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:

An Ma, PetroChina, "How CNPC can learn from the Silicon Valley Innovation Model"

The Silicon Valley forms a series of efficient innovation models, gives birth to a large number of world class high-tech companies, and greatly influences science and technology innovation for the U.S. and the world.  The policy mechanism, venture capital investment, multicultural society, talent aggregation, supporting services and government backing are all factors in the development of the Silicon Valley.  In his research, Ma investigated the development process of the Silicon Valley and analyzed two energy-related companies — Tesla and The First Solar — to understand the Silicon Valley innovation model.  Based on his analysis of China National Petroleum Corporation (CNPC) business development and innovation task, Ma offers some suggestions on how CNPC can learn from the Silicon Valley innovation model in science and technology development.

Huaxiang Ma, Peking University, "Entrepreneurship Education in the Era of Globalization"

With entrepreneurship becoming a key driver of today’s economy, entrepreneurship education around the world has developed quickly in the past few decades.  China, as a new rising power, also pays more attention to the development of entrepreneurship and entrepreneurship education.  Ma’s research goes through the history of entrepreneurship education in both the U.S. and China and analyzes various reasons behind the prosperity.  Additionally, Ma discusses the pioneers of U.S. universities in this field such as Babson, Harvard and Stanford, conducting a comparative study between the U.S. and China.  In his research, he tries to uncover existing problems and suggests possible solutions for the development of entrepreneurship education in China focusing on how Peking University can support his ideas. 

Ryo Washizaki, Japan Patent Office, "How to Increase the Probability of Innovation Through Comparison of the US and Japan While Paying Attention to Start-up Companies"

Every year, large Japanese firms receive high rankings of the international application number and patented number of the World Intellectual Property Organization (WIPO) and the United States Patent and Trademark Office (USPTO).  Patents have a relationship with its business, but activities of start-up companies are not easy to see in such kind of rankings.  On the other hand, the World Economic Forum recognizes some start-up companies as “Technology Pioneers”, and the Organization for Small & Medium Enterprises and Regional Innovation, Japan has awarded Japanese start-up companies “Japan Venture Awards”.  Although those winning companies would have better possibility for success in business, their innovation ecosystem is different.  In his research, Washizaki illustrates the comparison of those Japanese and U.S. start-up companies’ growth, especially from a viewpoint of patents.

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.

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

Yuta Aikawa, Ministry of Economy, Trade & Industry, Japan, "A Study About a Government Policy to Develop Defense Industry"

In April 2014, under consideration of the recent situation of international cooperation and developing defense equipment in the world, the government of Japan decided on the “Three Principles on Transfer of Defense Equipment and Technology”.  Additionally, the Acquisition, Technology and Logistics Agency was newly established in the Ministry of Defense (MOD) in October 2015, consolidating and reorganizing acquisition-related organization in the MOD to address the new age and duties.  These recent changes could have a big impact on the defense industry in Japan.  In his research, Aikawa tries to figure out how to develop the defense industry by looking at the situation in South Korea, whose government recently developed to export defense equipment to other countries.  Aikawa uses this example to illustrate implications for the government of Japan on the future of the defense industry.

Tsuzuri Sakamaki, MInistry of Finance, Japan, "What Impact Would the Ongoing Basel III Implementation Procedure Have on Banks' Value Creation and Risk Management?"

Basel III has been developed in response to the financial crisis that started in 2007 and reached one of its many peaks with the Lehman Brothers bankruptcy in September 2008.  The aim of the Basel Committee on Banking Supervision (BCBS) implementing Basel III is to make the banking system more resilient to market stress, but this new regulation inevitably limits the ability of banks to take deposits and lend money to the real economy.  Banks are also under constant pressure from their own shareholders who are providing them with equity capital to maximize the usage of the capital in order to achieve high returns for them.  With all these regulatory policy intensions and market economic constraints taken into account, Sakamaki has researched into whether the Basel III would indeed lead to increased stability of the banking system, or what possibly unintended negative consequences could develop in its implementation process.

Ravishankar Shivani, Reliance Life Sciences, "Pharmaceutical Process Validation — A Science and Risk-Based Approach to Evaluate Impact of Changes on Regulatory Filings"

Regional differences in regulatory oversight of post-approval changes exists in the ICH regions and there is an urgent need for clarification of current expectations and how best to optimize the use of relevant regulatory tools in place in the different regions.  The key aspects considered are 1) inclusion of risk-based regulatory commitment approach to enable post-approval changes and continual improvement,  2) establishing criteria for an harmonized risk-based change management system, and 3) introducing the concept of post-approval change management plan for regulatory overview. 

