Preclinical Efficacy and Intermediate Endpoint Biomarkers
Added: Dec 15, 2011 3:10 pm
N01CN25002-78RESEARCH AND DEVELOPMENT SOURCES SOUGHT NOTICE INFORMATIONAgency/Office: National Institutes of HealthLocation:National Cancer Institute, Office of AcquisitionsTitle: PRECLINICAL EFFICACY AND INTERMEDIATE ENDPOINT BIOMARKERS STUDIESDescription(s):This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI).THERE IS NOT A SOLICITATION AVAILABLE. THIS IS STRICTLY MARKET RESEARCH.The purpose of this SBSS is to IDENTIFY QUALIFIED SMALL BUSINESS CONCERNS including Small Disadvantaged Businesses (SDB), Women-owned Small Business (WOSB), Historically Underutilized Business Zone (HUBZone) Small Business, Veteran-Owned Small Business (VOSB), 8(a) Small Business, and Service-Disabled Veteran-owned Small Business (SDVOSB) that are interested in and capable of performing the work described herein. Small Businesses whose size classification relative to the North American Industry Classification System (NAICS) Code 541711 may consider responding to this notice. 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. The NCI does not intend to award a contract on the basis of responses nor otherwise pay for preparation of any information submitted.Preclinical Efficacy and Intermediate Endpoint Biomarkers Studies, a project within the Chemopreventive Agent Development Research Group, Division of Cancer Prevention (DCP), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above, under NAICS Code 541711 (Research and Development in Biotechnology) with a size standard of 500 employees.The NCI, CADRG/DCP is seeking contractors who demonstrate the ability to develop assays.SUMMARY OF PROJECT: The purpose of the anticipated Indefinite Delivery/Indefinite Quantity (ID/IQ) requirement is to support the development of potential cancer preventive agents or vaccines by employing detailed preclinical efficacy studies and determining pharmacodynamic or efficacy biomarkers which parallel the efficacy of a given agent. The primary endpoint of the efficacy studies will be the development of invasive cancers whereas the biomarker studies will identify endpoints which correlate with the efficacy of a given preventive agent or vaccine. These endpoints might be measured in body fluids, normal or at risk tissue from the target or in histopathlogically altered tissue from the target. Services provided by the Contractor shall include but are not limited to:1. TASK AREA 1 - CHEMOPREVENTIVE EFFICACY EVALUATION OF CHEMOPREVENTIVE AGENTS BY ANIMAL BIOASSAYS Use of animal models as defined by the NCI for cancer prevention testing that may include, but are not limited to: mammary, bladder, lung, skin, esophagus, colon/intestinal tract, prostate, melanoma, trachea/bronchus, head and neck, brain, hematopoietic systems, pancreas, and ovary.Contractor shall specifically: 1. Breed and maintain animal colonies of wild type rodents and transgenic rodents in sufficient numbers for efficacy testing purposes 2. Procure the chemopreventive agent (unless provided by NCI) 3. Provide analysis of chemoprevention agents for purity and for homogeneity and stability of agent in administering vehicles 4. Administer chemopreventive agents by different routes including diet, gavages, topical, inhalation, injection, or pellet implantation 5. Administer vaccines and adjuvant(s) as required (typically intramuscular or subcutaneous route) 6. Administer carcinogens, promoters, hormones and or chemopreventive agents to laboratory animals as needed 7. Investigate different schedules of dosing (intermittent, weekly) 8. Conduct studies monitoring tumorigenesis, body weight and clinical appearance 9. Conduct gross necropsies in animals 10. Conduct histopathological examination of selected tissues from selected groups in different strains and species of animals used11. Collect and preserve tissue, serum, and urine from laboratory animals in the study 12. Perform statistical analysis comparing treatment groups with control groups: for example: tumor incidence and tumor inhibitor13. Present tumor inhibitor data in tabular or graphic form, as well as tumor incidence data and, where possible, multiplicity and latency data14. Collect tissues, sera or other body fluids, either fixed or frozen and maintain under appropriate storage conditions until utilized15. Ship some or all of these samples with technical documentation to other investigators at the direction of the NCI2. TASK AREA 2 - EVALUATION AND VALIDATION OF INTERMEDIATE ENDPOINTSThe Contractor shall conduct intermediate endpoint assays in rodent tissues and may perform studies in