If capable sources are not identified through this notice, then NMLC intends to 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 eight 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 & Development of Materials for Research & Clinical Trials
- Bioreactor Production of ST266
- Develop Large-Scale Filtration and Treatment of ST266
- Develop an Extended-Life AMP Cell for Production of ST266
- Develop/Identify Assays to Establish Comparability of ST266 Produced Using Alternative Methods.
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, 23 May 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected].