Table of Contents Coulter-Drexel Translational Research Partnership Program

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Coulter-Drexel Translational Research Partnership Program
2016 Request for Proposals
Table of Contents
Important Dates ............................................................................................................. 1
Program Description ..................................................................................................... 1
Eligibility Criteria ........................................................................................................... 2
Budget Period and Amount .......................................................................................... 2
Proposal Submission Guidelines ................................................................................ 2
Important Dates
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December 14, 2016: One-page Pre-proposal due through InfoReady System. Faculty
members are required to meet with the Coulter Program Director prior to submitting a
pre-proposal.
January 19, 2016: Invitations to faculty to submit Coulter-Drexel Translational Research
proposals from selected LOIs.
January 25-March 4: Coulter Workshop series
March 14, 2016: Proposals due through the InfoReady system, 5:00 p.m. An
overview of the proposal requirements is included below. Detailed instructions on the
content of the proposal will be provided in the invitations to faculty sent in January.
April 5, 2016: 1st Oral Presentation to Oversight Committee, Business Case Review
April 8, 2016: Invitations sent to selected faculty to submit research plan and budget.
May 8, 2016: Research plan and budget due at 5pm. Further details on submission
process will be supplied in the April invitation.
May 24, 2016: 2nd Oral Presentation to Oversight Committee, focusing on research
plan, killer experiment and project milestones.
June 1, 2016: Award announcements
July 1, 2016: Funding begins.
Seed Proposals (under $50K) are occasionally accepted on a rolling basis, JulyDecember, at the discretion of the Coulter Program Director, and depending on funds
available. The regular proposal process is appropriate for all awards requests. The
average award is $100,000, but the range has been $40K-230K annually, since
inception of the program.
Program Description
The annual grant from the Coulter-Drexel Translational Research Partnership (CoulterDrexel TP) program sponsors collaborative translational research projects led by teams that
include both an engineer/scientist and a clinical faculty member. The mission of this program is
to save, extend, and improve lives, in any size market, anywhere in the world. This mission is
accomplished through the commercialization process, to bring life-changing solutions to as
many people as possible. Examples of desirable translational research goals and outcomes
include diagnostic and therapeutic solutions for the improved diagnosis and treatment of
disease. The program also looks for solutions that meet the ever-changing needs of the
healthcare system, including digital health applications that increase patient access to care and
compliance.
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Eligibility Criteria
All primary investigators on a Coulter-Drexel TP sponsored project serve as Co-Principal
Investigators (Co-PI’s). Each proposal must include at least one clinical Co-PI from a
College of Medicine, Nursing or Public Health and at least one Co-PI holding an
appointment in an engineering field, including media arts and design. At least one of the
PIs must have a faculty appointment at Drexel University. The clinical Co-PI's job
responsibilities must include direct contact with patients or patient data. The research must
relate directly to applications in health care, and the objectives of the project should include an
outcome that will benefit patients when the technology is commercialized. Questions about
faculty eligibility should be referred to the Kathie Jordan, Coulter Program Director. Evaluation
of each proposal is based on the following criteria:
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Significant unmet or underserved clinical need
Scientific merit, and substantial improvement over current solutions or standard clinical
practice
Strength and nature of the clinical collaboration
Reasonable and achievable milestones
Intellectual property position
High probability of attracting follow-on funding, within 2-3 years of the Coulter award
In order to enhance Drexel University’s Translational Research Partnership with the Kimmel
Cancer Center Consortium at Thomas Jefferson University (TJU), joint teams are encouraged
to apply for Coulter-Drexel TP funding in cancer diagnostics and therapeutics.
Budget Period and Amount
Full Proposal: Coulter-Drexel TP full proposal funds are granted for a one-year period.
Full proposal budgets have historically ranged from $60K-230K of direct costs per year.
Proposals may be submitted for additional support in subsequent years, if the commercialization
and research milestones from the first year were completed successfully. Renewal applications
will be evaluated on a competitive basis with new applications.
Seed Proposal: Coulter-Drexel TP Seed proposal funds are for a period less than oneyear and their budgets have historically ranged from $10K-60K of direct costs.
Occasionally, the program is able to consider seed funding requests. Seed proposals may be
submitted for full funding upon successful completion of the initial milestones. Please contact
Kathie Jordan, kcj39@drexel.edu, for specific instructions regarding the application for seed
proposals.
Proposal Submission Guidelines
Proposal submission is a three-stage process. The first step is to submit a 1-2-page Preproposal. Selected projects will then be invited to submit a Full Proposal in step 2, and the
Research Plan and Budget in step 3.
Step 1: Pre-proposal Submission Guidelines
Deadline: December 14, 2015, 5pm, through the InfoReady System
Faculty members are required to meet with Kathie Jordan, Coulter Program Director,
prior to submitting a pre-proposal. To schedule a meeting, please e-mail Kathie,
kcj39@drexel.edu, with three times that you are available, prior to December 14, 2015.
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Body of the Pre-proposal:
The pre-proposal is a one-two page narrative which should include the following topics. For
the body of the text, please use Arial, 11pt font, 1” margins. Type density should confirm with
standard NIH guidelines (no more than 15 characters per inch, no more than six lines per
inch.) You are encouraged to use section titles and images or graphs, as necessary, to assist
the reviewers in understanding your proposal. Please do not exceed two pages total. Preproposals that do not conform to these guidelines may not be reviewed.
1. Non-Confidential Project Title
Provide a non-confidential title intended for a lay audience that succinctly conveys what the
envisioned product is, what it does, and what problem it solves.
2. Project Team
List each of your team members and their affiliations. For each, briefly describe their area of
expertise and what their proposed role on the project will be. Keep in mind that project
teams must be comprised of at least one faculty member who is developing the technology
and one practicing clinician, at least one of which must have a faculty appointment at
Drexel.
3. Clinical need
Describe the clinical problem or the unmet need. Use metrics, such as the number of
patients affected annually, health care expenditures for treatment and/or diagnosis, potential
for reduction in costs, and the likely future trends relevant to the problem, etc. Why is this
problem unresolved?
4.
Standard of Care
How is the clinical problem/unmet need currently addressed (current standard of care)?
Describe current protocols for management of the problem/unmet need. What specialized
diagnostic or therapeutic tools (drugs, devices or equipment) are currently used to address
the problem/unmet need?
5.
Value Proposition
How will your envisioned product address the problem/unmet need better than the standard
of care or other emerging approaches? What will compel or drive the adoption of your
product over others? How is your envisioned solution distinct and what are its advantages
compared to other approaches?
6. Technical solution
What is your proposed product or method that will solve this problem? What is unique or
innovative about it? What tangible components or services will be sold/deployed? How will
your product change or improve patient care?
7. Enabling Technology
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What is the innovation you have discovered or technology you have developed that will
enable your envisioned product? Briefly comment on the current stage of development, i.e.
what do you presently have in hand: a concept, drawings, a prototype, benchtop/in vitro
data, animal data, human data? What preliminary data suggests that your technology will
work in the way you predict, and be safe and effective? What other technology/components
will be required to create your envisioned product?
8. Estimated budget
One sentence, describing the one-year direct costs for personnel, minor equipment and
supplies, travel. There are no indirect costs on Coulter budgets.
9. Intellectual Property
The intellectual property status, including invention disclosures, patent applications filed,
shared IP ownership with others. Please note that while you do not need to have a
patent application filed for your idea, you must have submitted an Invention
Disclosure Form, http://drexel.edu/commercialization/drexel-community/process/, to
the Office of Technology Commercialization, in order to qualify for pre-proposal
review.
The pre-proposals will be screened by the executive committee of the Coulter-Drexel TP
Oversight Committee (OC). Investigators will be invited to proceed to the next step in the
application process on or before January 19, 2016.
Step 2: Full Proposal Submission Procedure
Deadline: March 14, 2015, Full Proposals due at 5pm
Full proposals consist of a cover page, proposal, conflict of interest statement, project team
profile, list of current grant support, timeline for obtaining follow-on funding, intellectual property
summary, and citations. The proposal section (no more than six pages) will build on the preproposal and will cover the clinical context, value proposition, business opportunity, regulatory
and legal considerations. Complete details regarding the full proposal will be sent to invited
faculty by January 19, 2016 and will also be available on the Coulter-Drexel website.
The Coulter workshop series, held from late January through early March, is designed to assist
faculty in preparing the proposals. Though not required, faculty members are strongly
encouraged to participate and bring any other members of the project team. Further details
about the Coulter Workshop series will be made available in December.
Step 3: Research Work Plan and Budget
Deadline: May 9, 2016, Research Plan and Budget due at 5pm.
