Representatives of the ASEAN Member States (AMS) and key government officials attended the 2nd Regional Meeting of the ASEAN Biobank Feasibility Study (ABFS) at Mactan, Cebu on September 5 to 7, 2023.
The ASEAN Canada’s Weapons Threat Reduction Program (WTRP), formerly Canada’s Global Partnership Program or (GPP), partnered with the Biological Risk Management Office of the Research Institute for Tropical Medicine (RITM-BRMO), to lead the conduct of a feasibility study to determine the need for a regional biobank in Southeast Asia.
During his welcome remarks, Senior Program Manager of the Biological and Chemical Security Weapon Threat Reduction Program of Canada Mr. Trevor Smith, recognized the leadership of Philippines and Singapore in the critical work that they are doing for biobanking.
He elaborated that “the presence of high-consequence pathogens around the world is a threat and is an opportunity for us to identify the ways to work together, to look at the secrets that are in these deadly pathogens, while at the same time, keeping these deadly pathogens out of the hands of those who would unfortunately do us harm.”
Mr. Smith encouraged the participants to pay close attention to the announcement that Canada’s Prime Minister Justine Trudeau will make at the 43rd ASEAN Summit on September 7, specifically on the level of commitment that Canada’s WTRP will be making in support of the next phase of the Mitigation of Biological Threats (MBT) program in the ASEAN region.
The Mitigation of Biologicals Threat (MBT) Program
Assistant Director and Head of the Health Division of the ASEAN Secretariat Dr. Ferdinal Fernando delivered and presented updates on the ASEAN Health Sector Cooperation on responding to all hazards and emerging threats, particularly the activities and achievements under the MBT Program Phase 2.
Dr. Fernando emphasized that the ASEAN Biobank Feasibility Study is currently operating under the overarching strategic direction of the ASEAN Health Sector through the ASEAN Post-2015 Health Development Agenda for 2021-2025, specifically the ASEAN Health Cluster 2 on Responding to All Hazards and Emerging Threats. Among the 21 health priorities that are distributed in the four (4) ASEAN Health Clusters, Mr. Fernando noted that the MBT Program is under the Health Priority 9 on Regional Preparedness and Response to Public Health Emergencies. He pointed out that Health Priority 9 is an additional health priority that has been endorsed by the ASEAN health ministers in May of 2022.
During his presentation, Dr. Fernando stated that “this biobanking initiative, together with other initiatives under ASEAN Health Cluster 2, as well as complimentary initiatives from other ASEAN Health Clusters, all point to the implementation of initiatives on public health emergencies and disaster health management, which encompasses the spectrum of preparedness, prevention, detection, and response; and operationalize through an all-hazards, whole-of-government, and whole-of-society approach. In other words, we are following the principles of One Health approach as well as One ASEAN, One Response.”
Dr. Fernando explained that the MBT program is the specific program looking into health security interface, with initiatives that aims to mitigate a wide range of biological threats, as well as future threats that could affect the regional capacities of the ASEAN Health Sector, as well the national capacities of each of the ASEAN Member States, in terms of responding to health threats, particularly those threats that are terroristic or bioterroristic in nature.
Out of the 142 project activities of the ASEAN Health Cluster 2 Work Programme for 2021 to 2025, Dr. Fernando highlighted that 45 project activities fall under the MBT component. He noted that MBT is a big program that is very well supported by the Global Affairs Canada through the WTRP, led by Mr. Smith.
Dr. Fernando emphasized that the ASEAN Health Sector hopes to utilize the impact of the MBT Program, including biobanking initiatives to the upcoming programs and activities in Phase 3, which is expected to begin in 2024 onwards.
