SOLICITATION NOTICE
A -- Preclinical Services for HIV Therapeutics
- Notice Date
- 10/4/2019
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and 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
- 75N93019R00021
- Archive Date
- 11/5/2019
- Point of Contact
- Patrick Finn, Phone: 2406695401, John R. Manouelian, Phone: 2406695152
- E-Mail Address
-
patrick.finn@nih.gov, manouelj@niaid.nih.gov
(patrick.finn@nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- Partial Small Business
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821 Duration of contract: 7 Years If Options will be included, describe Options: Base contract awards will not include Options. Task Orders may be issued with both term and quantity Options. Anticipated award date: October 15, 2020 Presolicitation Notice Information Background 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 to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The NIAID supports resources and services to assist academic, small business and other investigators, including contracts that provide or make available research materials, in vitro drug screening, chemical synthesis including small scale Good Manufacturing Practice (GMP) synthesis, small animal efficacy models, drug formulation, preclinical pharmacology and toxicology, and other discovery and preclinical services to aid the advancement of promising agents from bench to clinics. Over the past years, these contract activities have helped investigators to obtain critical data and materials to attract additional funding, gain prospective partnership, fulfill regulatory requirements, and complete studies before entering clinical trials. Information about these contract resources or activities can be found at the following website: https://www.niaid.nih.gov/research/resources. Some of these activities are currently being provided under the following NIAID contracts: • AIDS Reagent Program (HHSN272201200022C with Fisher Bioservices, Inc. 14665 Rothgeb Drive, Rockville, Maryland 20850) • Preclinical Development Services for AIDS Therapeutics (HHSN272201400006I with SRI International, 333 Ravenswood Avenue, Menlo Park, California 94025) • In Vitro Testing Resource for HIV Therapeutics and Topical Microbicides (HHSN272201400010I with Southern Research Institute, 2000 Ninth Avenue South, P.O. Box 55305, Birmingham, Alabama 32555) • Synthesis of Therapeutic Agents for Treatment of Infectious Diseases (HHSN272201500003C, with Starks Associates, Inc., 1280 Niagara Street, Buffalo, NY 14213) Purpose and Objectives The purpose of the proposed Indefinite Delivery/Indefinite Quantity contracts is to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. Although the focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services, at the discretion of NIAID, these contracts may also be used to advance vaccines, antivirals, and preventive strategies for these and other infectious diseases. Throughout this Pre-solicitation Notice, these candidate products and/or strategies will collectively be referenced as "products." Throughout this contract, preclinical (i.e., undertaken before testing in humans) and nonclinical (i.e., undertaken to address specific regulatory requirements during clinical testing) studies will collectively be referenced as "preclinical". The Government intends to solicit these services as multiple-award Indefinite Delivery/Indefinite Quantity contracts. Task Orders will be issued in the following Task Areas: • Task Area A: In Vitro Testing and Screening Resource for Therapeutics • Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases • Task Area C: Small Animal Models for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) • Task Area D: Small Animal Models of Mycobacterium Infection • Task Area E: Formulation Development and Manufacture of Clinical Dosage Forms • Task Area F: Preclinical Pharmacology and Toxicology Services • Task Area G: Reagent Program for HIV and Other Infectious Diseases Offerors may respond to one Task Area only, to several Task Areas, or to all Task Areas. It is anticipated that NIAID will award Base contracts to one or multiple contractors for each of the Task Areas listed (A, B, C, D, E, F, and G). NOTE: Task Area B, Synthesis of Therapeutic Agents for Treatment of Infectious Diseases, is set aside for small business concerns. The North American Industry Classification System (NAICS) code for this acquisition is 541715 with a size standard of 1,000 employees. Scope The Contractor shall provide preclinical development support for candidate products and drug development activities. The scope of work encompasses activities that range from initial product discovery to those required to support clinical trials and/or product licensure. The contract also provides for the acquisition and distribution of research materials in support of basic, drug discovery, and translational research. General Technical Requirements: The following requirements shall apply to all Task Orders, as applicable: 1. Meetings and Teleconferences The Contractor shall plan and conduct meetings between key Task Order personnel and other project staff (e.g., subcontractors, consultants, product sponsors, and/or other personnel designated by the Contracting Officer's Representative (COR)) at regular intervals, to review protocols, data, the status of approved projects, and to discuss any matters relevant to the scientific and/or financial administration of the contract and future activities. The schedule for these meetings will be established by the COR after Task Order award (i.e., weekly, biweekly, monthly, or as needed to address emerging issues). 