The diagnosis, prevention and treatment of orphan and neglected diseases present an unmet medical need. To address the obstacles of product development research in these areas, the Wellcome Trust is seeking to fund pilot studies to develop assets and de-risk future development.
The Pathfinder Award Scheme is intended to kick-start pilot projects that have significant potential to help develop innovative new products in these disease areas whilst stimulating academic/commercial partnership/collaboration. In the scheme, an academic lead (or a lead from a not-for-profit entity) will build on or establish a partnership/collaboration with a company that has specialist knowledge and access to technologies to facilitate the development of a specific product.
Projects covering any aspect of product development for neglected and orphan diseases could be considered provided the company partner provides a matching funding contribution. Typically, an eligible partnership/collaboration would be with an established company who can provide evidence that it has previously developed and subsequently taken a product to market.
However, by invitation only, the scheme could consider the following partnerships/collaborations provided that they operate under the vision for the scheme:
a) a small or medium-sized enterprise (SME) working with an academic partner
b) a not-for-profit entity working with an academic partner.
At the end of the Pathfinder Award, the innovation should be a credible asset ready to be developed further by the company and/or be competitive for another Innovations awards scheme, through which substantial resources may be sought.
Priorities for the Pathfinder Award scheme are:
- encouraging effective partnership between a public sector applicant (academic or not-for-profit entity) and a company partner
- building credible assets by funding quality pilot studies
- stimulating product development in difficult diseases, which could ultimately improve the outlook for patients afflicted by orphan and neglected diseases
- encouraging the development of paediatric products
- sharing knowledge and experience to de-risk early-stage projects.
The partnership/collaboration between the academic partner and the commercial partner must be a “real” partnership/collaboration and not merely a fee for service or CRO relationship.
In the context of this scheme:
- neglected diseases are those listed in the Global Funding of Innovation for Neglected Diseases (G-FINDER) report and website
- orphan indications are those listed by the NIH Office of Rare Diseases Research.
- Useful advice for European orphan designation can be accessed on the EuropeanMedicines Agency website.
Pathfinder Awards are intended to facilitate requests that would be normally be considered too early for funding under the Wellcome Trust’s other translational funding schemes. They might be used to support the clinical development of any products, including drugs, biologics, medical devices, enabling technologies and vaccines. The focus of the scheme this time is on orphan and neglected diseases and where no current therapy exists or where the proposed product will be superior to the existing options.
The project duration will be a maximum of 18 months from the agreed commencement date.
The Wellcome Trust contribution to the partnership will be capped at £100 000. Evidence of a matching funding contribution from the company partner will be expected.
In most cases:
- awards will be made directly to the company (industry lead)
- awards will cover the costs relating directly to the programme proposed
- requests to cover subsistence for a lead academic applicant spending time at a company and/or a postdoctoral salary for carrying out work at a company will be considered
- equipment, building or refurbishment expenditure will not be eligible
- working capital costs incurred by the company will not be eligible.
If you hold a tenured academic university post, you cannot re-charge your salary (in full or in part) to a Pathfinder Award.
If the company partner is an SME or a not for profit entity applications will be considered on a case by case basis by invitation only.Please contact email@example.com(reference “PATHFINDERS”) with details of the proposed project that the collaboration is seeking funding for; details on the proposed partnershipdescribing what both parties will be bringing to the proposed programme to support the research through to a credible exit. Lastly, how will the company partner be able to provide the required match funding contribution to the partnership as required.
1. Projects must address an unmet need in a neglected or orphan disease. The proposed project should aim to build credible assets that would be competitive to attract further investment by the company or funding schemes provided by Innovations.
2. The concept to be tested must be at a stage where an application for a full award through Innovations' current funding schemes is unlikely to succeed because it is too early; however, it must not be so early that at the end of the pilot work it would still be premature to compete for full funding under such schemes.
3. There should be a strong project focus (not a pipeline or undefined future scope of work).
4. The scheme will not support:
- target validation
- ‘blue skies’ or curiosity-driven research
- late-stage programmes already developed to a point where funding from commercial or venture sources could readily be sought to complete the pathway to market.
1. Applications should establish or build on a partnership between a public sector applicant (from either an academic or a not-for-profit entity) and an industry (company) partner.
2. Partnerships need to demonstrate they have the means to support the research through to a credible exit (i.e. to an exit that ensures a public benefit can be realised by a downstream development partner, whether that is the company itself or a third party). Evidence that the company has previously developed and subsequently taken to market one or more product lines arising from its own research and development is desired but not essential.
3. An SME working with an academic partner or a not-for-profit entity working with an academic partner can be considered on a case by case basis by invitation only, providing the proposed partnership is operating under the vision for the scheme.
4. The Wellcome Trust contribution to the partnership will be capped at £100 000 with a minimum matching funding contribution from the company (in cash and/or in kind).
5. The company will normally be the recipient of these funds.
6. There are no geographical restrictions. Applications are welcome from appropriate public sector-company partnerships in a global setting.
The partners must enter into a suitable collaboration agreement including provisions detailing: ownership of Trust-funded IP, necessary licences in respect of background IP, confidentiality, publication and arrangements for the protection, maintenance, exploitation and commercialisation of Trust-funded IP.Lambert templates can be used as a guide if necessary see http://www.ipo.gov.uk/whyuse/research/lambert/lambert-mc.htm
7. The lead applicants should normally hold a position of responsibility within the eligible organisations and must be able to agree and comply with the conditions governing the Pathfinder Award scheme.
8. Postdoctoral research assistants - whether seeking their own salary as part of the Pathfinder Award, funded by the Wellcome Trust on another grant or funded by another agency - are eligible for coapplicant status if they make a significant contribution to a research proposal and have agreement from their funding agency.
9. If there are any restrictions on intellectual property or publications relating to background IP or arising from the proposed research, you must provide a written statement that details them.
There is no preliminary application phase.
Applicants should contact the office to confirm that the proposed partnership/collaboration is eligible before submitting a full application form.
Please note that in addition to established companies, SMEs and/or not-for-profit entities working with an academic partner can be considered at our discretion on an invitation only basis.
Applicants should submit a full application by email (see the Forms and guidance tab) before the next deadline 7 July 2014
Full applications will be considered by a dedicated internal Pathfinders Assessment Group and independent external experts. There will be four rolling deadlines in a 12-month period, subject to available budget in the current financial year.
Pathfinder Grants are governed by the terms and conditions of the Trust’s Grant Conditions (except as set out below), an ward letter, and the Policies and Positions for Trust Grants ( www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/index.htm).
The Trust has waived the application of the Trust Grant Condition 7(ii) to Pathfinder Awards. Grantees of Pathfinder Awards DO NOT HAVE TO:
(i) seek prior written consent from the Trust to any commercial use of, or grant to any third party of any exploitation rights over Trust-funded IP; and/or
(ii)share with the Trust any benefits arising from the exploitation/commercialisation of Trust-funded IP;
Email firstname.lastname@example.org (Reference PATHFINDERS)
The next deadline for Pathfinder Award applications is 7 July 2014
Applications submitted by this date will normally be notified of the outcome in September 2014.
There will be four rolling deadlines in a 12-month period, subject to available budget in the current financial year.
For informal enquires or to confirm the eligibility of a proposed partnership, please contact Innovations and quote PATHFINDERS in connection with your enquiry.
The Wellcome Trust
215 Euston Road. London NW1 2BE
T +44 (0)20 7611 5757
F +44 (0)20 7611 8857