In addition to the updates on the MBT Program, he also highlighted the following activities and programs developed and/or implemented under MBT Phase 2:
- ASEAN Emergency Operation Center (EOC) Network
- ASEAN Risk Assessment and Risk Communication Center (ARARC)
- ASEAN Plus Three Field Epidemiology Training Network (ASEAN+3 FETN)
- ASEAN BioDiaspora Virtual Center (ABVC)
- ASEAN Biosafety and Biosecurity Network
- ASEAN Leaders’ Declaration of One Health initiative
- ASEAN Center for Public Health Emergencies and Emerging Diseases (ACPHEED)
- ASEAN Public Health Emergency Coordination System (APHECS)
- ASEAN Health Sector COVID-19 Response: Scaled-up and sustained
- ASEAN Health Sector Governance and Implementation Mechanism
Dr. Fernando emphasized to the team that biobanking initiatives, including the results of the regional meeting, need to be coordinated through the ASEAN Health Cluster 2, reported to the ASEAN Senior Officials’ Meeting on Health Development (SOHMD), and elevated to the ASEAN Health Ministers’ Meeting, to determine direction in what to do in the recommendations of the feasibility study.
Biobanking in the ASEAN region
Shanghai Jiao Yong University Medical School, School of Public Health Expert and AFBS Core Group Member Dr. Cheong Io Hong focused on global trend developments in biobanking and presented case studies showcasing the impacts of biobanking to public and global health. He cited the different types of biobanks – population biobanks, tissue biobanks, blood biobanks, cell biobanks, organoid biobanks, and digital biobanks – and emphasized that although most diseases happen in the developing world, most biobank structures are found in developed countries.
He noted that this is of great interest to the World Health Organization which led to the establishment of a Biobank Cohort Building Network (BCNet). BCNet was created with the aim to bring global biobank partners together to create a network of sharing resources and to help establish a biobank cohort and network. Dr. Cheong also highlighted the impacts of the UK Biobank, various tools for viral diseases, the China National Genebank, and various databases such as the Virus Data Integration Platform (VirusDIP) and the National Pathogen Resource Center.
Meanwhile, security issues concerning a biorepository took the spotlight during the presentation of ABFS Core Group Member and Expert from the Department of Safety Health, Emergency Management Research Integrity and Compliance, Duke-NUS Medical School, National University of Singapore, Dr. Viji Vijayan.
Dr. Vijayan highlighted the far-reaching uses of biorepository such as (1) strengthening diagnostics by validating lab tests, (2) informing research and development (i.e., drugs like antibiotics and antifungals, diagnostic devices, tests, or assays); (3) performing testing to ensure drug effectiveness; (3) studying biology and pathogenic mechanisms; and (4) detecting new and unusual public health resistance threats. She also discussed the potential threat points when managing a biorepository and pointed out the importance of anticipatory governance and practices as technology may affect the types of biological material stored in the future. Dr. Vijayan stated that once established, ASEAN biobanks may be an easy target as regional differences may pose as a threat. During her presentation, she also showed a process flow on how to identify biosecurity risk as well as the vulnerabilities and effectiveness of mitigation measures on biosecurity.
Following Dr. Vijayan, National Implementation of the Verification Research, Training, and Information Center (VERTIC) Co-Programme Director Dr. Sonia Drobyz, talked about biosecurity and the relevant international and regional instruments for biosecurity.
Dr. Drobyz pointed out that there is no specific instrument related to biosecurity in the context of biobanking, but explained that biosecurity requirements from a number of international instruments are applicable to activities with biological agents and toxins, and are relevant for any biobank storing such agents and toxins. To develop a national biosecurity legislation, Dr. Drobyz noted the need to develop biosecurity measures in (1) detection, response and investigation of incidents/emergencies and security breaches; (2) enforcement measures such as inspections and investigations; and (3) offences and penalties for violations of the rules.
Dr. Drobyz’s presentation was followed by a discussion led by ABFS Co-Lead Dr. Raymond Lin from the National Public Health Laboratory of the National Center for Infectious Diseases in Singapore. Dr. Lin focused on the types of regulations, guidance, and framework governing biobanking in Southeast Asia and their limitations and challenges. He highlighted that most of the existing regulations cover general application and cannot capture the operational activities of collecting, storing, and referring isolates for further characterization. He added that existing guidance and framework does not address the safe and adequate way of sharing information. He also noted that each member state has different set of laws, regulations and guidance at different degrees to which they are addressed. Dr. Lin enjoined that there may be a need for international and regional regulations and guidelines to be ratified and applied nationally.