2. Intellectual Property The Contractor shall ensure the protection of third-party intellectual property, information provided by third parties or by the Government, as well as data generated through this contract. Information shall be deemed as proprietary and shall not be used or distributed without the expressed consent from the third party or as authorized in Agreements between NIAID and the provider. 3. Technology Transfer As required by the Task Order and as specified by the COR, the Contractor shall prepare and submit to the COR for review and approval, technology transfer packages for the transfer of assays, processes, methods, Standard Operating Procedures (SOPs), reagents, animal models, and/or any other material or documentation generated under the contract, to any third party designated by the COR, or directly to the COR. 4. Document and Data Management The Contractor shall provide an information technology (IT) system infrastructure to meet the requirements outlined in the Task Order Statement of Work and institute such systems as required to transfer required/specified data materials to a database designated by the COR. 5. Material Receipt, Storage, Shipping, and Inventory Develop and maintain effective procedures to support contract activities for receiving, storing, shipping and inventory of products including the secure, safe, and stable storage of contract materials under the required conditions (e.g., Biosafety Level, aseptic, Good Manufacturing Practice (GMP), etc.) and according to specifications provided by the supplier, as applicable. Obtain and maintain the appropriate licenses and permits required by international, federal, state, and local authorities for the safe storage and shipping, of products, drugs, biologics, pathogens, specimens and reagents for the safe import or export, storage, handling, transportation, and distribution. Provide for safe packing, labeling, and shipment of products, pathogens, specimens and reagents, so that shipments are coordinated for timely receipt. Establish and maintain an electronic inventory of specific contract materials as designated by the COR or in the Task Order SOW, such as in an Excel spreadsheet or database, that includes searchable information, such as compound identifiers, amounts available, storage locations, shipping data and other biological and chemical characteristics of the compound, source and relevant material transfer agreements, or animal inventories and animal data. 6. Regulatory Compliance When required, all activities supporting specific regulatory requirements shall be conducted in compliance with Good Laboratory Practice (GLP; 21 CFR 58), current Good Manufacturing Practice (cGMP; 21 CFR 210-211), International Conference on Harmonization (ICH) guidelines, or other local, state, Federal, or non-U.S. product quality development regulations. For FDA submissions, this shall require performance of studies at a level of quality that is sufficient for incorporation into pre-IND, IND, IDE, and NDA documents. Although studies that support product development outside of regulatory requirements (i.e., non-GLP or non-cGMP) may also be performed, the resulting data, processes and data/record keeping shall be well-documented and of sufficient quality to be acceptable for inclusion in an IND/IDE/NDA filing. When applicable, the preclinical development services should meet the FDA recommended preclinical requirements for the product (e.g. for antiviral products (http://www.fda.gov/media/71223/download. 7. Site Visits If required in the Task Order Statement of Work, arrange for and conduct site visits (e.g., study initiation, interim, or termination visits) for Contractor/subcontractor staff, NIAID staff, contract consultants, and/or other third-party individuals designated by the COR to review and discuss activities related to the Task Order SOW. 8. Quality Assurance/Quality Control (QA/QC) The Contractor shall have and implement a written Quality Plan and program to monitor all operations and processes, develop, implement and evaluate SOPs; define metrics to assess performance; methods to identify and address deficiencies and resolution of issues; and QA training of staff. Project-specific QA/QC requirements will be specified in each Task Order. The COR may require an external audit of the QA/QC infrastructure before awarding a Task Order. Maintain a system for quality control of data. 9. Biocontainment Facilities and Safety As required for all studies conducted under these Task Areas, the Contractor shall provide safe facilities and resources and conduct work with hazardous biological materials in compliance with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, guideline available at: https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF. Where applicable, address conflicts between biosafety and clean facility requirements. 