How to reduce the cost of a clinical trial less than USD 1 million for a new therapeutic?
There are some reports that show average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around USD 4, 13, and 20 million respectively in United States of America to be approved by the Food and Drug Administration (FDA). Even this cost may be more than USD hundred millions for very novel and innovative pharmaceuticals. Most of the researchers in this field knows that the cost of a clinical trial depends on several factors, such as study size (number of patients), locations (number of countries), number of clinical sites, therapeutic area, drug type, and the specific tests and procedures needed per protocol, among other aspects.
How can reduce clinical trial costs for a new therapeutic?
There are some developing country around the world which because of devaluation of their currency or subsidies that provides in the country, can provide very good infrastructure for clinical trials. Among them Iran has very good situation from scientists and researchers in the field of biotechnology, pharmaceuticals and nanotechnology that are working with a salary less than USD 1000 per month. Most of them have access to qualified and modern laboratory equipment to proceed health related researches in universities and research centers. There were more than 17909 PhD scientist in medical universities of Iran and there were more than 256 national medical science related journals in Iran up to 2020.
Hopefully activity of these scientists in private companies is eligible and most of them established their own knowledge-based company in Iran to commercialize their researches. Among them, some companies provide services like clinical trials for new invented or new formulated products. They completely do these activities regarding ethical issues and under defined and approved protocols under direct supervision of ministry of health and medical education of Iran.
These private companies have very good access to researchers to design test protocols and also, they can find eligible patients in educational hospitals to run these clinical trials. There is a unique Preclinical Core Facility in Tehran university of medical science which has very modern micro-CT, High resolution animal SPECT imaging system, Preclinical PET Imaging system and other novel devices that can provide non-expensive and valuable services for clients.
Although it differed with cases, but mostly a package of providing preclinical services and also full clinical trial of a novel pharmaceutical in Iran was less than USD 1 million in 2020, which means that the country with all infrastructures and its reliable scientists can be a very good partner for the companies in developed countries to transfer some parts of their research and developments and also their clinical trials to Iran.
How can find a non-expensive partner for R&D and clinical trial?
The office of Solutia Group in Iran can connect any R&D company in north America, Europe and other countries to professional teams in medical universities of Iran to reduce the costs of developing new pharmaceuticals. With the network of Solutia group, the costs of clinical trial for a project can reduce even one tenth of its costs in Europe, USA, Japan, South Korea and other countries.
Clinical trial regulatory affairs in Iran such as ethics committee (EC) and regulatory authority (RA) initial submissions, study amendments, EC/RA reporting/communication, are very easy going and define a project and proceed it until receiving results is not so long and the investors can reach to their expected results very soon. Solutia International Business Group can provide consulting services for companies active in the field of pharmaceutical, vaccines and biotechnology or nanotechnology health related products.