Invited faculty members will be asked to prepare a detailed research plan and budget (4 pages
total), for final review by the oversight committee. An overview is provided below. Additional
details will be supplied by Friday, April 8, 2016 to faculty who are invited for this step.
Research Plan:
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A detailed research plan should address the milestones over the year of funding. In addition, the
plan should demonstrate understanding of the timelines needed to bring the product to the point
of licensing and/or to market. Graphical timelines work well to show the quarterly and yearly
milestones the project will need to hit on the way prior to licensing, gaining regulatory approval
and eventually reaching the market.
a. Killer Experiment (1 page): Describe the objectives, plan and rationale that
demonstrates whether the technology works or not and that it can be licensable
in 1-3 years. More generally, this can also be thought of as an experiment that
significantly mitigates risk of commercialization. Document any business
advisers or commercial partners who have helped you define the killer
experiment. Examples are below:
i. Initial proof-of-concept.
ii. Demonstration of safety and efficacy in an animal model that is highly
predictive to success in humans.
iii. Small clinical trials in target patient populations or healthy volunteers.
iv. Demonstrating that the technology will be adopted and have a positive
clinical impact.
b. Got-to-Market Timeline (1 page): Describe the major technical and business
milestones that the project needs to reach after Coulter funding. Include possible
sources of funding after Coulter funding expires, and how that funding will be
used to further derisk the project. Examples of appropriate sources of follow-on
funding include SBIR/STTR grants, state commercialization funds (eg. Ben
Franklin Technology Partners), sponsored research agreements, angel and
venture capital. Do your best to provide informed estimates for both time and
funds required.
c. Gantt chart (1 page): A Gantt chart template will be provided, and made available
on the Coulter website. Use this to list specific activities for your killer experiment,
as well as commercial goals, and intellectual property milestones over the year of
Coulter funding.
Budget:
Prepare a detailed research budget including all the direct costs for personnel, materials,
supplies and equipment needed to meet your stated research goals. Please describe the use of
funding in detail. Major capital expenditures are not permitted, but minor capital equipment items
specifically needed for the execution of the research plan are acceptable. Outsourcing as
possible is encouraged to improve quality and speed.
Funds may be used for salary support of faculty, graduate students, and other research staff,
but may not be used for general staff or administrative support. Please note that the milestonedriven nature of Coulter projects makes them more appropriate to be staffed by senior graduate
students, post-doctoral fellows or staff scientists, rather than new graduate students. Operating
supplies, minor equipment items, prototyping expenses, imaging time and travel directly
associated with the research activity are examples of eligible budget items. Since this is an
internal award, indirect costs (i.e. overhead) are not permitted. Please include direct
costs only.
Post Award:
All award recipients, including clinical investigators, will be required to submit quarterly
progress reports using the quarterly report form and to meet once monthly with the Coulter
Program Director and advisors. Projects that are on schedule may have a reduced meeting
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schedule. Guidelines for the quarterly report will be sent 2-3 weeks prior to each report due
date.
Full grant awardees will also be required to present one progress report to the Coulter-Drexel
Oversight Committee, typically scheduled for December. Continuation of funding is dependent
on Oversight Committee approval at these meetings, as well as regular meetings with the
Coulter Program Director, and timely submission of quarterly reports.
PLEASE NOTE: THE COULTER PROGRAM OFFICE RESERVES THE RIGHT TO PERFORM
DILIGENCE ON ALL SUBMISSIONS USING INTERNAL, STUDENT OR EXTERNAL
RESOURCES. SUCH DILIGENCE MAY INCLUDE BUT IS NOT LIMITED TO MARKET
RESEARCH,
PATENTABILITY,
REIMBURSEMENT
AND
REGULATORY
ANALYSIS. PLEASE NOTE THAT BY SUBMITTING A PROPOSAL FOR CONSIDERATION,
YOU IMPLICITLY AGREE THAT YOUR PROPOSAL CAN BE REVIEWED BY THE ABOVE
MENTIONED RESOURCES AND THAT YOU MAY BE CONTACTED FOR ADDITIONAL
INFORMATION/CLARIFICATION IN RELATION TO SUCH DILIGENCE PROJECTS.
Questions:
For questions regarding the award and/or preparation of proposals, please contact:
Kathie Jordan, PhD
Coulter Program Director
kcj39@drexel.edu
Office 215.895.1860
Amy Campbell
Assistant Coulter Program Director
akc32@drexel.edu
Office 215.571.3704
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