10. Acquisition, Care, and Housing of Animals As required for all animal studies conducted under these Task Areas, the Contractor shall comply with all applicable laws, policies, and guidelines regarding the care and use of laboratory animals, including the PHS Policy on the Human Care and Use of Laboratory Animals ( http://grants1.nih.gov/grants/olaw/references/phspol.htm ). Description of Individual Task Areas: The Contractor will carry out Task Orders in one or more of the following Task Areas: Task Area A: In Vitro Testing and Screening Resource for Therapeutics Scope for Task Area A: Under this Task Area, the Contractor shall conduct in vitro evaluation of potential anti-viral therapeutic agents that block infection, inhibit gene expression and replication, or eliminate infected cells. The studies will include confirmatory and specialized in vitro testing using assays in standard (i.e., up to 96 wells per plate) and high throughput screening (HTS) formats (i.e., greater than 96 wells per plate). New in vitro assays shall be developed, or transferred from third parties, and validated as needed to identify, or confirm, the activity of potential therapeutics. The Contractor shall conduct lead identification and optimization. The primary focus of this Task Area shall address HIV targets. NIAID may elect screening for HBV or HCV or other viral targets to meet emerging public health needs. Requirements for Task Area A: Under this Task Area, the Contractor shall conduct in vitro assays in standard and HTS formats to evaluate the potential of anti-viral therapeutic agents. The interventional agents used shall include, for example, small molecules, peptides, oligonucleotides, biologics, polymers, or other substances. These assays shall be developed directly by the Contractor or transferred to the Contractor from a third party specified by the COR. State-of-the-art techniques and technologies shall be used with emphasis on under-represented targets. The specific services shall include but are not limited to: 1. Conduct confirmatory and specialized in vitro testing and screening of interventional agents in standard formats. The Contractor shall confirm the putative activity of interventional agents that are purchased by the Contractor or provided by the COR. Cells to be used shall be of human or mammalian origin and shall include established cell lines as well as primary cells from blood and tissue. 2. Develop, or transfer from third parties, in vitro assays and validate the assays as needed to identify or confirm the activity of potential therapeutics. Use state-of-the-art techniques and technologies with emphasis on under-represented targets. 3. Provide an approach to select compound libraries needed to support HTS format screening. 4. Acquire and store a library of approximately 100,000 chemical compounds to support HTS format screening. 5. Perform HTS on at least 700,000 compounds per year in cell based or biochemical assays. Activities shall include adapting standard format assays to a HTS format, plating of compound libraries for use in HTS studies, and utilizing state of- the-art systems to perform HTS using a single compound concentration in cell-based or biochemical assays. The Contractor shall confirm all hits by dose-response evaluation in the primary assay. The Contractor shall perform confirmatory testing of anti-viral activity in continuous or primary cell types. 6. Conduct lead identification and optimization studies using in vitro screening and cytotoxicity studies with the objective of identifying and characterizing agents with anti-viral activity. The hit-to-lead progression studies should include one, or all, of the following activities: a. Analyze compound structures. b. Design a lead optimization scheme (LOS) for generating chemical analogues based on specific structural scaffolds of leads. c. Conduct structure activity relationship (SAR) studies to identify analogs of the interventional agents for subsequent lead optimization activities. d. Procure or synthesize chemical analogues of a selected lead compound to improve pharmacological properties. e. Conduct assays to determine absorption, distribution, metabolism, and excretion (ADME) characteristics. f. Perform optimization of chemical leads to improve a specific physiochemical or pharmacological property, such as solubility, bioavailability or metabolism. g. Conduct mechanism of action (MOA) studies. h. Conduct in vitro studies to determine toxic properties. i. Perform in vitro safety pharmacology evaluations. Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases THIS TASK AREA IS SET ASIDE FOR SMALL BUSINESS CONCERNS (see above). Scope for Task Area B: The scope of this effort is small scale synthesis of compounds in quantities required for testing in either in vitro or in animals, and large scale synthesis of compounds for early Phase I clinical studies. Some compounds will require synthesis in compliance with Current Good Manufacturing Practices (cGMP) regulations. This contract will provide resources for the synthesis of promising compounds for the treatment of HIV, TB, hepatitis B and C, and other infectious diseases of relevance to the research agenda of NIAID. Requirements for Task Area B: Under this Task Area, the Contractor shall: 1. Acquire or conduct synthesis of small scale (10mg - 10g) and large (10-1000 g) batches of compounds of purity greater than 95 percent for subsequent biological and biochemical analyses, in vitro and in vivo testing. Compounds will be candidates for treatment of infectious disease and may include but are not limited to antiviral or antimicrobial agents and immune regulatory molecules. The focus of this Task Area will be for the synthesis of small molecules. When requested, the Contractor shall develop experimental design(s) and methodology for synthesis and/or analytics and identify or develop specific route(s) or procedure(s) for synthesis of compounds. 2. When requested, the Contractor shall conduct synthesis of compounds for use in human subjects or laboratory animals requiring full cGMP compliance. Upon completion of the studies, the Contractor shall provide the reports and documentation to support regulatory submissions and shall be fully compliant with cGMP manufacturing regulations and standards (refer to Guidance Documents Q7A, Q8, Q9, Q10, and Q11 of ICH) and must maintain all the facilities, procedures, and documentation in compliance with cGMP. 3. Purify and/or characterize compounds or therapeutic agents for purity, perform chemical screens for physiochemical properties, confirm chemical identity and purity of compounds by established methods such as 1H-nuclear magnetic resonance (NMR), infrared (IR) and ultraviolet- visible (UV-VIS) spectroscopy, and elemental analysis. When requested, methods shall include mass spectroscopy (MS), 13C NMR, optical purity, or HPLC-UV or HPLC-MS chromatography. 4. As applicable, develop and/or provide data sheets and preparative methods, provide Material Safety Data Sheets (MSDS) for all compounds and maintain documentation needed for regulatory requirements. Task Area C: Small Animal Models for HIV, HBV and HCV: Scope for Task Area C: The Contractor shall provide and refine or improve small animal models for HIV, HBV, and HCV and perform testing of single products or combinations of products in the animal models. The primary focus will be small animal models for HIV. This Task Area also includes other activities associated with small animal studies, such as obtaining biosamples, endpoint assays, histopathology, data documentation, and reports, etc. Primates are excluded from this Task Area. Requirements for Task Area C: Under this Task Area, the Contractor shall conduct small animal studies for testing of products related to the treatment, cure, or prevention of HIV, HBV, and/or HCV. Facilities shall be compliant with Animal Biosafety Level (ABSL-2) requirements (https://www.cdc.gov/labs/BMBL.html) and have current full Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation. Test products will be either provided to the Contractor by the Government or third parties or shall be acquired by the Contractor as specified by the Task Order. Specifically, the Contractor shall conduct pharmacokinetic (PK), safety, and efficacy studies in animal models of HIV, HBV, and HCV in order to characterize products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent animal or human studies. The Contractor shall provide two or more of the following small laboratory animal models: conventional mice, humanized knock-out and knock-in mouse strains, conventional and transgenic (humanized) rats, guinea pigs, and/or laboratory rabbit varieties. Task Orders may include up to approximately 1,000 animals, but numbers will be dependent on the species and the study to be conducted. The animal species and models chosen shall be appropriate for the proposed study. Other small animal models of similar size to rabbits and rodents, such as woodchucks, are also permitted upon approval of the Contracting Officer's Representative (COR). Animal studies should be conducted as outlined under the National Institutes of Health, Office of Laboratory Animal Welfare, Policies and Laws. Primates are excluded from this Task Area. Models may utilize human tissue of any origin, excluding embryonic stem cells. Tissue acquisition must be in compliance with federal, state, and local laws and regulations as well as current Department of Health and Human Services requirements and NIH policies. The Contractor shall assure that humanized animals meet accepted model standards and/or study-specific or Task Order-specific standards for creating the humanized model (e.g., degree of engraftment of human cells and susceptibility to infection). The Contractor shall: 1. Perform confirmatory in vitro assays of products to be assessed in the small animal model including in vitro cytotoxicity assessments to determine the therapeutic index. 