1. CCNE-TD Pilot Projects (RFP-CCNE-PP-C3)

Center for Cancer Nanotechnology Excellence and Translational Diagnostics (CCNE-TD)

Request for Proposals

1. CCNE-TD Pilot Projects (RFP-CCNE-PP-C3) and 2. CCNE-TD Developmental Projects (RFP-CCNE-DP-C2)

Program guidelines: http://med.stanford.edu/rmg/funding/CCNE_TD.html

Deadline: October 18, 2017 (see "Submitting an Application" section below)

Amount of Funding/Budget Information: Applicants may request $25-30K (for Pilot Projects) or $50K (for Developmental Projects) in total direct costs under this program. Although it is strongly discouraged, under exceptional circumstances and with a strong demonstrated potential to external funding within 1 year of CCNE-TD support, the Center may fund Developmental Projects at up to $100K (total directs) level.

Up to 2 Pilot Project and up to 8 Developmental Project applicants will be selected for funding. A team may submit to both mechanisms, however, the proposals should be clearly distinct in science and the concept(s) being tested. Continuation (up-to 4 years) of a project beyond its first year will be contingent upon the programmatic need and the success of the previous year as determined by the Center Executive Committee based on the resultant publications and/or submitted external proposals with high potential for funding.

Once all required documents are received, the selected candidates will have a funding period from 11/1/2017 – 7/31/2018 (Pilot Projects) and 11/1/2017-11/1/2018 (Developmental Projects).

Eligibility:  Stanford faculty with UTL, MCL, NTLR, and CE faculty appointments. (Note: CE faculty PI waivers are not required for internal Stanford funding opportunities.)  Postdoctoral scholars and Instructors (clinical and non-clinical) are required to include a PI-eligible- faculty-member as co-PI on the application.  The funds cannot solely be used for career development or personnel expenses. Equipment only requests are also not suitable for either mechanism.  Since the Center is interested in introducing new capabilities to the Stanford CCNE Program, preference will be given to those investigators who are not currently involved with CCNE-TD or the existing affiliates who propose entirely new directions of research.  All applications, regardless of relationship to CCNE-TD, will undergo the same level of scrutiny before being identified as an appropriate Pilot or Developmental Project.

Purpose: The Center for Cancer Nanotechnology Excellence and Translational Diagnostics (CCNE-TD), an NIH-NCI funded Phase-III U54 grant (PI: S.S. Gambhir, MD, PhD, co-PI S.X. Wang, PhD, Dep. Director: D. Akin, DVM, PhD), is soliciting proposals for two categories of Cancer Nanotechnology research projects: 1. Pilot Projects and 2. Developmental Projects.

The purpose of Pilot Projects (RFP-CCNE-PP-C3) is to fund up to 2 seed projects that are exploratory in nature and have minimal preliminary data. The proposed science and approach need to be solid and feasible. The goal of these projects are to generate new knowledge about cancer, develop new types of devices with existing technologies or novel concepts/technologies that can make a drastic impact in early detection of cancer and its response to medical interventions. This mechanism is more suitable for new interdisciplinary teams and will allow them to test out new avenues of Cancer AND/OR Nanotechnology Research. Proposal applications with more novel Nanoengineering perspectives or sensing principles but limited or no existing medical/cancer linkages are also suitable for Pilot Project funding since one of the goals of CCNE-TD is to facilitate formation of new bridges within Stanford broadly so that these interdisciplinary teams can explore fresh ideas in Cancer Early Detection, Prevention, Predictive Capabilities in selection and assessment of existing Treatments. We plan to link these types of investigators with appropriate Medical expertise within CCNE-TD network. Likewise, the Center will facilitate linkage of cancer researchers who lack engineering expertise with engineering faulty who may be able to help them with the question at hand. The purpose of Developmental Projects (RFP-CCNE-DP-C2) is to support more mature or maturing Cancer Nanotechnology projects with established teams. It is expected that these proposals will have significant preliminary data relevant to the proposal. Ideally, the Center seeks Developmental Project proposals that are at or near pre-clinical stage and more in clinical translation nature but not early explorations. These projects should show strong promise to lead into R01/P01 type NIH support within 1 year of CCNE-TD funding.

Potential Application Technical Areas: Previously awarded projects and the Stanford CCNE Program activities can be found in the following links: http://med.stanford.edu/ccne/ccne-td/pilot-projects.html http://med.stanford.edu/ccne/ccne-t/pilot-projects.html http://med.stanford.edu/ccne/ccne-tr/pilot-projects.html

Although there is no limit on the application technical areas, the Center is particularly interested in the following broad categories:

 Nano-based/enabled In Vivo Imaging Instrumentation/Sensing, Intraoperative Surgical Guidance/Theranostics  Novel Nano-based/enabled Imaging Contrast Agents/Mechanisms that are biocompatible or minimally toxic (e.g. new types of nanoparticles with photoacoustic, ultrasound, Raman, optical, electrical, magnetic contrast)  In vitro Nanodiagnostics with cost <$25/assay, Specificity >90%, multiplexing capable.  Theranostic Strategies/Platforms (e.g. combined Nanoimaging + Photothermal/dynamic Therapy or Nano/Micro Devices for Selection of Correct Therapy)  Wearable Devices, Non-Invasive Sensing with Nano/Micron scale components  Cancer focused non-invasive nanosenrosrs (e.g. multiplexing capable salivary diagnotiscs, breath/gas analyzers, electronic tongues, tear,/urine/stool interrogating sensors),  Implantable/Inhalable/Swallowable Nanomedical Diagnostic/Imaging Technologies,  Biological Barrier Crossing Nanoparticles or Nano Strategies  Active (non-EPR based) or Magnetically Guided Nanoparticle Targeting/Delivery,  Novel Types of genetic or non-genetic Secreted but Source Traceable Reporters (e.g. barcoded nano- reporters, xenoreporters),  Portable Imaging Platforms that have Nano/Micro components.  Novel Single Cell Detection, Comprehensive Analysis Platforms  µTotal Analysis Systems (µTAS) that can integrate more than 2 different types of analytes (e.g. nucleic acid+protein+chemical or DNA+RNA+protein or chemical+electrical+physical)  Devices/Technologies/Approaches for continuous monitoring of health and deviation from it that utilize integrated nano/micro sensors/technologies that are available cheaply off-the-shelf.  Medically Relevant Intracellular Electronic Sensing or Nanorobotics (e.g. synthetic/biohybrid approaches for detection and repair of DNA damage or phenotypic/genotypic reversion of oncogenic signal transduction, externally trigger-able multifunctional nanoparticles/devices with diagnostic or theranostic potential)  Computational Predictive Tools for better Assessment of Nanoparticle In Vivo Behavior  Big Data Analytics relevant to Cancer Nanomedicine (e.g. Cancer Nanomedicine Knowledge Mining, Automated Extraction of Nanoparticle:Biology Interactions, Correlation of Physiochemical Properties of Nanoparticles with Biological Response to them, Prediction of Hemodynamics of nanoparticles)  Fundamental Knowledge Generation: novel discovery investigations that occur in cancer biology and/or nanotechnology that utilize the nanoscale phenomena.

The vision of Stanford CCNE Program is to bring together researchers from different disciplines to form synergistic teams that can make significant advances in developing and validating nanotechnology that will impact cancer diagnosis, therapy and management. Projects mainly include those that have a high potential for linking nanotechnology to diagnostic/theranostic devices, nano-based or nano-enabled imaging or to pre-clinical imaging models for improved cancer medical management. The Center’s focus areas are in Cancer Early Detection and Therapy Response Monitoring. Nanoengineering-based/enabled fundamental cancer-related knowledge generation or medical interventions at the intersection of health and early cancer development stages are also highly interesting to the Center’s research missions. The Center has minimal interests in merely cancer therapeutics or experimental drugs alone, non-novel uses/combinations of existing nanoparticle imaging strategies and monotypic biological/biomarker discovery and/or validation studies. Applicants are welcome to discuss their research related inquiries in response to this solicitation with Dr. Demir Akin, Deputy Director of the Stanford CCNE program. He can be reached at [email protected].

The CCNE-TD Executive Council will review and recommend action on all applications. Funding is contingent upon receipt of all required documents and protocols. An interim and yearly progress report in NIH format will be required. The due dates will be provided upon selection of applicants. Attendances to monthly CCNE meetings are required to show progress of project and interact with the other members of the CCNE-TD. In addition, a presentation of progress is required for the annual NCI site visit, which will be held sometime in early 2018.

Submitting an Application: A complete application package in single pdf format should be emailed to Billie Robles ([email protected]) in the Department Radiology by 5:00 pm on October 18, 2017.

File name: Last name_CCNE-TD_pilot_projects.pdf or Last name_CCNE-TD_dev_projects.pdf

TEMPLATE: the contents and the format of the application materials are as follows: ------

Applying For (check only one):

a) Pilot Project Funding (RFP-CCNE-PP-C3):

b) Developmental Project Funding (RFP-CCNE-DP-C2):

1) Title page with the following information:

Proposed Project title:

Project leader(s): Name (Last, First and Full Contact Middle) Degrees Academic Title Department(s) Email Information

Co-Investigators: Name (Last, First and Academic Full Contact Middle) Degrees Title(s) Department(s) Email Information

Please answer all of the questions below

Does your project involve/require the following? 1) Human Subjects? Yes No 2) Cancer Related Research? 3) Human Stem Cells? 4) Human Blood or Body Fluids? 5) Vertebrate Animals? 6) Radiological Hazards? 7) Recombinant DNA Molecules? 8) Infectious/Biohazardous Agents? 9) Select Agents Research? 10) Will export-controlled or proprietary information be received on campus? 11) Will Stanford personnel hand-carry or ship equipment, components, materials, or software on media internationally? 12) Do you* OR anyone* involved in this research who has responsibility for the design, conduct or reporting of the research have a relationship or receive payment for services or have stock or stock options in the proposed sponsor, vendor(s), or subcontractor(s) or in a company that would be interested in the study results but is not sponsoring the study?

2) Research Proposal: Format: 4-single spaced pages with, Arial/Calibri 11 point font, 0.5 inch margins. References and the item numbers 3-7 below are not included in the page limits. The entire submission should be a single pdf/ or MS-word file.

Proposal Content: A description of proposed research, including the following:

a. Filled out form pages from #1 above

b. Research plan b1. Research Summary, b2. Hypothes(i/e)s, b3. Novelty, b4. Impact, b5. Approach, b6. Expected Results, b7. Challenges/Why Project may fail, b8. Plans for External Funding or a description of evidence of previous NIH or Foundation proposal submission(s) that were not funded using the same approach

c. A brief description of the team members and the interdisciplinary characteristics of this project

d. Not required but if it exist an explanation of how the proposed research will link with or capitalize on the existing CCNE-TD Projects [see the CCNE-TD website at http://med.stanford.edu/ccne/ccne-td/overview.html.

3) Detailed budget: For up to $30K (direct cost) for Pilot Projects. For up to $50K (total direct cost; no indirect costs can be charged) for development projects.

Estimated budget periods: 11/1/17-07/31/18 (Pilot Project, 9-month budget period) or 11/1/16-11/1/2018 (Developmental Project, 12-month budget period) Please note: you do not have to have your RPM prepare your budget. An informal but NIH style descriptive budget prepared by the PI/PD will suffice.

5) Budget Justification (NIH format)

6) Biosketch (NIH format) for the Project Leader and Co-Investigators

7) Other Support (also NIH format). Please include both active and pending support

Note: the release of funds will be contingent upon verification by CCNE-TD of the recipient's human subject, SCRO, and animal subject approvals and compliance with other administrative issues.

http://med.stanford.edu/ccne