Introduction
Translational Medical Research (TMR) is the integrated application of new, innovative pharmacology tools, clinical technologies, biomarkers, clinical methods and study designs to improve confidence in drug candidates as well as drug targets in the human body during the development process.
It is now recognised that TMR can be used to better understand the potential therapeutic index in humans and enable more cost-effective decisions to be made earlier on in the exploratory phases.
In fact, even before clinical ‘learning’ Phase II trials are initiated, as TMR is able to focus on the early translation phase between discovery and the proof of mechanism/concept (POM/POC) step in humans.
From an Industry viewpoint, integration of these new pharmacology tools has become a major strategy to increase Phase II success.
Fusion’s research services specifically support the new requirements of this drug development strategy as displayed in the figure below.
The inclusion of these new TRM methods often means however, that the design and content of these trials in humans become much more complex than traditional ones.
In these situations, the successful approval of the corresponding trial protocols is highly dependent on a) the clinical experience of the investigator, b) the use of Ethics Committees experienced in experimental medicine concepts, c) the close relationship with the corresponding Regulatory Authorities in order to obtain when necessary efficient advice and review of clinical trial applications.
Fusion is developing close work relationships with each of these organisations in the MENA to enable exciting new possibilities for both research and development..
New Tools and Technologies
Biomarkers related to the drug target and the disease pathway are emerging as the primary method to demonstrate the validity of the drug concept and often changes in multiple biomarkers can be related to a desired pharmacological effect or to unwanted toxicity when exaggerated effects occur.
Multiplex immunoassays and flow cytometry technologies are now used to measure these in addition to the ELISA accepted gold standard.
As an example, as more and more diseases are recognized to involve an immune response, signalling molecules (transmitting information between cells) are being increasingly evaluated in drug development.
Flow cytometry measures cytokines and chemokines produced by a range of immune and inflammatory cells and these are used as surrogate markers of the impact of the drug on the disease pathway.
Fusion research is enabling the integration of these methods into many clinical trial situations.
Skilled Teams
Once a series of biomarkers has been identified and validated these need to be adapted to different conditions (biological matrices, animal species and humans (healthy and patients)).
Then as the complexity of these early clinical investigations increases so too does the requirement for skilled teams of biomarker scientists and clinicians to ensure accurate assessment and rapid decision making when abnormal and/or exaggerated biomarker responses are measured.
Fusion’s management expertise ensures efficient co-ordination of the network of scientific teams located in the centres of excellence across the MENA region.
A whole host of different forms of information directly related to the new technologies are efficiently co-ordinated relating to recruitment, clinical operations, laboratory, data management and biometry and this ultimately ensures the overall quality of the operation and intelligent reporting
Conclusion
So as the Industry develops new targets that are specifically related to the disease pathway and progression, the goals of the early drug development are now clearly to verify that the pharmacology of the drug candidate is respectively safely expressed in animal models, in human and ultimately beneficial to patients.
Aside from the standard pharmacokinetic bio-analytics and biochemical methods for systemic biomarkers traditionally used, new biological technologies are becoming essential and under these conditions, the biomarker data generated is critical for the demonstration of the validity of the drug concept.
Facing this new challenge of the biomarker era, Fusion research team in MENA offers the appropriate technologies in immunology and cell biology as well as strong scientific capabilities to cope with the continuous increase of complex of biological methods being used.
Fusion’s are playing a pivotal role in the chain of discovery/design, developing product to market through thorough testing during preclinical experimentations and clinical trials.
We are extremely active in the region bringing Inventors with proof of concept requirements for technologies together with developers with skills in the physical sciences as well as areas of biology and medicine to advance innovations to the point where they become attractive for others in the pharmaceutical industry.
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