2. Provide and/or refine/improve small animal models of HIV, HBV, and/or HCV. 3. Assess mainly therapeutics, but also vaccines, other prophylactic methods, and diagnostics for use against HIV, HBV, and HCV in small animal models. 4. Evaluate clinical manifestations, body weight, complete blood counts, and serum chemistries to determine the health of the animals. 5. Develop, standardize, and validate assays and assay components to support animal model improvement and in vivo product evaluation. 6. Characterize (e.g., purity, sterility, identity, concentration/titer, stability), and distribute reagents and biological samples to support infectious disease research. 7. When applicable, other activities (e.g., immunology, histopathology, in situ hybridization, whole body and tissue imaging, etc.) may be solicited by a specific Task Order. Task Area D: Small Animal Models of Mycobacterium Infection: Scope for Task Area D: The Contractor shall provide and refine or improve small animal models for Mycobacterium tuberculosis (MTB) complex and perform testing of single products or combinations of products in the animal models. This Task Area also includes other activities associated with small animal studies, such as obtaining biosamples, endpoint assays, histopathology, data documentation, and reports, etc. Primates are excluded from this Task Area. Requirements for Task Area D: Under this Task Area, the Contractor shall provide services and conduct studies to support the in vivo evaluation of potential therapeutic agents against Mycobacterium tuberculosis (MTB) in small animal models. Task Orders on other Mycobacterium species may be issued under this Task Area as well. The therapeutic agents will be either provided by the Government or third parties to the Contractor or shall be acquired by the Contractor as specified by the Task Order. Facilities shall be compliant with ABSL-3 requirements (https://www.cdc.gov/labs/BMBL.html) and have current full AAALAC accreditation. The Contractor shall: 1. Provide and optimize one or more established/accepted small animal models of MTB and/or HIV/TB co-infections suitable for testing combinations of therapeutic strategies. These may include mice, rabbits, ferrets or guinea pigs for TB. For HIV/MTB co-infection studies, only humanized small animals or small animals transgenic for HIV genes are permitted. Task Orders may include up to approximately 500 animals, but numbers will be dependent on the species and the Task Order. Aerosol challenge capabilities are preferred, but not required. Animal studies should be conducted as outlined under the National Institutes of Health, Office of Laboratory Animal Welfare, Policies and Laws. 2. Improve existing small animal models for Mycobacterium tuberculosis infection and/or adapt other existing or newly developed models for use in studies under the contract. 3. Evaluate mainly TB therapeutic (for active or latent disease) candidate(s), but also vaccines, other prophylactic methods, and diagnostics alone or in combination with other products for efficacy and toxicity in an appropriate small animal model for TB and/or HIV/TB. Products shall be administered using a variety of routes including oral, parenteral, and/or aerosol. Obtain appropriate body samples for evaluation (e.g., to allow for pharmacokinetics and pharmaco-dynamics studies, measure viral or bacterial burden or cellular markers). 4. Evaluate clinical manifestations, body weight, complete blood counts, and serum chemistries to determine the health of the animals. 5. Provide histopathologic examinations of selected tissues to determine the extent of disease/tissue damage. 6. Provide appropriate bacterial or viral assays (e.g., quantitative cultures of tissue) for determination of the efficacy of the product intervention. 7. Perform safety and tolerability assessments of products in animal models. 8. Perform other assays and studies as required by the Task Order, for example, but not limited to drug susceptibility testing, determination of minimum inhibitory concentration (MIC), and alternative assays for determination of bacterial or viral levels. 9. Develop, standardize, and validate assays and assay components to support model development and product evaluation. 10. Characterize (e.g., purity, sterility, identity, concentration/titer, stability), and distribute reagents and biological samples to support M. tuberculosis research. 11. When applicable, other activities (e.g., immunological assays, detailed histopathology, whole body and tissue imaging, etc.) may be solicited by a specific Task Order. Task Area E: Formulation Development and Manufacture of Clinical Dosage Forms: Scope for Task Area E: The Contractor shall provide services and conduct studies to support the development of formulations of potential therapeutic agents. Targeted formulations shall include tablets, capsules, lyophilized powders, solutions, suspensions, aerosols, nanomaterials, etc., for oral, intravenous, subcutaneous, intramuscular, intranasal, vaginal or rectal delivery. The Contractor shall also manufacture, package, label, release, and ship final versions of these formulations intended for evaluation in clinical trials. Activities shall be performed in compliance with current Good Manufacturing Practice (cGMP) guidelines (21 CFAR 210-211) and other applicable regulatory guidelines when requested. Formulations shall be manufactured as sterile products when requested. Requirements for Task Area E: Task Orders shall incorporate one or more of the following activities/studies: 1. Determine the physicochemical and stability properties of drug substances and formulated products. 