requests-for-proposal

New Drug Candidates for Inflammatory Bowel Diseases

Request Number REQ3363312
Due Date February 14, 2018
Request for Proposal Details
RFP Title
New Drug Candidates for Inflammatory Bowel Diseases
RFP Description

NineSigma, representing a pharmaceutical company specialized in gastrointestinal diseases, seeks new drug candidates for the treatment of inflammatory bowel diseases.

Background

Using the strength of drug discovery and clinical development in the above therapeutic area, the client strives to further strengthen its product lineup and pipeline.

 

To develop drugs that meet unmet medical needs in inflammatory bowel diseases, the client has issued this open request to accelerate clinical application of new drugs in collaboration with external organizations that have developed a potential drug candidate.

 

Key Success Criteria

Requirements for Drug Candidates

The client seeks new drug candidates that meet the following requirements:

  • Target diseases: Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, etc.)
  • Modality: Low molecular compounds, peptides, proteins, nucleic acids
  • Route of administration: Oral administration is preferable
  • Has a new mechanism, which differs from that of existing drugs
    • Drug candidates that promote mucosal healing without having an anti-inflammatory action as a mechanism of action are eligible.
    • Drug candidates with the same mechanism of action as existing injections and enemas that can be orally administered are also eligible.
    • Drug candidates with the same mechanism of action as that of existing drugs that can be clearly differentiated from existing drugs are also eligible.
  • The action on the target molecule has been verified in an in vitro or in vivo study.
    • Preferably, an in vitro study has been conducted to predict clinical pharmacological action.
    • It is preferable that an in vivo study has been conducted to verify the efficacy.
  • Preferably, the selectivity to the target molecule has been evaluated.
  • The safety and toxicity have been evaluated.
  • Development level:The client seeks drug candidates in the following stages, and it is preferable that early transition to a clinical trial is possible.
    • Drug candidates in a non-clinical to phase II study
    • Preferably, a first-in-human study or proof of concept study has been conducted.

 

Approaches not of interest

The following drug candidates are out of the scope:

  • Known substances with poor exclusivity
  • Antibodies
  • Biologics
  • Development candidates whose phase II study has been completed in subjects with the target diseases

 

Anticipated Project Phases or Project Plan

Respondents should submit proposals using the attached Response Template.

The client will review submitted proposals and possibly ask clarifying questions before selecting the most suitable candidates for collaboration. The client will select the best candidate(s) through evaluations. During the selection process, the client may execute non-disclosure agreements (NDA) with selected respondent(s), seek further information disclosure, and discuss specific development targets or potential opportunities.

The client will execute necessary agreement(s) with the selected respondent(s) and move to the advanced development phase. Specifics of any collaboration will be determined through consultation with the concerned parties.

 

Preferred Collaboration types
  • Joint Development
  • Technology Licensing
Items to be submitted

Responses will use the Proposal Template which is linked to the “attachments” shown at the bottom of the link <REQ3363312> and include the following items:

  • Target diseases
  • Overview of the new drug candidates (modality, route of administration, mechanism of action, etc.)
  • Current performance
    • Data obtained from an in vitro or in vivo study
    • Data showing the selectivity to the target molecule
    • Data obtained from safety and toxicity studies
  • Current R&D stage
  • Future development plan
  • Request regarding the form of collaboration
  • Current status of intellectual property related to the proposed technology
  • Research achievements

 

Area of Interest
Request Priority
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