Release Date: September, 2015
PART I: OVERVIEW INFORMATION AND EXECUTIVE SUMMARY
Sponsoring Organization
The Maryland Stem Cell Research Commission, on behalf of
The Maryland Stem Cell Research Fund ("MSCRF")
Title
Exploratory Research Grant
For Basic, Translational and Clinical Stem Cell Research
In Support of Medical Therapies
Request For Applications (RFA) Number
RFA-MD-16-2
The Maryland Stem Cell Research Commission strongly encourages collaborations
between for-profit and not-for-profit organizations and researchers. All Proposals
must pertain to stem cell based therapy & regenerative medicine. Priority shall be
given to translational and clinical research Projects.
Key Dates
Letter of Intent Submission Deadline: November 19, 2015, by 5:00 p.m.
Application Submission Deadline: January 14, 2016, by 5:00 p.m.
Peer Review Date(s): March 2016
Commission Review Date: May 2016
Earliest Anticipated Start Date: June 2016
Introduction
Stem cell research offers extraordinary promise for new medical therapies and a better
understanding of debilitating human diseases, injuries and conditions. The development
of new medical strategies for the prevention, diagnosis, treatment and cure of human
diseases, injuries and conditions through human stem cell research is a high priority for
the State of Maryland.
The Maryland Stem Cell Research Fund was established by the Maryland General
Assembly, under the Maryland Stem Cell Research Act of 2006 (the "Stem Cell Act”), to
promote State-funded human stem cell research and medical treatments through Grants
to public and private entities in the State. The Maryland Stem Cell Research Commission
("the Commission") sets policies and administers the MSCRF.
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The primary goal of the MSCRF is to support research that will advance the field of
regenerative medicine with the goal of achieving human stem cell therapies to
repair or replace missing, damaged, or diseased cells, tissues and organs. The
MSCRF does not fund research aimed at killing or disabling stem cells implicated in
the growth of cancer. Only Applications involving the study of human stem cells and
the process of their differentiation shall be considered for funding.
The Commission has established several research funding mechanisms, including:
Investigator-Initiated Research Grants, Exploratory Research Grants and Post-Doctoral
Fellowship Research Grants.
This Request for Applications, RFA-MD-16-2, is soliciting Applications for Exploratory
Research Grants to be funded by the MSCRF. Exploratory Research Grants are designed
to attract and support Investigators who are new to the stem cell field (young
Investigators and Investigators from other fields) and for new and/or innovative
hypotheses, approaches, mechanisms or models that may differ from current thinking in
the stem cell field and have little or no preliminary data supporting the Application. Grants
awarded under this RFA will fund basic, translational and/or clinical research involving
human stem cells.
Investigator-Initiated Research Grants are designed for Investigators with preliminary
data supporting the Grant Application, who wish to conduct basic, translational and/or
clinical research Post-Doctoral Fellowship Research Grants are for post-doctoral
fellows, who wish to conduct post-doctoral basic, translational and/or clinical research.
Pre-Clinical and Clinical Stem Cell Research Grants are designed to attract Applications
from for-profit Companies that wish to conduct research in the State of Maryland using
human stem cells to advance medical therapies. The projects must have clearly defined,
achievable milestones, and conduct the funded therapeutic human stem cell research in
Maryland.
In addition, the Commission continues to sponsor a Program that offers Maryland-based
scientists an opportunity to collaborate with certain investigators funded by the California
Institute of Regenerative Medicine (CIRM) (see www.MSCRF.org, Funding Opportunities).
All State-funded stem cell research must be conducted in Maryland. Applicants must
commit to make the results of their MSCRF-funded research readily available to others,
through publications (preferably), public presentations or other accessible means.
Objectives
The purpose of this RFA is to fulfill the provisions of the Stem Cell Act by promoting Statefunded stem cell research to broaden and advance the knowledge of human stem cell
biology and develop clinical applications for the prevention, diagnosis, treatment and cure
of human diseases, injuries and conditions.
The Commission is seeking the widest range of research Projects that may contribute to
the achievement of the goals of the program. There is currently a need for more
investment in all stages of research to pursue the potential of stem cell therapies.
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Executive Summary
Eligible Applicants: An Exploratory Research Grant Application shall have only one
(1) Principal Investigator ("PI”), but may have multiple Co-Investigators (“Co-PIs”).
PIs and all other MSCRF-funded personnel must be employed or retained by an
eligible Maryland-based research organization while conducting State-funded stem
cell research. Such affiliations may be permanent or temporary, full-time or part-time.
Applicants from Maryland-based public and private, for-profit and not-for-profit
research organizations of all types are eligible for this Award (e.g., universities,
colleges, research institutes, companies and medical centers).
Applicants may submit a Revised Application that was previously reviewed by the
Commission but not funded. Such Proposals must include the Application Number
of the previous MSCRF submission and a point-by-point response to the prior
scientific review.
