In this session of the Corporate Affiliates Research Presentations, the following will be presented:
Avni Jethwa, Reliance Life Sciences, "Biosimilars in the U.S.: Regulatory & Technological Challenges for Manufacturers"
In March 2015, the first biosimilar product was approved in the U.S. as per the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, section 351(k) biologics license application (BLA). Five years after the enactment of the BPCI Act and following its first biosimilar approval, the U.S. Food and Drug Administration (U.S. FDA) finalized its initial guidance describing the scientific and regulatory expectations for biosimilar approval under the 351 (k) pathway. Biologic manufacturers are provided with regulatory guidance in the form of scientific considerations, quality considerations and questions & answers regarding the implementation of the BPCI Act. With this new regulation, many BLA applications are under review by the U.S. FDA.
In her research, Jethwa has focused on barriers for biologics manufacturers in order to enter the highly regulated U.S. market. Her research identifies regulatory and technological challenges such as scientific issues, bioequivalence or interchangeability, quality consideration, innovator patents & strategies, healthcare spending and market potential.
Aki Takahashi, Nissoken, "A Study of Innovation Focusing on the Restructuring of Family Businesses for Longevity"
According to the National Tax Bureau in Japan, there were over three million Japanese family businesses in 2013. Additionally, companies in Japan are more sustainable than companies in the U.S. However, U.S. companies continue to find ways to be innovative. In her research, Takahashi attempts to answer the following questions – What is needed for sustainable management in the case of U.S-family businesses? and How have U.S. family businesses overcome external circumstances to become successful? Takahashi took over her family’s driving school business from her father in 2009. Based on her experiences owning a family business in Japan, she explored the successes and failures of family-owned businesses and how innovation of family business can sustain longevity in the U.S. Takahashi believes the conditions of management in Japan are rapidly changing, making companies unable to keep up with effective management. As a result, Takahashi offers suggestions to Japanese family businesses to help improve sustainable management in Japan.
Hideaki Tamori, The Asahi Shimbun, "A Study of News Notification for Multi-Devices"
The IT industry is producing many new types of internet-connected devices for consumers, including wearable devices, such as glasses and watches. Such devices may be more convenient than traditional devices because they are small and wearable and thus, literally always at hand. Every day, we receive many notifications on these devices making them very important connecting points for the media. Publishers prefer to distribute short texts for notifications, but this is not easily done. Because there are so many different types of devices available and no unified screen size, publishers cannot decide on the best format and length for these notifications. In his research, Tamori discusses suitable formats for notifications on small devices. By using a natural language processing method for automatic text summarization, Tamori developed an application that produces various formats of notifications for news depending on the display size. He also evaluated which form is best for small devices.