requests-for-proposal

Innovative Self-Administration for Biopharmaceuticals

Request Number REQ2339341
Due Date April 3, 2017
Author Seh-Rin Sung
Request for Proposal Details
RFP Title
Innovative Self-Administration for Biopharmaceuticals
RFP Description

NineSigma, representing a major medical device manufacturer, is searching for a partner to develop innovative self-administration technology to administer a volume of 5–10 mL of biopharmaceutical at one time (either one shot or bolus).

Background

Recently, biopharmaceuticals are highly anticipated, and devices are required which enable patients to self-administer outside hospitals.

 

As the biopharmaceuticals have high molecular weights, an innovation is necessary for non-oral administration, such as improving permeability. Subcutaneous administration, such as with a needle-free injector, poses a challenge in that it cannot be applied to pharmaceuticals in large doses, owing to its limited volume being administered in several milliliters. Although longer administration time can increase the volume to be administered, it is less convenient.

 

Under such a circumstance, both pharmaceutical start-up companies and universities are extensively investigating subcutaneous administration methods for biopharmaceuticals. Therefore, the client has issued this open request to further accelerate its development in collaboration with potential partners.

 

Technology to concentrate 5–10 mL of drug solution by about five times to reduce the volume of one dose is also welcome.

 

Key Success Criteria

The client has a great deal of knowledge and experience in device application and aims to realize innovative technologies for drug administration, not just an improvement of existing technologies such as microneedles, but by incorporating the proposing organization’s innovative technologies/concepts for long-term development.

 

Details of the required technology

  • Targeted pharmaceutical: Administering biopharmaceuticals (i.e. antibody drugs, protein formulations, SiRNA)
  • Requirements for administration technology:
    • Self-administration excluding oral-administration (i.e. subcutaneous)
    • One dose: 5–10 mL
    • Versatile for any type of pharmaceuticals

 

Requirements for the proposer

  • Their technologies should be at or beyond the concept level, which would ultimately realize the requirements above.

 

Possible Approaches

Anticipated approaches include, but are not limited to, the following:

  • Increase the dose at one time and promote absorption by disintegrating subcutaneous connective tissue
  • Improve subcutaneous permeability with high viscosity
  • Concentrate pharmaceuticals, without degenerating the conformation of or aggregating their drug substances
  • Concentrate pharmaceuticals without increasing their viscosity
  • Combination of existing technologies such as microneedle and iontophoresis, ultrasound, etc.

 

Approaches not of interest

The following approaches are excluded from this request:

  • Oral administration 

 

Preferred Collaboration types
Items to be submitted

Items to be Included in the Proposal

  • Overview of the proposed technology (outline, characteristics, and principle)
  • Uniqueness of the technology
  • Development stage
  • Current performance
    • Type of pharmaceuticals to be administered with the technology
    • Dose administered at one time
    • Image of the device to be developed (if any)
    • Detailed experimental data (Methods and Results, if any)
  • Current issues and development plans
  • Past achievements (additional information indicating R&D capabilities, such as research papers and patents)
  • Organization overview

Anticipated Project Phases or Project Plan

The client will review submitted proposals and possibly ask clarifying questions before selecting the most suitable candidate(s) for collaboration.The client will select the best candidate(s) through evaluations. During the selection process, the client may execute non-disclosure agreement(s) (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 project execution phase.Specifics of any collaboration will be determined through consultation with the concerned parties.

Area of Interest
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