The 2023 Introductory Course for Biologics Development and Manufacturing kicked off on June 19 at the Seoul National University Shiheung Campus in Gyeonggi Province on June 19. Credit: IVI
The 2023 Introductory Course for Biologics Development and Manufacturing kicked off on June 19 at the Seoul National University Shiheung Campus in Gyeonggi Province on June 19. Credit: IVI
June 19, 2023, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) is conducting the 2023 Introductory Course for Biologics Development and Manufacturing for bio-R&D and production personnel from low- and middle-income countries (LMICs). The course, the second of its kind, is hosted by the Korean Ministry of Health and Welfare (MOHW) and organized by IVI to support LMICs in strengthening their biomanufacturing and infectious disease response capabilities by training human resources and to address global vaccine inequity. The course started with a kickoff ceremony at Seoul National University Siheung Campus in Gyeonggi Province on June 19 and will conclude on June 30.
235 trainees are participating in the course, including 205 from 47 LMICs and 30 from Korea, focusing on the theme: Technology transfer, talent development and facility management, and aseptic processing. The trainees are early-career professionals with 6 years or less of experience in private companies in the vaccines and therapeutics field, as well as participants from government and public organizations in LMICs including those participating in the mRNA technology transfer program led by WHO and the COVAX Facility. The course is offered free of charge (excluding travel expenses) with MOHW’s support. The 30 Korean trainees include officials from industry and students from universities who seek to broaden their professional skills, knowledge, and global networking experience.
The course covers the full cycle of vaccine research and development, production, and use, including immunology, vaccine technology, product development, preclinical and clinical development, quality control, intellectual property, product licensing, and vaccination, and features special lectures and case studies. The course is taught by a faculty team of more than 40 experts from over 15 organizations around the world, including IVI, WHO, CEPI, the Korea Disease Control and Prevention Agency’s National Institute of Health, Karolinska Institutet in Sweden, and the Wellcome Trust in the United Kingdom.
The course was prefaced by a week-long pre-training followed by the two-week offline training. This also includes a ‘Mini Convention’ for networking with Korean bio companies and field trips to leading bio companies and institutions in the country. As in the previous course last year, IVI aims to ensure that by the end of the training, all trainees will have mastered the basic and essential theories and gained the practical knowledge and skills necessary to operate a biomanufacturing facility.
The course is part of the Global Training Hub for Biomanufacturing (GTH-B) that IVI has been implementing in collaboration with MOHW since last year. In February 2022, IVI was designated by MOHW as the operator of the ‘Global Bio Intensive Training Courses,’ a workforce training program supported by the Korean government to address global vaccine inequity and strengthen pandemic preparedness. At the time, Korea was designated by WHO as the world’s only GTH-B tasked with providing training to help LMICs sustainably produce their own vaccine and biologicals.
Facing significant inequalities in access to vaccines and biopharmaceuticals, LMICs have been stepping up efforts to establish a biopharmaceutical manufacturing base in their countries. Last year, WHO designated South Africa as an mRNA vaccine technology transfer hub to promote local production of vaccines in LMICs. However, efforts to build this manufacturing capacity, whether through bilateral technology transfer or local R&D, have been hampered by the lack of a trained workforce. To help countries overcome these challenges, MOHW established the GTH-B with the support of WHO and the WHO Academy.
In his congratulatory remarks, Seung-hyun Hwang, Director General of the Global Vaccine Hub Office at MOHW said, “I hope this training will contribute to improving vaccines and biopharmaceuticals manufacturing capacities in LMICs.” He added, “In the second year of the GTH-B initiative, Korea will spare no effort to build infrastructure such as the Global Bio Campus, expand practical training, and cooperate with international organizations to foster a sustainable global vaccine manufacturing workforce.”
Strengthening vaccine-related capacities in LMICs is a core part of IVI’s mission. As the only international organization dedicated to the discovery, development, and delivery of vaccines for global health, IVI has robust experience and capabilities to provide quality training in vaccine R&D, technology transfer, biomanufacturing and capacity building. Since 2000, IVI has organized the IVI International Vaccinology Course annually to train a total of more than 3,000 professionals worldwide.
