As the second day of the World Bio Summit 2023 unfolds in Seoul, Korea, global leaders convened to address the heightened need for swift and collaborative efforts in the fight against infectious diseases.

The second session, which started on Tuesday morning, focused on accelerating pandemic therapeutic development and manufacturing.

In the aftermath of the Covid-19 crisis, there is a shared global commitment to pioneer advancements in the rapid development, production, and distribution of therapeutics for future pandemics.

Participants from various sectors, including the biotech industry, government bodies, international organizations, and foundations, will present forward-looking strategies and visions for combating emerging infectious diseases.

Laurent Muschel, the Acting Director-General of the European Health Emergency Preparedness and Response Authority, opened the session with a focus on enhancing pandemic preparedness and response through therapeutics.

He outlined three central topics -- strengthening capacities for pandemic readiness, advancing translational technologies in development, manufacturing, and supply, and adopting a global research approach.

"While vaccines have been central to the Covid-19 response, therapeutics have played a crucial role in saving lives and will continue to be essential," Muschel said. "Especially given the uncertainties of future pandemics and the challenges seen with diseases like HIV where efficient vaccines are still awaited."

Muschel highlighted the importance of continued public support and investment in developing treatments.

"The need for global cooperation, extending beyond regional support mechanisms, to ensure that new treatments and technologies are available and accessible during health crises is of the utmost importance," Muschel said.

Carmen Pérez Casas, Unitaid's Senior Strategy Lead and Head of PPPR (Pandemic Prevention, Preparedness and Response), talked about ensuring equitable access to lifesaving tools to low- and middle-income countries (LMICs).

"Our approach to pandemic preparedness hinges on three fundamental aspects -- Preparation, Innovation, and Collaboration," Casas said. "We must integrate these into the fabric of our strategy to ensure rapid development and distribution of therapeutics."

According to Casas, the recommendations Unitaid gathered from our global consultation emphasize a concerted effort towards novel business models.

"These should prioritize accessible monoclonal antibodies in LMICs (low- and middle-income countries), with a focus on strategic partnerships, intellectual property management, regulatory pathways, and shaping the market to serve public health needs," she said. "LMICs face significant barriers in accessing monoclonal antibodies, which are essential in treating infectious diseases."

These barriers range from affordability and supply chain complexities to regulatory challenges and a need for better market data to inform policy and investment, she added.

Casas stressed that access should not be an afterthought in the pandemic response.

"It is essential to develop products with access in mind from the outset, secure dedicated financing, and coordinate medical strategies effectively to ensure prompt deployment," she said.

World Health Organization(WHO) Unit Head Local Production & Assistance Unit Jicui Dong outlined the complexities and strategic efforts surrounding access to pharmaceuticals during her presentation.

"Access to medicines is a multifaceted challenge, influenced by factors such as insufficient R&D, concentrated production capacities, and misaligned demand and supply," she said. "The Covid-19 pandemic highlighted these issues, as production was concentrated in just a few regions, affecting universal health coverage and the achievement of Sustainable Development Goals (SDGs)."

Affordability and availability are two major pillars of accessibility and access is limited when health products are available but not affordable, or vice versa, she added.

Dong stressed that WHO is working hard to support member states in improving access by strengthening pricing policies, updating the WHO Model List of Essential Medicines, and supporting regulatory reliance, convergence, and harmonization."

"Local production and technology transfer are essential," she said. "The WHO's WHA74.6 resolution emphasizes the strategy of local production and technology transfer to improve equitable access."

Local production is not just about a single country as it encompasses national and regional production, she added.

Dong also explained that capacity building is crucial to ensure quality.

"Since 2020, WHO has conducted good manufacturing practice (GMP) training to provide in-depth topics and quality assurance to manufacturers and regulators, with programs like GMP eLearning to complement existing resources," Dong said. "WHO's Global Training Hub for Biomanufacturing, in partnership with Korea, offers technical assistance to manufacturers for quality and sustainable production."

In our collective effort to promote access, WHO's role includes coordinating global partnerships, providing technical assistance for local production, and ensuring that technologies are transferred effectively, she added.

Third session focuses on diagnostics

Amidst the concluding phases of the Covid-19 pandemic, the third session was centered on international support for in-vitro diagnostic industry growth.