Applicants may request Continued Support for a previously funded MSCRF Project
under the same or a different MSCRF funding mechanism, after the previous funding
period has ended. Such Applications must include a Progress Report from the prior
MSCRF-funded Project.
Applicants who have received prior MSCRF funding may apply for a New Award, in
a subsequent funding year, on a related or different topic, under the same or a
different MSCRF funding mechanism. Such Proposals must include Progress
Report(s) from any prior MSCRF-funded Project(s).
Any one candidate may apply to the MSCRF as the PI for only one new Award in any
given year.
Individuals from underrepresented minorities and individuals with disabilities are
encouraged to apply.
Eligible Organizations: All non-federal Maryland-based organizations of all types
are eligible for Exploratory Research Grants. Organizations based outside the State of
Maryland are not eligible for funding. Collaborations with non-Maryland based
organizations or persons may be allowable if the Applicant demonstrates that none of
the MSCRF funding will be used to support work performed outside of Maryland.
Eligible Research and Cell Types: Research funded under this program must
include human stem cells. All types of human stem cells, as defined in the Stem Cell
Research Act, are eligible. Animal cells may be used to supplement human stem cell
studies. Basic, translational and clinical research Proposals are all eligible for MSCRF
funding. However, priority shall be given to translational and clinical Projects.
Funding: Applicants for an Exploratory Research Grant may request up to one
hundred thousand dollars ($100,000) of direct costs in any single year, for up to two
(2) years.
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Collaborations: The Commission strongly encourages collaborations among
scientists and clinicians in academic, for-profit and not-for-profit organizations,
particularly collaborations that will integrate basic, translational and/or clinical
research.
Intellectual Property: Intellectual property developed under an MSCRF-funded
Exploratory Research Grant shall be owned by the Awardee, in accordance with
standard U.S. intellectual property law on inventorship and ownership and the PI's
institutional guidelines.
Sharing of Cell Lines: New cell lines developed with MSCRF funding must be made
available to other qualified researchers. Awardees who develop such cell lines with
State funds may require reasonable compensation for sharing them. Awardees shall
determine whether and to what extent to cover such new cell lines with intellectual
property and contractual protections.
Reports, Presentations, Publications and Subsequent Non-MSCRF Funding:
Awardees must submit Annual and Final Progress reports during the funding period
and present their results at an Annual in-State symposium. Awardees must notify the
Director of the MSCRF of any publications, patents and/or subsequent non-MSCRF
funding resulting in whole or in part from MSCRF-funded research.
Letter of Intent: Applicants are required to electronically submit a Letter of Intent
("LOI") through the TEDCO on line submission system.
Grant Application: The Application must include the following Sections:
 Project Summaries: One (1) technical and one (1) nontechnical Summary
describing the proposed research, and explaining how that research will contribute
to accomplishing the goals of this RFA.
 Research Plan: A description of the Research Strategy and Design, including
Significance, Preliminary Data, Innovation and Approach.
 Key Project Personnel: A list of personnel, including the PI, who commit
significant effort and contribute to the scientific development and/or execution
of the Project in a substantive way.
 Other Significant Contributors: A list of other personnel who contribute
significantly to the Project, but are not committing specified measurable effort.
 Translational Potential and/or Plan: A description of the relevance and
potential clinical application of the proposed basic, translational or clinical
research, and the projected plan and time line for accomplishing such clinical
application(s).
 Impact on Biotechnology in Maryland: A description of the impact of the
proposed research on the development, expansion and/or improvement of
biotechnology operations or capabilities in the State of Maryland.
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 Bioethics: A description of the ethical issues related to: cell type(s), cell line(s),
animal welfare (i.e., IACUC), IRB review and related concerns regarding human
subjects and Stem Cell Research Oversight Committee (ESCRO/SCRO) review.
Applicants should refer to the Maryland Stem Cell Research Act and existing
human stem cell research ethics guidelines.
 Budget and Budget Justification: An itemized yearly budget and
corresponding justification for the personnel, supplies and other costs
required to complete the proposed Project. Projects may be funded at or below
the requested amount, at the recommendation of the Scientific Peer Review
Committee.
 Resources and Environment: A description of the scientific environment, and
how it will contribute to the probability of success.
 Appendix: Supplemental pages that support the Proposal, including Literature,
Biosketches, Publications, other Current Support, Key Personnel and, where
applicable, a Summary of Prior Research Progress, a Response to Reviewer
Comments, Letter(s) of Collaboration and a Collaborative Plan.
Length limits for each Section are specified in the full text of this announcement.
Applications with sections that exceed the specified length limits will not be
reviewed.
Submission Process: PIs, must register in TEDCO on line submission system at least
one month before the Application Submission Deadline. Applications must be
submitted electronically through the TEDCO on line submission system. In addition,
one signed paper copy of the Application must be submitted to TEDCO by mail. Late
submissions and hand deliveries will NOT be accepted.
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TABLE OF CONTENTS
Part I: Overview Information and Executive Summary
Part II: Full Text of Announcement
Section A: Funding Objectives
Section B: Eligibility Information
1. Eligible Applicants
2. Eligible Organizations
3. Eligible Research and Cell Types
4. Other Eligibility Criteria
Section C: Award Information
1. Mechanisms of Support
2. Available Funds
3. Award Size and Duration
4. Terms, Conditions and Allowable Costs
5. Intellectual Property
6. Sharing Research Results and New Cell Lines
7. Publishing
8. Reporting
a. Annual Progress Reports and Funding Request Letters
b. Annual Symposium Presentations
c. Final Report
d. Publications, Patents and Subsequent Non-MSCRF Funding
9. Compliance
10. Award Decision Criteria
Section D: Application and Submission Information
1. Source for Application Information
2. Content of Letter of Intent
3. Submission Deadlines and Review Dates
4. Methods of Submission
a. Letter of Intent
b. Grant Application
5. Content and Format of Application
a. Project Summaries
b. Research Plan
c. Key Project Personnel
d. Other Significant Contributors
e. Budget and Budget Justification
f. Resources and Environment
g. Translational Potential and/or Plan
h. Impact on Biotechnology in Maryland
i. Bioethics
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j.
Appendix
(1) Literature in Support of the Application
(2) Biosketches and Publications
(3) Response to Reviewer Comments (if applicable)
(4) Summary of Prior Research Progress (if applicable)
(5) Letter(s) of Collaboration (if applicable)
(6) Collaborative Plan (if applicable)
(7) Other Current Support
Section E: Award Administration Information
1. Notification
2. Agency Contacts
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Part II: FULL TEXT OF ANNOUNCEMENT
SECTION A: FUNDING OBJECTIVES
The purpose of this RFA is to fulfill the provisions the Stem Cell Act by promoting Statefunded stem cell research to advance the knowledge of human stem cell biology and
expedite the development of preventions, better diagnoses improved treatments and
cures for debilitating human diseases, injuries and conditions.
SECTION B: ELIGIBILITY INFORMATION
I. Eligible Applicants
Individuals who meet the in-State eligibility requirement specified below, and who
have the skills, knowledge, resources and institutional support necessary to carry out
the proposed research, may apply for an Exploratory Research Grant. PIs and all
MSCRF-funded personnel must conduct their work in Maryland and be employed or
retained by an eligible Maryland-based organization while conducting such work. This
employment or retainer may be permanent, temporary, full-time or part-time.
Applicants from Maryland-based public and private, for-profit and not-for-profit
research organizations of all types are eligible for this Award (e.g., universities,
colleges, research institutes, companies and medical centers).
Applicants may submit a Revised Application for an Exploratory Research Grant
that was previously reviewed by the Commission but not funded. Such Proposals
must include in the Appendix the Application Number of the previous MSCRF
submission, and a point-by-point response to the prior scientific review.
Applicants may request Continued Support for a previously funded MSCRF Project,
under the same or a different MSCRF funding mechanism, after the previous funding
period has ended, if additional studies are warranted. A summary of the research
progress and any publications and/or presentations that resulted from the former
MSCRF funding must be included in the Appendix of such an Application.
Applicants who have received prior MSCRF funding may apply for a New Award
in a subsequent funding cycle on a related or different topic, under the same or a
different MSCRF funding mechanism. A summary of the research progress and any
publications and/or presentations that resulted from the former MSCRF funding must
be included in the Appendix.
Each Application for an Award funded by the MSCRF shall have only one (1) PI, but
may have multiple Co-PIs, Investigators and/or collaborators. PIs may participate as
Investigators or collaborators in any number of MSCRF-funded Projects in the same
funding cycle.
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Any one candidate may apply to the MSCRF as the PI for only one new Award in any
given year. PIs must register in the TEDCO on line submission system at least one
month prior to the Grant Submission Deadline. Individuals from under-represented
minorities and individuals with disabilities are encouraged to apply.
II. Eligible Organizations
Organizations eligible for an MSCRF Exploratory Research Grant must be based in
Maryland. An organization is considered based in Maryland if its primary location of
operations is in Maryland. Such entities include:
For-profit organizations
Not-for-profit organizations (excluding federally supported or affiliated foundations)
Public or private institutions (e.g., universities, colleges, medical centers,
companies and laboratories)
III. Eligible Research and Cell Types
All research funded by the MSCRF must involve human stem cells. Animal cells
may be used to supplement studies with human stem cells. Basic, translational and
clinical research Projects are all eligible for funding. All types of human stem cells, as
defined in the Stem Cell Act, are eligible without preference. The Stem Cell Act defines
eligible human stem cells as follows. The full text of the Stem Cell Act is available on the
MSCRF Web site (see www.MSCRF.org).
“State-funded stem cell research” means stem cell research conducted using
material obtained in accordance with section § 10-438 of the Stem Cell Act or
“adult stem cells.”
“Stem cell” means a human cell that has the ability to: (1) divide indefinitely, (2)
give rise to many other types of specialized cells, and (3) give rise to new stem
cells with identical potential.
"Adult stem cell" means a cell within fully differentiated human tissue that
maintains the ability to give rise to additional specialized cells as needed.
Material obtained in accordance with Section § 10-438 of the Stem Cell Act
means human embryos (not oocytes) obtained by a licensed healthcare
practitioner who treats individuals for infertility, and who provides information
to such individuals to enable them to make an informed and voluntary choice,
including a choice to donate such embryos for research.
IV. Other Eligibility Criteria
Awardees will receive MSCRF funds only after providing documentation to TEDCO
confirming that the research to be conducted with MSCRF funds has been approved by
the relevant Institutional Review Board (“IRB”) and Institutional Animal Care and Use
Committee (“IACUC”). Awardees conducting research that involves human embryonic
stem cells ("hESC") must provide documentation of approval by a Stem Cell Research
Oversight Committee before MSCRF funds shall be released.
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SECTION C: AWARD INFORMATION
I. Mechanisms of Support
The Commission has created several funding mechanisms. This RFA pertains only to
Exploratory Research Grants. It is intended to attract and support Investigators who
are new to the stem cell field (young Investigators and Investigators from other fields),
and to fund highly innovative research Proposals that have little or no preliminary
data. Grants awarded under this RFA will support basic, translational and/or clinical
research involving human stem cells.
II. Available Funds
The MSCRF is currently budgeted to commit up to $9.4 million, in aggregate, in FY
2016 to fund Grants under all of its RFAs. The number of Grants awarded will depend
upon the quality, size and mix of Applications received.
III. Award Size and Duration
Under this RFA, the total direct costs proposed may not exceed one hundred thousand
dollars ($100,000) per year, for a maximum of two (2) years.
Because the nature and scope of the proposed research will vary from Application to
Application, the size and duration of Awards also will vary. Approved Projects may be
funded at or below the requested/proposed amount.
IV. Terms, Conditions and Allowable Costs
MSCRF funds cannot be used to support any Project that is or has been funded in its
entirety by another funding source. However, an Applicant may receive
complementary funding from another source to cover other work that is related to the
same overall Project.
PIs shall assume responsibility for the planning, directing and execution of their
proposed Projects. MSCRF-funded Exploratory Research Grants will be subject to the
terms and conditions set forth in detail in the Grant Agreement entered into between
an Awardee’s affiliate institution, company, or organization and TEDCO.
Under this RFA, MSCRF Grant Award funds may be used for the following direct
costs, commensurate with the time dedicated solely to the proposed research:
Salary and fringe benefits for the PI and essential personnel
Equipment
Supplies
Consultant costs
Contract services
Collaboration expenses
Travel and conference expenses
Publications and miscellaneous costs
Additional MSCRF funds will cover indirect costs, not to exceed fifteen percent
(15%) of direct costs.
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Under an Exploratory Research Grant, MSCRF funding for personnel costs may only be
expended for Investigators who conduct work in Maryland (including out-of-State
Investigators who move to Maryland to conduct this work in Maryland) and who are
employed or retained by an eligible Maryland-based organization, as described in
Section B-II. MSCRF funds may not be used to cover personnel costs of Investigators
who are located and conduct the work outside the State of Maryland, regardless of
whether such out-of-State Investigators are employed or retained by a Maryland-based
or non-Maryland based organization. Applicants are permitted to include out-of-State
Investigators and/or collaborators under an Exploratory Research Grant if they
demonstrate that no MSCRF funds will be used to support work or personnel costs for
the out-of-State Investigators.
Purchase of equipment and supplies, publication costs, conference expenses, contract
manufacturing and services and other non-personnel costs may be incurred outside
the State of Maryland, in accordance with customary practices of researchers. MSCRF
funds may not be used for patent and other intellectual property fees and expenses.
Certain pre-Award costs are allowable. Applicants may, at their own risk, and without
the Commission’s prior approval, incur obligations and expenditures to cover costs up
to ninety (90) days before the beginning date of the initial budget period of an
Exploratory Research Grant, if such costs are necessary to conduct the Project and
would be allowable under the Grant, if awarded.
The incurring of pre-Award costs in anticipation of Award of an Exploratory Research
Grant imposes no obligation on the Commission either to make the Award, or to
increase the amount of the approved budget if an Award is made for less than the
amount anticipated. Awardees should be aware that pre-Award costs result in
borrowing against future support, and that such borrowing must not impair Awardees'
ability to accomplish their Project objectives in the approved time frame or in any way
adversely affect the conduct of their Projects.
Once a Grant has been awarded, up to ten (10) percent of funds can be reallocated
between budget categories without prior TEDCO approval (e.g., from salaries to
supplies). However, reallocations in excess of ten (10) percent must be approved in
advance by TEDCO.
