SEOUL, South Korea, Sept. 3, 2025 /PRNewswire/ — This is an article published in The Korea Herald:
The Ministry of Food and Drug Safety announced Wednesday that it kicked off Global Bio Conference 2025, under the theme "Bio, Navigating Infinite Possibilities."
The conference will be held from Wednesday to Friday at the Grand InterContinental Seoul Parnas in southern Seoul.
Celebrating its 11th year, GBC has established itself as a leading global platform, bringing together approximately 5,000 participants each year from regulatory authorities, the pharmaceutical industry and academia.
The event provides an opportunity to share trends in biopharmaceutical development, discuss future growth strategies and reflect on the evolving role of regulators.
This year’s program will feature keynote and special lectures addressing the rapidly changing global biopharmaceutical landscape, shaped by cutting-edge technologies. Additionally, 17 thematic forums will be held on vaccines, advanced biopharmaceuticals and other specialized areas.
The ministry will also host bilateral meetings with global regulators, including the European Medicines Agency, Germany’s Paul-Ehrlich-Institut, Japan’s Pharmaceuticals and Medical Devices Agency, and Ecuador’s ARCSA, to promote international regulatory harmonization.
- Opening ceremony, keynote & plenary session (Sept. 3)
This year’s conference opened with keynote and plenary sessions addressing regulatory innovation, next-generation biotechnologies and strategies for international cooperation in a rapidly evolving global landscape.
Keynote speakers included Robert S. Langer, professor at the Massachusetts Institute of Technology; Yukiko Nakatani, assistant director-general for health systems at the World Health Organization; Dennis Slamon, professor at the University of California, Los Angeles; and Chung Jin-ho, president of the Korean Academy of Science and Technology.
Industry voices such as Kim Dong-joong, vice president at Samsung Biologics, and Jeffrey Francer, vice president of global regulatory policy and strategy at Eli Lilly, also shared insights on global trends in biopharmaceutical development.
- Vaccines, regulatory trends, policy discussion (Sept. 4)
On Thursday, forums will be held on key topics including vaccines, recombinant protein products and regulatory science innovation.
The "Vaccine Forum" will address global regulatory trends and case studies, such as reviews of self-amplifying RNA vaccines and viral safety assessments using next-generation sequencing.
The "Recombinant Protein Products Forum" will explore new directions in the development of next-generation therapies, such as antibody-drug conjugates and bispecific antibodies, with a view to expanding patient access to innovative therapies.
The 11th "Regulatory Science Innovation Forum" will convene global experts to discuss strategies for advancing regulatory science both in Korea and internationally.
Additional sessions will include the "Policy Discussion on Patient-Centered Medical Product Safety Management," aimed at enhancing communication on patient safety and rights; the "Workshop on Core Partnership Strategy to Strengthen National Regulatory Systems for Biomedicines in the Western Pacific," which will discuss regulatory advancement through the use of innovative technologies; the "WHO PQ Certification Support Forum"; and the "Global Pharmaceutical Innovation Technology GMP Seminar."
- Regulator meetings, support initiatives (Sept. 5)
The final day, Friday, will feature the "Regulatory Workshop," the "Biopharmaceutical Supply Chain Forum," and the "Advanced Biopharmaceuticals Policy and Quality Forum."
The "Regulatory Workshop" will introduce the latest authorization and review systems from participating regulatory agencies and discuss the role of regulators in supporting the development of biotherapeutics through technological advancement. Following the workshop, one-on-one meetings will be arranged between officials from overseas regulatory authorities — including those from Australia, Europe, Japan and Thailand —and Korean companies to support the industry’s global expansion.
The "Biopharmaceutical Supply Chain Forum" will examine current trends in global vaccine supply chains, strategies for diversification, and measures to enhance resilience in times of crisis, drawing on case studies from both regulators and companies.
The "Advanced Biopharmaceuticals Policy and Quality Forum" will look at quality management and regulatory compliance for rapidly developing advanced biopharmaceuticals, and also explore regulatory frameworks and safety management approaches by country for human tissue use.
In addition, regulatory support agencies will present their programs directly, offering domestic researchers and developers an accessible way to connect with diverse support initiatives.
Participating agencies include the National Institute of Food and Drug Safety Evaluation, Korea Fund for Regenerative Medicine, KBIO Health, Regenerative Medicine Advancement Foundation, Korea Regulatory Science Center, Korea Biomedicine Industry Association and the Council for Advanced Regenerative Medicine.
The program will also include the "Workshop on Animal Testing Alternatives for Biologicals," discussing the latest trends in biopharmaceutical quality control, and "Beyond the Horizon of the Animal Alternative Testing Era," which will review current trends and future directions in the development and validation of alternative testing methods to animal use, employing advanced technologies such as organoids.
Furthermore, a mentoring program, "Mentoring for Bio Youths," will be held to inspire and guide young talent who will lead the next generation of biotechnology.
Minister Oh Yu-kyoung emphasized that GBC is not only a platform for global regulatory dialogue but also a critical step toward positioning Korea as a global leader in biopharmaceuticals.
The Food and Drug Safety Ministry stated that the conference is expected to strengthen Korea’s international presence in biopharmaceuticals by sharing the latest regulatory and technological trends, while supporting the global competitiveness of Korean companies.