Sharing FDA approval strategies and case studies…Offering practical insights for the entire novel drug development process
[by Sung, Jae Jun] The Korea Biotechnology Industry Organization (KoreaBIO) announced on April 3 that it will host the '2025 BIO Regulatory Innovation Conference' to support Korean biotechnology companies' in entering the U.S. market.
The conference is scheduled to take place on April 23 and 24 at the Sheraton Grand Incheon Hotel in Songdo. The event will primarily focus on sharing strategies for obtaining approval from the U.S. Food and Drug Administration (FDA).
Held under the theme 'Roadmap to the Finish Line,' the conference will center on key strategies and real-world case studies related to the U.S. FDA approval process. It will particularly address the entire novel drug development cycle, including CMC (chemistry, manufacturing, and controls), non-clinical and clinical trials, and regulatory approval strategies. The event aims to provide practical insights that Korean 강원 랜드 바카라tech companies can directly apply to their regulatory and development processes.
A dining reception will be held on the evening of the first day, providing an opportunity for presenters and industry professionals to engage in open discussions. Korea강원 랜드 바카라 emphasized that this informal gathering, where participants can freely exchange experiences and insights on industry trends, is a key highlight of the event and is highly anticipated.
The United States accounts for more than 40% of the global pharmaceutical market, making FDA approval a critical milestone for gaining international credibility and achieving business success. With the recent inauguration of the second Trump administration, the likelihood of regulatory policy changes in the U.S. has increased, underscoring the increasing importance of thorough preparation and strategic planning by 강원 랜드 바카라tech companies.
On the first day of the conference (April 23), U.S. regulatory experts Dr. Park Jun-tae (KHIDI) and Dr. Shin Yang-mi will provide an introduction to current FDA regulatory trends. Additionally, Dr. Choi Jun-young (Head of R&D at ST Pharm) will share practical experiences in addressing challenges faced by companies in the field. Researcher Cho Chang-hee (National Institute of Food and Drug Safety Evaluation) will also present strategies to support the commercialization of new drug development.
On the second day of the conference (April 24), SK 강원 랜드 바카라pharmaceuticals CEO Lee Dong-hoon will present practical strategies based on firsthand experience with the FDA approval process. Following this, Dr. Ahn Hae-young (Ahn 강원 랜드 바카라 Consulting) and Dr. Jung Sang-mok (강원 랜드 바카라star) will provide an in-depth analysis of the realistic challenges encountered during FDA clinical trials and approval procedures.
The two-day panel discussion will be moderated by Dr. Lee Sun-hee from the Ewha Womans University Pharmaceutical 강원 랜드 바카라-Convergence Education Center. Lee is a recognized expert and former director of the National Institute of Food and Drug Safety Evaluation and will address participants’ practical questions.