Does Southeast Asia have a growing role in vaccine development? – Pharmaceutical Technology

Seoul will trade gatherings at its famous royal palaces for meetings at two key clinical trial events to be hosted next month.

The 9th Annual Clinical Trial Supply East Asia 2024 and 9th Annual Outsourcing in Clinical Trials East Asia 2024 will run concurrently at the JW Marriott Hotel in the South Korean capital city from 3 to 4 December to discuss key takeaways for clinical trial operation, as well as discussions about regional pharmaceutical business in Asia.

The two events will open with shared sessions, including a presentation by Novotech’s clinical services senior Chris Chong on advancing vaccine development in a post-pandemic world. Set against the backdrop of uncertainty in the US after President-elect Donald Trump decided to appoint vaccine sceptic Robert F Kennedy Jr as head of the Department of Health and Human Services (HHS), Chong will give an overview of the vaccine trial landscape.

As per the theme of the two conferences, Chong will also explain how to leverage Southeast Asia in vaccine development – companies in South Korea, for example, have undergone several manufacturing upscales recently to increase product output.

Clinical trial supply

In the stream looking primarily at streamlining and protecting supply chains, sessions during the first day will look at navigating challenges that may arise during clinical trial supply, as well as choosing the right contract development and manufacturing organisation (CDMO) for the highly promising space of cell and gene therapy.

A panel then takes to the stage in the afternoon to discuss the importance of orchestrating global supply chains to overcome potential delays. With Fiona Barry, editor-in-chief and director of PharmaSource at GlobalData; Baek-Jae Kim, country manager Korea at IATA; and Kang-Pyo Lee, vice president at Hanul TL, as speakers, the session will investigate strategic partnerships and factors to consider when outsourcing certain supply chain processes. A session on the second day looks ahead to 2025, with Barry returning to highlight opportunities, and indeed threats, in the new year.

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Outsourcing in clinical trials

It’s not long after breaking into the two streams on the first day that the hottest topic in healthcare is tackled – AI. Daewoong Pharmaceutical’s AI drug discovery team leader Seungwoo Shin will outlay in Stream A how to use AI models to identify pharmaceutical compounds of therapeutic potential and implement machine learning to optimise lead candidates. AI is set to transform drug development, with biotechs that use AI-led drug pipelines seemingly enjoying higher investment attraction.

The afternoon panel discussion, with speakers Moon H Kim, chief technical officer at InnoCure Therapeutics; GSK’s Asia Pacific clinical quality assurance director Maggie Lim; and Seongyun Bang, chief development officer and vice president at SPARK Biopharma, will deep dive into the industry landscape. Touching upon medical strike impacts, the latest points in the regulatory arena, and financial considerations, the panel will provide delegates with key takeaways and solutions for clinical trial operations.

The second day will play host to a talk on biologics and biosimilars, a space quickly becoming lucrative as patient access becomes a principle of growing importance in the drug industry. Aprogen director Hyerim Lee will cover requirements for submitting a clinical trial application to the European Medicines Agency (EMA) and items to consider when developing biosimilars

Converging guidance

The two streams will once come together as the event draws to an end, with Vasee Moorthy – R&D senior adviser at the World Health Organization (WHO) – conducting a session on the WHO’s 2024 clinical trial guidance. Published in September this year, the guidance aims to strengthen clinical trials to ensure well-designed and well-implemented studies. Moorthy will outline key aspects from the guidance, including regulatory and ethical frameworks, data transparency, and streamlining approval while maintaining safety.

Before the chairperson’s closing remarks, there will be two speaker-hosted roundtables discussing inspection readiness and contract research organisation (CRO) sponsorships.

Clinical Trial Supply East Asia 2024 and Clinical Trials East Asia 2024 will take place at the JW Marriott Hotel in Seoul, South Korea, on 3 and 4 December. Information and registration can be found on the Arena International website.