RITM National Reference Laboratory for Influenza Technical Supervisor Ms. Vina Lea Arguelles followed Dr. Lin’s presentation with updates on the establishment of ILI and SARI surveillance at RITM from 1998 to present.
In 2004, RITM was recognized by WHO as the National Influenza Center (NIC) with primary functions on (1) collect virus specimens in their country and perform preliminary analysis; and (2) ship representative clinical specimens and isolated viruses to WHO for vaccine composition. In 2014, RITM was designated as the Philippine National Influenza Center by the DOH through Administrative Order No. 023 s., 2014. Ms. Arguelles highlighted the significant contributions to surveillance and pandemic response of the ILI and SARI surveillance as well as the laboratory algorithm being implemented at RITM from receipt of specimens, case detection, storage of samples, and to release of results.
She further emphasized that there is a strong referral system of specimens from sentinel sites/disease reporting units to RITM. She also added that it is essential to continue doing virological surveillance and responding to other infectious diseases to consistently collect and store biological specimens that will be used to accelerate the research and development of diagnostic tests, vaccines, and to better respond to outbreaks and pandemics.
Results and Recommendation
The afternoon sessions of Day 1 were dedicated to the presentation and discussion on the overview, methods, results, and recommendations of the ABFS entitled “Employing a Feasibility Study as a Tool for Establishing a Regional Biobank of High-Risk Biological Agents and Emerging Dangerous Pathogens.”
ABFS Project Lead and RITM BRMO Head Mr. Plebeian Medina presented the activities and accomplishments of the study, followed by a discussion on the methods and results by ABFS Core Group Member and Laboratory Services and Biobanking of the International Agency for Research on Cancer (IARC/WHO) Head Dr. Zisiz Kozlakidis. The session was concluded with the presentation of recommendations from the study by ABFS Core Group Member and Laboratory Diagnostics Consultancy Clinical Microbiologist Mr. Alan Calaor, and a synthesis from Dr. Lin.
During his presentation, Mr. Medina highlighted the central question that the feasibility study aims to address – is it feasible to establish a biobank of high-risk pathogens in the ASEAN region? Through the conduct of the feasibility study, Mr. Medina highlighted the following achievements and accomplishments of the project:
- Gathered and organized a network of biobank and biosecurity experts in the ASEAN region which shall introduce the expansion of biobanking initiatives in individual countries;
- Developed a Biobank Feasibility Study Toolkit;
- Conducted a Feasibility Study in the Philippines, specifically at RITM;
- Published three (3) publications on biobanking for infectious diseases (Medina et al., 2022), laboratory readiness for biodefence and global health security (Adisasmito et al., 2022), and integrating research infrastructures into infectious diseases surveillance operations (Medina et al., 2022); and,
- Delivered oral presentation on enhancing the response to emerging infectious diseases in the Philippines at the ISBER Conference (Garcia et al., 2022).
This was followed by Dr. Kozlakidis’ presentation on the methodology and results of the ABFS project. Dr. Kozlakidis highlighted two issues: (1) the ASEAN region has no definitive unifying system and standards in biobanking of high-risk pathogens; and (2) fragmentation fosters the pre-conditions for risks in biosecurity.
