Scientific Technical Consulting

The Food and Drug Administration is seeking sources to provide consulting services collaborate for a research program entitled, - Gene expression profiling as a tool for development of predictive biomarkers for mesenchymal stem cells and their differentiation to multiple progenitor cells. This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. Mesenchymal Stem cells (MSC) are isolated mainly from bone marrow and adipose tissue but can be found in other tissues such as synovium, periosteum or placenta. They differentiate into three lineages; chondrocytes, osteoblasts and adipocytes. These cells have been shown to inhibit immune responses meaning that MSCs from allogeneic donors can be used in recipients of many different HLA haplotypes. MSC may modulate the function of the major immune cell populations, including antigen-presenting cells, T cells, B cells and natural killer cells. This project will use gene expression profiling of these two cell populations to identify some marker genes which could be responsible for adipocyte differentiation and also for maintaining proliferation capacity in small cell population. Similar studies will be also carried out on other lineages of mesenchymal calls such as bone, cartilage, muscles etc. 1) technical knowledge and experience in micro-array analysis of gene expression for human embryonic stem cells, 2) technical knowledge and practical experience in validating micro-array data by established and qualified assays, 3) demonstrated ability to perform bio-informatic analysis of micro-array results and data validation as evidenced by publications in peer-reviewed journals and scientific meeting presentations, 4) demonstrated ability to maintain mouse and human embryonic stem cells in tissue culture. A monthly Deliverable with Biologic Research results will be required (6 total), The period of performance is 06/15/2008- 12/15/2008. Proposals will be evaluated 80% on technical qualifications, 20% on price. REQUEST FOR QUOTE (RFQ) any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to joseph.pishioneri@fda.gov. No phone calls will be accepted. An award will be made in fifteen (15) calendar days from the date of this notice. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.