Company Adds Independent Directors Ahead of FDA BLA Plans
Kolon TissueGene board of directors (from left): Kim Young-jun, auditor; Jan Van Acker, outside director; Jeon Seung-ho, CEO of Kolon TissueGene; Noh Mun-jong, CEO of Kolon TissueGene; Kim Jeong-in, inside director; Lee Kyu-ho, inside director; Robert Ang, outside director. (Photo=Kolon TissueGene)
Kolon TissueGene has completely restructured its board of directors.
The company announced that it held its regular board meeting and strategic review meeting at its headquarters in Rockville, Maryland, on May 13 and 14 (local time).
The central change in this board reorganization is the appointment of Lee Kyu-ho, Vice Chairman of Kolon Corporation, as an inside director. Lee has been serving as chair of the bio-healthcare working group within the APEC Business Advisory Council (ABAC) since last year, engaging in discussions on public-private cooperation frameworks and expanding his influence across the broader industry. This move clarifies the group-level commitment to responsible management while also making it possible to support management operations through global networks.
CEO Jeon Seung-ho emphasized, “Now that a board structure with independence and expertise has been established, we will lead close consultations toward entering the global market, beginning with TG-C’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).”
The lineup of outside directors has also been significantly reinforced. Jan Van Acker, who led the commercialization of blockbuster drugs at MSD including the immuno-oncology therapy Keytruda, and Robert Yuen Lee Ang, a surgeon-turned-expert in biotech company management, have joined the board. They will provide specialized insight into local market positioning and regulatory procedures, helping TG-C establish a firm footing in the U.S. market.
Kolon TissueGene is preparing for the announcement of top-line results from TG-C’s U.S. Phase 3 clinical trial, scheduled for July. Preliminary preparations for submitting a BLA to the FDA are currently underway, and the company signed a contract with global contract manufacturing organization (CMO) Lonza last October.
An industry official assessed, “This is a structure that combines the responsible management of the controlling shareholder family with the practical expertise of global specialists,” adding, “Independent decision-making by the board is expected to play an important role during the commercialization phase that will follow the clinical results announcement.”
Choi Mun-hee
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