BHSC Delegation (From left to right): Dr Yong Chern Chet (Chair of BHSC), Dr Mukkesh Kumar (Head of Data Management, A*STAR Bioinformatics Institute), Ms Yang Fan (Head of CoRE-SDO), and Dr Adrian Yeo (Chair of TC-BTLT, Convenor of NMWG for ISO TC 212 and 276)

The Centre of Regulatory Excellence’s Standards Development Organisation (CoRE-SDO) and the Biomedical & Health Standards Committee (BHSC) recently participated in a Precision Medicine (PM) study trip to Washington, D.C., and New York from 16-19 September 2024. Representing Singapore as part of a delegation led by Enterprise Singapore, CoRE-SDO and BHSC engaged with key U.S. stakeholders to strengthen collaborations and explore opportunities to shape the future of PM.

Strengthening Global Collaboration

The study trip provided CoRE-SDO and BHSC with opportunities to engage with prominent U.S. standards development organizations (SDOs), regulatory bodies, and technical consortia.

The delegation met with 10 key public and private standards and conformance (S&C) entities in the PM sector in the U.S., across:

• Government/Regulatory Bodies, such as the U.S. Food and Drug Administration (FDA), National Institute of Standards and Technology (NIST), and the Assistant Secretary for Technology Policy (ASTP);

Meeting with FDA

Meeting with NIST

Meeting with ASTP

• Standards & Conformance Ecosystem, including the American National Standards Institution (ANSI), ANSI National Accreditation Board (ANAB), Clinical and Laboratory Standards Institute (CLSI), Standards Coordinating Body for Regenerative Medicine (SCB), and the Association for the Advancement of Medical Instrumentation (AAMI); and

Meeting with ANSI and ANAB

Meeting with CLSI

Meeting with SCB

Meeting with AAMI

• Technical or Professional Consortia, such as the Advanced Medical Technology Association (AdvaMed) and Observational Health Data Sciences and Informatics (OHDSI).

Meeting with Chair of ISO TC 215 and A/VP of AdvaMed

Meeting with OHDSI

These engagements highlighted:

• Alignment of Standards Development Efforts: Both the U.S. and Singapore emphasise a patient-centric approach to PM, where robust standards are foundational to ensure safety, efficacy, and interoperability in emerging technologies like next-generation sequencing and genomic data management.
• Addressing Standards Gaps: The discussions revealed key areas for collaboration, including the development of standards for genomic data privacy, AI-driven healthcare solutions, and precision diagnostics, aligning with CoRE-SDO’s and BHSC’s strategic plan to spearhead innovation in PM domain through standardisation.

Bridging the Regulatory Landscape

For CoRE-SDO and BHSC, the trip underscored the importance of aligning regulatory frameworks with international standards. For instance, the FDA’s recognition of voluntary consensus standards as part of regulatory submissions highlighted a pathway for Singapore standards to gain broader acceptance.

Enhancing Regional and International Influence

The meetings also focused on opportunities for CoRE-SDO and BHSC to increase their engagement and influence within international standards committees such as ISO/TC 212 (Medical laboratories and in vitro diagnostic systems), ISO/TC 276 (Biotechnology) and ISO/TC 215 (Health Informatics). Deep participation in these committees will enable Singapore to contribute to emerging standards in genomics, regenerative medicine, and AI-driven healthcare tools, while ensuring alignment with the needs of the biomedical ecosystem in ASEAN.

A view from ODSHI office at Columbia University

Future Directions

Following the trip, CoRE-SDO and BHSC are set to deepen collaborations with U.S.-based SDOs and regulatory bodies. Key priorities include:

• Participation in International Standards Committees: Leveraging insights from the study trip to enhance Singapore’s contributions to ISO and other global initiatives.
• Advancing PM-related Standards: Addressing gaps in genomic data management, security, and interoperability to support cross-border healthcare solutions in PM.
• Enhancing Operational Management: Leveraging best practices from U.S. counterparts to improve the quality and efficiency of local operations.

Commitment to PM Excellence

The study trip reflects CoRE-SDO’s and BHSC’s unwavering commitment to advancing healthcare standards that enable innovation and safeguard public health. By engaging in the global PM landscape, we aim to drive standardisation, enhance patient outcomes, and position Singapore as a leader in precision medicine.

The Singapore Delegation, consisting of representatives from Enterprise Singapore Quality & Excellence, BHSC, and CoRE-SDO.