Sergey Suchkov

Abstract

Biodesigners, biotechnologists and biomanufacturers are beginning to realize the promise of PPM, translating to direct benefit to patients or persons-at-risk. For instance, companion diag-nostics tools and targeted therapies and biomarkers represent important stakes for Bio-Pharma, in terms of market access, of return on investment and of image among the prescrib-ers. 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. The areas where companies are most likely to encounter challenges, are data analysis and workforce expertise, biomarker and diagnostic test development, and cul-tural awareness. Navigating those complexities and ever-evolving technologies will pass regu-latory muster and provide sufficient data for a successful launch of PPM, is a huge task. So, partnering and forming strategic alliances between researchers, biodesigners, clinicians, busi-ness, 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 transformation, and it is imperative to leverage new technologies to support the advent of Personalized and Precision Medicine (PPM). Both PPM, nanobi-otechnologies, precision biocatalysts and engineering biology are new to medical practice, which are being integrated into diagnostic and therapeutic tools to manage an array of medi-cal conditions. Novel nanomedicines, biocatalysts and design-driven biomolecules have been employed in the treatment of several diseases, which can be adapted to each patient-specific case according to their genetic profiles.

For instance, clinical application of nanotheranostics would enable subclinical detection and preventive treatment of diseases.

Abzymes can fully prevent the emergence of autoimmune disorders, especially in the field of infection and immunity, where the process of its occurrence and development often takes a long time. Novel monoclonal abzyme-based therapeutics are set to revolutionize existing drug therapies targeting a wide spectrum of diseases, thereby meeting several unmet medical needs. The unique properties of abzymes make them an attractive tool in nanotechnology. They can be designed to catalyze specific reactions, allowing for the synthesis of complex mol-ecules and nanoparticles with high precision and efficiency. Moreover, abzymes can be engi-neered to operate under mild conditions, making them suitable for applications in biomedical nanotechnology.

In this context, a special class of catalytic monoclonal Abs are an emerging class of therapeu-tics that combine two powerful modalities: the high specificity of Abs for targeting distinct cell surface antigens and the protein targeted proteolytic capabilities. this bipartite design facili-tates a catalytic mode of action where a single molecule of the antibody conjugate can trigger the elimination of target proteins that may be otherwise "undruggable" with conventional small molecules or antibodies alone. The above-mentioned antibodies are being developed as a novel class of therapeutics that integrate the precision targeting capabilities of antibodies with the catalytic efficacy of protein degraders. As evidenced by both academic studies and industry partnerships documented in seminal patents and clinical reports, the field has seen rapid innovation and is transitioning from concept to clinic. The convergence of antibody en-gineering, targeted protein degradation, and advanced nanobiomaterial chemistry promises not only improved outcomes for patients but also a broader application across various disease modalities.

PPM has thus become an interdisciplinary challenge where nanotechnology-enabled theranostic approaches may indeed become a key driver in harmonizing the needs of the various stakeholders by allowing cost-effective delivery and monitoring of drug efficiency and safety, and close-meshed high-quality data collection.

With the support of nanotechnology and biocatalysis-driven engineering, the solubility, ab-sorption and targeting of traditional drugs were greatly improved by modifying and fabricat-ing with various types of nanoparticles to some extent, though many shortages remain. For in-stance, candidate proteins associated with disease development and progression might provide novel targets for new targeted therapeutic agents and biomaterials, or aid the devel-opment of assays for disease biomarkers and identification of potential biomarker-target-lig-and (drug) tandems to be used for the targeting. Latest technological developments facilitate proteins to be more thoroughly screened and examined in the context of drug discovery and development.