dMed founder and Chairman, Dr. Lingshi Tan, summarized the opportunity, saying, “Western drug and device companies increasingly recognize the need to stay on the leading edge of the fundamental changes in the global clinical landscape as China becomes a key driver behind faster drug development as well as an increasingly attractive market for innovative therapies.”
Target Health’s President, Dr. Jules Mitchel, added, “At the same time, Chinese biotechs need a trusted partner to support their efforts to develop and gain FDA approval for their innovative therapies in the US. As part of dMed, we can work seamlessly with Chinese sponsors leveraging dMed’s nearly 400 professionals in China and its regulatory team in Washington led by former FDA examiner, Dr. Eric Zhang.”
Combining resources of these two full-service clinical CROs and deploying innovative business models, the partnership delivers integrated capabilities targeted to meet the needs of agile, innovative biopharma and device companies on both sides of the Pacific.
Dr. Mitchel says, “Our combined teams are particularly excited about the potential to help Western firms take advantage of China’s large pool of patients in areas such as immuno-oncology, NASH, orphan disease and a wide range of chronic indications where patient recruitment is a growing challenge in the US. Combined US/China studies producing data capable of standing up to FDA scrutiny offer a time and cost-effective alternative to the largely US-centric model pursued by most biotech firms in the past.”
Dr. Tan adds, “With China now willing to accept global clinical data and approve local trials within 60 working days, our integrated approach creates additional value for Western innovators by advancing registration of their drugs or devices in China, where innovative therapies are now regularly being added to the country’s National Reimbursed Drug List.”
dMed, founded in Shanghai in 2016, has already grown to nearly 400 professional staff covering 12 cities in China and three US offices, including its Regulatory Affairs operations in both Beijing and Washington DC. Led by Dr. Lingshi Tan, who built Pfizer’s global R&D center in China to more than 1,000 staff, and a team of top clinical development specialists from leading multinational biopharma firms, the company is committed to bringing China’s clinical development capabilities to global standards while helping innovative Chinese companies grow globally.
Co-founded in 1993 by CEO Joyce Hays and Dr. Mitchel, Target Health has been a leader in innovative technologies and brings full-service clinical capabilities as well as a strong regulatory team. Target Health currently represents over 50 companies at FDA and had completed many clinical programs with multiple regulatory approvals. With the company’s cutting-edge work in Direct Data Capture EDC software, Target Health has become known in the industry as “Champions of the Paperless Clinical Trial”.
The combination of dMed and Target Health is able to handle studies and regulatory filings in all phases, for biopharma and medical device companies large and small, regardless of geography. Individually, both teams have demonstrated repeated success bringing entrepreneurial biotech and device firms a level of data quality, strategic thinking with personalized service and nimble responses not generally found among the large CROs, creating a truly unique and powerful combination.
Source: Company Press Release.