He also emphasized that driven by the complexity of context and diverse aims of the study, they’ve employed both qualitative and quantitative methods, including a SWOT Analysis on the current state of biobanking in the Philippines. Dr. Kozlakidis stated that employing both methods allow the ABFS Core Group to cover a comprehensive set of themes and issues and allows participating member countries to highlight many of their ongoing activities. The challenge, he noted, is to bring all the rich information together and to reconcile the varying views of each member. Through the study, Dr. Kozlakidis highlighted the following results:
- The biobanking landscape in ASEAN is highly fragmented
- Islands of excellence exist and can become the foundation for the future
- Networks are limited in nature and membership, they can foster protocol harmonization
- Professionals are aware of biosafety and biosecurity aspects
- Professionals are aware with the idea of biobanking, not necessarily the practicalities
- The Philippines is in a strong position to further develop biobanking
Plenary discussions were also facilitated by ABFS Core Group Member and Biobanking Operations and Management Private Consultant Ms. Debra Garcia during the morning and afternoon sessions, where ASEAN AMS representatives and experts shared their inputs and experiences to various issues on biobanking and biosecurity.
The first day of the regional meeting ended with the proposed recommendations from the study presented by Mr. Calaor. During his presentation, he discussed four (4) major recommendations:
- Creation of National Biobank Council with administrative, operational, and representative role to the ASEAN Biobank Council
- Creation or identification of a National Biobank Facility
- Create a Universal Declaration of Sharing Biosamples Agreement in ASEAN Group
- Creation of ASEAN Biobank Council
The recommendations were supported by the group with experts looking forward to sharing their learnings and experiences to their respective health ministers and institutions, as well as to the next phase of the project.
During his synthesis, Dr. Lin highlighted the recommendation of Dr. Fernando to summarize the results of the study into a policy brief that should contain the Background of the Study, the Recommendations, and Concerns for Considerations. He also advised the group to set multi-year and/or multi-phase projections in terms of the activities and deliverables of the project. Dr. Lin also emphasized that the ASEAN is one of the important regions in terms of threat reduction on the spread of infectious diseases. He added that concerns on bioterrorism is prevalent in the region, highlighting the need for a regional biobank or a network of biobanks in the region. Dr. Lin noted that the meeting covered a wide-range of issues on handling emerging infections/pathogens as well as getting a closer look on each country’s experiences and challenges on biobanking and biosecurity.
The second day of the regional meeting was dedicated solely for the conduct of focus group discussions on essential components in establishing a biobank facility, intellectual concerns in biobanking, questions and strategies in implementing a biobank facility in association with ASEAN, creating standardized repositories for high-quality biospecimens, quality management systems, and the importance of community engagement. Further feedback on their experience and inputs to the presented recommendations were gathered from the participants.
Ways Forward
On the last day of the regional meeting, Mr. Medina convened the ABFS Core Group members together with the Program Coordinator of the Mitigation of Biological Threats Phase 2 of the ASEAN – Canada’s Global Partnership Program Mr. Michael Glenn, and Dr. Fernando (via Zoom) to review the project results and recommendations as well as to discuss the proposed ways forward for the MBT Phase 3 Proposal.
Following the successful completion of the MBT Phase 2, specifically the conduct of the feasibility study, Mr. Medina presented the proposed activities under the MBT Phase 3:
- Creation of single points of contact per AMS relevant to biobanking of high-risk pathogens;
- Endorsement of a regional framework for biobanking of high-risk pathogens under the umbrella of existing ASEAN structures (e.g., ACPHEED and/or One Health Network);
- Introduction of ‘twinning opportunities’ between recent and more mature facilities, with peer-to-peer visit of experts, driving knowledge transfer and the harmonization of practices;
- Creation of educational materials, dedicated to biobanking of high-risk pathogen relevant to the ASEAN context;
- Testing the educational materials by face-to-face delivery in dedicated workshops in the Philippines, incorporating trainee feedback; and
- Creation of a ‘National Biobank Council’ for high-risk pathogens, to review existing national health security frameworks, eventual endorsement into a national, functional body, in alignment with ASEAN frameworks and activities
Mr. Medina is set to attend the 2nd 2023 Mitigation of Biological Threats Program Coordination Meeting in Bali, Indonesia on September 21-23, 2023, to present the results and recommendations of the study and the proposed activities for the MBT Program Phase 3.
by Ma. Patricia M. Lansang