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.