human samples examining relevant intermediate endpoints. In many work assignments the relevant tissues shall be supplied to the contractor via separate WAs. Intermediate endpoints that shall be examined include but are not limited to: 1. Large scale genomic, proteomic and metabolomic assays performed either on the relevant tissues, serum or urine 2. Quantitative levels of specific genes or proteins (e.g. RT-PCR, quantitative IHC, Western Blotting) which are understood to be involved in the mechanism of a given agent 3. Pharmacodynamic endpoints directly related to the preventive agent e.g. levels of the parent compound or metabolites 4. Pharmacodynamic endpoints which may be directly modulated by the preventive agent or protocol but which are not necessarily related to the mechanism of action 5. Immunologic assays, e.g. antibody levels, elispot, CTL assays which demonstrate that a vaccine has elicited a relevant immune response against its intended target antigensContractor shall specifically: 6. Collect and preserve tissue, serum, and urine from animals or humans for use in biomarker studies in the majority of task orders related to potential biomarkers NCI will supply the necessary samples 7. Process tissue, serum or urine for use in endpoints studies 8. Perform biomarker studies using the tissues collected - the specific biomarker studies to be employed will be determined based on agreement with project officers from the NCI 9. Perform endpoints studies 10. Perform statistical analysis of endpoints studies 11. Present endpoints results in tabular or graphic form, as well as offer a written commentary regarding the endpoints results 3. GENERAL PROCEDURES A. Animal Facility The Contractor shall be required to conduct studies under the Food and Drug Administration Good Laboratory Practice Regulations as published in the Federal Register CFR Title 21, Part 58). Laboratories shall be accredited by or registered with the following: • Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC or equivalent) • Office of Laboratory Animal Welfare (OLAW) • United States Department of Agriculture (USDA), and • Institutional Animal Care and Use Committee (IACUC)All animals for studies shall be furnished by the Contractor from established, reputable, known commercial breeders. The Contractor shall quarantine the animals for an appropriate period prior to placing them on test for studies and their release shall be documented by the attending American College of Laboratory Animal Medicine (ACLAM) veterinarian. B. PathologyThe Contractor shall ensure that proper examination and reporting of pathologic alterations in organs and tissues in each study are of conducted to demonstrate histopathological evaluations correlated to clinical, hematologic, or clinical chemistry evidence of toxicity to an organ system with direct injury to that system. The Contractor shall ensure that precision and accuracy in reporting the type and severity of lesions in animals is provided in order to increase the efficiency of prediction for toxic manifestations of agents administered to patients in subsequent clinical trials. The Contractor shall ensure that: • All lesions are categorized as either drug-related or non drug-related; • Each lesion is listed and coded by the most specific topographical and morphological diagnoses, severity, and distribution using Systemized Nomenclature of Medicine (SNOMED) codes. DURATON: It is anticipated that the ordering period for this ID/IQ contract will be 24 months. Task Orders may extend beyond the 24 month contract period.CAPABILITY CRITERIA: Capabilities will be judged based on the following criteria: Interested qualified small business organizations should submit a capability statement, not to exceed 15 total single-spaced pages using a 12 point font size at a minimum, that clearly details the ability to perform and that addresses the specific requirements described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.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 responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).All capability statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via email) to Deborah A. Baca, Contract Specialist, at dbaca@mail.nih.gov either in MS Word, Wordperfect or Adobe Portable Document Format (PDF) not later than FRIDAY, JANUARY 13, 2012, 3:00PM EST. All responses must be received by the specified due date and time in order to be considered. ANY RESPONSES RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED.
N01CN25002-78 Department of Health and Human Services National Institutes of Health
12/15/11, 3:10 PM