V. Intellectual Property
Intellectual property developed under an Exploratory Research Grant funded by the
MSCRF will be owned by, and the responsibility of, the recipient PI, in accordance with
standard U.S. intellectual property law on inventorship and ownership and the
Awardee's affiliate institutional guidelines.
Award recipients shall determine whether to apply for patents or other intellectual
property protections on discoveries or inventions developed with MSCRF funding
under the Grant. In the event that an Applicant decides to apply for such intellectual
property protections, the Applicant shall be responsible for all fees and expenses
involved, and may not use MSCRF funds for such fees or expenses.
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VI. Sharing Research Results and New Cell Lines
Awardees are required to share with qualified researchers their research results and any
cell lines and other materials developed with MSCRF funding. Awardees may require
that the recipient researcher(s) pay reasonable compensation for such new cell lines or
materials. Awardees may include in the Grant Budget, and use MSCRF funds to pay for,
reasonable expenses associated with sharing arrangements. Awardees shall determine
whether and to what extent to cover such sharing of new cell lines and materials with
intellectual property and contractual protections (i.e., Confidentiality Agreements,
Material Transfer Agreements, Data-Sharing Agreements, License Agreements, Supply
Agreements, etc.).
VII. Publishing
Applicants must commit to make the results of their MSCRF-funded research readily
available to others, through publications (preferably), public presentations or other
accessible means.
VIII. Reporting
A. Annual Progress Reports and Funding Request Letters
PIs must file Annual Progress Reports describing the research conducted, and the
interim and/or final results of that research, at the end of each funding year. At the
end of the funding year, PIs must also submit written Letters of Request for
continued support for the following year. Financial reporting relevant to the
MSCRF-funded Project shall be specified in the Grant Agreement executed
between TEDCO and the Awardee's affiliate institution, company or organization.
The format, content and length of the Annual Progress Report and Letter of
Request shall also be specified in the Grant Agreement. Such Progress Reports and
request letters must be submitted to the MSCRF electronically through the TEDCO
on line submission system, no later than thirty (30) days after the end of the
annual period covered in the report.
The MSCRF will review all Annual Reports and Letters of Request to evaluate the
progress that has been made relative to the plans, timetables and budgets
proposed in the respective Applications before funding for the subsequent year is
approved.
B. Annual Symposium Presentations
The Commission will conduct an in-State Annual Symposium to report to the
scientific community and the public the progress of the MSCRF program. All PIs
must present, orally or in poster format, their on-going or completed MSCRFfunded research at each Annual Symposium, during and immediately following
their Grant period.
C. Final Report
Within forty-five (45) days after the end of the overall Grant period, PIs must
file their Final Reports, describing the research conducted and the results of this
research. This Final Report shall include explanations and justifications for any
proposed studies that were substantially changed or not completed. The Final
Report must also describe the impact, significance, translational potential
and/or clinical applicability of the research results.
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The details concerning the format, content and length of the Annual Progress
Report shall be specified in the Grant Agreement executed between TEDCO and
the Awardee's affiliate institution, company or organization.
D. Publications, Patents and Subsequent Non-MSCRF Funding
During the funding period and after it has ended, Awardees must continue to
notify the Director of the MSCRF of any clinical application(s), publication(s),
patent(s) and/or non-MSCRF funding and/or income (licensing fees, royalties,
etc.) that result(s) in whole or in part from MSCRF-funded research and/or its
commercialization. Such metrics demonstrate the success of the MSCRF Program
and support the Commission's appeal for continued funding. To facilitate future
communication, the PI and the Awardee shall ensure that their contact
information is kept up to date.
IX. Compliance
A Principal Investigator not in compliance with the reporting obligations under an
Exploratory Research Grant shall not be eligible to apply for continued or subsequent
MSCRF funding.
X. Award Decision Criteria
The Scientific Peer Review Committee will review all Applications and rank them
based on scientific merit. The NIH scoring system of 1-9 will be used to rate the overall
impact/priority of the proposed research. In this system, “1” indicates the highest
impact/priority and “9” indicates the lowest impact/priority. The Commission will
then review the ranked Applications and make recommendations to the TEDCO Board,
which will make the final funding decisions.
To receive a high scientific priority score, an Application must be judged strong
in all of the following categories:
Meeting the Overall Objectives of The MSCRF Program: Do the proposed
studies broaden and advance the knowledge of human stem cell biology? Are they
relevant to the development of clinical application(s) to prevent, diagnose and
treat human diseases and conditions? Will these studies enable, support and
expedite such clinical applications?
Relevance to Regenerative Medicine: Does the proposed research use adult,
embryonic, iPS or other human stem cell lines? Does the PI justify the use of
human stem cells in the proposed research as necessary or advantageous as
compared to other approaches? Does the Project address problems in
regenerative medicine, as defined by the Commission?
