• Project


  • Target Product


  • Therapeutic Gaps

    and Competition

  • Predict Treatment


  • Early Risk


  • Project









Accurate Project Assessments require cross-functional involvement and the integration of multiple sources of information optimally converging into a seamless picture of the risks and opportunities as well as the resources needed to finally demonstrate an added clinical value of a future product


Translational Medicine Insights are crucial in getting YOUR Target Product Profile right from the very start and link it to YOUR Market Access Strategy.


• What are your own up-front expectations on the future product?

• What would be the clinical and competitive edge(s)?

• What obstacles and challenges could be identified already from start?

• What resources will be required to get you to your targeted profile?


TM Bridges have the expertise to identify particular challenges as regards:


• The therapeutic concept and potential risks

• Preclinical feasibility and technical risks

• Intellectual Property

• Clinical feasibility

• Unmet medical needs

• Competition

To translate YOUR research into clinical use requires a thorough understanding of current clinical practice and unmet needs - as well as of the competitor environment. TM Bridges will provide these elements.


To get the picture right, an informed and constructive dialogue with the right stakeholders is of vital importance. TM Bridges is prepared to assist you in gaining the necessary insights and better understand:


• The perceived added value of your product in the light of current treatment practices and therapeutic alternatives?

• What other treatment regimens are currently in development?

• If your own concept is met by skepticism or hesitance what would it take for your stakeholders to change their mind?

Translational Medicine is essential in predicting treatment responses and avoiding costly, potentially disastrous mistakes throughout the R&D process.


TM Bridges understand the pathogenesis of diseases and different patient population characteristics and how these can be modeled.


TM Bridges have the expertise to analyze discovery and toxicology data and predict the potential clinical value and risks linked to a novel target or pathway in the management of human disease.


TM Bridges have the experience to suggest the safest possible pathways through clinical development to product approval.


TM Bridges expertise also includes advice on execution of late preclinical and early clinical experimental studies to facilitate the transition to full clinical development, including choice of technologies and appropriate biomarkers.

Drug development is largely about managing risks against benefits. The risks will span over a broad range of areas with patient safety as the No 1 priority.


A thorough risk analysis needs to include not only obvious risks but also

less likely ones. Usually it is possible to eliminate many risks by proactive planning - but it is practically impossible to avoid all of them. Some risks simply need to be managed, limited to a minimum and followed closely.


Some of the key questions which need to be addressed from start:


• What potential patient safety risks could be identified?

• What risks would be a showstopper for the project?

• What measures could be taken to eliminate, or limit, your risks?


Has a Risk Management Plan been outlined?

If not, TM Bridges are prepared to help you complete YOUR plan.

Successful Research & Development is only possible with a strong flow of innovative ideas, while resources rarely are unlimited. Thus, there is a need for prioritization based on a systematic evaluation and the final objectives.


TM Bridges will provide you with tools for decision-making within YOUR projects as well as between YOUR projects. Our tools are logic, easy too understand and will facilitate transparency within your company.


The model used by TM Bridges will include experience from all involved functions and is intended as an integrated part of the Market Access Plan.


© Translational Medicine Bridges 2010