2. Develop, validate, and/or perform analytical assays for characterization of active pharmaceutical ingredients (APIs) and degradation products. 3. Procure reference standards. 4. Develop and characterize formulations to meet one or more of the following: increased drug solubility, drug stability; bioavailability; enhancement of recipient's immune response to a supplied antigen; targeted drug delivery; sustained drug release; taste masking; alternate routes of administration; and/or alternate dosage strengths or physical dosage forms. 5. Evaluate the compatibility of APIs with potential formulation excipients. 6. Conduct in vitro drug absorption/permeability studies. 7. Conduct scale-up formulation development studies necessary for achieving the characteristics of targeted dosage forms for clinical manufacturing. 8. Develop and perform analytical assays to determine the identity, strength, quality, and purity of manufactured drug products that include (but are not limited to) stability indicating assays, drug release methods, and content uniformity assays. 9. Develop robust and scalable cGMP-compliant manufacturing processes and procedures, including cleaning validation of equipment. 10. Manufacture and package pharmaceutical products in compliance with cGMP guidelines. 11. Conduct product stability studies in compliance with cGMP guidelines. 12. Retain all records as required under cGMP guidelines. 13. Other specific activities in support of this Task Area as required by FDA (21 CFR 312.23(a)(7)) to advance products into clinical testing. 14. When requested by the COR, prepare reports to be included in the Chemistry, Manufacturing and Controls (CMC) section of FDA regulatory submissions. Task Area F: Preclinical Pharmacology and Toxicology Services Scope for Task Area F: The Contractor shall conduct studies to assess the pharmacology and toxicology of potential therapeutics. Testing shall be conducted in vitro or in relevant animal species and shall be performed in compliance with Good Laboratory Practice (GLP) guidelines (21 CFR 58) when requested. The Contractor shall conduct all animal studies in a facility accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) or its equivalent. Requirements for Task Area F: The Contractor shall conduct activities suitable to facilitate regulatory submissions and intellectual property applications of third parties and to support decision-making by the investigator/sponsor and the FDA. The Contractor shall conduct GLP and non-GLP studies, as appropriate. Products may include small organic molecules, polymers, or biologics (e.g., peptides, oligonucleotides, antibodies), cellular and genetic drug products (e.g., CAR-T cells), or products with nanomaterials in their finished dosage form, and will have been selected for further development based on their potential to advance to clinical testing. The Contractor shall conduct the following types of activities: 1. Develop, validate, and/or perform analytical assays for characterization of active pharmaceutical ingredients (APIs), degradation products, or metabolites in biological samples (e.g., plasma, blood, urine, feces, tissues). 2. Synthesize or purchase reference standards. 3. Evaluate stability of APIs in formulations, biological fluids, and/or tissues. 4. Conduct pharmacology studies of potential therapeutic agents including in vitro studies to assess absorption, distribution, metabolism and excretion (ADME); and/or plasma protein binding; in vivo studies in mice, rats, dogs, non-human primates, and other relevant animal species to assess pharmacokinetic parameters of ADME, bioavailability and bioequivalence; potential drug interactions. 5. Conduct toxicology studies of potential therapeutic agents including in vitro studies to assess: genotoxicity; off-target toxicity profiling (e.g. mitochondrial toxicity, cardiovascular toxicity, hepatic toxicity, renal toxicity, or vasculitis); in vivo studies in mice, rats, dogs, non-human primates, and/or other relevant animal species to assess genotoxicity; determination of No Observed Adverse Effect Level (NOAEL); toxicity associated with single dose and repeated dose administration; local tolerance and/or irritability; reproductive toxicity, carcinogenicity, and/or immunotoxicity. 6. Conduct safety pharmacology studies of potential therapeutic agents (e.g., pharmacodynamic effects on cardiovascular, immunologic, respiratory, gastrointestinal, genitourinary, and central nervous systems). 7. Conduct toxicogenomic, proteomic, and/or metabolomic studies of potential therapeutic agents. 