The widespread global outreach potential of stem cell therapies is becoming apparent, especially given the recent news of a second person going into long-term remission (some saying “cured”) of HIV after undergoing a stem cell transplant. Regenerative medicine is becoming a powerful instrument for providing cures to previously incurable diseases. According to a recent statement, the US FDA expects to receive over 200 investigational new drug (IND) applications per year by 2020, many of which include cell and gene therapies. In fact, the FDA estimates that 10 to 20 new cell and gene therapy products per year will be approved by 2025. The number of stem cell trials carried out globally has also been growing exponentially, having over 7000 trials registered on ClinicalTrials.gov with 16 FDA-approved cellular and gene therapies.
The Russian Federation government has recently issued specific decrees which outline the stem cell technologies development strategy for 2018-2020. This program undertakes the development of knowledge sharing centers, both from the product development and production points of view, as well as medical center accreditations for them to be eligible for such studies,” Vadim Merkulov, Deputy Director of the Russian Ministry of Health Scientific Centre for Expert Evaluation of Medicinal Products, elaborated.
The Russian pharmaceutical and healthcare markets have a lot of potential for stem cell studies and clinical trials in general. Key strengths of the region include fast patient enrollment, large clinical trial participation and favorable currency exchange rates. Fast patient enrollment is especially essential for early-stage trials to allow for faster project initiation. Some US and European corporations might be cautious to enter the market because of language barriers or logistic issues. However, these concerns can be avoided by choosing a reputable CRO with experience.