Solicitations

Exploratory Research Projects on Point-of-Care Devices for Emerging Neuro-Technologies

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Solicitation Number: POC-CENT_08_01

Key Dates

Release/Posted Date: May 6, 2008

Letters of Intent (LOI) Receipt Date(s): May 30, 2008

LOI Review complete/Request for Full Proposals: June 16, 2008

Application Submission/Receipt Date(s): July 18, 2008

Proposal Reviews Completed: August 29, 2008

Earliest Anticipated Award Dates: October 1, 2008 

Issued By

A solicitation from the Point-of-Care Center for Emerging Neuro Technologies (POC-CENT) at the University of Cincinnati as part of their Point-of-Care Technologies (POCT) Network funded under RFA-EB-06-002.

Purpose

The Point-of-Care Center for Emerging Neuro Technologies (POC-CENT) announces an exploratory research program of $400,000 in Fiscal Year 2009 to fund exploratory research projects focused on the development of novel point-of-care technologies for addressing clinical needs in the area of neurologic emergencies. The purpose of this program is to identify new and emerging technologies that focus on CSF and blood biomarkers as diagnostic and prognostic indicators in neurological emergencies such as, but not limited to, subarachnoid hemorrhage, traumatic brain injury, and stroke. The Center will support two types of project proposals: 1) supporting emerging device development activities and 2) early stage clinical evaluation (i.e. early stage clinical studies using archived samples and producing results not used for information to the physician.

Emerging device development activities are funded through Core 2 funding (Center Core discription)and are intended to support proof of concept development for novel/emerging point-of-care technologies. Emerging device technology proposals should clearly identify the current state of technology development and the technological barriers that need to be overcome before the proposed technology will be viable as a point-of-care device that is ready for transition in to a clinical evaluation activity.

Early stage clinical evaluation activities are funded through Core 1 funding and are intended to validate the function and operation of the proposed point-of-care device technology. It is anticipated that projects funded through this activity will use archived samples and/or animal models with the specific objective being to verify the performance and usability of proposed device technologies. Projects involving human subjects and/or utilization of device information by the physician will not be supported through this solicitation. Early stage clinical evaluation projects should clearly identify the technology evaluation objectives that will be addressed and how achieving these objectives will advance the clinical applicability and commercial viability of the proposed point-of-care technology.

In addition to addressing the project specific details indicated above, all supported projects under this activity are recommended to demonstrate, or discuss potential in, the following:

1. How the proposed device/technology will substantially improve the quality of medical treatment through the use of a point-of-care approach.
2. The engineering and manufacturing viability of the proposed device.
3. The commercial viability for the proposed device including market size, competing technologies and any potential barriers to market entry.

POC-CENT is a university based center jointly established by the Colleges of Engineering and Medicine to aid in the development of medical instrumentation for emerging neuro technologies. The Center has staff and external contacts to help aid the engineering, development, testing, and commercialization of medical instrumentation devices. The Center has numerous individuals with entrepreneurial experience and we also have close ties to the local startup and venture funding communities. The Center is associated with BioStart which is a biomedical, bioengineering, and biotechnology business incubator. In addition, we have close ties to other business incubators, business advisors and FDA consultants. Thus, POC-CENT can offer services and expertise to facilitate the point of care development of projects funded.

Background

Human cerebral spinal fluid (CSF) is a filtrate of human plasma that surrounds, bathes and protects the brain. Thus, the composition of the CSF is a reflection of the health of the brain and the brain’s environment. When certain neurologic diseases occur the CSF can be a very good source of diagnostic and prognostic information concerning the disease(s) in question. For example, a diagnostic lumbar puncture to obtain CSF is required for the diagnosis of two life threatening diseases; meningitis and hemorrhage. In the USA there are over 1 million lumbar punctures performed annually to screen for these two diseases. Unfortunately, the diagnosis of either disease, can take hours to days. In addition, a lumbar puncture is often obtained for other diagnostic and therapeutic reasons with approximately 6 million lumbar punctures performed annually. Similar diagnostic needs exist for the use of blood and blood products as diagnostic fluids for neurologic based diseases.

Clearly, a large and clinically relevant number of CSF samples are being obtained for diagnostic and prognostic purposes. Unfortunately, existing technologies are not meeting the need to provide this information quickly in a point-of-care setting. In Clinical Neurosciences, Emergency Medicine and Critical Care there is a critical need for information that can rapidly provide insights into the pathological events occurring in the brain. We consider urgent information about a patients’ condition that can be obtained and/or delivered at or near the bedside as point-of-care. This 'point of care' information is particularly critical in neurologic emergencies because of the extreme vulnerability of the brain and spinal cord to physical and physiological insults that may be easily tolerated by other organ systems.

The Point of Care Center for Emerging Neuro Technologies (POC-CENT) was created with the specific charge to develop point of care technologies for neurological and neurosurgical patients, in the urgent care and emergency settings. This Center, funded by the NIBIB (RFA-EB-06-002), is located at the University of Cincinnati but is national in its scope and funding opportunities.

For this solicitation, we anticipate funding up to 8 projects in the range of $25,000 to $100,000 (in direct costs) per year. Most awards will be for $50,000 or less per year per project, with the possibility of repeat funding for a second year when this is strongly justified and research milestones achieved. For this first solicitation we have chosen to focus on CSF and blood biomarkers as diagnostic and prognostic indicators in neurological emergencies such as, but not limited to, subarachnoid hemorrhage, traumatic brain injury, and stroke. We will also consider proposals for technologies that can simplify or provide surrogates for direct blood or CSF. Diagnostics measures using urine, expired air, saliva, sweat and others will be considered as surrogate opportunities. Technologies that may be considered include lab on a chip and transdermal measurements where the information yielded can be used by the physician in a neurologic emergency. The role of the Center is in part to communicate user-based clinical needs as well as facilitate linking point of care technologies to the right users. Clinical settings for the employment of these technologies include but are not limited to the Emergency Department, Pre-hospital/urgent care, Neuro Intensive Care Unit and the Operating Room.

We will not be funding projects that are large clinical trials, or technologies that are primarily of research interest and have limited clinical applicability. Because our emphasis is on neurologic emergencies, we will not be funding projects that involve the diagnosis of chronic diseases, unless the disease can present with acute exacerbations that may constitute a neurological emergency. All research projects must address a specific or clear clinical need(s). Hypothesis testing is not required.

Eligibility

This funding opportunity is open to all academic, commercial and foundation-based PIs. Applications from early career investigators are encouraged. At this time foreign investigators are not eligible to apply.

Submitting an Application

Letter of Intent

The PI must submit a letter of intent that includes the information provided below on a maximum of two pages using Times New Roman font size 11 or larger with a minimum margin of 0.5". The deadline for submission of the LOI is May 30, 2008. Applicants will be informed by June 16, 2008 whether or not their proposal has been found to be of clinical potential, commercial potential and responsiveness to the solicitation to warrant a full application. Additionally, the selected applicants will be assigned a project advocate that will serve as a point of contact to the Center and a project development resource that can assist the applicant during the preparation of a full application.

Deadline for submission of full applications from the selected applicants will be July 18, 2008.

Outline of the Letter of Intent:

The entire LOI correspondence must be contained in two pages as per the format guidelines stated above. The LOI must contain the following:

• PI contact information
• Brief description of the proposed solution, including specific aims
• Brief explanation of the clinical need for the proposed technology
• Brief description of the project type (emerging devices or clinical evaluation) information as detailed above
• Summary of the expertise that the team has in the proposed area
• Expected timeline
• Approximate direct cost

All LOIs will be reviewed by clinical and scientific professionals in the field for responsiveness to the clinical focus of this solicitation.

Commercialization oriented strategies, plans or pathways are permitted and encouraged with details as appropriate to the developmental level of the proposed project. A commercialization plan, with milestones, will be required in the full proposal. Note it is anticipated that the commercialization milestones will vary depending upon the level of project development. Clearly emerging device development projects will have different commercialization milestones than technologies that are entering the clinical evaluation stage of technology development. Regardless of project type (emerging devices or clinical evaluation), milestones will be required that serve as quantifiable endpoints and can substantiate a demonstrable step in the point of care device development pathway.

No biosketch is to be submitted with the LOI. No references are required, but if used must also be within the two pages allowed.

We anticipate accepting approximately 20 proposals for submission of a full proposal. An LOI is required in order to be considered for the submission of a full proposal. Full proposals will be due on July 18, 2008.

Full Proposals

Full proposals will be formally solicited after review of the LOI’s has been completed. Full proposals can be submitted by invitation only after a successful review of the LOI. Full proposals must also be submitted electronically as a PDF attachment. Applicants should use form PHS 398 and follow PHS 398 application instruction except as modified in the outline for full proposal given below.