Shivani has researched the possibilities of changes to the attributes of a product over the life cycle that are necessary to maintain product quality and efficacy.  His research identifies the methodology for inclusion of the proposed changes during the development phase as commitments in dossiers to facilitate regulatory assessment. 

The United States has transformed its relationships across the Asia-Pacific region under President Obama’s “rebalance” policy.  America’s top diplomat for the region will speak about the strategy the administration has pursued and what lies ahead.

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Prior to joining the NSC in January of 2009, he served as Director of the Office of Japanese Affairs and had assignments as U.S. Consul General in Osaka-Kobe, Japan (2005-2008); Deputy Chief of Mission at the U.S. Embassy in The Hague, Netherlands (2002-2005); Deputy Chief of Mission at the U.S. Embassy in Nicosia, Cyprus (1999-2002); Chief of Staff to the Under Secretary of State for Political Affairs, Ambassador Thomas R. Pickering (1997-99); Special Assistant to the Under Secretary of State for Political Affairs (1995-96); Political Section Unit Chief at U.S. Embassy Seoul, Republic of Korea (1992-95); Political Advisor to the Permanent Representative to the U.S. Mission to the United Nations, Ambassador Pickering (1989-92); Vice Consul in Osaka and Branch Office Manager in Nagoya, Japan (1987-89); and Assistant to the Ambassador to Japan, former Senate Majority Leader Mike Mansfield (1985-87).

In 1996, Mr. Russel was awarded the State Department's Una Chapman Cox Fellowship sabbatical and authored America’s Place in the World, (Georgetown University Press). Before joining the Foreign Service, he was manager for an international firm in New York City.

Mr. Russel was educated at Sarah Lawrence College, University College, UK and University of London, UK.

Sponsored by the U.S.-Asia Security Iniatitive 

Announced earlier this year, Yoichi Funabashi is the 2015 Shorenstein Journalism Award recipient. As part of the annual ceremonies, Funabashi will deliver remarks on the U.S.-Japan alliance, followed by comments from three Japan experts.

The postwar alliance of the United States and its former wartime foe, Japan, is one of the most enduring relationships of the postwar era. It remains a cornerstone of the foreign policy of both nations. But it is also an alliance in the midst of change. In both countries, domestic politics affects the security alliance, as well as the impact of economic turmoil and the challenges of slowing growth. Populism in the United States is already challenging the need for the alliance. Similar questions are raised by the hollowing out of Japan’s postwar moderative conservativism which long supported the alliance. Both the U.S. rebalance to Asia and Japan’s “proactive pacifism” are now in question. 

Featuring:

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Yoichi Funabashi

Co-founder and Chairman, Rebuild Japan Initiative Foundation

former Editor-in-Chief, Asahi Shimbun (2007-2010) 

Commentators:

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Deputy Executive Editor, former Foreign Editor and Tokyo Correspondent

New York Times

Michael Armacost, Shorenstein Distinguished Fellow

Michael Armacost

Shorenstein APARC Distinguished Fellow, Shorenstein Asia-Pacific Research Center, Stanford University

former U.S. Ambassador to Japan

Moderator:

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Daniel Sneider

Associate Director for Research, Shorenstein Asia-Pacific Research Center, Stanford University

former Foreign Correspondent, San Jose Mercury News

Yoichi Funabashi is an award-winning Japanese journalist, columnist and author. He has written extensively on foreign affairs, the U.S.-Japan Alliance, economics and historical issues in the Asia-Pacific.

He has a distinguished career as a journalist. He served as correspondent for the Asahi Shimbun in Beijing (1980-81) and Washington (1984-87), and as U.S. General Bureau Chief (1993-97). In 2013 he won the Oya Soichi Nonfiction Award for his book on the Fukushima Daiichi Nuclear Accident ‘Countdown to Meltdown,’ he won the Japan Press Award known as Japan’s “Pulitzer Prize” in 1994 for his columns on international affairs, his articles in Foreign Affairs and Foreign Policy won the Ishibashi Tanzan Prize in 1992 and in 1985 he received the Vaughn-Ueda Prize for his reporting on international affairs.

As co-founder and chairman of the Rebuild Japan Initiative Foundation (RJIF) he oversaw the “Independent Investigation Commission on the Fukushima Daiichi Nuclear Accident” (Routledge, 2014) that was ranked in the top 24 policy reports produced by a think-tank in the ‘2012 Global Go-to Think Tank Ranking.’ Since its establishment in 2012, RJIF has published several influential reports on a broad range of key policy challenges facing Japan and the Asia-Pacific.

