Technical Objectives. [Provide an explanation of the means of achieving the result/product(s).]
Technical Objectives. The following mainframe systems have output processing feeds that need to be captured and processed; Cyberlife with IPS and work flow system (ViewStar), Paris, Vantage, LAB-Income Annuities, RPS, DSS, FMS systems, and Group Systems. Specifications are presented in 9 parts in Section 2 of this Output Processing Services SOW – Output Processing Specifications:
Technical Objectives. The technical objectives of this CRADA project are to develop a new therapeutic entity with activity against gram-negative category A and B biothreat agents. The therapeutic will be a small molecule that can be administered intravenously (i.v.), preferably once- or twice-a-day and will be available for use both as a prophylactic and as a therapeutic against a wide range of biodefense pathogens. These include the gram-negative biodefense pathogens: Escherichia coli, Salmonella (enteritis and Typhi), Shigella dysenteriae, Yersinia pestis, Burkholderia pseudomallei, Campylobacter jejuni and Francisella tularensis, as well as potentially the Category A gram-positive pathogen Bacillus anthracis. This new therapeutic will act through inhibition of bacterial DNA topoisomerase IV and DNA gyrase (ParE and GyrB, respectively). 08IS1120 SOW App. A 3/10 TC02128.0 Trius Therapeutics, Inc.
Technical Objectives. KRASNOYARSK-45
Technical Objectives. The Collaboration project aims to achieve the following objectives:
A.1.1 To design and develop a working touch-less medical image data control system using the Kinect controller.
Technical Objectives. Proof of concept preclinical studies and preliminary toxicological studies will be completed during the Phase I efforts. The objective of the proposed Phase II efforts has the overall goal to file an exploratory IND (eIND) for a Phase 0/1 clinical study. Several specific objectives must be met to reach the overall goal to file an eIND.
Milestone 1.1: Demonstrate tumor accumulation, high reproducibility and accuracy in two additional animal models.
Milestone 1.2: Generate and characterize a MCB for manufacturing of the imaging agent.
Milestone 1.3: Manufacture clinical grade imaging agent.
Technical Objectives. Proof of concept preclinical studies and preliminary toxicological studies will be completed during the Phase I efforts. The objective of the proposed Phase II efforts has the overall goal to file an exploratory IND (eIND) for a Phase 0/1 clinical study. Several specific objectives must be met to reach the overall goal to file an eIND.
Objective 1: Manufacture and test clinical grade material
Milestone 1.1: Demonstrate tumor accumulation, high reproducibility and accuracy in two additional animal models.
Milestone 1.2: Generate and characterize a MCB for manufacturing of the imaging agent.
Milestone 1.3: Manufacture clinical grade imaging agent.
Objective 2: Complete dosimetry and toxicology studies.
Milestone 2.1: Generate report for CMC section.
Milestone 2.2: Generate report for pharmacology section.
Milestone 2.3: Generate report for toxicology section.
Objective 3: Generate the documentation required for the filing of an eIND
Milestone 3.1: Prepare eIND package and submit investigator brochure for IRB review
Technical Objectives. The EaaS solution shall achieve the technical objectives to achieve a high degree of confidentiality, integrity, reliability and availability in accordance with the GSA EaaS BPA.
Technical Objectives. The three technical objectives of this proposal focus on determining the feasibility for establishing paired cancer and normal epithelial cell lines from African-American patients presenting with prostate cancers. We will extend technology developed by colleagues at Georgetown University for growing “conditional reprogrammed cells” to clinical application for potential use in precision medicine. In the first objective, three previously harvested, de-identified and bio-banked prostate cells from AA patients will be grown and characterized in a process that will develop standard operating protocols and optimal media conditions. The second objective will be to determine if modifications of growth medium can promote growth without feeder layer cells to enhance wider applications for the AA cell lines. The third objective is to consolidate the intellectual property (cell-lines) within Georgetown University policies and obtain a license to develop and commercialize the cell lines for research and drug development in personalized medicine. Achieving the milestones for the phase I contract should allow SBIR staff to judge the feasibility for establishing 50 prostate epithelial cell lines from AA patients through a phase II contract that will include a commercialization plan for the prostate cell lines.
Objective 1: Grow paired cancer and normal epithelial cell line from AA prostate tumors and normal biopsy specimens bio-banked on protocol IRB protocol # 2012-163. GU will perform only items identified in bold type. GU will provide data for quarterly reporting by Shuttle to NIH. GX will assist in preparing SOPs for cell collection and growth.
Task 1.1. (performed by GU under sub-contract) Establish malignant and non-malignant cell lines from banked AA prostatectomy specimens.
Milestone 1.1. Expand and freeze 20 vials for each cell line to perform characterizations. Task 1.2. (performed by Shuttle) Characterize and annotate AA cells.
Milestone 1.2. Have full characterization of established AA cell lines by cell origin, cell growth > 30 passages, capacity to form xenograft tumors, karyotype at early and late passages, expression of prostate tissue and tumor specific markers, STR analysis to authenticate the established cell lines and mycoplasma testing
Task 1.3. (performed by GU under sub-contract) Expand early passages of CRCs for freezing and banking in the CRC bio-repository.
Technical Objectives. Objectives:
