Agency for Science, Technology & Research

CONFIDENTIAL BEP 2011 Grant Call Pre-Proposal (POV)

AGENCY FOR SCIENCE, TECHNOLOGY & RESEARCH

BIOMEDICAL ENGINEERING PROGRAMME

A Healthcare & Lifestyle Programme Office Initiative

Pre-Proposal for Proof-of-Value (POV) Project

To fill in the title of the proposed idea

SUBMITTED BY:

To insert organization logo of the Clinical Lead-PI (To be filled in by Clinical Lead-PI from the Hospital/Specialist Centre/Medical School)

To insert organization logo of the Technical Lead-PI (To be filled in by Technical Lead-PI from A*STAR SERC/BMRC RI OR Non-A*STAR Institutes: Universities, Polytechnics, Publicly-funded Institutes)

* To be completed by the Healthcare and Lifestyle (H&L) Programme Office

CLOSING DATE: 10th Jan 2011 (Tuesday) at 5pm, SST.

* Please add in more rows depending on the number of Co-Is or Collaborators

SUBMISSION DETAILS

IMPORTANT: EVERY SECTION AND FIELD MUST BE COMPLETED. PLEASE INDICATE ‘NA’ WHERE A PARTICULAR SECTION OR FIELD IS NOT APPLICABLE. INCOMPLETE APPLICATIONS WILL BE REJECTED.

Softcopy submission must comprise both the Word document (without signatures) and the PDF format (with Lead-PIs’ signatures and Host Institutions’ signatures) and have to be submitted to:

with the subject header “BEP 2011 Grant Call Submission_(Name of Clinical Lead-PI’s Institution)_(Name of A*STAR Research InstituteORUniversities, Polytechnics, Publicly-funded Institutes).”

The deadline for softcopy submission is 10th Jan 2011 (Tues) at 5pm, SST.

All hardcopy proposals with signatures must be submitted through either the Clinical Lead-PI’s or Technical Lead-PI’s respective Office Of Research / Principal’s or Directors’ Office / Agency Headquarters / RI ED’s Office/ Institutes or equivalent.

Address for hardcopy submission:

Healthcare & Lifestyle Programme Office

61 Biopolis Drive

Proteos Building, #01-02

Singapore 138673

Attn: Dr. Denise Teoh

The deadline for hardcopy submission is 16th Jan 2011 (Mon) at 5 pm, SST.

For further enquiries, please feel free to email:

Dr. Denise Teoh

INTRODUCTION

The Biomedical Engineering Programme (BEP), administered out of A*STAR’s Healthcare & Lifestyle Programme Office, is a competitive, multi-disciplinary grant programme aimed at engaging the local clinical community with engineers and scientists to develop cost-effective innovations through a needs-driven approach that will improve patient care.

The BEP 2011 Grant Call is funded by the Science and Engineering Research Council (SERC) and seeks to foster Clinical-Engineercollaborations to develop medical devices and solutionsfor clinical problems. The BEP supports collaborative research projects, with emphasis on devices, procedures, diagnosis, and clinical systems.

Projects will have to be driven by needs identified by Clinicians that are matched to a potential technological solution from the A*STAR SERC/BMRC Research institutes (RIs) or Non-A*STAR Institutes (Universities, Polytechnics, Publicly-funded Institutes). The philosophy is to approach the needs, problems or gaps from a medical/healthcare point of view,and not from a technology push perspective,right from the start.

It is critical that technicalresearchers can understand and appreciate, even at a preliminary level, the motivation for the problem and the key features from a non-technical perspective for a successful resolution. This includes understanding the existing (even if unsatisfactory) solution in the current situation,how the proposed solution will be tested and used in the clinical setting as well as the likely impact of a successful implementation on the end user/patient and/or healthcare organization.

Therefore, it is highly important that the clinical and technical collaborators meet and discuss comprehensively both the clinical need and potential technical solution to ensure there is value in such a collaboration.

The Pre-Proposal is structured in a way to elicit the necessary information that will show full explanation of the clinical need with an outline of the potential technical solution.

All projects must also demonstrate high potential for commercial outcomeand show a high likelihood of rapid impact on patient care. This is essential because funded projects will need to show that they can be commercialized and not remain as a pure science project.

The applications for this grant call are not restricted to a particular clinical area but need to show a strong collaboration between the clinical and technical partners to solve a specific clinical need.

There are two application categories: Proof-of-Concept (POC) and Proof-of-Value (POV).

This application is for the Proof-of-Value (POV) Category:

1. Design Freeze – refinement of existing prototype; to lock in the design of the prototype for pre-clinical or clinical trials
2. Animal (invasive device/technology)/Human (non-invasive device/technology) trials
3. Estimated duration: 18 – 24 months
4. Estimated funding amount: $1 – $1.5M
5. Estimated number of funded POV projects: 6 projects

Definition of POV:

The POV application is for projects that have an existing prototype or device that has been previously developed from funding from other grants for a particular clinical need. The prototype will have bench data, possibly some patents filed and papers published as prior work has been done. The prototype design should be locked in and frozen, with minimal changes to the core design as the prototype will need to be tested in animal or human trials or pilot batch manufacturing.

The POV grant is to assess the prototype in animal (invasive device) or human (non-invasive device) trials and to refine the prototype based on the results of the trials. Therefore, the cost of funding for the animal or human trials will need to be included in the grant. The trial protocol and methodology have to be clearly articulated in the full proposal and applicants have to show proof of communication with either their respective Investigation Medicine Units (IMUs), the Singapore Clinical Research Institute (SCRI), or the Health Sciences Authority (HSA).

The articulation of the plans for proper quality management systems, regulatory pathways and reimbursement models need to be included in the proposal in terms of project milestones and budget. A project may need several POCs to go for a POV grant. The data that is generated should be adequate to initiate talks with regulatory agencies for commercialization.

INSTRUCTIONS

The following instructions serve as a guideline in completing this Pre-Proposal and are by no means exhaustive.

For Sections A.1. – A.4, the originators of the Pre-Proposal are encouraged to concisely articulate their responses in the boxes provided for each section in Arial, font size 11 in a manner that may be easily understood by any educated, but non-medically trained, individual.Note: Please do not extend the size of the boxes provided.

Sections B – E are to be filled out according to instructions and additional boxes/pages should be added if required.

A.1.CLINICAL NEED

• Background of Problem: What is the problem observed? Why is this a problem that warrants significant attention?
• Treatment options: What are the current treatment options? What are the shortcomings of the current treatment options?
• Define unmet need: What is needed to address the problem and/or treatment gap identified above?
• Market Size: Who is/are the target patients? What is the incidence and/or prevalence? What is the total amount spent per year to address the problem faced by these target patients?

A.2. POTENTIAL TECHNOLOGICAL SOLUTION

• Previous work: Summary of prior work demonstrating how the proposed solution addresses the defined need and any publications or patents filed for the technology.
• Technology: Provide a summary of the core technology and how it works.
• Competitive Analysis: How is the proposed solution better than existing/emerging competing technologies?
• Include necessary references (in Appendix)

A.3. POTENTIAL IMPACT OF SOLUTION

• Value Proposition:How does the proposed solution benefit various stakeholders (patients, physicians, payers)? This can be from both clinical and economical perspectives.

A.4. AIMS OF PROJECT, OVERVIEW OF METHODS AND THE TEAM

• Aims of project:List briefly the key aims/objectives of the project
• Overview of Methods: Provide an overview of the methods that will be employed
• The Team: Provide briefbackground of each team member.

B. GRANT SUPPORT

Provide the details for all currently held or applied grants by the two Lead PIs and Co-Is. These include those supported by / applied to A*STAR, NMRC, NRF,Universities, Clusters and other public funding agencies.

<Name of Clinical Lead PI

<Name of Technical Lead PI

<Name of Co-Investigator No. 1>

insert additional boxes if necessary

C. CURRICULUM VITAE

In no more than 1 page,please provide the following information on each Lead-PI and Co- Investigator:

• Name

• Current position and past employment history (Please provide full details, eg, joint appointments, percentage of time spent in Singapore every year, if applicable)

• Academic qualifications (indicate institution’s name and year degree awarded)

• Latest 10 publications

• Patents held (related or unrelated to study)

• Recent awards (Scientific awards)

• Research outcomes from other grants (e.g. publications, patents, awards, etc.)

D. DECLARATION AND ENDORSEMENT

We declare that the facts stated in this application and the accompanying information are true and that this is an original and latest version of the Pre-Proposal.

*Lead Co-PIs and Co-Is from any of the A*STAR institution will require endorsement by Executive Direction of the host institution to verify official affiliation.

Clinical Lead-Principal Investigator

To be completed by the Head of Department (or his nominee) of the Hospital/Specialist Centre/Medical School (for Clinical Lead-PI)

TheHospital/Specialist Centre/Medical School,supports/does not support this version of the Pre-Proposal.

Technical Lead-Principal Investigator

To be completed by the Executive Director of the A*STAR Host Institution (or nominee)

OR the Head of Department (or nominee) of the Universities, Polytechnics, Publicly Funded Institutes (for Non-A*STAR Technical Lead-PI)

The RIsupports/does not support this version of the Pre-Proposal.

Other Co-Investigators

Note: Co-Investigators can receive funding

Other Collaborators (no signature required)

Note: Collaborators do not receive funding

E. APPENDIX FOR REFERENCES

• Include only necessary references

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