontraditional, proactive and developmentally-oriented contract to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. NIAID uses this contract to more rapidly and efficiently close development and production gaps. These functions support the fundamental goals of the Vaccine Translational Research Branch (VTRB) under the Vaccine Research Program (VRP), Division of AIDS (DAIDS). This Sources Sough Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID. Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it is deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The purpose of this contract is to provide all aspects of the development, manufacture, IND enabling preclinical testing, and the production of regulatory documents for prototype HIV-1 prophylactic vaccines for human clinical trials. This includes all types of HIV-1 vaccines including DNA plasmids, viral vectors, and protein antigens. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Project Requirements The Contractor shall manage a preclinical research program that will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. The Contractor shall assist in identification, testing, and development of products; participate in and manage preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce products. Furthermore, the Contractor shall maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products. The Contractor shall carry out tasks in the following areas: 1. Essential Core Activities: This task area includes essential activities that shall be performed by the Contractor on a regular basis and consists of the following: a. Project Management b. Quality Assurance/Quality Control c. Information Technology and Data Management d. Storage and Shipping e. Reporting Requirements/Deliverables f. Transition 2. Feasibility Assessments: Under this task area, the Contractor shall assess products for feasibility of design, development, manufacture, potency assay development and stability for the development of phase I-III clinical trial materials. 3. Audits: Under this task area the Contractor shall conduct, review and evaluate audits. Types of audits to be conducted include, but are not limited to, technical and/or facilities audits. 4. Regulatory Documentation: Under this task area, for products produced and/or tested for use in NIAID-sponsored research, in collaboration with the product supplier, the Contractor shall develop a Chemistry, Manufacturing and Control (CMC) Master File, Investigator's Brochure, and compile an IND application, including a clinical trial protocol (provided by NIAID) 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 (www.fda.gov/cber).] 5. Process Development and cGMP Manufacture: Under this task area the Contractor shall produce vaccines and research-grade products as requested by the COR, including process development and production of cGMP pilot lots suitable for early phase human clinical trials, and perform the necessary characterization tests required for release for clinical use. 6. Safety and Immunogenicity Testing: Under this task area the Contractor shall perform pre-clinical testing of products as required for regulatory compliance prior to initial human clinical trial evaluation. Performance Requirement and Anticipated Period of Performance A single award indefinite delivery/indefinite quantity contract is anticipated. The period of performance is from August 29, 2015 through August 28, 2016. The maximum value of the contract is $22 million. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (Eight (8) page limitation, excluding resumes) 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; and (5) demonstrated ability to carry out the work. Respondents should have scientists, laboratories, cGMP facilities, and fill-finish facilities to allow production of prototype or intermediary components for vaccines. Interested contractors should have the onsite capacity and experience to perform cGMP manufacturing including protein manufacture through transient transfection (electroporation) in CHO cells and be able to scale up cGMP protein upstream processes to produce sufficient materials for clinical trial use. Essential personnel include project managers, scientists, quality assurance, quality control, manufacturing, auditing, regulatory, and business contracting staff. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in the CCR, located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Capability statements must be electronically submitted to Kishan Patel at the e-mail address indicated below by no later than 3:00 PM (Local Time), on January 26, 2015. Capability statements will not be returned and will not be accepted after the due date. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID-RDSS-NIHAI2015035. Kishan Patel Contract Specialist Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fisher Lane, Room 3D10, MSC 9821 Bethesda, MD, 20892-9821 E-mail: patelki@niaid.nih.gov 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 Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Kishan Patel Email Address: patelki@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov 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.
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