Interview with Dr. Christine Guillard, Knowledge Management Advisor, Office of the Director Regulation and Prequalification Department, World Health Organization
We learned from COVID-19 that expanding the production capacity of vaccines and medicines and strengthening regulatory systems are critical to reducing health inequalities in low- and middle-income countries. But getting facilities up and running requires not only investing in infrastructure and supplies, but also in a knowledgeable workforce. Last year, the Republic of Korea and the World Health Organization established the Global Training Hub for Biomanufacturing to provide vaccine manufacturing personnel and officials from government and public organizations with a more comprehensive training of the manufacturing process. In an interview, Dr. Christine Guillard, WHO Knowledge Management Advisor, explains why they developed this program, how it works, and what’s next for strengthening health systems.
What are the 3 things that need to change to bring the manufacture of vaccines and biologics to low- and middle-income countries?
First, there needs to be more commitment and sustained support from governments. Fiscal budgets allocated to these activities are not enough to make a lasting impact.
Second, there isn’t a deep enough understanding of the manufacturing ecosystem, which requires a holistic approach in terms of legislation, policy, and regulation. Developing capacity for vaccine manufacturing can’t be done in isolation. Collaboration has to happen across science and technology, intellectual property, education, and health for a conducive ecosystem.
Finally, there is also a huge need to build capacity and capabilities—we don’t have enough competent workforces to develop and produce vaccines and medicines in developing countries. The ones we do have don’t all possess the skills and knowledge needed to cover the entire spectrum of manufacturing, from research and development to manufacturing to quality assurance.
When it comes to a competent workforce, what was the WHO’s initial thinking in planning for a global training hub?
The need for vaccine manufacturing training is significant, so finding effective ways to work together is essential. Just look at the African continent. The African Union aims to develop, produce, and supply over 60 percent of the total vaccine doses needed across the continent by 2040. Achieving this ambitious goal will require more than 10,000 individuals to be trained. We can expect comparable figures in other parts of the world.
To address this gap, WHO established a special initiative on the area of workforce development in biomanufacturing—the WHO Biomanufacturing Workforce Training Initiative—which relies on existing capacity-building activities within the organization to be complemented by a network of training hubs covering hands-on trainings in industrial-like settings. The first training hub is this one in the Republic of Korea. To address geographical diversity and languages issued, more centers will be identified. We want to ensure the training hub in the Republic of Korea and regional training centers are aligned and complementary and not competing with each other.
The WHO is well-positioned to collect and gather information from Member States to identify weaknesses and translate these needs into quality courses and training programs. We also disseminate and promote the activity of regional training centers to all stakeholders and member states and facilitate the networking among the centers to really synergize the effort because there is no point to enter into any competition. The need is just so great.
But aren’t there already training centers for vaccine manufacture?
Manufacturing vaccines requires a broad range of specialties, and one needs to learn in an environment that mimics the actual conditions. However, most biomanufacturing training facilities are located in high-income countries. They operate on a fee-based system so usually they are costly and out of reach for trainees from low- and middle-income countries.
The Republic of Korea has vast experience producing vaccines, and they have an extensive range of training facilities and offer a full spectrum of biological manufacturing programs. Since the WHO can’t run these hands-on training programs, the Ministry of Health of the Republic of Korea and WHO became ideal partners. These programs are affordable and continuously adapted to the latest industry developments, focusing on learning in an industry-like setting.
How does this global training hub prepare trainees to go back home to recruit, upskill, and retain employees?
This is a really important point, and it’s something that we are actively working on with our colleagues in the Republic of Korea. To be effective, the number of trainees per hands-on training session is limited. So we have adopted a “training the trainer” approach to ensure employees who go through the training know how to disseminate newly acquired knowledge and skills within their facilities.
Additionally, as part of the selection process for this training hub or other regional training centers that we will establish, we expect those institutions to have strong partnerships with local universities in their countries, which serves two purposes. First, collaborating with local universities to build into the curriculum the relevant skills and knowledge needed in the biotechnology sector will help develop a more robust next-generation workforce. Second, partnerships with higher education institutions will make it easier to establish alternative credential programs for upskilling and reskilling an institution’s current workforce and support career development. We are looking for institutions who keep an eye on the future.
The feedback from initial participants has been very positive. What are your projections for the future?
The initial selection process began in February 2022, and so far, over 800 professionals from low- and middle-income countries have gone through the training, which included some hands-on training and courses in manufacturing best practices and vaccinology. Once the Republic of Korea expands this into a global campus by the end of 2024, they will be able to offer 300 people per year the intensive, hands-on training in laboratories, which is typically done in small batches of 12-20.
This interview has been edited for length and clarity.
Published in December 2023
Dr. Christine Guillard is the Knowledge Management Advisor for the WHO’s Regulation and Prequalification department. She develops strategies, policies, and mechanisms aimed at promoting the capacity of regulatory authorities and other stakeholders to undertake their functions and thereby help ensure that health products are safe, effective, and quality-assured.
Dr. Guillard’s career spans both the public and private sectors. She spent the first 10 years in the pharmaceutical industry, in charge of the clinical development of new drugs for non-communicable diseases. She then moved to the public sector, joining the Special Programme for research and training in tropical diseases of the WHO in 2007. Dr. Guillard joined the Global Vaccine Safety Team, WHO Geneva in 2011, and supported member states in strengthening their capacities in vaccine pharmacovigilance, through the coordination of the Global Vaccine Safety Initiative and also managed active vaccine safety research projects in pregnant women and infants.
Christine Guillard is Pharm D by education, specialized in clinical research, pharmacovigilance and public health, and holds a Master of International Public Health.