Sergey Suchkov
A new systems approach to subclinical and/or clinical states of the disease and wellness being personalized resulted in a new trend in the healthcare services, personalized and precision medicine (PPM). To achieve the implementation of PPM concept, it is necessary to create a fundamentally new strategy based upon the biomarkers and targets to have a unique impact for the daily Practice, Biopharma and Biotech. In this sense, despite breakthroughs in research the translation of discoveries into therapies for patients has not kept pace with medical need.
Translational researchers, bio-designers and manufacturers are beginning to realize the promise of PPM, translating to direct benefit to clinical practice. For instance, companion diagnostics tools, theranosticums, molecular imaging and targeted therapies represent important stakes for the Biopharma in terms of market access, of return on investment and of image among the prescribers. So, developing the next-generation medicines and diagnostic tools requires changes to traditional clinical trial designs, that result in new types of data. Making the best use of those innovations and being ready to demonstrate results for regulatory bodies requires specialized knowledge that many clinical development teams don’t have. Navigating those complexities and ever-evolving technologies will pass regulatory muster and provide sufficient data for a successful launch of PPM, is a huge task. So, partnering and forming strategic alliances between researchers, bio-designers, clinicians, business, regulatory bodies and government can help ensure an optimal development program that leverages the Academia and industry experience and FDA’s new and evolving toolkit to speed our way to getting new tools into the innovative markets.
Healthcare is undergoing a global transformation. This is the reason for developing global projects in the area of PPM and TraMed to elicit the content of the new trend. The latter would provide a unique platform for collaboration among thought leaders and stakeholders with an interest in improving the system of healthcare delivery on one hand and drug discovery, development, and translation, on the other one, whilst educating the policy community about issues where biomedical science and policy intersect.
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