The session focused on discussions pivoting towards enhancing global health capacities, as underscored by the 76th World Health Assembly's recent resolutions.

Korea's diagnostic acumen, recognized for its potential to fortify global health systems and promote health equity, sets the stage for discussions on its anticipated role in the global healthcare framework.

During the initial presentation, Willo Brock, Executive Vice President of FIND, emphasized the vital role of diagnostic testing in preparing for future pandemics and how primary healthcare testing is where there is a high unmet medical need.

"Without the ability to diagnose common infectious diseases, it would be impossible to identify new pandemics," Brock said.

Brock highlighted the 11 pillars of developing diagnostic tools, including rapid tests and platforms, which are part of FIND's mission to lead the development of diagnostic workflows for future pandemics.

He called this a "100-day mission," a sprint to prepare for the next outbreak, and stressed the importance of groundwork as a marathon that needs collaborative effort before the sprint begins.

The expansion of markets for In Vitro Diagnostics (IVD) was discussed, particularly the potential for the Korean industry to extend its reach into LMICs, leveraging opportunities presented by the COVID-19 pandemic and other diseases like tuberculosis, malaria, and HIV.

Brock also spoke about innovative procurement modalities, the need for integration of diagnostics into the wider healthcare system, and the importance of resolutions like the World Health Assembly Resolution on diagnostics.

He concluded by highlighting Korea's potential in the global diagnostics market, urging Korean companies to take leadership positions and join the ranks of other prominent industry partners.

Catharina Boehme, WHO's Assistant Director-General, External Relations and Governance, underscored the urgent need to address the global disparity in diagnostic access, the significance of diagnostics in managing health crises and diseases, and the collective effort required from states and industry stakeholders to integrate and strengthen diagnostic capabilities worldwide.

"Diagnostics have often been the Cinderella in the room – the forgotten but essential tool," Boehme said. "The Covid-19 pandemic has really served as a wake-up call for the public and has shown very clearly the value and importance that diagnostics play in a pandemic situation."

About 50 percent of the global population has very little access to diagnostics and there is a need to change that, she added.

Boehme stressed that WHO's individual member states have recognized this and have put forward and approved a resolution to strengthen diagnostics capacity on a global level,

"This call to action this resolution for diagnostics is basically describing actions that countries can commit to take to drive access," she said. "For us at WHO, when we look at the Sustainable Development Goals 2030, diagnostics are an important element to achieve the objectives."

"The market for diagnostics is not easy and WHO has formed a task force in response to the resolution that our member states published earlier this year," she said. "On this pathway to creating uptake of critical testing, of making diagnostics available everywhere and to everyone, we need your help."

Final session spotlights CEPI 100-day mission

Finally, the summit spotlighted the Coalition for Epidemic Preparedness Innovations (CEPI) 100-day mission, advocating for effective strategies and international cooperation to counter both pandemic and endemic infectious threats.

"There is an importance of learning from past pandemics and preparing for future outbreak," Jane Halton, Chair of CEPI Board, said. "The 100-day mission aims to have a vaccine ready within 100 days of identifying a novel viral threat."

She described the initiative as ambitious yet realistic and necessary for a safer future and explained that a timely vaccine could have dramatically reduced the toll of Covid-19 and saved lives and economic loss.

Halton stressed that while case numbers and death rates from Covid-19 are waning, the collective desire to move on must not lead to complacency.

"The dangerous cycle of panic and neglect that has historically followed pandemics and stressed the importance of learning from each event," she said.

Halton emphasized Korea's exemplary response to severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS), demonstrating the value of learning and preparation.

Halton cited Korea's ability to apply those lessons to the Covid-19 response as an example for the world and urged that the Covid-19 pandemic should remain in our collective memory to prevent the repetition of past mistakes.

In closing, Halton expressed optimism that with sustained investment in vaccine research, development, and manufacturing, along with robust international cooperation, the world can be better prepared for future health threats.

She reinforced the belief that despite the challenges, there is good reason for optimism in the fight against pandemics.

The session also included talks about collaboration efforts by companies and institutions with CEPI, including the International Vaccine Institute, Korea Disease Control and Prevention Agency, Italy's Vismederi, Indonesia's Bio Farma, SK bioscience, and the University of Queensland in Australia.