Likelihood of Success: Are there limitations of the proposed studies that will
make it difficult to apply findings or strategies in the clinic? Are there
completed or on-going clinical trials that will impede/accelerate the proposed
research?
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Translation Potential and Plan:
Does the Application include strong
interactions between basic, translational and/or clinical components? Is there a
clear plan for translating research results to the clinic? Will the Project lead to
new medical therapies or test new therapies in patients? Will the research help
explain the course of any human disease(s) or condition(s)? Will it identify new
biomarkers or other methods for preventing or diagnosing disease(s) or
condition(s)? Will it identify new targets for treatment? Will it develop new
treatment strategies, products or tools?
Impact on Biotechnology in Maryland: What is the potential impact of the
proposed research on the advancement of biotechnology in Maryland’s academic,
business and/or non-profit sector(s)? Will this Project help create new
biotechnology jobs, grow companies and/or program opportunities in Maryland?
Collaboration(s): Does the proposed research involve collaboration(s) among
scientists and/or clinicians from for-profit and not-for-profit institutions,
companies and organizations, as emphasized by the Commission? If so, is there a
demonstrated commitment from each institution? Is there a management plan
that addresses how the Applicant and collaborator(s) will communicate, handle
confidential information, use milestones to determine resource re-allocation
and Project re-direction, share data and resources, prepare required reports and
handle geographic separation, if applicable?
Scientific Merit: Is the Project likely to have major scientific impact and make a
substantial contribution toward accomplishing the goals of the MSCRF program?
Research Significance: Does this Project address an important scientific
problem, relevant to human stem cells? What is the relationship between the
proposed research and the etiology, prevention, diagnosis or treatment of human
diseases or conditions? If the aims of the Application are achieved, how will
scientific knowledge or clinical practice and treatment of human diseases or
conditions be advanced? What effect will these studies have on the concepts,
methods, technologies, treatments, services and/or preventative interventions
that drive stem cell biology?
Innovation: Is the Project original and innovative? Does it challenge existing
paradigms or clinical practice or address a novel hypothesis or critical barrier
to progress in the field? Does it develop or employ new concepts, approaches,
methodologies, tools or technologies in the field? What is the potential impact
on the advancement of biotechnology or medical innovation?
Approach: Is there adequate preliminary data to support the rationale of the
Research Project? Are the conceptual or clinical framework, design, methods
and analyses adequately developed, well integrated, well reasoned and
appropriate to the aims of the Project? Is relevant literature appropriately
referenced? Are anticipated results discussed? Does the Applicant acknowledge
potential problem areas and consider alternative tactics? Are the experiments
as designed likely to significantly impact the field?
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Investigators: Are the Investigators appropriately trained and well suited to
carry out the Project? Is the proposed Project appropriate to the experience
level of the PI and other Investigators? Does the research team bring
complementary and integrated expertise to the Project?
Budget and Budget Justification: Is the requested period of support
appropriate for the scope of the Project? Is the effort listed for all personnel
appropriate for the proposed work? Is each budget category realistic and justified
in terms of the aims and methodology? If equipment is requested, is it justified,
cost effective and budgeted appropriately?
Resources and Environment: Does the scientific environment in which the
work will be conducted contribute to the probability of success? Do the proposed
studies benefit from any unique features of the scientific environment or subject
population? Do these studies employ useful collaborative arrangements involving
on-site resources or personnel? Is the institutional support adequate?
Bioethics: Does the proposed research use adult, embryonic, iPS or other
human stem cell lines? If an existing line is to be used, what are the
justifications for that line? If new lines are to be created, what measures will be
taken to comply with the Stem Cell Act as well as existing stem cell research
bioethics guidelines? If human donors are involved, have they been properly
consented? If human subjects are involved, what protections will be in place to
ensure their rights and welfare? If animal subjects are to be used, what
measures are taken to comply with IACUC guidelines?
If the PI's work was previously funded by the MSCRF, in whole or in part,
the Application will be evaluated on the following additional factors: Did the
Investigator make significant scientific progress towards the goals of the
previously funded research? Were results of the previously funded Project
reported in scientific publications and/or presented at conferences? Did the
previously funded research result in new collaborations, inventions or Projectgenerated resources as proposed in the original Application? Did the previous
Project generate subsequent funding from non-MSCRF sources?
SECTION D: APPLICATION AND SUBMISSION INFORMATION
I. Source for Application Information
Application information will be available electronically on the MSCRF Web site (see
www.mscrf.org). Telecommunications for the hearing impaired are available at TTY
443-539-0180.
