If capable sources are not identified through this notice, then NMLC intends add the additional work to current contract N62645-13-C-4014 under the authority of FAR 6.302-1 to Stemnion, Inc. 100 Technology Drive Suite 200, Pittsburgh, PA 15219 for the performance of the described requirement.
Stemnion's research group has conducted at least six years of prior research and has the data and resources to support advancement of this effort. Stemnion currently controls 33 U.S. patents and 7 patents in other countries that are directly related to the AMP cell and ACCS cytokine solution therapies needed to continue this research project. The core research and development for AMP cells and ACCS cytokine solution has progressed to a first in-man clinical trial and they have currently undertaken a regimen of FDA human clinical trials.
The additional effort includes:
-Preparation and Development of Materials for Research and Clinical Trials
-Analytical assay development that ensure lot-to-lot reproducibility of ACCS and AMP Cells
-Immortalized cells development and production
-Facilities planning to expand ACCS production
-Immunology regarding the effect of AMP cells on Natural Killer and Natural Killer T cells and the effect of AMP cells on B lymphocytes.
-Formulation and Delivery of lyophilized and/or spray dried powder.
-Pre-clinical Animal Studies to evaluate ACCS control of systemic vascular permeability
This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a modification to the current contract.
Capability statements are due by 5:00 PM Eastern Time, 02 June, 2015. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected].