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					                  Strategic Translation Awards in
                     Seeding Drug Discovery
                       Preliminary Application

                      Information for Applicants




How to Contact Technology Transfer

Technology Transfer
The Wellcome Trust
215 Euston Road
London NW1 2BE, UK


Tel:        (0)20 7611 8202
Fax:        (0)20 7611 8857
E-mail:     techtransfer@wellcome.ac.uk
                       Information for Applicants

                                Contents

                                                    Page

Important Notice                                     3

Seeding Drug Discovery - Overview                    4

Seeding Drug Discovery - Key Points at a Glance      5

Guidance Notes for Preliminary Applications          6
   Completing the Form
   Explanatory Notes for Specific Questions

How to Submit the Application                        8

Problems?                                            8
                           Important Notice

   This and related documents are designed to inform applicants about the
    Seeding Drug Discovery initiative and are meant for guidance only. They
    should not be relied upon as definitive.

   Applicants will be expected to disclose proprietary information in their
    Preliminary Application, including chemical structures. They should be
    aware that their project applications (and any supplementary
    information provided) will be made available to staff of the Wellcome
    Trust and external advisors for the purposes of peer-review and due
    diligence.

   The Wellcome Trust operates a conflicts of interest policy and places
    obligations of confidentiality on its external advisors (some of whom are
    employed in the industrial or financial sectors). Whilst the Wellcome
    Trust attaches great importance to its policies and procedures
    concerning confidentially and conflicts of interest, it cannot provide any
    warranty to applicants in this regard.

   Because the day-to-day business of the Wellcome Trust involves the
    receipt and review of confidential grant applications, it is only under
    highly exceptional circumstances that it will enter into a confidentiality
    or non-disclosure agreement with applicants.

   Under some circumstances Applicants may receive feedback from the
    Wellcome Trust on their project proposal. This feedback is meant to
    inform and guide applicants but is not meant to be definitive. Applicants
    should seek their own independent advice on feedback and its validity.

 Any invitation to apply for funding from the Wellcome Trust does not
    necessarily mean that such funds will be forthcoming.

   Applicants are responsible for the complete and accurate disclosure of
    any requested information and of the project proposal therein.
                     Seeding Drug Discovery - Overview
The Seeding Drug Discovery scheme provides funding for Applicants to demonstrate
that their innovative biology or chemistry can be therapeutically relevant with the
discovery of suitable drug-like small molecules. The aim is that these will be the
springboard for further research and development by the biotechnology and
pharmaceutical industry in areas of unmet medical need.


            Seeding Drug Discovery - Key Points at a Glance
   Seeding Drug Discovery is a Strategic Translation Award scheme, administered
    by Technology Transfer at the Wellcome Trust.
   The scheme has global eligibility and is open to not-for-profit organisations, such
    as universities as well as privately held or publicly listed companies. Applicants
    from outside the UK should confirm their eligibility with Technology Transfer
    before submitting a Preliminary Application.
   Proposals should have a focus on a specific drug discovery challenge and should
    address an unmet medical need.             Applications for capacity building or
    infrastructure support will not be considered.
   There is no set amount for the size of these awards. This will be determined on
    the basis of the justified costs of yielding a chemical series and intellectual
    property that is attractive to follow-on developers/investors.
   Funding will be milestone based and provided in advance instalments.
   Outsourcing should be used where appropriate and providers or collaborators
    may be based overseas.
   Intellectual property that arises under the award will be owned by the Applicants’
    employing organisation(s). Background intellectual property owned or under the
    control of the employer must be freely available to enable both the project to be
    performed and translation of the arising intellectual property to be realised.
   Applicants who are short-listed for submission of a Full Application will be
    expected to engage with independent drug discovery advisors during the detailed
    planning of the project, and beyond if the project is funded.
   Recipients of an Early Stage Award, which is successfully completed, will be
    eligible to submit a Full Application for a Late Stage Award.
              Guidance Notes for Preliminary Applications
This Preliminary Application form aims to categorise applications into the Early or
Late Stage projects and allow each Application to be assessed in the appropriate
category. The aim is to ensure the best opportunities are funded in each segment
and that the scheme has the greatest possible impact on unmet medical need.


The Trust recognizes that the information necessary to assess a project for Early
Stage (Screen to Lead) funding differs, both in nature and detail, from that needed
for Late Stage (Lead to Clinical) funding. An Early Stage project should aim to
deliver a Lead chemical series and assay cascade that both validates the target
mechanism and acts as the input to the Late Stage (Lead to Clinical) funding area. It
is expected that Late Stage projects will build on these solid foundations to deliver
patentable, drug-like preclinical candidates, with optimised and favourable
pharmacological, physicochemical, toxicological and metabolic characteristics.


Completing the Form

      Applications must be completed in a typeface of adequate size and must be
       no smaller than 11 point Arial font.

      Answers are to be restricted to the text boxes provided; the text boxes will
       extend automatically as you type. Any word limits must be adhered to.

      Abbreviations should not be used unless fully explained.

      The Application must be complete in itself; no additional pages will be
       accepted unless specific instruction is given. Applications which do not
       conform to this and/or are not suitable for reproduction will be returned.

       Incorrectly completed forms may lead to a delay in consideration.
       Applications which cannot be read easily will be returned to the applicant for
       resubmission.



Explanatory Notes for Specific Questions

Question 2: The identity and/or nature of the target (if known) and the disease
indication should be included in the project title.

Question 3: Unmet medical need is a key driver for The Wellcome Trust. Applicants
are asked to give a brief but precise description of the impact the project could have
for patients in a particular disease population. How this will translate to an
improvement over the current or predicted future standard of care should also be
addressed.

Question 4: This question aims to summarise the key points that are expanded in the
answers to later questions. They are intended to highlight the areas where the two
elements of the Seeding Drug Discovery (SDD) funding overlap and also relate to
the Wellcome Trust definitions of a Hit and a Lead

Question 5: Given the answers to Question 4, it is anticipated that the choice of
which part of the scheme to apply to will be evident allowing the rest of this
Preliminary Application to be completed appropriately. However there may be
innovative projects which, the Applicant feels, are beyond the Lead identification
stage but have not generated the expected range of data outlined in Question 4. In
this situation, Applicants may choose which part of the scheme they wish to apply to,
but are expected to justify why their project is atypical.

Question 6: This question is looking for a detailed description of the unmet medical
need, the patients who will benefit and how the project can deliver these benefits.

For Late Stage projects the additional questions probe the clinical environment that
the project will be entering and the complexity of the clinical plan required.

Question 7: Applicants are asked to show the evidence that modulating the biological
target, in vitro or in vivo, will provide a robust selection process to obtain a small
molecule that can achieve the desired effects in man. Assay development is
expected to continue as the project progresses but the ability of the screening
cascade to match the compound synthesis will have an important bearing on the
project plan.

For Late Stage projects, potential partners will be interested in the development risks
inherent to the target and possible off-target risks due to the type of mechanism or
compound class involved. The additional part of this question allows Applicants to
show they have considered these aspects.

Question 8: Seeding Drug Discovery Awards are made to fund the translation of new
targets or new chemistry to a point where the project is attractive to further funding,
either by the Wellcome Trust or others. The chemical matter, and its
characterisation, is crucial to a thorough assessment of the opportunity by the Trust
and its expert advisors. Chemical structures, if available, must be provided unless
agreed otherwise in advance with the Wellcome Trust. Failure to do so will result in
the Application not being considered.

For all projects, evidence that activity in the assays is due to interaction with the
specific target, rather than acting by some less specific mechanism, is sought. This
question aims to generate a table of basic information for the hit series being studied
or for the more advanced members of a single compound series. The question
allows the applicant to show the strengths of the compounds and to highlight what
further optimisation will address. A Late Stage project should show what drug
candidate profile will be used to select compounds for preclinical development.

The additional parts to the question are for Late Stage projects to show the
confidence that the project can be evaluated in vivo for activity and safety and can
be optimized to give a clinical candidate suitable for an experiment in man. For
projects that propose a new approach to treat certain patients, the degree of
differentiation to existing therapies is key, as it will determine the opportunity for
reimbursement.

Question 9: This question is for Late Stage applicants to outline the clinical trials that
the optimized candidate molecule is expected to complete. Given the degree of
investment required to fund studies in man, a clear path to well conceived
experiments in man is a definite advantage.

Question 10: The project work plan should include at least two Milestones or Go/No
Go decision points.

Question 11: An estimated budget should be provided at this time with an indication
of costs allocated to salaries, out-sourced services and any other categories of major
expenditure. Details of eligible and non-eligible costs are available on the Wellcome
Trust website.

http://www.wellcome.ac.uk/Funding/Biomedical-science/Application-information/WTD004084.htm

http://www.wellcome.ac.uk/Funding/Biomedical-science/Application-information/WTD004090.htm

The question regarding previous Wellcome Trust funding is for tracking purposes
only and there is no bias or selection of a Preliminary Application based on this
information.

Question 12: It is not necessary for an Application to have existing Intellectual
Property in order to be considered for Seeding Drug Discovery Award. However,
some indication of whether or not there is freedom to operate will strengthen the
Application.
How to Submit the Application

    Completed Preliminary Application Forms should be sent by the closing date to
     techtransfer@wellcome.ac.uk.

Problems

    If you have a general question about the application procedure, please call
     +44 (0)20 7611 8202, or e-mail: techtransfer@wellcome.ac.uk who will direct
     your enquiry.

    If you are experiencing technical difficulties with the form please email
     techtransfer@wellcome.ac.uk

				
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posted:10/8/2012
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