Personalized and Precision Medicine (PPM) through The View of Biodesign-Inspired Transla-tional Research: An Option for Clinical Oncologists, Caregivers and Consumers to Realize the Potential of Genomics-informed Care to secure the Human Biosafety

A new systems approach to diseased states and wellness result in a new branch in the healthcare services, namely, personalized and precision medicine (PPM). Meanwhile, the era of genomics-based medicine and thus genomics biomarkers promises to provide molecular tests that will permit PPM as applicable to personalized & precision oncology (PPO).

To achieve the implementation of PPM-guided oncology concept, it is necessary to create a fundamentally new strategy based upon the subclinical recognition of biopredictors (including genomics ones) of hidden abnormalities (pre-cancer conditions) long before the disease clinically manifests itself.

Every human has a unique genetic makeup that causes them to respond differently to cancer. In this context, the genomic profiling can be done using genomic, transcriptomic, epigenomic or metagenomic information, and will look at the genetic structure of the tumor. This helps us discover “actionable” mutations that can be targeted with therapy. These discoveries can lead to new treatment recommendations that may effectively treat your cancer on a personalized level. Through those analyses, we can not only diagnose and classify cancer patients and/or pre-cancer persons-at-risk based on their comparative risk, but also monitor their response to emerging canonical, preventive or prophylactic therapies. Continued progress using these methods will transform how we approach treatment modalities for cancer patients.

The advent of next generation sequencing (NGS) and GWAS technologies has advanced our understanding of the intrinsic biology of different tumor types. Prospective randomized clinical trials will determine whether matching actionable aberration with targeted therapy will contribute to improve survival in patients with malignancies.

PPM globally holds great promise, especially in cancer therapy and control, where PPO would allow practitioners to use this information to optimize the targeted treatment of a patient. PPO for groups of individuals would also allow for the use of population group specific diagnostic or prognostic cancer biomarkers. The integration of PPM-guided genomics into clinical practice is transforming treatment paradigms. Identification of oncogenes and tumor suppressor genes can become the stimulus for rational design of novel, selective drugs that execute specific activity directed at underlying genetic aberrations. This information can be used to track the progress of cancer, and to establish the molecular basis for drug resistance and allow the targeting of the genes or pathways responsible for drug resistance.

The enormous development of biodesign-driven genomics research has raised great expectations concerning its impact on PPM aiming to customize medical practice with a focus on the individual, based on the use of genetic tests, identification of genomic biomarkers, and development of targeted drugs. In this sense, the impact of precision cancer pathology allows a modular approach, as its various aspects are under development in sometimes unrelated areas of PPM. Integration of the concepts will provide a true challenge for the future, requiring collaboration between clinicians, physiologists, pathologists, biodesigners and bioengineers and remaining a real challenge to bioindustry.

Meanwhile, each decision-maker values the impact of their decision to use PPM and PPO on their own budget and well-being, which may not necessarily be optimal for society as a whole. It would be extremely useful to integrate data harvesting from different databanks for applications such as prediction and personalization of further treatment to thus provide more tailored measures for cancer patients and/or pre-cancer persons-at-risk resulting in improved outcomes, reduced adverse events, and more cost effective use of health care resources. A lack of medical guidelines has been identified by the majority of responders as the predominant barrier for adoption, indicating a need for the development of best practices and guidelines to support the implementation of PPM in clinical practice!

Sergey Suchkov was born in the City of Astrakhan, Russia, in a family of dynasty medical doctors. In 1980, graduated from Astrakhan State Medical University and was awarded with MD. In 1985, Suchkov maintained his PhD as a PhD student of Sechenov University and Institute of Medical En-zymology. In 2001, Suchkov maintained his Doctor Degree at the National Institute of Immunology, Russia. From 1989 through 1995, a Head of the Lab of Clinical Immunology, Helmholtz Eye Re-search Institute in Moscow. From 1995 through 2004 - a Chair of the Dept for Clinical Immunology, Moscow Clinical Research Institute (MONIKI). In 1993-1996. At present, Dr Sergey Suchkov, MD, PhD, is: Vice-Director for Research and Development of the National Center for Human Photosynthesis,    Aguascalientes, México. Member of the New York Academy of Sciences, USA; Russian Academy of Natural Sciences, Russia; American Chemical Society (ACS), USA; American Heart Association (AHA), USA; Euro-pean Association for Medical Education (AMEE), Dundee, UK; EPMA (European Association for Predictive, Preventive and Personalized Medicine), Brussels, EU; ARVO (American Association for Research in Vision and Ophthalmology); ISER (International Society for Eye Research); Personalized Medicine Coalition (PMC), Washington, DC, USA.