• Building

    the Evidence

  • Validation of

    novel targets

  • Biomarker

    Selection

  • Disease Insights -

    Origin and MoA

  • Patient Population

    Characteristics

  • Clinical Trial

    Development

  • Clinical Trial

    Designing

• R&D success is based upon rapid and accurate identification of drug targets with true clinical potential. This requires validation tools which mimics and reflects the postulated effects in humans as closely as possible.

 

• In addition, the validation requires a good understanding of the disease and its underlying causes as well the patient population characteristics.

 

• Finally the primary hypothesis needs to be confirmed in clinical trials designed not only to meet regulatory needs for approval but also to provide convincing evidence to demonstrate the added value of your product.

 

• TM Bridges have extensive experience from working with the different components that that ultimately should result in a solid body of evidence to support the Market Access and clinical endorsement of YOUR product.

The chain of evidence.

Translational Medicine is largely about assimilating information from multiple preclinical and clinical sources and provide the best possible prediction of the potential value of an early concept for disease management.

 

This interdisciplinary approach to medicine will encompass advances in for example; bioengineering, chemical genomics, drug discovery, drug delivery, imaging, nanotechnolgy,, biomarkers, toxicology, pharmacokinetics, data mining, cell culture, animal models, human studies and medical informatics.

 

Only 7% of the drugs in preclinical development make it to the market. To identify and clear away failures early by a proper validation process is very cost-effective and limits the risks of hugely expensive failures later on.

  

TM Bridges are experienced in analyzing discovery data and subsequently validate their potential relevance for humans and map out potential clinical development pathways.

Biomarkers could be used as endpoints, as surrogates for natural endpoints or irreversible morbidity, or in evaluating potential drug therapies. TM Bridges will provide insights and support in selecting the optimal biomarker solutions for YOUR project as regards:

 

Prediction and diagnosis

 

• Prediction of toxicology, tolerability and efficacy in humans, based on preclinical data, i.e. decision-making in early discovery

• Diagnosis of disease

• Target responders

• Identification of patients at risk

 

Tailoring the treatment for a disease

 

• Guiding dose selection

• Monitoring of the clinical response to your intervention

• Staging and prognosis of disease

• Differentiating disease diagnosis

A central question which needs to be addressed in drug development is; What added therapeutic value could be expected from a novel drug substance interacting with a certain target?

 

The added value of Translational Medicine experience is obvious when it comes to expertise as regards:

• Disease origin

• Disease progress

• Disease prognosis

• Current treatment regimens

• Unmet medical needs

 

TM Bridges are experienced in linking mode of action data to anticipated pharmacological effects and subsequent clinical values.

The biotechnology revolution, with its new etiological insights, has highlighted the need for a re-classification of many diseases on the molecular level, as well as the need for more therapeutic differentiation.

 

These new insights may result in a disease management paradigm shift from classic blockbuster drugs to personalized medicine solutions tailored to meet the specific needs of a certain individual and/or subgroup of patients.

 

However, novel molecules developed to target certain diseases or pathways more selectively, will increasingly also need to have a biomarker strategy associated with them, becoming an integrated part of the drug development.

 

TM Bridges will provide you with translational medicine insights to address these topics and the potential opportunities for your particular molecule.

A gradual increase in Personalized Medicine therapeutic concepts together with the demand for faster and more cost-effective drug development will irrevocably result in alternative clinical development models, increasingly embracing and implementing adaptive clinical methods.

 

There is clearly a need for more streamlined, systematic development programs based on real-time data consolidation. A scale-up should normally not be necessary until Proof of Concept is available.

 

Translational Medicine insights, reliable biomarkers and carefully prepared experimental medicine studies will all be important elements in creating a strong basis for later stage clinical trials and proactively manage risks.

 

TM Bridges will provide you with guidance on Clinical Development Plans to maximize your chances for Market Access at the Right Price, including endorsement from YOUR stakeholders as regards the added clinical value.

TM Bridges are prepared to assist you in designing clinical trials to better capture the value of your concept for patients, providers and payers. The enablers will include focus on tailored therapies, routine use of advanced analytics and electronic tools and adaptive trial designs.

 

Some of questions which need to be addressed:

 

• What would you like to demonstrate, to whom and for what reason?

• Have the objectives been discussed and agreed YOUR stakeholders?

• Are the suggested claims considered clinically important?

• What alternative study designs could be considered?

• Would it be possible to combine multiple phases in your trial?

• How could the risks associated with your trial be minimized?

• Would it be possible to address cost-effectiveness in the study design?


 

© Translational Medicine Bridges 2010