Request for Applications - International Progressive MS Alliance

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Collaborative Network Awards
Request for Applications
The International Progressive MS Alliance (the Alliance) is pleased to announce
a new funding initiative designed to accelerate the development of therapies for
progressive MS. The Collaborative Network Awards are intended to challenge
scientists from around the world to pursue bold, innovative and rigorous research
in pursuit of new treatments for progressive MS. This program is a component of
the Alliance’s comprehensive €22 million research strategy.
Goal
The Collaborative Network Awards will create interdisciplinary, global,
collaborative networks focused on accelerating the development of new
therapies for progressive MS, including new and repurposed drugs,
rehabilitation strategies and/or other treatment approaches. The goal of these
awards is to establish teams of excellence that engage in transformative
research leading directly to clinical application and tangible improvements for
people living with progressive MS.
Research Priorities
The Alliance has identified a number of priority research areas (Setting a
research agenda for progressive multiple sclerosis: The international
collaborative on progressive MS. Multiple Sclerosis Journal 2012 Nov;
18(11):1534-40). A variety of funding models designed to be complementary and
interdependent, will be implemented by the Alliance to address these priority
research areas and accelerate the development of therapies for progressive MS.
The Collaborative Network Awards are designed to support pre-clinical and/or
clinical translational research that address major obstacles and focus on these
key research areas:
1. Drug discovery programs that identify and validate molecular and cellular
targets and screen and characterize drug candidates, which may be either
repurposed or first-in-human drugs
 Expected Impact - Development of one or more pre-clinical drug
candidates within the 4 year funding period
2. Discovery, advancement and validation of new or existing biological or
imaging biomarkers
 Expected Impact - Development of a meaningful outcome
measure that could be integrated into early clinical development
within the 4 year funding period
3. Proof-of-concept trials and proof of concept trial designs, including, but not
limited to trials in remyelination, neuroprotection, enhanced plasticity or
other first-in-human, exploratory clinical trials for progressive MS, including
both pharmacological and rehabilitative strategies/interventions
 Expected Impact – Initiation of clinical trials of new
interventions for progressive MS within the 4 year funding
period
This RFA is not intended to solicit the typical investigator-initiated research
grant; rather, it is designed to bring together experts in a number of disciplines
to focus on overcoming the most significant barriers to the development of
effective treatments for progressive MS. As such the Alliance will focus its
efforts on funding teams of excellence not teams of convenience.
Through this RFA the Alliance expects to accelerate research and demonstrate
progress and results in order to improve outcomes and the quality of life for
people living with progressive MS.
Eligibility
Proposed networks must have an organizational structure to foster and conduct
integrated research activities and promote data sharing and knowledge
exchange in the key areas outlined in this RFA. Eligible personnel and
organizations include: (1) public research institutions, (2) non-profit research
organizations (3) commercial organizations with a medical research focus and
mission.
New networks must consist of at least three organizations and a minimum of
three different countries must be represented in the network. Investigators
leading the network must have demonstrated track records of directing
outstanding research programs. At least 50% effort of the partnership is required
to be performed in an academic or not-for-profit research organization.
Submitted proposals are required to fulfill the following criteria:
1. Network Structure:
a. Each network must consist of researchers from at least three
organizations and at least three different countries must be
represented in the network. Forming a network should add
demonstrable value to the project. Proposals that do not meet
these criteria will receive lower priority during consideration for
funding
b. A single public institution or non-profit research organization will be
the official recipient of the grant. Sub-awardees may be public
institutions, non-profit research organizations or commercial
organizations. Organizations may be located in any eligible country.
c. Eligible organizations include: public research institutions, nonprofit research organizations and commercial organizations (e.g.
pharmaceutical or biotechnology companies, and contract research
organizations) with a medical research focus and mission.
d. Proposals that include commercial organizations must incorporate
cross-sector collaboration (e.g. academic-industry collaboration) as
part of the research plan. At least 50% effort of the partnership must
be performed in a public (e.g. academic) institution or non-profit
research organization and all funds will flow through the
academic/non-profit organizations (with sub-awards to other
investigators in the network). Commercial organizations (e.g.
pharmaceutical and biotechnology companies) with a medical
research focus and mission are invited to participate in this RFA
and bring their particular skills and capabilities in drug discovery
and development to bear on the Alliance goals. The Alliance also
appreciates willingness to co-fund important projects.
