Biostatistics Core

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CORE D: The staff of the Biostastics Core will be responsible for providing biostatistical support to the research of this program. The Biostatistical Core is under the supervision of Dr. Timothy D. Johnson of the Biostatistics Department in the University of Michigan School of Public Health. The core provides assistance in the design, analysis and interpretation of preclinical and clinical experiments of the program project. Core personnel will interact with project investigators to ensure that appropriate designs and methods of analysis are used. Design issues involve selection of dose, randomization, timing of measurements, number of animals or patients. For analysis of data, the core will ensure that efficient methods are used. Standard graphical, group comparison and correlation methods of analysis will be used for initial investigation of the experimental data. Mixed model methods will be used for efficient use of the data in experiments involving repeated measures. Core personnel are experienced in the design and analysis of both animal and clinical data. This will ensure that all data obtained from MR measurements (Projects 1-3), tumor histology (Projects 1-2), cell kill and growth changes associated with therapy (Projects 1-2) and patient outcome (Project 3) will be collected efficiently and analyzed appropriately. Pub. Health: Overall, this research effort willprovide therationale for initiation of clinical trials with combinations of molecularly targeted therapies for the treatment of malignant brain tumors. In addition, imaging biomarkers for early assessment of treatment response will be identified and validated which will lead to individualization of patient treatment. University of Michigan Ann Arbor, Michigan PHS 398 (Rev. 09/04) Page "*>3Q Form Page 2 Principal Investigator/Program Director (Last, First, Middle): ROSS, Brian D. KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name eRA Commons User Name Organization Role on Project Johnson, Timothy D. University of Michigan Core Director Taylor, Jeremy University of Michigan Co-Investigator OTHER SIGNIFICANT CONTRIBUTORS Name Organization Role on Project Lee, Julia University of Michigan Human Embryonic Stem Cells ^ No |~~| Yes If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: http://stemcells.nih.aov/reqistrv/index.asp. Usecontinuation pages as needed. If a specific line cannot be referencedat this time, include a statementthat one from the Registrywill be used. Cell Line Disclosure Permission Statement. Applicable to SBIR/STTR Only. SeeSBIR/STTR instructions. [~] Yes l~1 No PHS 398(Rev. 09/04) Page J^ Form Page 2-continued Number the following pages consecutively throughout the application. Do not use suffixes such as 4a, 4b. Principal Investigator/Program Director (Last, first, middle): Ross, Brian D. FROM THROUGH DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY CoreD/johnson 12/1/2006 11/30/2007 PERSONNEL (Applicant organization only) DOLLAR AMOUNT REQUESTED (omit cents) TYPE EFFORT INST. ROLE ON APPT. ON BASE SALARY FRINGE NAME PROJECT (months) PROJ. SALARY REQUESTED BENEFITS TOTALS Core Johnson, Timothy Director 12 25% $98,808 $24,702 $7,411 $32,113 Co- Taylor, Jeremy Investigator 9 5% $136,500 $6,825 $2,048 $8,873 Co- Taylor, Jeremy Investigator 2 5% $30,333 $1,517 $455 $1,972 Lee, Julia Biostatistician 12 10% $75,020 $7,502 $2,251 $9,753 GSRA GSRA (TBN) 12 100% $23,422 $23,422 $7,027 $30,449 ¿ SUBTOT A 10 ^ $63,968 $19,192 $83,160 I CONSULTANT COSTS EQUIPMENT (Itemize) SUPPLIES (Itemize by category) Research Supplies $300 Computer $2,500 $2,800 TRAVEL Attendance to 1-2 Scientific Meetings per Year $1,000 PATIENT CARE COSTS INPATIENT OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize bycategory) OTHER EXPENSES (Itemize bycategory) GSRA Tuition $14,772 (Fall & Winter tuition) Computer Maintenance $900 Computer Maintenance $100 Software Licenses $1,000 $16,772 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PEF (Item 7a, FacePage) I * 103.732! CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATION COSTS 1 TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD * 103,732| SBIR/STTR Only: FEE REQUESTED PHS 398 (Rev.09/04) Page Form Page 4