BIO Asia–Taiwan 2025 亞洲生技大會

BIO Asia–Taiwan 2025 亞洲生技大會

講師

Marc Goemans

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Session A-5 – CMC Program Design: Pioneering Biologics Development Excellence

Date:24 July 
Time13:00– 13:15  (GMT+8)

Marc Goemans

Chief Commercial Officer
Bora Biologics

 

Marc Goemans serves as the Chief Commercialization Officer at Bora Biologics, where he leverages his 25 years in the biopharmaceutical sector to drive the successful market introduction of new products. In this role, Marc is responsible for developing and executing commercialization strategies that ensure Bora Biologics meets the evolving needs of its clients and the broader market. Prior to joining Bora Biologics, Marc held senior leadership positions at DSM Biologics, Patheon, Consort Medical and Catalent. His expertise spans both drug substance as well as drug product, enabling him to navigate the complexities of bringing innovative solutions to market effectively. Marc is committed to fostering a collaborative environment that emphasizes cross-functional teamwork and strategic partnerships. He believes that strong relationships with clients and stakeholders are crucial for achieving commercial success. With MSc degrees in Engineering and Business Administration, Marc combines his technical knowledge with a keen understanding of market dynamics, positioning Bora Biologics for continued growth and leadership in the biopharmaceutical industry.

Speech title & Synopsis

Global CDMO view on decision making on outsourcing in the current changing economic environment​

At the BioAsia conference I will address the view of Bora Biologics on the CDMO trends for Biologics in Asia and USA. Bora Biologics have a presence in both Taiwan and the USA. At BIO in Boston and by GlobalData the trends for a mAbs and ADC remain strong. The USA maintains a leading role in scientific innovation, VC funding, and first-in-class asset development. The FDA remains the gold standard, and being FDA-registered is a major commercial asset, especially for supporting global clients seeking U.S. approvals. Asia is now 31% of all new pipeline assets (vs. 35% for the U.S.), indicating rapid catch-up. For a CDMO based in Asia with U.S. capabilities, this is an advantage: you offer Asian cost-efficiency with U.S.-grade compliance. Total pipeline size continues to expand: 23,875 drugs in development in 2025, up 4.6% YoY. 39% of new assets are anticancer, a key area for mAbs and ADCs. Emerging biotechs are driving pipeline growth and now account for 55% of clinical programs. 84% of all programs are still in early clinical stages, highlighting a continued need for clinical-phase manufacturing support. ADCs, while a niche, are part of the broader oncology focus, which remains the top therapy area in terms of pipeline assets and deal value. Large pharma companies maintain a 50:50 split between internal and externally sourced innovation, reinforcing sustained demand for CDMO partnerships. FDA-approved facilities with 2,000L single-use bioreactors are well-positioned, especially for commercial supply of niche biologics. While economic relationships get reformatted thru new trade relationships by the US Administration a.o., the above trends remain strong. Bora Biologics offers an excellent proposition of first in human service out of its facilities in Zhubei with a seamless technical transfer capacity to the FDA licensed facility in San Diego provides a secured access to US patients. In 2026 Bora Biologics will open new 2000 L SUB capacity in San Diego. Our parent Bora offers Fill and Finish services from its facilities in Baltimore which are part of our integrated offering.

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