The CREATInG Initiative marked a major milestone with the launch of its first Executive Development Programme, held from 27 – 29 September at Duke Kunshan University.
Jointly organised by the Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School and Duke Kunshan University, the programme convened senior representatives from government, academia, and non-governmental organisations to collaborate with companies and manufacturers. Together, they explored ways to build an enabling ecosystem for in-vitro diagnostic (IVD) products—accelerating their global market access and strengthening the delivery of high-quality diagnostic solutions to people in developing countries.
The highly experienced faculty included Dr. L. Rizka Andalucia, Director-General of Pharmaceuticals and Medical Devices at Indonesia’s Ministry of Health; Dr. Wenfeng Gong, Deputy Director of the Gates Foundation Beijing Office; Dr. Di Dong, Senior Economist at the World Bank; Yong Xu, Head of Shenzhen Third People’s Hospital and Director of the Shenzhen IVD Proof-of-Concept Center; Prof. Jinhua Cao, Chair of the International Cooperation Committee of the Chinese Society of Biotechnology; Mr. Boxing Huang, former General Manager of Roche Diagnostics Greater China and Founder of Shanghai IVD Consulting; Dr. Trevor Peter, Senior Director of Diagnostics at the Clinton Health Access Initiative; Dr. Hani Kim, Executive Director of the Right Foundation (Korea); Prof. John Lim, Founding Executive Director of the Centre of Regulatory Excellence (CoRE) at Duke-NUS; Prof. Christopher Laing, Associate professor and Vice-Dean, Office of Innovation & Entrepreneurship, Duke-NUS Medical School; and Prof. Shenglan Tang and Prof. Fujie Xu, the two Co-Directors of Duke Kunshan University Global Health Research Center.
A total of 38 companies, represented by their leaders or senior executives, participated in the two-day seminar for learning and discussion. Notable attendees included leading global and regional firms such as Boditech, Bioneer, Hugobiotech, GenBody, Wantai Biopharm, and Coyote Bio.
During the seminar, participants exchanged insights and shared experiences on topics related to the global expansion of IVD products and solutions, including strategic planning, market analysis, regulatory requirements, risk management, and cross-cultural communication.
Professor John Lim, Founding Executive Director of the Centre of Regulatory Excellence (CoRE) and the CREATInG Initiative Project PI at Duke-NUS, said:
“Innovative diagnostic technologies only achieve their true value when they reach the people who need them most. This initiative bridges the gap between innovation and access by building capacity, optimising pathways, and creating an ecosystem to ensure that quality diagnostics benefit populations in low- and middle-income countries–a critical step forward for global health.”
Prof. John Lim hosted the panel disscussion
Professor Fujie Xu, Co-Director of the Global Health Research Center, and Co-PI of the CREATiNG Initiative at Duke Kunshan University, added:
“As a co-founding partner of the CREATInG Initiative, Duke Kunshan University is committed to a global expressway for exceptional IVD enterprises from China, South Korea, and ASEAN. The Initiative serves not merely as a training platform, but as a strategic lever. We are dedicated to mobilising worldwide resources to systematically empower these companies, enabling them to navigate developing markets and regulatory landscapes with deeper insight. Through these efforts, we transform Asian IVD innovations into a dynamic force for global health, advancing from market access to meaningful impact.”
Prof. Fujie Xu delivered Opening Remarks
This Executive Development Programme was the second major event since the launch of the Initiative, following the International Roundtable: Impactful Interventions for In-Vitro Diagnostics Access in Global Health convened by Duke-NUS in Singapore in July 2025. Upcoming activities include a regulatory affairs functional training programme on November 10-12 at Duke Kunshan University.
Participant Feedback
“The EDP program was a truly enriching experience. Domestic and international experts shared valuable insights on market strategy, expansion, and risk management etc. It was also a great pleasure to reconnect with old acquaintances and make new connections.” — Noah Chen, Pluslife
“Thank you to the organizers and all the experts for such a valuable program. I hope the Initiative continues to grow and drive positive change in the industry.” — Justin Zhang, LivZon Diagnostics
About the CREATiNG Initiative
Launched in 2024, the CREATInG Initiative is a joint effort of Duke-NUS Medical School’s Centre of Regulatory Excellence (CoRE) and Duke Kunshan University. The programme convenes global experts and industry leaders to strengthen regulatory and market access for affordable IVD solutions in low and middle-income countries through international conferences, executive training, and capacity-building programmes.
Learn more: https://www.duke-nus.edu.sg/core/think-tank/gates-core-and-duke-kunshan-regulatory-strengthening-project
About the Regulatory Functional Training
The upcoming Regulatory Functional Training is jointly organized by the Centre of Regulatory Excellence (CoRE) at Duke–National University of Singapore Medical School and Duke Kunshan University (DKU). This program aims to strengthen the global regulatory capabilities of professionals involved in the research, development, and manufacturing of in-vitro diagnostics (IVDs).
The training will focus on key areas including global market registration and access pathways for IVDs, compliance requirements, clinical and manufacturing regulatory practices, and optimization of Quality Management Systems in accordance with ISO 13485.
The two-part training will be held at Duke Kunshan University from 10–12 November 2025 and 11–13 May 2026, using the Duke-NUS team-based learning pedagogy in a closed, small-group workshop format to encourage interactive discussions and peer learning.
For registration and inquiries, please contact: Mengxi Yan (mengxi.yan@dukekunshan.edu.cn)
Written by Zhangyang Pan
