Natural Matrix Assessment for Physiological Mode of Action
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Solution Overview
Problem
Existing methods fail to assess the therapeutic or beneficial effects of natural matrices through a physiological mode of action, which are crucial for regulatory compliance and holistic therapeutic approaches, as conventional pharmacological methods are inadequate for understanding network interactions within these complex systems.
Innovation Solution
A method involving cell-based assays to evaluate the regulation of biological activity networks and functional resilience across different batches of natural matrix products, determining if they modify a pathological or altered physiological state rather than individual functions, using systems theory and omics sciences for validation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional pharmacological methods are used to assess therapeutic products, then individual molecular targets and mechanisms can be identified, but the network interactions and holistic therapeutic effects of natural matrices cannot be evaluated
Solution Approach 1:
The patent segments the assessment into two complementary approaches: (1) identification of individual molecular targets and mechanisms using conventional pharmacological methods, and (2) evaluation of network interactions and holistic effects using systems biology and omics sciences. This segmentation allows both reductionist and holistic perspectives to coexist and inform each other in the comprehensive assessment of natural matrix therapeutic products.
Solution Approach 2:
The patent employs a composite assessment methodology that integrates multiple scientific disciplines including pharmacology, systems biology, genomics, transcriptomics, proteomics, and metabolomics. This composite approach combines the strengths of molecular-level analysis with network-level evaluation, enabling simultaneous assessment of individual targets and holistic therapeutic effects of natural matrices.
2Reliability
If natural matrices with variable composition are used, then functional resilience and holistic therapeutic effects are maintained, but batch-to-batch variability in composition makes conventional quality control inadequate
Solution Approach 1:
The patent applies dynamic assessment strategies that monitor multiple biological activities and pathways simultaneously across different batches. Rather than requiring static compositional uniformity, the methodology dynamically evaluates functional outcomes through omics-based profiling, allowing natural variation in composition while ensuring consistent therapeutic effect through network-level functional assessment.
Solution Approach 2:
The patent implements feedback mechanisms where omics-based data from batch testing informs quality control decisions. By measuring network-level biological responses and comparing them against reference profiles, the system provides feedback on functional consistency, enabling acceptance or rejection of batches based on functional resilience rather than rigid compositional specifications.
3Reliability
If regulatory compliance requires demonstration of physiological mode of action, then holistic therapeutic protocols can be validated, but conventional pharmacological assessment methods are insufficient
Solution Approach 1:
The patent develops a universal assessment framework using omics sciences that can evaluate multiple aspects of physiological mode of action simultaneously. This multi-functional methodology can assess gene expression changes, protein modifications, metabolic pathway alterations, and network interactions in a single integrated approach, making it suitable for regulatory compliance demonstration across different natural matrix products.
Solution Approach 2:
The patent introduces omics-based biomarkers and network-level metrics as intermediaries that bridge the gap between complex natural matrix compositions and regulatory assessment requirements. These intermediaries translate holistic therapeutic effects into measurable, standardized parameters that can be used for regulatory compliance demonstration while preserving the complexity of physiological mode of action.
Data Source
AI summary
The present invention relates to new methods enabling the evolution of the medical arts passing from the use of artificial substances that are chemically or biologically defined to self-assembling natural entities, obtained from natural raw materials with industrial processes that preserve the endogenous properties thereof, thereby preserving their capability to interact with the networks of the living kingdom (including humans); wherein said natural entities cannot be defined with the classical quali-quantitative composition schemes. The invention therefore provides new methods for determining when a therapeutic or beneficial product exerts its therapeutic or beneficial effect through a physiological mode of action. This method provides a necessary tool for the skilled person to assess the mechanism of action of a therapeutic or beneficial product which, with the new developments in the regulatory framework for medical devices and food supplements has become a relevant feature to assess and for which no methods are available in the art.