TISTA recognizes that there is a widening gap between researchers and information evaluated through various initiatives. One of the main reasons for this is the duplication of data because researchers are either unaware of, or do not have access to, data and information that has already been compiled. This limits the possibilities of sharing intelligence and the benefits from research data convergence, as well as the possible benefits of mining intelligence out of basic research data and clinical research data.
Simply stated, the objective of Translational Research is to fundamentally improve human health and in order to do this, scientific discoveries must be translated into practical applications as quickly and efficiently as possible. Such discoveries typically begin at “the bench” with basic research — in which scientists study diseases at a molecular or cellular level — then progress to the clinical level, or the patient’s “bedside.” Having the ability to share conclusions, data, and information will allow for more broadened views and more complete evaluations of developing and potential therapies. The key to enabling this is to understand the full lifecycle for therapeutic discovery and development, mapping existing tools that are either already developed or being developed to this life cycle, and performing a gap analysis of the essential tools needed to successfully translate bench-side research, to the bedside, and importantly to the public.
There have been various barriers that are growing between clinical and basic research, along with the ever increasing complexities involved in conducting clinical research, that are making it more difficult to translate new knowledge from the bench to the clinic. The Critical Path initiative includes recognition for advancements in technologies that can be utilized in expediting the process by which a new drug or therapy goes from the discovery stage to the delivery stage.
TISTA’s bioinformatics division primarily focuses on modernizing the scientific tools (e.g. in vitro tests, computer models, qualified biomarkers, and innovative study designs) as well as harnessing the potential of bioinformation used to evaluate and predict safety, effectiveness, and manufacturability of potential medical products. To combat the bottleneck of using the older tools and technologies for evaluating the innovative advancement in the bioscience arena and to quickly traverse through the process, TISTA has employed an innovative approach that is focused around process and technologies. It streamlines the process by cutting out unnecessary or redundant steps while improving the accuracy, access and availability of information. TISTA is also using many “critical path tools” including biomarker qualifications, utilizing advanced imaging technology to take quantitative markers of effects and positively influence participant experience during trials.
TISTA believes that by incorporating these critical path initiatives during the development process, the payoff will include having a more predictable process with higher success rate and lower development cost. It will also include availability of more accurate information about product performances resulting in continuous improvement of development science and processes. On an individual patient basis, the payoff will include personalized treatment in form of a more targeted therapy with better results. The ability to stop ineffective therapies faster, avoidance of side effects and injury through prevention, and lastly having better/earlier product availability will all lead to an overall higher quality of care.