Korea has globally competitive bio companies with excellent manufacturing capabilities in addition to a strong training infrastructure and a government committed to developing the nation’s bio industry while supporting LMICs. Dr. Jerome Kim, Director General of IVI, said, ”Through the GTH-B project, we are synergizing Korea’s excellent bioindustry infrastructure with IVI’s demonstrated capabilities to provide high-quality biomanufacturing training. To help increase local production of vaccines and biopharmaceuticals in LMICs and address the global vaccine access gap, IVI will continue to collaborate with MOHW, WHO, and Korean and global industry partners.”
Last year, IVI trained a total of 325 people through the first Introductory Course for Biologics Development and Manufacturingand Introductory Course for Standard Practice (GxP). The institute also conducted three overseas on-site training sessions, including one in Bangladesh and two in South Africa. Additionally, IVI just completed GTH-B on-site consulting in Kenya in late May of this year and will conduct the second Introductory Course for Standard Practice this fall.
####
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.
IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO), and developed a new-generation typhoid conjugate vaccine that is currently under assessment for WHO PQ.
IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.
Awardees and dignitaries pose for a commemorative photo at the 2024 IVI – SK bioscience Park MahnHoon Award Ceremony at the Plaza Seoul Hotel on April 25, 2024. From left: Mr. Jae-Yong Ahn, President of SK bioscience; Dr. John Clemens, first Director General of IVI; Dr. Lars Hammarström, Head of the Office of Science & Innovation, Embassy of Sweden in Korea; Dr. Youngmee Jee, Commissioner of the Korea Disease Control and Prevention Agency; Prof. Jan Holmgren, Prof. Jason McLellan, Prof. Barney Graham, Dr. Jerome Kim, Director General of IVI; and Ms. Joy Sakurai, Deputy Chief of Mission, US Embassy, Seoul. Credit: IVI
Date:Tuesday, 29 November 2022
Objectives:
A total of 39 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 7 was to:
Session 15: Presentation of Formative Evidence Brief for Policy
The final Webinar/Session focused on the Presentation of Formative EBP. Participants from Bangladesh, Malawi, Nepal, and Uganda presented their EBP, with a peer review, and feedback and comments from the EVIPNet/K2P team. The session finished with reflections on the next steps, including the potential for scale-up.
Wrap-up and closing
Date:Thursday, 10 November2022
Objectives:
A total of 39 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 6 was to:
Feedback from country teams on preparatory work/progress to date:
Uganda, Malawi, Nepal briefly shared progress and EVIPNet/K2P team commented on the progress.
Webinar Session 13: Organizing a policy dialogue presented by EVIPNet-K2P Center, focusing on how policy dialogues influence the use of evidence in health policy and decision-making including:
Considerations for conducting policy dialogues, i.e., does the dialogue address a high priority issue? Does it provide opportunities to discuss/address the issue, and considerations for implementation? Is there fair representation among those involved in/affected by future decisions related to the issue? Are follow-up activities undertaken to support action?
Preparation for policy dialogues, i.e., informed by pre-circulated evidence on the policy issue.
Stakeholder selection, i.e., degree of involvement in/knowledge about the issue and relevant solutions; ability to constructively engage in discussions; ability to take forward recommended actions within respective constituencies; and the importance of the dialogue facilitator’s role.
Dialogue summary, i.e., tools to outline the results of the discussions during the policy dialogue; and post-dialogue summaries.
Session 14: Data visualization and role of media in policy-making
Group or individual work with support from EVIPNet/K2P
The webinar ended with Group work based upon Session 14.
Wrap-up and closing
The final Webinar (#8) will be a Simulation Meeting: Presentation of Formative EBP, with the objective:
To present the draft formative EBPs among countries teams (peer review)
To propose outreach strategies for EBPs
To reflect on next steps (including potential for scale up)
Preparatory work (prior to Webinar 8): To complete the formative EBP
Presentation slides are available here
Date:Thursday, 27 October 2022
Objectives:
A total of 42 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 5 was to:
Feedback from country teams on progress to date (10 minutes per team)
Uganda, Malawi, Nepal briefly shared progress and EVIPNet/K2P team commented on the progress.
