Export Coffee Talk | Japan Biotech Panel | Market Entry Insights

Join us in-person or virtually Thursday, October 31, from 10:00 am to 12:00 pm ET for a special hybrid Export Coffee Talk in RTP. The panel will provide drug development and market entry insights focused on Japan’s biotechnology industry. The information would benefit biotech companies that aim to enter Japanese and Asian markets and contract research organizations (CROs) supporting those biotech companies.

Panelists:

• Hiroshi Yamabe, Founder and CEO, Swanielle, Inc. –  Tokyo, Japan-based proposal and business execution consultant for the healthcare industry will brief on “drug loss” in Japan and discuss policy change implications.
• Paula Brown Stafford, CEO of Allucent – Leader of a North Carolina-headquartered CRO that supports small and mid-sized biotech companies will provide insights on business with Japanese pharmaceutical companies.
• Tomoko Maeda-Chubachi, President, TMC Clinicial Development Consulting, Inc. –  Advisor and consultant for pharmaceutical and biotech companies, will add her expertise and provide some information about Japan’s Pharmaceuticals and Medical Device Agency (PMDA).
• David Robinson, the program moderator, brings decades of Japan-related business experience to the conversation. He is the Honorary Consul for Japan in North Carolina, Chairman of the Board of the Japan-America Society of North Carolina, and an International Trade and Investment and International Corporate Compliance Attorney with the national law firm, Maynard Nexsen.

In-Person Location

RTP Headquarters – Board Room

700 Park Offices Drive

Research Triangle Park, NC 27709

Please specify when you register if you plan to join us in person by leaving a note in the comment field.

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About the Panelists

Hiroshi Yamabe is the founder and CEO of Swanielle, Inc., a consulting firm based in Japan. The company specializes in providing consulting services such as out-licensing, PMDA consultation, NHI price consultation, and commercial analysis, aimed at addressing the issue of “Drug Loss” in Japan.  Prior to establishing Swanielle, Inc., Mr. Yamabe accumulated approximately 30 years of experience, primarily in sales and marketing, at both multinational corporations (MNCs) and Japanese companies within the pharmaceutical industry across Japan, the United States, and Taiwan. His extensive career includes various management roles, such as Global Marketing Director at Pfizer/Schering-Plough in the United States, Chief Commercial Officer at Ferring Japan, Country Manager at Ferring Taiwan, and Head of International Operations at Meiji Seika Pharma.  Mr. Yamabe holds an MBA from Duke University and a Bachelor of Science degree from Kyoto University in Japan. Additionally, he is a licensed pharmacist in Japan.

Tomoko Maeda-Chubachi, MD, PhD, MBA is an advisor and consultant for pharmaceutical and biotech companies by utilizing 20+ years of unique experiences as a physician drug developer, in both large pharma and small biotech, who brought 8 products into the various markets. She was a global project leader in Pfizer, Eli Lilly and GSK, and a chief medical officer of Novan, Inc (now Pelthos Therapeutics). She has broad knowledge of drug development, strategic and bold communication skills with regulatory authorities. She graduated from Osaka University School of Medicine and has a broad network with cultural understanding between the US and Japan. She was awarded Best Pharmaceutical Business Women by Acquisition International and 10 Most Impactful Chief Medical Officer by Women Achiever in 2023. She was also received Women in Business Award by Triangle Business Journal in 2022. She is passionate about young professionals’ career advancement and leadership development in the industry, and navigating Japanese universities spinoffs and startups to conduct clinical trials in the US.

Paula Brown Stafford, CEO of Allucent, is an industry veteran, brings to Allucent more than 35 years of industry experience. At Quintiles (now IQVIA), she played a key role in growing its CRO services. As president of their largest business unit delivering Phase I-IV clinical research services, she served in many administrative and operational capacities leading 22,000 employees across 60 countries. In addition, Ms. Stafford was president, CEO and chairman of Novan, Inc., a biotechnology company with commercial assets and a clinical platform. She is also an adjunct professor in Public Health Leadership for the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Among many awards and accolades, Brown Stafford received the 2022 Triangle Business Journal’s Lifetime Achievement Award for Women in Business and was named one of the 10 top women in biotech by FierceBiotech in 2012. In 2016, she was presented with the Distinguished Alumna award from the University of North Carolina at Chapel Hill, where she received her Bachelor of Science and Master of Public Health in Biostatistics.

David S. Robinson, Attorney and Diplomat, serves on the Board of Advisors at the NC Japan Center and is the Honorary Consul for Japan in NC. Mr. Robinson is a Member with Maynard Nexsen’s International, Government Solutions and Compliance Teams. His practice is focused in the areas of international, corporate, compliance, trade and commercial law. His experience includes cross-border movement of companies, goods, services and personnel; start-up financing and establishment of US & International subsidiaries and branches; mergers and acquisitions and joint venture arrangements; contract drafting and negotiation; site selection and lease negotiation; state and federal regulation; international trade guidance and facilitation. Mr. Robinson is also a frequent lecturer on international trade and business start-up issues. He has served clients in the European Union, Japan, China, Singapore, Australia, Jordan, Saudi Arabia, India, the former Soviet Union, South America, and Mexico. Mr. Robinson lived in Tokyo, Japan for 8 years and has traveled to more than 55 countries. He received his B.S. Degree in Foreign Service from Georgetown University and received his J.D. Degree from the George Washington University National Law Center.