Title : Personalized and Precision Medicine (PPM) as a unique healthcare model via bi-odesign, bio- and chemical engineering, translational applications, and upgraded business modeling to secure the human healthcare and biosafety
Abstract:
Traditionally a disease has been defined by its clinical presentation and observable characteristics, not by the underlying molecular mechanisms, pathways and systems biology-related processes specific to a particular patient (ignoring persons-at-risk). A new systems approach to subclinical and/or diseased states and wellness resulted in a new trend in the healthcare services, namely, personalized and precision medicine (PPM).
Translational researchers, bio-designers and bioengineers, bio-manufacturers and bio-market experts are beginning to realize the promise of PPM, translating to direct benefit to patients or persons-at-risk. And across worldwide basic, translational, clinical and applied research, and throughout the bio-industries, scientific breakthroughs have been the launching point for principal bioproduct developments in the translational trajectory. For instance, companion diagnostics tools, theranosticums and targeted therapies and biomarkers represent important stakes for the pharma, in terms of market access, of return on investment and of image among the prescribers. At the same time, they probably represent only the generation of products resulting translational research and applications. So, developing medicines and predictive diagnostic tools requires changes to traditional clinical trial designs, as well as the use of innovative (adaptive) testing procedures that result in new types of data.
Nanobio’ applications are as diverse as sustainable energy, regenerative medicine, biomedical imaging, drug and vaccine delivery, and personalised medicine. The impact of these new technologies will be felt across a wide range of endeavours, from therapeutic and tissue regeneration products, to bioderived consumer products and environmental applications. Of particular interest is nanotechnology research at the biointerface, including nanoparticles developed to detect pre-early cancer biomarkers; ‘smart surfaces’ mimicking conditions in the body and encouraging high rates of stem cell production; and the engineering of cells to produce the building blocks for plastics.
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. The areas where companies are most likely to encounter challenges, are data analysis and workforce expertise, biomarker and diagnostic test development, and cultural awareness. 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.
The global biotechnology market integrating Biodesign, Bioengineering and Biomanufacturing, is driven by government initiatives owing to the growth of the design-based biotechnology sector. Government initiatives are oriented towards modernizing the drug regulatory pathway, standardizing clinical studies, improving reimbursement policies, and speeding up the product approval process, thereby offering lucrative growth opportunities to the market.
In this sense, the new-age business ventures are more idea-centric and not just product-based. The key to success in business is not just inheritance; it is creation of more wealth and the constant innovation, from the prevailing to the next best practices. An entrepreneur, typically, is inspired to start a business because the entrepreneur perceives a consumer need that is not being adequately filled.
Meanwhile. The Bio-entrepreneurship can be described as a process of action an entrepreneur undertakes to establish his Biodesign- and Bio-industry-related enterprise being based on a set of the transdisciplinary principles to have the final bioproduct developed and succeeded. The bioentrepreneur is often a scientist/researcher-turned-entrepreneur who wishes to see their research successes put into practice through commercialization.
Even the most innovative healthcare (including nanobio-) technologies being translated in the right direction, would provide patient benefits only when adopted by clinicians and/or patients in actual practice. So, co-development between innovation-related builders and customers is a key agile principle. And in the coming wave of innovation in the broad-scope applications, learning rapidly what new bioproduct features work well for clinicians and patients will become even more crucial.