Webinar 6 provided a ‘Refresher: from problem statement to policy options‘ on the content of Evidence-to-Policy Briefs (EBP) including the problem statement, options and elements, and implementation considerations; framing the problem, clarifying its underlying causes, the appropriate types of evidence to use in framing problems, and framing, developing, and expanding on the options/ elements to address the problem. The refresher session finished with ‘Case examples’.
The webinar then focused on
Session 11: Identifying Key Implementation Considerations Framing presented by EVIPNet-K2P Center. Session 11 included: approaches to policy implementation (i.e. ‘top-down’ and ‘Bottom-up’); identifying and addressing barriers to implementing policies; health system, and social and political constraints; and tips on developing the implementation considerations.
Session 12: Overview of EBP outline (and semi-structured interviews/litmus) including: the policy brief outline, e.g., identification of how the problem related to risk factors/disease, to a program or service, and/or to the current health system; viable policy or programmatic options to address the problem; and potential barriers that could influence implementation policy options. The session also covered: stake- holder selection framework for litmus testing, and semi-structured interviews with stakeholders.
The next steps for countries include:
To agree on preliminary timeline for the updated policy brief outlines
To coordinate with assigned team lead for each country team
Group or individual work with support from EVIPNet/K2P
The webinar ended with Group work – using the EBP template – based upon Sessions 11 and 12.
Presentation slides are available here
Date:Thursday, 15 September 2022
Objectives:
A total of 51 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 4 was to:
The introduction to the webinar provided: an Overview of methodologies to measure antibiotic use, and the use of surveillance data; the link between AMR and use of antimicrobials; and the integrated national action needed on optimal use of antimicrobials, including through data, surveillance, and monitoring.
The webinar then focused on Session 10: Framing Viable Policy Options to Address a Problem: A Step-by-Step Guide presented by EVIPNet-K2P Center. Session 10 included: Content of EBPs (i.e. problem statement, options or elements, and implementation considerations); Developing options/elements to address the problem (i.e. policy options, and health system/governance/financial arrangements/delivery arrangements); Steps for developing options/elements to address the issue (literature review, thematic analysis, tailoring to the country issue/context, and selecting 3-4 options); and practical examples of AMR and underlying causes to policy options.
A Q&A session followed, with questions on the behavioural and economic dimensions of policy response and options; the specificity and feasibility of options; and appropriate types of research evidence for developing options.
The webinar ended with Group work – with support from EVIPNet/K2P and using the EBP template to:
Identify 3-4 policy options/elements to address the problem and its underlying causes
Date:Thursday, 8 September 2022
Objectives:
A total of 57 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
Webinar 4 began with the ‘Feedback on preparatory work’ outlined in Webinar 3, which was to:
Dr Fadi El-Jardali from the American University of Beirut updated participants on the progress of the four countries including: on the topics selected (Uganda on irrational antibiotic use; Nepal on AMR National Action Plan (NAP) implementation [adjudged to be more about the solution than the problem]; Malawi on the utilization of AMR evidence generated at facility/national level and translation into policy [also more about the solution than the problem]; and Bangladesh, which had not yet been reviewed. The review also included country search strategies. The feedback included questions from participants.
The webinar then focused on the next (of the 15) training sessions:
Session 9. Preparing the EBPs: clarifying and framing the problem including:
Knowledge Translation (KT). Which facilitates the process of translating research into policy and action; and KT products which allow evidence generated from systematic reviews – the basic units of KT – to be packaged in a user-friendly format, written in clear language, and with key messages to increase the likelihood of adoption by policy-makers, and resonance among different target audiences. The use of systematic reviews enable policy-makers to scan large bodies of research evidence to address key features of any policy issue of interest.
