The word unregulated used anywhere in this report means the following:
Unregulated: Any aptamer and/or aptamer based product and/or aptamer based application and/or aptamer based technology and/or aptamer based area of use and/or aptamer based services that can be sold/rented/leased/used commercially without the need of approval from various health and food regulators that operate in any country or geographical region worldwide. By worldwide, we are referring to countries and geographical regions that we are tracking in our study. By unregulated, we are only referring to the “no need of” approval by the health and food regulators and the above specified aptamer based products/services might still need other business related approvals such as business license, tax license among other approvals that might be needed for doing the business. These business related approvals might vary from country to country and geographical region to region.
As per our research (both primary and secondary), except research, everything else is regulated. Research is also not completely unregulated, instead there is regulated research and unregulated research. Please find the definitions for both below:
Regulated Research: This research involves any research activity involving aptamers and the expected end product/result of this research is meant for human/animal use. This means, all the clinical trials will be considered as regulated research. In case a company is planning to apply for the permission to conduct Phase-I trials based on the results of preclinical studies, in that case even the preclinical studies will be regulated. These preclinical studies will be regulated even if they do not involve any animal models and are performed on just cell lines or might only involve computational studies. In any case, these preclinical studies will be regulated.
When we say human or animal use, we are referring to both direct and indirect use, by direct use, we mean the products/services that might be used for treatment, diagnosis or any other human related application that is performed directly on the human/animal body or is remotely related to human or animal health. When we say remote, it also involves things like mass genomic profiling where in the people involved are just volunteers but the technology that is used for it is regulated.
Similarly if a aptamer is used for developing a solution, treatment, technology etcetera wherein the end product is not going to be aptamer based. But the end product is going to be developed using a step involving aptamer at some point of development. Then it will a part of regulated research.
Similarly, the use/application of aptamer under regulated research is not just limited to medical or therapeutic purposes. Instead if some product that is based for human or animal consumption is if it is even remotely related to wellness, then it will be regulated.
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As per our research (both primary and secondary), the institutes/organizations involved in regulated research do not buy from aptamer suppliers who are unregulated, instead they either synthesize the required aptamers in-house or they contract with a regulated CRO. This fact has been validated through extensive primary and secondary validation.
Unregulated Research: Any research activity whose purpose is only academic, when we say academic we mean it is done only for the sake of understanding things or for discovering new things or for finding new ways of doing experiments etc. Simply saying, the outcomes of the unregulated research are the things that we generally study as theories and hypothesis in our textbooks in schools and colleges. Even if a research activity is remotely related to any commercial/noncommercial motives involving human or animal use, then it will come under regulated research. The research work done as part of a study project in case of post graduate or PhD education or for the purpose of just gaining exposure or for just publishing a paper will be considered as unregulated research.
Again please note that, commercial entities also publish research papers and they come under regulated research if they are developing products for human or animal use. Similarly industry academia collaborations where in the use of final outcome is human/animal use will come under regulated research. At the same time, some academic research can be performed with commercial motives, wherein the universities or professors license out the technology or product and that will be regulated research.
There is a thin line that separates regulated and unregulated research. It’s the ultimate motive of the research that determines whether its regulated or unregulated. For instance a large scale cancer research can be regulated depending on the motives of the research. Please find below some examples of regulated and unregulated research.
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