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.

In this session of the Corporate Affiliates Research Presentations, the following will be presented:

Satoshi Koyanagi, Ministry of Economy, Trade & Industry, Japan, "Effectiveness of the Silicon Valley Ecosystem in the Clean-Tech Sector"

The energy sector in the Japanese government faces two big problems.  The first is how to achieve the basic principle for the power supply-demand structure – by introducing renewable energy and optimizing energy consumption, this would lower dependency on nuclear power generation.  The second problem is how to tackle climate change.  The key factor in overcoming both of these problems is the innovation in the clean-tech sector while maintaining international competitiveness and quality of life.  In his research, Koyanagi investigates the features of venture capital investments, the features of start-ups in the clean-tech sector and current public support of clean-tech start-ups.  He tries to answer the question of “Does the Silicon Valley Ecosystem Work Effectively in the Clean-Tech Sector?”  From his research findings, Koyanagi makes some recommendations for the Japanese government to promote innovation in the clean-tech sector.

Tsuneo Sasai, The Asahi Shimbun, "Fostering Entrepreneurship in Japan:  A Look at the Personal History of Japanese Entrepreneurs in Silicon Valley"

In Japan, the electronic industry has been on the decline for the past 10 years and the automotive industry is facing many new challenges.  In order to maintain and develop its scale of economy, Japan needs to increase its number of entrepreneurs who can revitalizes the economy and make innovation happen both inside and outside of Japanese companies.

There is, however, a growing trend of highly motivated young people in Japan interested in start-ups and some have immersed themselves in the Silicon Valley to seek greater business opportunities.  Based on his interviews with them, Sasai believes their personal history, including their childhood and what steps they took to create their own start-ups in Silicon Valley, can help explain their entrepreneurial aspirations.  In his presentation, Sasai shows how this knowledge can provide useful insights to help Japan develop more entrepreneurs.

Mariko Takeuchi, Sumitomo Corporation, "What is 'Fintech" and what is its Outlook for Japan?"

Financial technology or “Fintech” is a term that, in the last couple of years, has been used often and widely.  Most people understand this technology is related to the financial market.  However, because the Fintech market is huge, it is difficult to understand exactly what it is and what it can provide to us.  Additionally, the wave of Fintech is coming to Japan with several Fintech start-ups emerging recently.  In her research, Takeuchi studied the activities of both the U.S. and Japanese governments and traditional financial institutions and how they relate to Fintech.  Based on her findings, Takeuchi divides Fintech into twelve categories and shows that the category map between Japanese and U.S. Fintech market is slightly different.  In her presentation, she explains the reasons for the difference from the regulations stand-point and provides some insight for the future of Japanese Fintech.

Despite the increasing state control over free speech, the Russian media market is still alive — and huge. There are tens of independent online media with a multimillion audience and each year we get more. How do you survive on the internet when it is controlled by the state? How do you find professional journalists when there are no decent schools of journalism? How do you manage a media outlet when you do not know what is going to happen tomorrow? Publisher of the popular Russian language online media outlet Meduza Ilia Krasilshchik will explain how the world of Russian media works.

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Space reports back these days ― in a brutal way. While we are told that Europe's external borders have stopped to exist, old legal-political concepts loom in the background of the current discussion on the Decline of the West: mare nostrum, mare clausum, res omnium, and the (impossible) Nomos of the Sea.

With the dangerous concept of res omnium an ominous figure is back, too: the pirate, the enemy of mankind, the terrorist in the disguise of the refugee. Linked inseparably to the birth of the concept of the state itself (by means of exclusion), this abysmal figure underwent a number of significant shifts since the enlightenment era, like the sea itself. Already in JF Cooper the pirate became a metasign, designating the readability of signs as such, the recognizability of figures, and the birth of the nation. The lecture therefore pushes forward the thesis (by drawing on art, literature, and media history at the same time) that the media and crisis history of the nomos of the sea underlies the concepts of representation and aesthetics of our modernity. The order of sense making, the order of the recognizable (i. e. aesthetics) and the possibility to discriminate between friend and foe are neither ontologically nor transcendentally "given" in the modern era but dependent on media, and therefore are permanently related to the danger of becoming indiscriminate. Hence, the ultimate metasign is the seascape.

Bernhard Siegert is the Gerd Bucerius Professor for the Theory and History of Cultural Techniques at the Department of Media Studies at Bauhaus-University Weimar and Director and Co-Founder of the International College of Cultural Technologies and Media Philosophy at Weimar. His books include Cultural Techniques: Grids, Filters, Doors, and Other Articulations of the Real (2015) and Relays: Literature as an Epoch of the Postal System (1999). He is a leading scholar of German Media Studies.

Hans Gumbrecht, the Albert Guerard Professor in Literature in the Departments of Comparative Literature and of French & Italian at Stanford and TEC affliliate faculty, will be the respondent. 

This event is co-sponsored by the Stanford Humanities Center, Department of Comparative Literature, and The Europe Center at Freeman Spogli Institute for International Studies.

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Joon Nak Choi is the 2015-2016 Koret Fellow in the Korea Program at Stanford's Shorenstein Asia-Pacific Research Center (APARC). A Stanford graduate and sociologist by training, Choi is an assistant professor at Hong Kong University of Science and Technology. His research and teaching areas include economic development, social networks, organizational theory, and global and transnational sociology, within the Korean context. He recently coauthored Global Talent: Skilled Labor as Social Capital in Korea which he developed the manuscript from 2010-11 while he was a William Perry postdoctoral fellow at APARC.

This event is made possible through the generous support of the Koret Foundation.