Resource Base
Nature has traditionally provided the basis for the majority of the drugs in use today. The discovery of new drugs and compounds from natural resources is becoming popular simply because of the advances in biotechnology screening, extraction and manufacturing systems. Regulatory authorities around the world are taking positive steps towards recognising the inherent characteristics of naturally sourced, processed and derived compounds and are changing certain criteria requirements on the condition that R&D companies can generate the data using recognised protocols and methods.The new trends in natural compound developments are:
- Combinatorial chemistry is largely unfulfilled (Combinatorial chemistry involves the rapid synthesis or the computer simulation of a large number of different but structurally related molecules).
- Natural compound development problems can be overcome by new technology and progressive regulatory legislation.
- There is an intrinsic utility of natural compounds as sources of drugs, products and biochemical leads.
These include natural products (6%), natural product derivatives (27%), synthetic compounds with natural-product-derived pharmacophores (5%), and synthetic compounds designed on the basis of knowledge gained from natural products [natural product mimic] (23%). In certain therapeutic areas, the productivity is higher: 78% of anti-bacterial and 74% of anti-cancer compounds are natural products or have been derived from, or inspired by, a natural product”.
It is the current paradigm of some regulators and scientific communities that naturally sourced or derived compounds should be treated in the same way in terms of analysis, actual single active compound activity and metabolic influence as the synthetically and combinatorial products.
This paradigm is slowly changing as new technology is developed to aid in the discovery, development and commercialisation of our unique natural resources for the benefit of humans, animals and the environment as a whole.
BioProspect takes considerable effort to discuss regulatory strategies and the respective development programs with its regulatory consultant and the respective government authorities. All of the research and development work conducted is done in accordance with international standards to ensure scrutiny and assessment is standardized and well founded.