SK Biopharma Shares Cenobamate Success In US

Key figures take a commemorative photograph at the 'From Unmet Need to Patient Access' conference held in New Jersey, the United States, on October 10 (local time). (Provided by SK Biopharmaceuticals)  SK Biopharmaceuticals hosted a conference under the theme 'From Unmet Need to Patient Access' in New Jersey, the United States, on Oct. 10 (local time) in collaboration with the New Jersey and New York chapters of the Korean American Society in Biotech and Pharmaceuticals (KASBP). The event was attended by approximately 170 officials from SK Biopharmaceuticals, its US subsidiary SK Life Science, KASBP, and the pharmaceutical and biotech industry and academia to discuss major challenges in new drug development and potential collaboration. The conference consisted of three sessions covering the stages from research and development to post-commercialization. In the first 'Discovery & R&D' session, faculty members from New York Medical College and Rutgers Medical School addressed the unmet needs in the development of epilepsy treatments, and SK Biopharmaceuticals shared major turning points and practical implications of the Cenobamate research and development process. The second 'Clinical & Regulatory' session focused on the new drug review process of the US Food and Drug Administration (FDA) and the clinical development case of Cenobamate. Attendees conducted an in-depth examination of the key factors to consider during the clinical and approval processes. In the final 'Commercial & Beyond' session, drug pricing, market access strategies, and commercialization and business expansion strategies within the US were discussed. Discussions continued on the entire process from when a new drug leaves the laboratory until it reaches actual patients, as well as strategies for sustainable growth. SK Biopharmaceuticals is expanding its role within the global new drug development ecosystem based on the experience accumulated through the independent development, FDA approval, and direct commercialization of Cenobamate in the US. Min-seok Kang, President of the KASBP New Jersey and New York chapters, evaluated, "The journey of a Korean company directly achieving everything from new drug discovery to local launch in the US is a great source of pride for Korean scientists," and added, "It is meaningful in that it is the first attempt to bring together experts from each stage of research, clinical trials, approval, and commercialization in one place." Dong-hoon Lee, CEO of SK Biopharmaceuticals, said, "We prepared this event to share the concerns and decision-making experiences we faced in the process rather than just the achievements of Cenobamate itself," and stated, "We hope that the experience we have accumulated will help reduce trial and error in other challenging processes."