[Press Release, Sept. 4 / Unofficial translation] Global Bio Conference(GBC) 2020 will Open - Discussions on the ▲direction and future of K-Bio ventures, ▲access to COVID-19 vaccines, and other topics to be held - □ The Ministry of Food and Drug Safety (MFDS, Minister Eui-Kyung Lee) announced that the “Global Bio Conference (GBC) 2020” will take place for three days from Sep. 7 (Mon.) until Sep. 9 (Wed.) under the theme of “Advanced Bio, People-centered Value Creation.” ○ This year’s conference will be held virtually on GBC homepage (www.gbckorea.kr) as an online platform in compliance with the COVID-19 quarantine measures. ○ Now on its 6th year, the GBC will serve as an opportunity to share current status development status and prospects of COVID-19 treatments and vaccines across the globe. Moreover, it will provide information on development landscape in advanced biopharmaceuticals, global trends of regulatory framework, and many others. - The conference will also be a chance to promote discussions among bio experts and regulatory authorities to overcome the COVID-19 pandemic and to enhance the competitiveness of the Korean biopharmaceutical products. ○ This year, a total of 61 speakers (34 from overseas) from 18 countries were invited to present 61 different lectures, and more than 3,000 participants are expected to attend the conference through the live streaming service. □ The Conference consists of “Open Forums” and “Back to Back Events.” ○ The Open Forums include ▲opening ceremony, keynote speech, and ▲forums on vaccines, recombinant protein products, advanced biopharmaceuticals in each field※. ※ [Sep. 7 (Mon.)] WHO PQ [Sep. 8 (Tue.)] vaccines, combination products, GMPs, recombinant protein products, human tissues [Sep. 9 (Wed.)] blood products, advanced biopharmaceuticals ○ Among Back to Back Events, ▲Global Pharmaceutical Experts Workshop (1:1 consulting) and ▲Mentoring for Bio Youths will be opened for all visitors, and ▲Recombinant Protein Products Reviewer Workshop and ▲WPR-NCL(Western Pacific Region-National Control Laboratories) Workshop will be held in a closed session, and only opened to regulatory authorities. ○ In particular, the events will offer COVID-19-related topics such as the current state of COVID-19 vaccine development, regulatory measures for vaccine developments in emergency, the development status and prospects of COVID-19 convalescent plasma therapy. ■ GBC Open Forums ○ Keynote Speech Part 1, which is to be held under the theme of “Advanced Bio, People-centered Value Creation,” will begin with a special speech from the chairman at Celltrion Group, Jungjin Seo and a special video interview with the executive vice president at the MSD, Julie Gerberding. The director of the leadership team at Roche Pharma International, Joerg Michael Rupp and the head of International Affairs Division at the EMA, Agnes Saint-Raymond, will present on the R&D direction of biopharmaceutical technology, efforts to create a sustainable healthcare environment, and proper regulatory responses amid the COVID-19 pandemic. - Keynote speech Part 2 will be held under the theme of “Advanced Biopharmaceuticals, the Key to the Future.” During the session, the Senior Vice President of Global Rare Disease Business at Pfizer, Robert Joseph Smith, the Vice President of USP, Fouad Atouf, the Regional Vice President of APAC region at Merck, Liz Henderson, the director of the Surrey Cancer Research Institute, Hardev Pandha, and the CEO of MedPacto, Seong-Jin Kim will speak about the new treatment paradigm, development status of COVID-19 treatments and vaccines, public-private partnerships in the public health sector, and efforts necessary for K-bio to win competitive edge. ○ In each forum, experts from the field will thoroughly discuss the recent development trend and factors to be considered for the harmonization of regulations. - On September 8th, the various topics will be shared in “Vaccine Forum” such as the current status and prospects of COVID-19 vaccine development, things to consider for increasing accessibility and securing safety/efficiency, the latest regulatory considerations and strategies, etc. - In “Recombinant Protein Products Forum” on September 8th, the following will be examined: what the “Real World Data” and “Real World Evidence” are, how they are being used in actual drug development, and what challenges will need to be solved in the future. - In “Advanced Bio-pharmaceuticals Forum” on September 9th, the current and future development trends in personalized (customized) advanced bio-pharmaceutical products will be shared and discussed. Such personalized advanced bio-pharmaceutical products have been gaining attention as a new futuristic industry since they have the potential to treat and cure serious or rare diseases. - In “Blood Products Forum” on September 9th, global trends for securing safety of source plasma and plasma derivatives, and the development status of COVID-19 plasma treatments will be shared. ■ Back to Back Events ○ In “Global Pharmaceutical Experts Workshop” on September 9th, various lectures will be provided by overseas experts on R&D planning, clinical tests, regulations, and GMP sector. - Also, 1:1 Online Consulting with global pharmaceutical experts from China, Russia, UK, UAE, etc. will be provided to support domestic bio companies’ access to global markets. ○ In the mentoring session called “Bio-pharmaceutical, take care of my tomorrow” on September 9th, the online lecture on the theme of “Bio Venture, Next in K-Biohealth” will be provided by the experts on bio industry ecosystem, bio start up strategies, etc. Also, contactless communication will be possible for job-seekers, graduate school students majoring in bio-pharmaceuticals, and people preparing for startup business. □ The MFDS hopes that this event will support the development of bio-pharmaceutical products applied with the advanced technology by sharing the global bio-pharmaceutical regulation trends and the development/approval cases. Also, the Ministry expects the event to be informative for preparing the safety management system for whole procedure from the R&D stage to the production. ○ The MFDS has announced that it will dedicate the best effort to make the event a meaningful opportunity for overcoming COVID-19 and promoting the health of humanity. - For more specific information, please visit Global Bio Conference official website (www.gbckorea.kr). [ Attachment] (in Korean) - Detailed Schedule of the Opening Ceremony - Detailed program of GBC 2020 - Special and Keynote Speaker Profile - History of Global Bio Conference - Poster of mentoring program - Agenda of each forum - Summary of the special and keynote speech - Promotion brochure of 2020 Global Bio Conference