1. Cover letter identifying this program and providing full principal investigator (PI) contact information.
2. Face page. The title of the project (Box 1). This Notice (number and title) should be cited in Box 2, and the “yes” box should be checked. The remaining items on the face page should be filled out using the PHS 398 form and according to the PHS 398 application instructions.
3. Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells) from PHS 398.
4. Biosketch(es) for key personnel: Consultants and subcontractors are NOT allowed in the proposed work. Letters of commitment other significant contributors, with no salary, are welcome. Four page maximum as per NIH guidelines.
5. Resources page and Other Support page(s). In addition to identifying the resources that are available to the project applicant, this section should clearly identify any resources that may be needed from the Center to facilitate the success of the project. The applicant is strongly encouraged to identify resource limitations that could impact the success of the project and work with their project advocate (Center contact) to develop a resource utilization plan that will support the successful completion of the proposed project.
6. Budget for the project with justification for the direct costs being requested. The budget can include labor, equipment, and disposables but subcontracting or the use of consultants is specifically not permitted.
7. Research Plan for items A-D not to exceed five pages. This section should include a description of the project’s specific aims (A), background and significance (B), preliminary studies (C), and research design and methods (D). If collaborators are not at the same institution, describe how they will work together on the project (Note: Collaborators from other institutions cannot receive funding as consultants or subcontractors). Specific milestones must be included and identified at quarterly mid-points through the program plan. Annual reviews of the program will be conducted and continued funding will be conditional based on the successful completion of these milestones.
8. Commercialization Plan, not to exceed two pages. A commercial viability statement showing expected market size, penetration strategy, and 5 year marketing strategy. A demonstrated feasible plan to commercial viability and continued funding beyond the requested program must be outlined. This can include a discussion of the target market(s) as well as market competitors and other barriers to market, revenue potential and growth potential. Clearly emerging device development projects will require a different commercialization plan than technologies that are entering the clinical evaluation stage of technology development. The feasibility and viability of the commercialization plan will be used in evaluating projects for funding.
9. Human subjects research. Follow PS 398 instructions and is not included in the 5 page limit.
10. Vertebrate animals: follow PHS 398 instructions and is not included in the 5 page limit.

Review Criteria

Full project proposals will be reviewed administratively for compliance with submission guidelines and responsiveness to the solicitation. Additionally, applications will undergo a peer review to assess:

• Scientific/technical merit
• Advancement of project type (emerging devices or clinical evaluation) development objectives
• Expertise of the PI and research team.
• Commercialization potential
• Clinical need and potential impact
• Suitability of Milestones

Awards will be determined on the basis of scientific merit, programmatic relevance, commercial viability, and the availability of funds. Prior to funding approval, milestones will be finalized as recommended by the review committee and agreed to by the proposer. All funding decisions are final and are not subject to appeal. Resubmission is possible although the focus area of subsequent solicitations must be met.

Budget Information

Applicants may request up to $100,000 in direct costs per year up to two years under this program. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. Applicants should provide a budget justification that details the direct cost budget items requested. These are 2-year projects but continued funding is dependent upon meeting agreed upon milestones. The proposer determines the milestone timeline.

Policy Information

Additional information about the point of care technologies network (POCT) can be found in the parent RFA as well as on the NIBIB web site.

As an NIH funded entity the projects we will be funding are sub-projects to the parent NIH award. All rules and regulations concerning receipt of funds and management therein fall within the remit of the NIH’s guidelines. This includes Animal Research, Human Studies, Biohazards and all compliance and reporting guidelines. Please consult the Office of Laboratory Animal Welfare and the Office for Human Research Protections, for more information.

All projects will be required to at a minimum submit annual reports on the progress of the project and funding. Milestones must be reported on or before the due date of said milestones. Milestone reporting does not replace annual progress reports except by prior approval. Progress reports will follow a similar template to that of NIH non-competitive renewal including a 2 page scientific summary, list of publications, summary of expenses and encumbered expenses, changes in personnel etc.

For further guidance, you can consult the NIH Grants Policy Statement (NIH GPS).

All application materials must be submitted electronically. LOI applications must be received on or before May 30, 2008.  Applicants should submit one electronic copy as an e-mail attachment in PDF format to:

Dr. Fred R. Beyette, Jr, Director
POC-Center
Department of ECE, PO Box 210030
University of Cincinnati
Cincinnati, OH 45221-0030
Email: POCCENT_Application@ececs.uc.edu

Applicants who are successful in the LOI review will be assigned a project advocate who will act as a point of contact and project development resource during the development of full proposals. The Center will communicate the advocate name and contact information along with any additional logistical information to the accepted applicants through a formal invitation to submit a full proposal. The Center will issue formal invitation on or by June 16, 2008. Full proposals can be submitted by invitation only after a successful review of the LOI. Full proposals must also be submitted electronically as a PDF attachment.

Inquiries

Applicants are encouraged to discuss their plans for responding to this Notice by phone or e-mail. Direct these inquiries to:

Dorothy Young
POC-CENT Program Coordinator
Department of ECE, PO Box 210030
University of Cincinnati
Cincinnati, OH 45221-0030
Phone : 513 556 3036
Email: POCCENT_Info@ececs.uc.edu

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