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:

Wataru Fukuda, Shizuoka Prefectural Government, "Software Solutions of Tourism Promotion"

In his research, Fukuda investigates the possibilities of expanding the inbound tourism market in Japan, especially in the Shizuoka prefecture, a local area of Japan.  He provides an overview of the online travel industry and how they are expanding their market with new technologies and innovations.  After reviewing how software services for international travelers is currently being used in Japan, he focuses on specific applications with the highest potential to make Shizuoka more accessible and attractive for international travelers.  Additionally, he reviews regulations and obstacles that could prevent these new technologies and innovations from being implemented.  As a result, Fukuda suggests that the suppliers of local tourism provide their services with a holistic utilization of the applications.

Catherine Huang, Beijing Shanghe Shiji Investment Company, "How the U.S. Capital Market Helps Enterprises Grow From the Infant State to Mature Businesses"

China is slowing down its pace for development, facing the so-called “middle income trap”.  While the attention to the macroeconomic picture is necessary, it is not sufficient.  Extraordinary monetary policies buy time, but they do not solve the fundamental problem.  The focus needs to be on the structural reforms – the microeconomic entities, to which the capital market acts like a lifeline, will drive future growth.  The productivity, competition and innovation in all sectors – all of which are largely fueled by an efficient, healthy and accessible capital market – ensure a productive supply-side growth.  In her research, Huang explores the culture, participants and regulatory system of the U.S. capital market and tries to figure out what China’s capital market development can learn from this system.

Yuichiro Muramatsu, Mitsubishi Electric, "Manufacturing Industry with Big Data Analysis on IoT"

The Internet of Things (IoT) is major technology that connects devices and cloud service.  Cloud service computes device data and returns meaningful results for abnormal detection, performance improvement and prediction.  One key component of IoT is big data analysis.  Japan’s Ministry of Economy, Trade and Industry’s 2015 Whitepaper states that innovation in the manufacturing industry by using IoT and big data analysis is about to launch, but few cases exist in Japan.  Innovative companies like Netflix, Uber and AirBnB are data driven companies and the manufacturing industry is also expected to have smart factories with big data analysis.  In his research, Muramatsu investigates the use of big data analysis on IoT and identifies useful cases of business efficiency and the methodology that supports big data analysis.

Fred Yang, MissionCare, "Private Hospitals in Taiwan and the Implications"

In most East Asian countries, including Japan, South Korea and Taiwan, private hospitals are the majority in the market.  In China, even though private hospitals have been in fast growth for the past 10 years, their size remains small and the market is still dominated by large public hospitals.  In the most recent move of healthcare reform in China, the government emphasized and encouraged the entry of private-non-profit hospitals into the market. 

In the National Health Insurance Administration’s (NHIA) Open Information System, a set of quality indicators is computed based on hospitals’ reimbursement data.  A committee comprised of representatives from government, academia and hospitals select these indicators and the data is published to the general public on a quarterly basis. 

By using statistical tools such as descriptive analysis, univariate analysis, and multivariable analysis, Yang focused on the comparison of hospital performance by ownership in Taiwan.  The results revealed limited differences among three types of hospitals by ownership, which is consistent with findings of most studies.  Based on his findings, Yang provides policy implications to the market and policy makers that include 1) hospital ownership might not be a key determinant of a hospital’s quality and 2) the real challenge to the government may be creating an environment where hospitals are committee to improve the quality of care.

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. 

Universal Health Coverage (UHC) is a well-embraced policy goal in the 21th century, which aims to ensure financial risk protection while assuring access to quality care.  However, up to this date, out-of-pocket (OOP) payment remains the principal means of financing health care throughout much of Asia, which leaves people financially unprotected in the face of illness.  High OOP payment at point of service is likely to either make people become medically impoverished after paying for health care, or force people to forgo treatment needed, which is detrimental to one’s health.   This presentation is based on empirical results derived from EQUITAP  (Equity in Asia-Pacific Health Systems) Project II on catastrophic payment that aims to estimate the magnitude and distribution of OOP payments for health care in 23 countries and territories in the Asia-Pacific Region in 2007.  We also draw comparisons to the results in 2000 as changes arise due to various reforms implemented since 2000.

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Her research interests are in assessing the impact of the NHI program on health care markets and household consumption patterns, and comparative health systems in the Asia-Pacific region with a focus on equity performance.  She is a long-time and active member of the Equitap (Equity in Asia-Pacific Health Systems) research network.  Professor Lu has also been appointed to serve on several advisory boards to the Taiwan Ministry of Health and Welfare and National Health Insurance Administration, Ministry of Science and Technology.

She received the Minister Wang Jin Naw Memorial Award for Best Paper in Health Care Management in 2002 and was the recipient of the IBM Faculty Award in 2009.