Around the Globe

DIA Singapore Annual Meeting 2019
Advancing Health in Asia Through Innovation
Silke Vogel
Senior Associate Dean, Graduate Studies; Deputy Director
Centre of Regulatory Excellence, Duke-NUS Medical School
Hozanna Ngoh
Medical Writer
Centre of Regulatory Excellence, Duke-NUS Medical School

orldwide demand for healthcare is rising rapidly and innovators are responding with vigor to meet patients’ needs. In a highly diverse region such as Asia where the political, socioeconomical, and environmental contexts vary across countries, the added complexity from the evolving healthcare needs and emerging trends in the region inevitably presents challenges but also opportunities for healthcare stakeholders. Within the increasingly complex healthcare ecosystem in Asia, how are stakeholders contributing to the drive for health innovation while also enabling patients’ access to these innovations?

DIA and the Centre of Regulatory Excellence (CoRE) at the Duke-National University of Singapore Medical School (Duke-NUS) jointly organized the second DIA-CoRE Singapore Annual Meeting to discuss these issues.

Key Takeaways

  • To meet rising healthcare demands in Asia, health innovations are advancing rapidly across the pharmaceutical, biopharmaceutical, and medical devices sectors, in particular through the emergence of digital health across the board.
  • Digital health aims to transform healthcare by optimizing clinical and operational effectiveness, increasing patient engagement, empowering patients for self-care, and boosting clinical research. Combining digital tools with advanced data analytics creates further potential to enable a well-informed, data-driven healthcare system.
  • Asian regulators and regulatory affairs professionals are making great efforts to keep abreast of innovations and facilitate the access of patients to these innovations by advancing regulatory science, employing risk-based approaches to regulation, and promoting multi-stakeholder collaboration.
Under the theme Advancing Health in Asia Through Innovation, the conference fostered discussions among regulators, professionals from industry and government, healthcare providers, academia, and other researchers on the emerging health trends and innovations in Asia and how these developments are changing healthcare delivery and driving better health outcomes for patients.

Innovations Galore in Asia

Sessions featured a variety of health innovations across the pharmaceuticals, biotechnology, and medical devices sectors in Asia, especially highlighting the permeability of digital health applications across the entire healthcare space.
DIA-CoRE Singapore Annual Meeting Program Speakers

DIA-CoRE Singapore Annual Meeting Program Speakers

Digital health is transforming healthcare.

The digital health applications featured at this meeting included artificial intelligence (AI) and machine learning technology, mobile health applications, and other health-related connected devices and platforms. Speakers described how integrating these applications into healthcare is impacting and driving better health in numerous ways, such as supporting clinical and operational decision-making to optimize effectiveness; transforming patient engagement; empowering patients for self-care; and boosting clinical research. Digital tools coupled with advanced data analytics also enable the harnessing of real-world data for translation into meaningful evidence for the benefit of patients.

Examples of Digital Health Applications

  • Implemented in a dengue-prevalent area in a Southeast Asian country, an AI-based dashboard predicts dengue outbreaks through real-time collection and analysis of dengue epidemiology data, enabling timely and accurate response by healthcare stakeholders.
  • AI algorithms have been developed to function as cost and risk predictors to inform operational decision making by healthcare providers.
  • Electronic labeling, or eLabeling, of healthcare products can facilitate communication of and access to accurate and up-to-date health-related information by patients and consumers.
  • User-friendly and intuitive digital technology such as mobile health applications, wearable devices, and connected platforms can empower patients and consumers for self-managing their own health.
  • Digital clinical research is being enabled through the merging of digital tools, machine learning, and advanced data analytics, improving clinical trial efficiency from biomarker identification to recruitment strategies to safety monitoring.

Innovations in (bio)pharmaceuticals and medical devices continue to progress.

