Grace Palma, CEO of China Med Device
On my flight to China, my seat mate is a Harvard Medical School professor specializing in stem cell research. We were talking about stem cell. I know this is a hot topic for China given the type of projects we have seen in recent years from our clients. Whenever we introduce a stem cell project to China, there are always a lot of inquiries.
What is fascinating to me is that you can take cells from our body, like a scrape of skin, and turn it into stem cell in dish (science term for container) and use these cells to understand generate stem cell and use them to study their function in specific tissues, their interaction with other cells, and their targets. The stem cell are currently used and studied in dish environment. Although some are working on this now, we have not yet understood their therapeutic capacity inside a human body.
Stem cell in dish shows the human ingenuity. I remember years ago the public media was fighting against harvesting stem cell from embryos. The scientist, Yamanaka invented a different way to get stem cell from adult cells. He got the Nobel Price for it. Now stem cell is readily available, despite only in dish, it will unleash a lot of potential therapeutic treatments down the road. The gene sequencing will identify and diagnose the gene mutation that causes the problems. Stem cell will be used to generate tissue growth to correct the gene mutation.
Her research area is in stem cell application in congenital diseases. It will be feasible one day that fetus can be diagnosed with the gene mutation that can cause the congenital diseases. Stem cell will be used to intervene the gene mutation development. There could be fewer new births with congenital heart diseases. Partly due to second-child policy adopted in late 2016, China has close to 20 million new babies born each year vs the 4 million in the U.S. Chinese parents will spend a lot of money our of their own pockets to make sure that their new borns are healthy and defect free. I see a huge demand if it becomes a reality.
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.