Frequently Asked Questions
1. The application format is different from what I am used to (i.e. the US NMSS). Please advise on what format to follow?
The PMSA is an international alliance among several countries and there may be differences between the Alliance’s practices and local country practices. Please use the format that is described in the RFA for the PMSA.
2. Is there an issue with having a sub PI in another country?
No, in fact, the Alliance encourages and welcomes collaboration with investigators in different institutions and countries.
3. How will currencies be worked out?
The Alliance currency is Euros. However, in making the awards, the Alliance will aim to make best use of resources and take advantage of exchange rates to pay its awardees (precise details still being worked out).
4. How many Challenge awards and how many Infrastructure awards – is there a defined number of each that will be awarded?
We have the opportunity to fund up to a maximum of 15 awards, between Challenge and Infrastructure awards. There is no pre-set breakdown and will be based on merit of the awards received.
5. While encouraging that this first RFA includes provision for work on clinical outcome measures, is it feasible to expect that this type of work can be completed in such a short time frame (1 year)?
The Alliance anticipates that the current RFA could allow for a clinical feasibility study to advance a clinical outcome measure or a database study.
6. What is the format for the Collaborative awards that were mentioned as the second RFA that will issue in 2014?
The next set of awards is focused specifically on multi center, multi country, Collaborative awards. Awards will be designed in 2 phases – phase 1 is a planning/feasibility of 6-12 months; phase 1 awardees will compete for a phase 2 award which is a multi-year award with significantly more resources. More details will follow next year.
7. Please provide additional examples of what an Infrastructure award is? Is it statistical support for Challenge Awards? Or common data elements?
The Alliance would like to support a research effort that is aimed at building new infrastructure to enable acceleration of new treatments for progressive MS – such as new tools and new data bases that are in alignment with the goals of the PMSA. Emphasis will be on new, different, innovative projects, rather than supplementary funding for an ongoing effort.
8. Is there an opportunity for follow on funding after the Challenge or Infrastructure award is complete?
There is no program for specific follow on funding, but the Alliance anticipates that any awardee might be able to build a Collaborative award proposal from the initial work conducted under a Challenge or Infrastructure award.
9. Recognizing that communication is key for successful collaboration, will the Challenge and Infrastructure awards support costs for in person meetings or telecons/Webex meetings?
The Alliance believes that this would be a legitimate and appropriate expense, if the meeting is important for delivering the goals of the project. Specifically excluded are costs to send investigators to a meeting/conference to present data.
10. What is the fate of the data sets/databases that might be created under an Infrastructure award?
The Alliance is currently establishing a set of data sharing, publication and IP policies, which will be issued prior to the awards being made. It is likely that such policies will include a general statement and encouragement for data sharing.
11. Is a proof of concept study in animals within the remit of the Challenge awards?
The Alliance anticipates that studying a new disease modifying treatment in animals would be eligible, particularly if focused on potential for progressive MS, such as studying remyelination and/or axon repair.
12. Can an Infrastructure award be used to establish a clinical trial network?
The Alliance does not anticipate providing bridge or supplemental funds to complete setting up a network, but will consider proposals that are to create/start a network, and to do work that wouldn’t happen otherwise.
13. Must a Challenge award have a collaborative aspect or can awards be given to a single team? Either model is acceptable.
14. Are the Challenge awards leading to the Collaborative awards?
No, these 2 awards are separate. Investigators can apply for either one or both.
15. Could an Infrastructure award be an imaging platform to monitor and/or study pathophysiology?
Yes, new technology or a new data base to support new imaging technology could be considered. Emphasis must be on innovation and not on supplementing an ongoing collaboration.
16. Is a scientific summary or Lay summary a required part of the application?
Yes, the application includes a section to complete a brief scientific summary and a lay summary that is written so that the general public can understand the proposal.
17. The Challenge Awards ask for innovation & novelty – It is often the case that when we go towards innovative and novel research, then the risk involved is higher. What is the risk tolerance of the Alliance?
It is recognized by the Alliance that this type of request often means that the chance of success is likely to be lower. However, the Alliance is committed to seeking the best proposals and finding innovative ways to solve the difficult challenge of progressive MS. Thus, in general, the Alliance will have a fairly high risk tolerance for this RFA.
18. MS is not my biggest specialty and I am a relative newcomer to this field. In terms of collaborative grants (mentioned in the presentation), it can be challenging for us to have networks in place to develop a collaborative project. Will the Alliance provide any assistance to researchers, to enable them to find partners to form collaborative networks?
It is recommended that individual researchers contact their local program officer(s) or other international program officers or the Alliance and establish a relationship with them. The Alliance intends to be helpful and supportive in establishing linkages and making connections to facilitate collaboration.
19. How large a consortium will be required for the Collaborative Awards and will biotech companies be eligible?
There is no preset size for a consortium, although larger consortiums may be considered to have a larger potential impact. Precise details of eligibility are still being worked out, but we anticipate that commercial organizations will be eligible. More details will follow in 2014.
20. Will the scientific merit and relevance/alignment scores be equally weighted?
There isn’t a weighting applied per se. Merit will be scored by the review panels. Proposals that don’t have the necessary relevance/alignment are likely to be weeded out at pre-application stage, since this will be an entry criteria that must be achieved before a full application will be allowed. Relevance/alignment will be taken into account by the PMSA Scientific Steering Committee in its deliberations of what to fund, following recommendations from the review panels.
21. Does each section of the scientific review criteria need to be called out specifically in the application?
No, this is not necessary. Applicants need to bear these things in mind, but it is not suggested to use the sections as a way to structure the narrative.
22. Does an application need to include all forms of progressive MS, or can an application focus on one type or another? (is an application focused on only one type of progressive MS likely to be viewed less favorably?)
There is no requirement to include all forms of progressive MS in any application and this is not likely to be less favorably viewed.
23. How will scientific merit be considered for the Infrastructure Awards? What are the review/evaluation criteria?
The Alliance reviewers will use similar criteria as for Challenge Awards. Most important criteria are likely to be:
· Significance of the application to progressive MS
· Innovation and focus on progressive MS
· Use of best and state of the art technologies
· Investigator capability and track record in the field of work proposed
24. Should Infrastructure Awards focus solely on infrastructure building or is it desirable to have a proof of principle aim as well (i.e. small test on a small group of patients to demonstrate that an analytic tool or database is “fit for purpose”)?
It is not a requirement to have a proof of principle aim, but it would certainly be helpful to have a plan to demonstrate functionality using real data from progressive MS.
25. I am from a commercial organization - what is the extent of the cross-sector collaboration that I must achieve to satisfy the requirement in the RFA? Must I have an academic Co-PI? What % effort is required?
The Alliance has not set specific criteria for this. As a general guide, any type of collaboration is acceptable; an academic Co-PI is not required. As a rough guide, ~20% effort or greater would be a reasonable level for collaboration.
26. I am collecting data from a set of patients with progressive MS for analysis, using a variety of international centers. Would this be a candidate for the Challenge Awards or Infrastructure Awards, or both?
While the Alliance cannot be definitive in the absence of a specific proposal, it is likely that this could be a candidate for both, depending on the emphasis of the area of study – e.g. is it primarily a pathophysiologic mechanism analysis or primarily a data sharing effort. Applicants with this type of proposal should consider discussing the project with their local program officer.
27. Can the same Principal Investigator apply to both Challenge awards and Infrastructure awards?
There are no current Alliance polices that would prevent a PI from submitting more than one application. However, it is unlikely that the scientific steering committee (2nd level of review) would chose to fund more than one grant per PI. Therefore, the Alliance would discourage multiple submissions from the same PI.
For additional information and questions: please contact any of the staff members of the PMSA
CONTACT INFORMATION:
ITALIAN MS SOCIETYName: Paola Zaratin, Ph.D.
Title: Director of Scientific research
Email:
Tel: +39 010 271 3410 / MS SOCIETY OF CANADA
Name: Karen Lee, Ph.D.
Title: Vice President, Research & Managing Director, endMS Research and Training Network
Email:
Tel: 416-967-3024
NATIONAL MULTIPLE SCLEROSIS SOCIETY
Name: Bruce Bebo, Ph.D.
Title: Associate VP, Discovery research
Email:
Tel: 212.476.0477 / UK MS SOCIETY
Name: Dr. Susan Kolhaas
Title: Head of Biomedical research
Email:
Tel: +44 (0)20 8438 0700
MULTIPLE SCLEROSIS INTERNATIONAL FEDERATION
Name: Dr. Dhia Chandraratna
Title: Head of Scientific and Medical research
Email:
Tel: +44 (0) 20 7620 1911