II. Content of Letter of Intent
Limited to one (1) page
Eligibility for an Exploratory Research Grant requires a Letter of Intent. The LOI must
include the following information:
Descriptive Title of proposed research
Type of MSCRF Funding Mechanism (Exploratory Research Grant) and
RFA Number (RFA-MD-16-2)
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Type(s) of Proposed Research (basic, translational or clinical)
Name, Address, Telephone Number and Email Address of the PI
Name(s) of Affiliate Organization(s) and, if applicable, Collaborating Organizations,
and Site(s) of proposed research
Targeted Disease, Injury or Condition, if applicable
Human Stem Cell Type(s) to be used (e.g., hESC, ASC or iPS)
Brief Description of the Proposed Research
Area(s) and Type(s) of Expertise necessary to evaluate the Proposal, including
Keywords that identify elements of the research Proposal (such as disease focus,
technical approaches, research fields and disciplines).
Applicants will not receive feedback on their Letters of Intent. LOIs will not be used by
reviewers or considered in the evaluation of Applications. The purpose of the Letter of
Intent (LOI) is to determine if the grant submission is consistent with the goals of the
MSCRF. The LOI is also intended to ensure that the members of Scientific Peer Review
Committee have the appropriate range of expertise to optimally conduct their review.
LOI’s that are incomplete, do not meet the format and/or content requirements, exceed
the specified length limit, are non-responsive to the RFA or are from ineligible
Applicants will not be reviewed.
III. Submission Deadlines and Review Dates
Letter of Intent Submission Deadline: November 19, 2015, by 5:00 p.m.
Application Submission Deadline: January 14, 2016, by 5:00 p.m.
Peer Review Date(s): March 2016
Commission Review Date(s): May 2016
Earliest Anticipated Start Date: June 2016
IV. Methods of Submission
A. Letter of Intent
Applicants are required to electronically submit a Letter of Intent ("LOI") through
the TEDCO on line submission system, by November 19, 2015, no later than 5:00
p.m.
B. Grant Application
PIs, must register in the TEDCO on line submission system at least one month
before the Application Submission Deadline.
Grant Applications must be submitted through the TEDCO on line submission
system by January 14, 2016, no later than 5:00 p.m.
One signed paper copy of the Application must be submitted by mail to the
Maryland Stem Cell Research Fund (see address below). The paper copy of the
Application must be postmarked no later than January 15, 2016.
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All submissions must be received by their respective due dates. Late submissions
and hand deliveries will be NOT be reviewed.
Paper copies should be sent to:
Maryland Stem Cell Research Fund
Maryland TEDCO
7021 Columbia Gateway Drive
Suite 200
Columbia, Maryland 21046
V. Content and Format of Application
All Sections of the Application must be submitted through the TEDCO on line
submission system
The document must be formatted using point size 12 Arial font, with margins no
smaller than one-half (0.5) inch on all sides. Uploaded file must be limited to 5
(five) megabytes (MB).
The Application must include the following Sections:
A. Project Summaries
Limited to one page each
Two (2) Project Summaries describing the proposed research and its potential
contribution toward the goals of the MSCRF and this RFA, as set forth in this
document. One Project Summary shall be technical and directed to a scientific
audience. The other Project Summary shall be nontechnical and directed to a
lay audience.
B. Research Plan
Limited to six (6) pages, including all tables, figures and charts
A description of the Research Strategy and Design, including Preliminary Data in
support of the Proposal, Significance, Specific Aims, Rationale, Approach and
Innovation.
C. Key Project Personnel
(A table format, not included in the page count)
A list of the names, affiliate organizations, and roles of all key personnel,
defined as the PI and individuals in addition to the PI, who contribute to the
scientific development or execution of the Project in a substantive way, and
devote measurable effort (in person months) to the Project, whether or not
salaries are requested. Typically, these individuals have doctoral or othe r
professional degrees, although individuals at the masters or baccalaureate level
should be included if their involvement meets the definition of key personnel.
"Effort of zero person months" and "as needed" are not acceptable levels of
involvement for key personnel.
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D. Budget and Budget Justification
(A table format, not included in the page count)
A detailed yearly budget and budget justification, including salaries that are
within the current NIH salary range and commensurate with the time allotted
to the proposed research. This budget will be used if the Application is funded.
Make certain that it is complete and accurate. Applicants should request only the
funds needed to complete the proposed Project. Requests for less than the
maximum allowable amount will not be considered as a weakness.
E. Resources and Environment
(Limited to one half page not included in the page count)
A description of the facilities in which the work will be conducted and how the
scientific environment will contribute to the probability of success, including such
things as collaborative arrangements involving on-site resources, unique features
of the subject population and institutional support.
F. Translational Potential and/or Plan
(Limited to one half page not included in the page count)
An explanation of (i) the relationship between the proposed research and the
etiology, prevention, diagnosis or treatment of human diseases or conditions;
(ii) how clinical practice and treatment of human diseases or conditions will be
advanced by the proposed research; (iii) how the proposed research may
contribute to new medical therapies or test new therapies in human patients;
and/or (iv) how the proposed research will translate prior research results
into new medical therapies or test new therapies in human patients, and the
projected time line for accomplishing such clinical application(s).