– Problem statement: A policy problem that summarizes the best available evidence to clarify the size and nature of the problem and its underlying causes.
– Options or elements: Three or more viable policy and programmatic options described.
– Implementation considerations: Potential barriers to implementing the options/elements and strategies for addressing those.
The EBP does not provide recommendations for action.
The remainder of Webinar 4 featured the Group work exercise facilitated by Racha Fadlallah from K2P Lebanon (and support from EVIPNet). The group work comprised four groups – one for each country (including representatives from WHO country offices, and observers from EVIP/RADAAR) – with the aim:
A template was provided by EVIP facilitators (based on the presentation from Session 9) with sections for completion by country groups.
Presentation slides are available here
Date:Thursday, 25 August 2022
Objectives:
A total of 59 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
Webinar 3 began with the ‘Feedback on preparatory work’ outlined in Webinar 2, which was to:
Fadi El-Jardali from the American University in Beirut updated participants on the progress of the four countries and provided further guidance for countries on completing these two crucial stages. Malawi was used as an example applicable to other countries, in terms of structuring thinking in relation to identifying the issue, the political context, what has already been done in terms of AMR, what is missing and why, and stakeholder mapping. Country participants summarised their experiences. The feedback ended with a discussion on the priority areas of focus for the Evidence Brief for Policy (EBP), with updates from countries.
Following feedback reporting, the webinar focused on the next two (of 15) training sessions:
Session 7. Designing search strategies to identify and access research evidence on priority topics including: the importance of effective searches (6,500 medical articles published daily); the use of ‘Boolean Operators (e.g., And, Or, Not); identification of search terms; building a search strategy, including formulating the question/issue, choosing appropriate databases, dividing the question/issue into 2 or 3 concepts, generating search terms for each concept, and combining concepts – and search terms within concepts – using Boolean operators; and validating/documenting the search.
An example of a ‘search’ template was presented, and which participants would complete in the group work at the end of the webinar. The template included: the Problem/Issue being addressed, the Options, the Concepts, the Search terms for each concept, and Combining concepts using Boolean operators
The importance of collecting the best available evidence for EBPs was stressed: local evidence and global research evidence from systematic reviews. Guidance was provided on where to search for such information, including local and national databases, websites of relevant organisations, search engines, ‘grey’ literature, and systematic reviews.
Session 8: Understanding the role of systematic reviews in influencing policy decisions including: the Concept of a systematic review; key databases to search – and how to search – for reviews (e.g., Health Systems Evidence, Cochrane, PubMed); a live demonstration of a search on Health Systems Evidence and PubMed databases; and assessing the quality of reviews (e.g., using AMSTAR).
The remainder of Webinar 3 featured the Group work exercise facilitated by Racha Fadlallah and
Lama Bou Karroum from K2P Lebanon (with support from EVIPNet). The group work was comprised of four groups
– one for each country (including representatives from WHO country offices, with observers from EVIP/RADAAR) – with the aim: To develop a search strategy and search key databases for systematic reviews.
A template was provided by EVIP facilitators (based on the presentation from Session 7) with sections for completion by country groups as follows: the Topic/Issue being addressed, the Concepts, the Search terms for each concept, Combining concepts using Boolean operators, and the Databases searched.
Date:Thursday, 18 August 2022
Objectives:
A total of 65 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and WHO.
After a brief introduction, Webinar 2 began with ‘Feedback on preparatory work’ outlined in Webinar 1:
The EBP Team is responsible for developing the EBP and conducting key informant interviews (KIIs), hence an appropriate mixture of expertise is key to a successful team, including members with experience in: methods of writing an EBP; administration; evidence search, appraisal and synthesis; technical expertise on the topic being addressed in the EBP; and communication. Each country must also appoint an EBP steering committee to support the EBP development process, comprising: 4-6 multisectoral, multidisciplinary and high-level stakeholders from government/policy-makers/researchers knowledgeable in the topic and able to contribute to the development of the EBP for AMR.
