Stem cell industry facing roadblocks in funding, talent crunch: Dr Satish Totey

India stem cell industry which has been existing for over last 15 years seems to be rapidly losing its global space. The sector is hampered by delayed regulatory clearance, constraint of government funds, lack of private equity and venture capital support besides paucity in talent pool. These issues are posing a serious road block for the Indian stem cell industry, said Dr Satish Totey, chief executive officer, Kasiak Research Pvt. Ltd Large pharma companies are not yet convinced that taking a risk on developing stem cell therapeutics is worthwhile since return of investment is longer. Although, science is getting better, interesting and convincing, investors and promoters are wary and unwilling to infuse funds as they fail to comprehend growth prospects of this sector. Now this has led India elude its prime position on the global platform rapidly, he added. Globally, there are already over a dozen FDA approved cell therapy products available in the market which is valued around $1 billion since 2013. US, South Korea and Canada have stem cell products approved for various indications like haematological diseases, bone grafting, osteoarthritis, myocardial infarction, diabetic foot ulcer, Crohn’s disease and graft-versus-host disease (GVHD). In addition there are several emerging stem cell products that may enter into the global market by 2014-15. However in India, despite the approval for two autologous stem cell products: limbal insufficiency and acute myocardial infarction, its demand and utility are unknown and new stem cell therapeutics may still take another 4-5 years to be developed and launched. Primarily, the setback for Indian stem cell industry is the inadequate initiative by domestic pharma in developing new drugs/biologics.  Over the last 15 years , several stem cell companies mushroomed in India to earn the quick buck and financially exploit patients. Another factor for the industry not to take off is the chaotic regulatory process. Standard time frame for regulatory approval in conducting clinical trials is three years. No start-up company can survive for such a long duration. As a result, India could develop only one or two companies in stem cell therapeutics, said Dr Totey. Yet another cause of concern is the failure of several global stem cell clinical trials at phase-II/III and a few of these include Indian companies. This raises questions on efficacy in several clinical indications. Unfortunately, hype and buzz created by  companies distorted the reality, he said. Further, there are challenges in stem cell isolation and manufacturing because of its  sensitive and unpredictable characteristics.  Lack of knowledge in stem cell culture, poor sterile technique, failure to adhere to good manufacturing standards, deficiencies in the processing of stem cells have also been major concerns.  Factors like donor variation, immunogenicity, type of stem cells and cryopreservation also affect the overall clinical outcome, he said.

Source:Pharmabiz