Detailed Program(2021)

GBC1

Opening Ceremony / Keynote & Plenary Session

Forum Overview

Date/Time	9.13(Mon) 13:30 - 18:00	Location	Grand Ballroom I,II,III (5F)
Overview	A New Normal: A Leap towards Newly Found Future of Biopharmaceuticals With a global paradigm shift in the health-care industry, where people turn more toward preventive measures than treatments, living a “healthy” long life is far more important than living “longer.” With this flow, biopharmaceuticals take center stage with their key potential in combining biology and advanced technologies to cope with a novel infectious disease and rare incurable disease. Now that we are on this shifting tide, it is imperative to take measures for biopharmaceuticals’ leap toward the newly found future. At the GBC 2021, world leaders in biopharmaceuticals gather to discuss “What is the current situation that biopharmaceuticals are facing NOW?” “What are we expecting NEXT?” and “What is the future and BEYOND?. In addition, there will be further discussions on the sustainable future and insights on advanced biopharmaceuticals toward the “New Normal” and even the “Next Normal.”

Program

Time		Program	Speakers
Keynote Speech : A New Normal: A Leap towards Newly Found Future of Biopharmaceuticals
14:00~14:15	15’		Peter Doherty (Peter Doherty Institute at the University of Melbourne)
14:15~14:55	40’	[Plenary] Preparedness and response against new pandemic in future	Jong-koo Lee (Seoul National University, College of Medicine/Hospital)
14:55~15:35	40’		Robert S. Kerbel (Sunnybrook Research Institute)
15:35~15:55	20’		Margaret Hamburg (Fomer FDA commisioner /Nuclear Threat Initiative)
15:55~16:35	40’		Aaron Ciechanover (Faculty of medicine at the Technion - Israel Institute of Technology)
16:35~17:00	25’		Rogério Gaspar (WHO)
17:00~17:20	20’		Larry W. Kwak (City of Hope Comprehensive Cancer Center)
17:20~18:00	40’	The public private partnerships utilized in the US Government program for COVID vaccine development	Lawrence Corey (Fred Hutchinson Cancer Research Center)

GBC2

Vaccine Forum

Forum Overview

Date/Time	9.14(Tue) 09:00 – 12:00	Location	Grand Ballroom I (5F)
Overview	Widespread adoption of novel platform-based vaccines and global vaccine strategies and regulatory directions in Next Normal era Although the whole world is still greatly suffering from COVID-19, multiple vaccines and treatments for COVID-19 have contributed to the concerted efforts to overcome the pandemic. However, expectations and concerns still coexist as to the stable supply of COVID-19 vaccines and treatments, especially so for vaccines using new platforms. In tune with ongoing shifts, Korea is focused on vaccine development to adapt to evolving healthcare trends and prepare for the Next Normal era. With all of this in mind, GBC 2021 Vaccine Forum will share the perspectives of overseas regulatory authorities and information on global vaccine development with respect to securing vaccine platforms that will enable a rapid response to emerging diseases and developing key source technologies for next-generation vaccines, etc.

Program

Time		Program	Speakers
Chair: Jin Han Kang Novel platform-based vaccines and global vaccine strategies and regulatory directions in Next Normal era
09:10~09:50	40’		Jerome Kim (International Vaccine Institute )
09:50~10:00	10’	Break
10:40~11:20	40’		Jae-Hwan Nam (The Catholic University of Korea)
10:00~10:40	40’	COVID 19 vaccine development and the future of mRNA strategy	Randall Hyer (Moderna)
11:20~11:30	10’	Break
11:30~12:10	40’		Jinho Shin (WHO)
12:10~12:50	40’		Ralf Wagner (PEI)

GBC3

Recombinant Protein Products Forum

Forum Overview

Date/Time	9.14(Tue) 14:00 – 18:00	Location	Grand Ballroom II (5F)
Overview	Compelling efforts to develop treatments in the COVID-19 era Vigorous efforts to develop treatments against COVID-19 are now being made as the world continuously suffers from the pandemic situation. The Recombinant Protein Products Forum will discuss the status and the future outlook of COVID-19 antibody treatments. Furthermore, by sharing practical examples, we’ll discuss the role that should be played by regulatory authorities in these development strategies.