Each of the four countries reported briefly on the steps taken to form the Core Team, Steering Committee, and in identifying AMR stakeholders (some countries had also informed RADAAR/EVIP prior to the Webinar via email).
Following reporting, the Webinar focused on the next two (of 15) training sessions:
Session 5. Understanding the political and health system and outlining key areas to keep in mind when mapping the policy and political context including: the importance of context-specific and actionable evidence, in particular the political/policy context (e.g., characteristics of government structures, civil service – and interests of – policy-making stakeholders, societal values and external factors, such as social and economic); and health system context (e.g., evidence on health system inputs, processes, and outputs and the analysis of how they combine to produce outcomes, such as – the WHO defined – service delivery, health workforce, information, medical technologies, finance, and leadership/governance).
Session 6:Stakeholder mapping including: on stakeholder interests, i.e., concerns over how a policy may impact them; their positions, i.e., degree of agreement or disagreement with the policy; and their power, i.e., capacity to influence policy. The steps in stakeholder mapping include: defining the goal and implications of the proposed policy change; listing interest groups involved in the issue; categorizing stakeholders according to their influence and power over, and level of interest in the issue; determining a strategy to engage relevant stakeholders; conducting KIIs; and presenting stakeholder analysis.
Stakeholders identified include: decision-/policy-makers (e.g., ministries, government agencies, parliamentarians, municipalities); influencers (e.g., NGOs/CSOs, religious leaders, media, private sector); and the public (e.g., those affected by AMR).
A case example from Ghana was presented to highlight the steps in stakeholder mapping.
Webinar 2 concluded with a Group work exercise (with support from EVIPNet/K2P)
Group work was comprised of four groups – one for each country (including representatives from WHO country offices) – with the aim of:
A template was provided by facilitators with nine questions to capture the above details including: the issue; progress made in addressing the issue; previous related policies/laws/regulations; whether the issue is on the government agenda; windows of opportunity; requirements to reach the policy objective; how laws/regulations are implemented to this purpose; stakeholders involved; and the power interplay among/between stakeholders. The questions provided background information to enable completion of full ‘Stakeholder Mapping’ template (including stakeholder, description, name, power, interest).
Date:Thursday, 11 August 2022
Objectives:
A total of 88 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and WHO.
After an introduction to evidence-informed policy-making (EIP) and EVIPNet, Webinar 1 included the first four (of 15) training sessions:
Session 1. Brief overview of the policy-making process including: promoting the use of research evidence in policy-making to improve health systems; increasing country capacity in/institutionalising knowledge translation (KT); approaches to increase research utilization; developing evidence briefs to inform health policy deliberations, and assess the impacts of policy options; and the evidence-action cycle, including priority-setting, evidence, convening deliberative dialogue, and policy implementation.
Presentation slides are available here
Session 2: Understanding role of evidence in policy-making process and efforts to support use of evidence in policy-making including: policy process overview; major public policy theories/frameworks; stages in public policy making, i.e., definition, agenda setting, and policy instruments/implementation/ evaluation; importance of robust research/data/evidence, as well as KT tools/strategies; and enhancing awareness/capacity of, and engaging policy-makers/stakeholders early, and sustaining engagement.
Session 3: Knowledge generation and knowledge translation as a spectrum: evidence on establishing and/or strengthening national health research system using a systems approach and the need of cross evidence ecosystem collaboration including: the National health research system (NHRS); WHO guides/ tools; key workstreams of the evidence ecosystem, i.e., partnering for complementary support in decision-making; HO workstreams, i.e., data analytics, guidelines, health technology assessment (HTA), evidence-informed policy-making supports, modelling, and behavioral research; and the evidence ecosystem framework and policy/action cycle.
Session 4: Learning from success stories of EVIPNet Member Countries: development of evidence briefs for policy on AMR including: Slovenia case study on ‘Translating AMR data and evidence into effective policies (EBP development); driving factors, challenges, and lessons learned; importance of a multi-level/sectoral approach; the need to integrate local evidence; the crucial role of Ministries of Health to put options on the political agenda (and sufficient capacity within the MoH and NIPH).