He received his bachelor of arts from the University of Tokyo in 1968 and his doctorate from Keio University in 1992. He was a Nieman Fellow at Harvard University (1975-76), a visiting Fellow at the Institute for International Economics (1987), a Donald Keene Fellow at Columbia University (2003), a visiting professor at the University of Tokyo Public Policy Institute (2005-2006) and a distinguished guest professor at Keio University (2011-2014). He previously served on the board of The International Crisis Group, and is a member of the Trilateral Commission. He is a former contributing editor of Foreign Policy, and sits on the editorial board of The Washington Quarterly.

Funabashi’s complete profile can be found here.

The Shorenstein Journalism Award, which carries a cash prize of $10,000, honors a journalist not only for a distinguished body of work, but also for the particular way that work has helped American readers to understand the complexities of Asia. The award, established in 2002, was named after Walter H. Shorenstein, the philanthropist, activist, and businessman who endowed two institutions that are focused respectively on Asia and on the press: the Walter H. Shorenstein Asia-Pacific Research Center (Shorenstein APARC) in the Freeman Spogli Institute at Stanford University, and the Joan Shorenstein Center on the Press, Politics, and Public Policy in the Kennedy School of Government at Harvard University.

Event media contact: Lisa Griswold, lisagris@stanford.edu

- This event is jointly sponsored by the China Program and the Japan Program at the Walter H. Shorenstein Asia-Pacific Research Center (APARC) -

Since September 2012, frictions between Beijing and Tokyo over uninhabited islands in the East China Sea have become unprecedentedly unstable. Both China's military and paramilitary activity in the surrounding waters and airspace and Japan's fighter jet scrambles have reached all­-time highs. Recent public opinion polls in both countries record mutual antipathy at the highest level since leaders normalized bilateral diplomatic ties in the 1970s.

Especially under these volatile conditions, risk has surged. Even an accident stemming from a low­-level encounter could quickly escalate into a major crisis between the world's second­- and third­-largest economies (and would entrap the first-largest: the United States). This seminar examines the strengths and weaknesses of China's and Japan's crisis management mechanisms and the implications of nascent national security councils (established in late 2013) in both countries for crisis (in)stability in the East China Sea. It will also examine the prospects for, and obstacles to, more effective crisis management.

Beyond its contemporary policy relevance, the discussion will also engage issues with important implications for Chinese and Japanese foreign policy decision­making, political reforms, civil­ military relations, and U.S. relations with both countries.

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Professor Liff’s research and teaching focus on international relations and security studies—with a particular emphasis on contemporary security affairs in the Asia-Pacific region; the foreign relations of Japan and China; U.S. policy toward the Asia-Pacific (esp. U.S. security alliances); the continuing evolution of Japan’s postwar security policy profile; and the rise of China and its impact on its region and the world. His scholarship has been published or is forthcoming in The China Quarterly, International Security, Journal of Contemporary China, Journal of Strategic Studies, Security Studies, and The Washington Quarterly, and has been cited widely in global media, including in The Wall Street Journal, New York Times, Financial Times, and The Economist. Other recent publications include several book chapters in edited volumes and articles in policy journals and online, including in Foreign Affairs, Foreign Policy, and The National Interest.

Professor Liff’s past academic research affiliations include the Princeton-Harvard China and the World Program, the Harvard Kennedy School of Government's Belfer Center for Science and International Affairs, the University of Virginia's Miller Center, the University of Tokyo's Institute of Social Science, Peking University's School of International Studies, the Stanford Center at PKU, and the University of Tokyo's Graduate School of Law and Politics.

American innovation has helped power economic growth and rising living standards at home and abroad for nearly two centuries.  Today, many government officials, corporate executives, and researchers worry that the American innovation machine is losing its dynamism.  Others worry that the United States is about to be overtaken by rising Asian technological superpowers, like China, and that this will constrain the living standards of future generations of Americans.  Lee Branstetter draws upon the most recent data and economic scholarship to argue that neither fear is consistent with the evidence.  Instead, the evidence points to the emergence of an increasingly integrated global R&D system in which the emerging innovative strengths of nations like China reinforce American technological progress and productivity growth far more than they threaten it.  Branstetter concludes with a set of policy recommendations that can help ensure robust technological progress and economic growth in the 21st century.       
 

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Although Japan had largely resolved the problem of banks’ non-performing loans and firms’ damaged balance sheets by the early 2000s, productivity growth hardly accelerated, resulting in what now are “two lost decades.” This presentation examines the underlying reasons of Japan’s low TFP growth from a long-term and structural perspective using an industry-level database and micro-level data. The data seem to show that, since the 1990s, some core characteristics of Japanese firms, such as tight customer-supplier relationships and the life-time employment system, have become obstacles to their TFP growth in an environment shaped by globalization and slow/negative growth in the working age population.

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