2. Research Team
a. A single principal investigator (PI) located at a public institution or
non-profit research organization must be identified as the overall
leader for the entire project and the award must be administered at
the organization where the PI is employed.
b. In addition to the PI, a research team consisting of no less than 2
co-investigators, responsible for the direction of individual elements
of the overall research program within the partnership should be
identified. The co-investigators can be named from a commercial
organization and/or public or non-profit organizations (as stated
previously, awards will be administered via the public or non-profit
organization). The principal investigator and co-investigators should
be established scientists and/or clinicians with demonstrated
leadership and research management experience.
c. The Alliance encourages applicants to recruit sufficient coinvestigators to ensure confidence that the multi-disciplinary
research goals of the RFA will be achieved.
d. The research team should consist of clinical, translational or basic
science investigators with demonstrated track records of directing
outstanding research programs in their respective disciplines. There
are no specific requirements regarding the number of clinical
translational or basic investigators involved, but the partnership
should have an adequate representation in order to ensure
credibility of basic, preclinical, clinical, and translational elements of
the proposal. The inclusion of young investigators is encouraged.
Important Note - The Alliance offers to act as a facilitator (via MS Society
representatives) to enable multidisciplinary networks (public - private- non-profit)
at an international level and to discuss issues (e.g. questions related to IP) that
may arise during the preparation of Collaborative Network Planning Award
applications.
Proposal Submission
Proposals responsive to this RFA will follow a 2-stage process. The first stage
consists of a proposal for a one-year planning award. Those investigators
receiving a planning award will be allowed to enter the second stage and
submit a full proposal for a multi-year Collaborative Network project.
First-stage: Collaborative Network Planning Award
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Duration: 12 months (Collaborative Network Award proposals will be due
after 9 months)
Award Amount: up to €50,000
Quantity: up to 10 awards
Second-stage: Collaborative Network Award
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Duration: 4 years
Award Amount: Up to €1 million/year/award
Quantity: the exact number of awards will be based on available resources
and the number of competitive applications
First Stage – Collaborative Network Planning Awards:
1. The objective of the planning award is to:
a. Provide start-up funds to plan and develop a competitive strategy and
produce a collaborative research proposal for the full Collaborative
Network Award
b. Support the formation and planning activities of the newly-configured
investigative teams
2. Planning activities include:
a. Assembling the multidisciplinary investigative team, including in-person
planning sessions
b. Hiring/funding a temporary research coordinator/project manager to
manage the planning process
c. Fully developing the collaborative research proposal
d. Identifying novel approaches/disciplines to address knowledge gaps.
e. Developing a feasibility and execution plan (e.g., resources and
competencies; timeline and deliverables)
Proposal (5 pages maximum) for the Planning Awards should include:
1. Aims and deliverables (1 page).
2. Overview of the Multidisciplinary Research Team and Proposal
a. Research team structure, list of team members and anticipated
roles of individual members (0.5 page)
b. Description of and brief rationale for the organizational structure
and mechanisms in place to foster integrated research activities
that address one of the key objectives outlined in this RFA (1 page)
c. Brief rationale and description of the future collaborative team
research proposal (1 page), including a brief outline of the research
proposed, key aims, timeline and deliverables for the Collaborative
Network Award
3. Planning Activities and Timeline of the planning award (1 page)
a. The deadline for submission of the full Collaborative Network Award
proposal will be nine months from the start of the Planning Award
(funding will be provided for the full 12 months)
4. Summary – brief summary of how the proposed project meets the eligibility
criteria, addresses at least one of the research priorities and aligns with the
expected impact outlined in the RFA (0.5 page)
5. Budget –full budget information for the planning activities will be required in
the online application
We anticipate funding as many as 10 planning awards, but the final number will
be determined by the Alliance Executive Committee and will be dependent on the
number of meritorious applications and the funds available.
The Alliance will use the National MS Society’s online application interface for
this RFA. All applications must be submitted in English. Only one investigator
should apply per team and this person must first register with the online
application site (https://nmss.fluxx.io). All applications must be submitted using
Chrome or Firefox browsers. IE is not supported at this time.
Planning Award Review
Proposals will be reviewed by the Alliance Scientific Steering Committee
(SSC). Applicants may be invited to present their proposal to the SSC by
conference call as part of the review process.