G. Impact on Biotechnology in Maryland
(Limited to one half page not included in the page count)
A description of how the proposed research should contribute to the
development, expansion or improvement of biotechnology operations or
capabilities in the State of Maryland. Examples (for illustrative purposes only)
include the introduction of improved, streamlined or automated processes
involving stem cells; expansion or improvement of stem cell production or
storage; training of stem cell researchers, technicians and related personnel and
the like.
H. Bioethics
(Limited to one half page not included in the page count)
A description of the ethical issues relevant to the proposed research and how
these issues will be addressed, including, but not limited to, a discussion of the
ethical issues related to the cell type(s) and cell line(s) to be used; animal welfare
(i.e., IACUC); IRB review and related concerns regarding human subjects, if
applicable; and Stem Cell Research Oversight Committee review (required of all
Projects that involve human embryonic stem cells). If new cell line(s) will be
created, the Application must explain how the biological materials used to create
them will be obtained and how subjects will be consented. Applicants should
refer to existing human stem cell research ethics guidelines and the Maryland
Stem Cell Research Act.
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I. Appendix
Limited to 25 supplemental pages (Upload in the same file as the application)
The Appendix shall include (in this order):
(1) Literature in Support of the Application
A list of scientific Literature in support of the Proposal, including Author,
Title, Journal, Volume, Publication Date, and Page Numbers.
(2) Biosketches and Publications
Limited to four (4) pages each
The Biosketches, and up to five (5) relevant Publications, for key
personnel, collaborators and pertinent others. Include online publicly
accessible links. Manuscripts in preparation, manuscripts submitted but
not yet accepted and those currently in revision cannot be included.
(3) Response to Reviewer Comments, if Applicable
Limited to three (3) pages (not counted in the Appendix page limits)
For Applicants Resubmitting an Application that was previously
reviewed under any MSCRF funding mechanism, but not funded: An
Introduction to the revised Application, including the Application Number
of the previous MSCRF submission, and a point-by-point response to the
prior scientific review.
(4) Summary of Prior Research Progress, if Applicable
Limited to two (2) pages (not counted in the Appendix page limits)
For Applicants who have had previous MSCRF funding and are requesting
either continued support or funding for a New MSCRF Award: The Summary
of the research progress and/or findings from the previously funded MSCRF
Project, including a list of any publications, new collaborations, INDs, IDEs or
patents, and any additional non-MSCRF funding that resulted from this
previous MSCRF funding.
(5) Letter(s) of Collaboration, if Applicable
Limited to five (5) one-page per collaborator (not counted in the Appendix page
limits)
For Applications that involve Collaboration(s): A Letter of collaboration
from each collaborator (i) agreeing to the proposed collaborative research;
(ii) briefly outlining the nature of the collaboration; and (iii) agreeing that,
if MSCRF funding is awarded, they shall share research results with each
other and comply with the progress reporting duties under the MSCRF
Grant Agreement, conditioned upon TEDCO’s duty to maintain the
confidentiality of the reported information to the extent reasonably
permitted by Title 10, Subtitle 6 of the State Government Article of the
Annotated Code of Maryland. Such letters must be co-signed by the
collaborators and responsible officials at the collaborators' affiliate
institutions.
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(6) Collaborative Plan, if Applicable
Limited to two (2) pages (not counted in the Appendix page limits)
For Applications that involve Collaboration(s): A detailed description of
the nature and terms of the collaboration, and a management plan
explaining such issues as how the Applicant and collaborator(s) will
communicate and handle confidential information, use milestones to
determine resource re-allocation and Project re-direction, share data and
resources, prepare required reports and handle geographic separation, if
applicable.
(7) Other Current Support
The Project Number(s), Title(s) and Funding Source(s) of all currently
supported research, and a short paragraph summarizing each Project.
The uploaded document is limited to maximum of 49 pages including all sections.
The Appendix may not be used to circumvent the length limitations of the Application .
Applications that are incomplete, do not meet the format and/or content requirements,
exceed specified length limits, are non-responsive to this RFA or are from ineligible
Applicants will not be reviewed.
SECTION E: AWARD ADMINISTRATION INFORMATION
I. Notification
The PI's affiliate organization will be notified electronically when the Application is
received. After the TEDCO Board has approved the Commission's recommendations, a
formal notification, in the form of a Notice of Award ("NOA"), signed by the MSCRF
Executive Director, will be sent via email to successful Applicants.
Selection of an Application for Award is not authorization to charge costs to the
MSCRF. Except as stated in Section C-IV, in regard to pre-Award costs at the
Applicant’s risk, Applicants may not charge costs or assume they will receive funds
until an MSCRF Grant Agreement has been signed by the Awardee's affiliate
organization and TEDCO. A template for the MSCRF Grant Agreement will be posted
on the MSCRF Web site before the Awards are announced www.MSCRF.org
II. Agency Contacts
Questions about this RFA must be submitted by email to: [email protected].
Telephone inquiries will not be accepted.
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