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 Official Launch of Biomedical Cell Products (BCP) in Russia
While the US, Europe and some Asian countries have had a fully functional, comprehensive regulatory platform for BCP procedures for over two decades, Russia is relatively new to the area, only recently approving a regulatory framework. 2018 marked a key breakthrough for the Russian market and the global pharmaceutical arena, when the Russian government enacted a law involving amendments to biomedical cell product guidelines, which officially opened the door for Russia to enter the stem cell technologies industry. The regulation stipulates and defines what a BCP is, specifying that both registered medical products and pharmaceuticals can be classified as BCPs.
“When speaking about the current pharma industry landscape, the major development of the past several years is, without doubt, the creation and implementation of stem cell product regulation and related clinical trial procedures,” Dmitry Goryachev, head of Expertise and Control of Ready Medicaments at the FSBI Russian Ministry of Health Scientific Centre for Expert Evaluation of Medicinal Products, noted during the 6th annual OCT Conference on Clinical Trials.
Although cellular biomedicines show great promise, there are some important scientific and practical nuances to note, such as patent rights, certification procedures, and BCP costs. Experts from the I. M. Sechenov Institute for Regenerative Medicine claim that one of the key challenges for biomedical stem cell production in Russia lies in the absence of suitable production sites, with an estimated cost of building such infrastructure as high as USD 7 million.
Alexey Martynov, Director of the Stem Cell Products Manufacturer Association, added that with the stem cell industry on the rise, there is an exponentially growing demand for trained professionals in the field, therefore relevant courses are being included in the universities’ curriculum for students as well as professionals. There are also a few widescale government programs which stimulate the emergence of new medical products and innovative technology in healthcare. One such program is aimed at developing stem cell technologies.
“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.
According to the previously mentioned BCP procedure law, the number of accredited entities eligible to accommodate stem cell clinical trials will grow from 5 in 2018 to 20 in 2019 then up to 50 in 2020. The budget for BCP production, called production capacity, is also estimated to reach USD 230 million by 2020, up from USD 180 million in 2018. This strategy will stimulate and potentially boost stem cell studies in Russia, ultimately resulting in increased patient access to stem cell therapies.
Russian Market Potential for Stem Cell Studies
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
“It is high time for the biomedicine and stem cell industry in our country to enter the phase when it is possible to grow and develop within the regulatory framework. Understanding the registration procedures and a solid regulatory platform, without doubt, create a very favorable environment to launch progressive stem cell studies in Russia,” commented Dmitry Sharov, president of OCT, a CRO located in Russia and Eastern Europe. “In the upcoming years, we will witness a giant leap in the development of new treatment methods.”
The first uptick in medical product applications is already being seen as the first licensing application for a cartilage restoration BCP was filed in February. Despite the fact that this technology has been in development since 2016, it is just now possible to apply for a license as the new bill is being implemented.