Research on cancer therapies continues to lead the pharmaceutical sector. Examples included research on next-generation antibody drug conjugates and on virus-specific T-cells for solid tumour immunotherapy. Other showcased emerging areas of research included development of lipid-based drug delivery systems to enable targeted delivery and sustained release of drugs, and renewed interest in botanical drug development coupled with the use of innovative technologies to support quality development of these drugs as alternative treatments.

In addition to digital health, other innovations in medical technology include the potential application of blockchain in the healthcare supply chain and ongoing efforts to develop diagnostic technologies that can be easily implemented and used in developing countries and other low-cost settings.

Advancing Regulatory Science and Promoting Multi-Stakeholder Collaboration

The rapid and massive advent of innovations across the Asia healthcare landscape begs the question: What is being done to ensure that patients and consumers actually gain access to these innovative approaches? A series of presentations by regulators in Asian National Regulatory Authorities (NRAs) and industry regulatory affairs representatives really highlighted the breadth of regulatory efforts to support innovation and facilitate timely patient access to products.
Regulatory stakeholders recognize the critical need to keep up with the rapidly advancing science and technology behind innovative products.
Regulatory stakeholders must expect to undergo mindset changes and strengthen their understanding of regulatory science, which has been evolving to ensure that quality, safety, and efficacy of these products could be properly assessed without stifling innovation. For example, the emerging use of manufacturing innovations such as continuous manufacturing to accelerate pharmaceutical development requires re-thinking quality control strategies and specification acceptance criteria.

Other regulatory science developments include the multiple regulatory science-based strategies implemented by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA); the Taiwan Food and Drug Administration (TFDA)’s considerations of real world evidence in regulatory decision-making; and the Singapore Health Sciences Authority (HSA)’s use of big data analytics for active post-marketing safety surveillance.

Accepting digital health requires re-imagining the regulatory paradigm.
Simply viewing digital health applications as medical devices is an inadequate approach because these increasingly diverse applications may be designed for and used by patients and consumers for various indications and purposes. Stakeholders agree that digital health requires a risk-based, fit-for-purpose regulatory framework. A number of NRAs and international regulatory platforms have embarked on various forms of pilot regulatory mechanisms to meet this need, including the US FDA’s Digital Health Innovation Action Plan; the International Medical Device Regulators Forum’s Software as a Medical Device (SaMD) definition; Singapore’s regulatory sandbox program with telemedicine as a focus area; and other efforts undertaken by NRAs in Europe, Japan, Canada, and Australia to focus on understanding regulatory considerations for digital health.
Regulatory collaboration is key to facilitating patient access.
Most NRAs in Asia have established expedited registration pathways designed to shorten regulatory timelines. Inter-agency regulatory collaboration such as reliance, work-sharing, and joint assessments are relatively new mechanisms to address NRA resource and capacity constraints. Other regulatory efforts include development of guidelines by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) to support and promote the conduct of first-in-human studies in Malaysia, as well as the launch of the Medical Products Consortium of Thailand to boost domestic innovative healthcare products through strong multi-stakeholder collaboration.
CoRE Executive Director Professor John Lim

John Lim, CoRE Executive Director

Senior Vice President & Managing Director, DIA South Korea and ASEAN Dr. Youngshin Lee

Youngshin Lee, Senior Vice President & Managing Director, DIA South Korea and ASEAN

Bringing It All Together: A United, Continually Improving, Data-Driven Healthcare System

The wealth of information presented at the second DIA-CoRE Singapore Annual Meeting has accentuated the unstoppable wave of innovation in Asia and, at the same time, signaled an urgency for all stakeholders to pave the way for patients to access the fruits of innovation. As underlined by CoRE Executive Director John Lim and Youngshin Lee (Senior Vice President & Managing Director, DIA South Korea and ASEAN) in their welcome remarks, it is absolutely vital for stakeholders to unite in the effort to advance health, scientific, and regulatory excellence. All stakeholders play a role in supporting and driving patient-focused goals within a continually innovative, data-driven health system.