Guest blog post by Bryan Spielman, Executive Vice President, Medidata
I am honored to join Secretary Pritzker on the business development mission to Japan and South Korea. Medidata is committed to developing our business and transforming clinical research throughout Asia, and this trip is bringing us invaluable connections to the region’s regulatory and industry leaders in the life sciences.
We are thrilled with Commerce Secretary Pritzker’s active engagement throughout the trip to Japan, and we are looking forward to our time in South Korea. The Commerce Secretary’s staff is doing a phenomenal job to keep us briefed and to take care of us, and they have gone the extra mile to make sure this is a successful trade mission. We were also honored to meet with Ambassador Caroline Kennedy, who invited us to the ambassador’s residence in Tokyo to exchange ideas. Secretary Pritzker and Ambassador Kennedy spent a great deal of time with us, and both of their teams have shown they can really roll up their sleeves and get meaningful work done.
During our trip to Japan, we had the opportunity to meet with Prime Minister Shinzo Abe and senior leaders from the Ministry of Economy, Trade and Industry (METI), and we were impressed with his administration’s commitment to drive real change in the Japanese economy. Two of the big initiatives of the prime minister’s economic stimulus plan relate to healthcare and women in the workplace. These issues align nicely with our values as a company—more than 40 percent of Medidata’s Japan office is female—and we are very excited about continuing to invest in Japan.
We also had productive meetings with Japan’s Minister of Health Yasuhisa Shiozaki, senior leadership at the Pharmaceuticals and Medical Devices Agency (PMDA) in charge of promoting information technology, and Japanese pharma industry leaders. In our conversations, it became clear that the idea of leveraging technology to increase the speed, quality and efficiency in the clinical trials process is clearly front and center in Japan. There is broad recognition that the ever-increasing R&D costs are not sustainable and that technology and new data sources can help.
At Medidata, we spend a lot of time thinking about where the future of clinical trials is headed. The pharma industry spends roughly $100 billion a year on clinical trials. There is a need for companies to find more efficient ways of running trials, particularly if the industry can speed time to market, reduce costs and reduce risk by leveraging new technology.
The job of regulatory authorities is to make sure that drugs are safe and efficacious. We’re beginning to learn a lot more about how effective a drug truly is in the real world. Drug effectiveness is about the sort of life that you live, for example whether you’re exercising or engaging with people. Technology is quickly evolving to measure these factors in a meaningful way, and with mobile health and connected devices, we are beginning to have the sort of data that we believe should be included in clinical trials.
As part of a PMDA initiative to strengthen its drug approval process, the Japanese agency will begin to require electronic submissions of standardized data for new drug applications in fiscal year 2016. PMDA has said it believes electronic submissions will reduce the burden of applicants and may increase both the efficiency and success rate of drug development. When we think about the future of clinical trials, we don’t have to look too far into the future. Clinical trials around the world are evolving to become safer, faster and cheaper, and we’re excited to be a part of it.
Otmane El Rhazi
Department of Commerce
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