Program

Time		Program	Speakers
Efforts for rapid development of biotherapeutics in the COVID-19 era
14:00~14:45	45’		John R Dobbins (Lilly)
14:45~15:30	45’		Junho Chung (Seoul National University College of Medicine)
15:30~16:15	45’		Minsoo Kim (Celltrion)
16:15~16:30	15’	Break
16:30~17:15	45’		Alexander Liakos (GSK)
17:15~18:00	45’		Marjorie A. Shapiro (FDA)

GBC4

Advanced Biopharmaceuticals Forum

Forum Overview

Date/Time	9.15(Wed) 14:00 – 18:00	Location	Grand Ballroom I (5F)
Overview	Developments and regulations in stem cell therapy and xenotransplantation The advanced biopharmaceuticals industry is rapidly growing as it has shown the potential to treat rare and incurable diseases. Stem cell therapy has garnered significant attention as new treatments, considering their potential application to various diseases. Xenotransplantation products have also been regarded as potential alternatives in which donated organs are short in spspsupply. Despite the high interest and expectation, technical limitations, safety issues, and ethical challenges still prevail. At The Advanced Biopharmaceuticals Forum, the latest information including development trends and future outlook on induced pluripotent stem cell therapy, embryonic stem cell therapy and xenotransplantation will be shared. With this information, we’ll look into their possibilities and limitations.

Program

Time		Program	Speakers
Session1: Present and future of cell therapy with using stem cell
14:00~14:40	40’	Current Trends of Cell Therapy Development Using induced Pluripotent Stem Cells (iPSC)	Jihwan Song (CHA University)
14:40~15:20	40’		Shin Kawamata (FBRI, Japan)
15:20~16:00	40’		Glyn Stacey (ISCBI)
16:00~16:10	10’	Break
Session2: Trends on transplantation study using xenotransplantation
16:10~16:50	40’		Wayne Hawthorne (Sydney University/IXA)
16:50~17:30	40’		Sung Joo Kim (GenNBio)

GBC5

Blood Products Forum

Forum Overview

Date/Time	9.15(Wed) 09:00 – 13:00	Location	Grand Ballroom I (5F)
Overview	Regulatory Environment and Development Direction of Blood Products and Plasma Derivatives The blood supply through blood donation is predicted to reduce with global environmental changes, such as the outbreak of a novel infectious disease like COVID-19, population decrease, and climate change. Thus, we will share the current situation of approval and safety management system of blood products in compliance with WHO’s principles of self-sufficient blood supply and banning commercial use of blood products, which cover medications derived from blood. In addition, we will also discuss the recent Korean and international trends of policies and good manufacturing practice (GMP) guidance on blood products, as well as the direction of development.

Program

Time		Program	Speakers
Regulatory Environment and Development Direction of Blood Products and Plasma Derivatives
09:00~09:40	40’		Dong Hi Hwang (Korean Red Cross Plasma Fractionation Center)
09:40~10:20	40’		Seungjoo Kim (SK PLASMA)
10:20~10:35	15’	Break
10:35~10:55	20’		Sungwon Jung (Baxter Korea)
10:55~11:15	20’	Biological Products: Human Blood and Blood Components	Gavriel Yifat (J&J)
11:15~11:55	40’	Safety Control Plasma-Derived Products in Korea	Sang Min Shin (Green Cross Corp.)
11:55~12:10	15’	Break
12:10~12:50	40’	Comparison of GMP regulations for global blood establishments	TAE KYU KIM (BnP Care)

GBC6

Human Tissues Forum

Forum Overview

Date/Time	9.14(Tue) 14:00 – 18:00	Location	Grand Ballroom III (5F)
Overview	Status of international and Korea safety management of human tissue in the COVID-19 era We will share several cases of aseptic process, including the collection and packaging raw materials of human tissue; the strategic method of setting a proper expiration date; and the purpose of use of human tissue. The discussion will also cover the international and Korea status of human tissue management in the COVID-19 era, including strategy to assess tissue donor suitability for safe human tissue management in times of novel infectious disease outbreak.

Program

Time		Program	Speakers
Status of international and Korea safety management of human tissue in the COVID-19 era
14:00~14:50	50’		Kwang-In Lee (L&C BIO)
14:50~15:40	50’	TBD	Yang-Guk Chung (Seoul St. Mary Tissue Bank under Korea Public Tissue Bank)
15:40~15:50	40’	Break
15:50~16:40	50’		YOUNG JOO CHA (Institute Pasteur Korea)
16:40~17:30	50’		John Boyd (AATB)

GBC7

Advanced Biopharmaceuticals & Combine Products Regulatory Science Forum

Forum Overview

Date/Time	9.14(Tue) 09:00 – 12:00	Location	Grand Ballroom III (5F)
Overview	Part 1: Current Development Trends and Regulatory Environments for Advanced Biopharmaceuticals We will look into the current development trends and the regulatory environments for Advanced Biopharmaceuticals. A further discussion will lead to how to develop reasonable policies in a rapidly changing environment. Part 2: Current Development Trends and Global Regulation Status on Combination Products Recently, the volume of the global combination product market sees the steady growth, and it has led the active development of combined products with advance biopharmaceuticals and medical devices. The forum shares the latest trend of development in Korea and overseas regulations on the combination product, especially focused on the advanced biopharmaceutical-combined product.