The following criteria will be used by the SSC to evaluate applications.
Significance and Relevance — The impact and importance of the long-term
endeavor
 Originality, significance and expected contribution to knowledge
 The degree to which a barrier to treatment will be eliminated or therapy
development will be enabled by this application
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Appropriateness of the theoretical approach or framework
Appropriateness of the methods/approach (including the creation of
knowledge)
Feasibility and Capability — The plan to achieve excellence
 Probability of effective and timely attainment of collaborative network
research objectives
 Quality of the team structure and the organizational structure of the
network, including involvement of collaborators and others in the
design and conduct of the planning activities
 Clarity of the value (skills and resources) that each team member will
bring to the aims of the research
 Quality of the plans to disseminate knowledge
 Strategies and timelines for the design and conduct of the
activity/activities proposed
 Quality, quantity and significance of past experience including
published and/or creative outputs of the applicant and/or team
members relative to their roles in the network and to their respective
stages of career
 Experience in large scale collaborative activities
Second Stage - Full Collaborative Network Awards (20 pages maximum)
Recipients of planning awards will be asked to submit their fully developed
Collaborative Network Research proposals nine months from the start of their
planning award.
Collaborative Network Research project applications will include:
Lay Summary
Complete the fields in the online application asking for a lay language
summary that describes the proposed research in language suitable for a
news release to the lay public.
Scientific Summary
The Scientific summary should capture the rationale, methods and potential
significance of the proposed research in one or two paragraphs.
Research Plan Proposals will be expected to state the mission, vision, goals,
and distinguishing features of the network that will ensure the likelihood of
achievement of the RFA objectives. A clear and compelling research plan, for
a funding period of up to four years, should be presented.
The research plan should be adequately described and should be
accompanied by specific milestones and a timetable for reaching them.
Investigators responsible for execution of specific research components -“division of labor” -- should also be clearly identified. While it is recognized
that research activities can and will occur independently, proposals should
clearly articulate the plans for collaborative integration of the partnership’s
research activities. Proposals should describe comprehensive
communications and information-sharing plans.
Clinical Translation Successful proposals will articulate how therapy
development will be enabled by this application and provide a clear and viable
path toward clinical applications (including a timeline and milestones) and will
also consider additional funds that might be required, and the potential
avenues for seeking additional funds, in order to fully develop proposed
therapies.
Institutional Commitment Applicant institutions/organizations should
demonstrate strong departmental and institutional commitment which might
include allocation of space, staff, cost-sharing, matching funds and other
mechanisms of institutional support.
Budget Applicants should be prepared to submit a detailed justified budget
for each year. This information will be part of the online application and will
not count against the 20 page narrative limit. Investigators may request funds
in the following categories: salaries for personnel, patient costs, consumable
supplies, inter-laboratory travel and other allowable expenses. For the
Collaborative Network Awards, the Alliance will support research costs that
have been fully justified in the application and not normally paid for by the
host institution. The Alliance will not provide funds for indirect cost recovery.
The Alliance recognizes that in some cases certain administrative costs
associated with an Alliance-funded program will not be borne by the
institution. In such cases applicants will be permitted to allocate Alliance funds
to defray these expenses, provided that the applicant and host institution
certify that these funds are required for execution of the project and that
institutional or other funds are not available to cover these costs. These costs
should be listed on the “Other Expenses” line item of the application.
Biographical Sketches. Brief 2-3 page biosketches of the PI and key coinvestigators must be included. This should include a summary list of relevant
publications. Please see the online application for formatting details.
Letters of Collaboration. Applicants may submit letters of collaboration that are
directly relevant to the proposal.
Collaborative Network Research Full Proposal Review
The review will be conducted by a scientific review committee convened by the
Alliance Scientific Steering Committee. The review committee will be
international, multidisciplinary and with expertise in the areas of research focus.
Applicants will be required to present their proposal to the review committee and
engage in a dialog with the review committee regarding the specifics of their
proposals.
The review criteria for the full application include:
1. Adherence to the specific scientific objectives of the RFA and alignment
and relevance to the mission and goals of the Alliance. In particular,
weight will be given to the networks which can demonstrate how their work
will eliminate a major barrier to therapy development.
2. Adherence to the collaborative network principles, incorporating different
countries and organizations.
3. Relevance of organizations and researchers contribution to address
knowledge gaps in progressive MS.