8. Develop new toxicology models and test systems, such as 3-dimensional culture, hollow-fiber cell culture, or organ-on-a-chip technology. 9. Retain all records samples and histology/microscopy slides, as required under GLP guidelines. Task Area G: Reagent Program for HIV and other Infectious Diseases Scope for Task Area G: The Reagent Program (RP) for HIV and Other Infectious Diseases will provide critical research materials to the scientific community. The Contractor shall maintain the Reagent Program (RP) for HIV and Other Infectious Diseases through identification, acquisition, production, receipt, storage, maintenance, distribution and disposal of biological and chemical research organisms, materials, and materials for HIV and other infectious diseases for use in basic and translation research. The RP does not provide materials intended for clinical use. Furthermore, the contract provides support for quality control and characterization of reagents, technology transfer, and execution of material transfer agreements prior to release of reagents to the community. A complete catalog of the current public material offerings can be found on the following website (www.aidsreagent.org). Requirements for Task Area G: The Contractor shall conduct the following types of activities related to research reagents, materials and products (referred to as materials in this solicitation): 1. Acquire, receive, produce, expand, maintain, store and dispose of research materials for HIV and other infectious diseases. 2. Support authentication and characterization of biological and chemical materials following quality control and quality assurance procedures. 3. Package and ship materials to qualified registered investigators throughout the world. 4. Provide an integrated inventory management system, including inventory tracking, to maintain a real-time and physical accounting of materials and material-specific records related to storage, sources, shipping and distribution history, restrictions for distribution, and forecasting for future needs. 5. Provide support for technology transfer and execution of material transfer agreements prior to release of reagents to the community. 6. Provide and maintain a user-friendly and 508 compliant web portal and web-based systems for research user registration, ordering and depositing of materials, and providing customer service. 7. Maintain an OMB compliant electronic database of registered users that is integrated with the ordering and shipping system. Anticipated Period of Performance It is anticipated that multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts will be awarded on or about October 15, 2020, for a period of 7 years, through October 14, 2027. Task Orders to be issued against the Base contracts will primarily be cost-reimbursement type, both term and completion form. The Government reserves the right, however, to issue fixed-price type Task Orders, when appropriate. The Government anticipates awarding the following number of Task Orders each year. This list is provided to indicate the general scope of work of this contract and should be considered an estimate only. Task Area, Title, and Estimated No. of Task Orders Per Year: Task Area A, "In Vitro Testing and Screening Resource for Therapeutics", Estimated 6 Task Orders Per Year; Task Area B, "Synthesis of Therapeutic Agents for Treatment of Infectious Diseases", Estimated 5 Task Orders Per Year; Task Area C, "Small Animal Models for HIV, HBV, and HCV", Estimated 3 Task Orders Per Year; Task Area D, "Small Animal Models of Mycobacterium Infection", Estimated 3 Task Orders Per Year; Task Area E, "Formulation Development and Manufacture of Clinical Dosage Forms", Estimated 1 Task Order Per Year; Task Area F, "Preclinical Pharmacology and Toxicology Services", Estimated 3 Task Orders Per Year; Task Area G, "Reagent Program for HIV and other Infectious Diseases", Estimate 1 Task Order every 3 Years. At this time, upon award of the Base contracts for this multiple award IDIQ, the Government anticipates awarding one Task Order as follows: Task Order #G -1, Reagent Program for HIV and other Infectious Diseases. The period of performance will be for a one (1) year (Base Period), plus 2 one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of three (3) years, beginning on or about October 15, 2020. The requirement will be for the delivery of 9.0 full time equivalents (FTEs) per year, for the Base Period (Year 1), and 9.0 FTEs per year for Options 1-2 (Years 2-3). Offerors are not required to propose on all Task Areas, but may choose to propose on any or all Task Areas. Task Area B, Synthesis of Therapeutic Agents for Treatment of Infectious Diseases, is set aside for small business concerns. The North American Industry Classification System (NAICS) code for this acquisition is 541715 with a size standard of 1,000 employees. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about October 21, 2019, and may be accessed through FedBizOpps http://www.fedbizopps.govl. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."
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