4. Scientific critique of the proposed work plan and resources requested:
a. Scientific merit, rigor, innovation and potential – these criteria will be
the yardstick by which all proposals will be measured.
b. Are the funds requested essential for the work, and do the
importance and scientific potential justify funding on the scale
requested?
5. Proximity to clinical translation and treatment development.
6. Potential for greatest long term impact.
7. Expertise and excellence of the investigators and organizations.
8. Appropriateness of the resources and environment.
Review panels will include members of the Alliance Scientific Steering Committee
and external expert reviewers. Recommendations from the panels will be
considered by the Alliance Scientific Steering Committee and final funding
authorization will be provided by the Alliance Executive Committee. The Alliance
will initiate negotiations on a sponsored research agreement with the networks
that are selected.
Key dates (estimated)
 November 3, 2014– Release of RFA
 December 15, 2014 – Online site opens for planning grant proposals
 January 31, 2015 – Deadline for final submission of planning grant
proposals
 February – June 2015 – Review of Planning Grant applications
 July 2015 – Planning Grant award notices sent out
 August 2015 – Start date for Planning Awards
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May - June 2016 – Deadline for Full Proposal submission (exact date
tbd based on Planning Award start date)
June - July 2016 – Review of full proposals
August 2016 – Award notices sent to new Collaborative Networks
September -October 2016 – Start date for full awards
Conditions of the Full Collaborative Network Awards
The Alliance will support projects with a maximum annual budget of €1 million per
year with a maximum term of 4 years.
Awards will be paid in regular installments and continued payments will be based
upon achievement of specific milestones outlined in the proposal, detailed in
progress reports and on the availability of funds.
Networks will be required to provide financial and research progress reports to
the Alliance at least every 6 months.
The team leaders will be required to present research progress at an Alliance
annual scientific meeting. In addition, the leadership of each network will meet
with the Alliance Scientific Steering Committee to review progress and receive
feedback on an annual basis.
A final written report of the work accomplished and an accounting of expenditures
will be required within 30 days after the project ends. The grantee organizations
will also be required to comply with the Alliance’s invention policy and other
Alliance policies and procedures.
CONTACTS
Interested applicants are strongly encouraged to speak with the Alliance scientific
staff listed below.
Italian Multiple Sclerosis Society
Gabriele Dati, Ph.D.
Coordinator Biomedical Research
and Grant Office
gabriele.dati@aism.it
+39 010 2713259
National Multiple Sclerosis Society
USA
Douglas S. Landsman, Ph.D.
Senior Director, International Programs
Douglas.Landsman@nmss.org
212.476.0536
UK Multiple Sclerosis Society
Susan Kohlhaas Ph.D.
Emma Gray, Ph.D.
Head of Biomedical Research
research@mssociety.org.uk
+44 (0)20 8438 0700
Multiple Sclerosis International
Federation
Dhia Chandraratna, Ph.D.
Head of Scientific and Medical Research
Dhia@msif.org
+44 (0) 20 7620 1911
Multiple Sclerosis Society of
Canada
Karen Lee, Ph.D.
Vice President, Research
Managing Director, endMS
Research and Training Network
karen.lee@mssociety.ca
416-967-3024
MS Research Australia
Lisa Melton, B.Sc., Ph.D.
Research Development Manager
lmelton@msra.org.au
02 8484 1306 • 1300 356 467
About Progressive MS: Progressive multiple sclerosis, a chronic condition that
disrupts the flow of information within the brain and body, is a form of MS that
gets worse over time. Each day, progressive MS takes things away from people:
vision, mobility, cognition, ability to work, and their very independence. MS is
found in every country where studies have been conducted, and more than 2.3
million people worldwide currently live with the disease; over 1 million people live
with a progressive form of MS.
About the Alliance: The Progressive MS Alliance is an unprecedented
international initiative that is connecting resources and experts around the world
to find answers and develop solutions to end progressive MS. The goal of the
Alliance is to speed the development of new treatments for progressive MS by
funding the best research, wherever it exists. The Progressive MS Alliance is
committed to finding the answers to progressive MS, with a growing number of
member organisations from around the world including MS Societies in the
United States, Canada, Italy, Australia, the United Kingdom, Denmark, Belgium,
The Netherlands, Spain, Germany and the MS International Federation.
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