Program

Time		Program	Speakers
Part 1: Current Development Trends and Regulatory Environments for Advanced Biopharmaceuticals
09:00~09:30	30’		YEON-SOO KIM (Chungnam National University)
09:30~10:00	30’	USP Standard Development for Advanced Therapies	Ben Clarke (USP)
Part 2: Current Development Trends and Global Regulation Status on Combination Products
10:00~10:30	30’		Jinah Jang (POSTECH)
10:30~11:00	30’		John Weiner (FDA)

GBC8

GMP Forum

Forum Overview

Date/Time	9.14(Tue) 14:00 – 18:00	Location	Grand Ballroom I (5F)
Overview	Sharing information on non-face-to-face GMP inspection in the COVID-19 era As the field inspection found its limitations because of COVID-19, non-face-to-face GMP inspection has been prevalent in biopharmaceuticals industries globally in recent years. GBC 2021’s GMP Forum will further discuss the latest information on this new trend of contactless inspection cases in Korean biopharmaceuticals manufacturers and the requirements for the inspection to thoroughly manage safety.

Program

Time		Program	Speakers
Sharing information on remote GMP inspection in the COVID-19 era
14:00~15:00	60’		Eunah Yoh (Samsung Biologics Site GMP Compliance)
15:00~15:10	10’	Q&A
15:10~15:30	20’	Break
15:30~16:30	60’		Nam Ho Baek (CELLTRION Quality Assurance Division)
16:30~16:40	10’	Q&A

GBC9

Global Vaccine Hub Strategy Forum

Forum Overview

Date/Time	9.15(Wed) 09:00 - 12:00	Location	Grand Ballroom III (5F)
Overview	Vaccine Hub Strategy of a Joint Response to the Global Pandemic in the Post-COVID-19 Era Based on the recognition of the importance of vaccine supply increasing for a joint response to the global pandemic in the post-COVID-19 era, we will introduce mid and long-term strategies and public and private sector cooperation in developing a hub for vaccine production and supply, and the possibility of establishing global production base utilizing Infrastructure of local vaccine production base. Further discussion will take place on future directions in preparation for the post-COVID-19 era, including government-wide policy support necessary for Korea to become a global vaccine hub

Program

시간		프로그램	연사
09:30-09:50	20’		You Joo Hun (Global Vaccine Hub Office of the Ministry of Health and Welfare)
09:50-10:20	30’	TBD	Baik-Lin Seong (COVID-19 Vaccine Initiative of Korean Government)
10:20-10:40	20’	Digital Transformation in Pharma	James Choi (Samsung Biologics)
10:40-11:00	20’	SK bioscience’s strategy of the global bio platform hub	HUN KIM (SK bioscience)
11:00-11:20	20’	Rethinking supply chain to emerge stronger from COVID-19: Cytiva’s commitment to Korean vaccine industry	Kihoon Kim (Cytiva Korea)
11:20-11:35	15’		Jeongsuk Lee (Korea Biomedicine Industry Association)
11:35-11:40	5’	Closing

GBC10

Regulatory Workshop

Forum Overview

Date/Time	9.15(Wed) 09:00 – 12:00	Location	Grand Ballroom II (5F)
Overview	Current state and future directions of regulatory authorities We will be discussing regulatory authorities’ current attitudes toward technological changes and innovations in the biopharmaceutical industry. Also, the directions that authorities will be taking for its successful development and safe society will be discussed. Any industries participating can enroll for one-on-one meetings with global regulatory authorities upon preregistration.

Program

Time		Program	Speakers	Files
Regulatory authorities' current attitudes and directions toward technological changes and biopharmaceutical industry
			Suna Habahbeh (Jordan Food and Drug Administration)
			Hui Ming Chua (Ministry of Health Malaysia)
			Semeniuk Oleh (State expert center of the Ministry of health of Ukraine)
			Erick Alexander Vaca (ARCSA Ecuador)
			Maria Savkina (Ministry of Health of the Russian Federation)

BtoB1

Korea-ASEAN Pharmaceutical GMP Conference

Forum Overview Registration for GMP Conference >

Date/Time	9.15(Wed) 14:00 – 17:00	Location	Iris (2F)
Overview	Since 2015, the Ministry of Food and Drug Safety (MFDS) has been organizing the “Korea-ASEAN Pharmaceutical GMP Conference" to enhance mutual understanding and cooperation between Korea and ASEAN Member States in the field of pharmaceutical GMP through presentations, panel discussions and site visit. However, due to the prolonged COVID-19 pandemic, the 2021 Korea-ASEAN Pharmaceutical GMP Conference will be held virtually from September 14-15 2021. As the rapid development and supply of COVID-19 vaccines and treatments have been a global issue due to the COVID-19 pandemic, MFDS is organizing the ”2021 Korea-ASEAN Pharmaceutical Conference” in conjunction with Global Bio Conference (GBC) under the topic of “GMP Assessment of Biopharmaceuticals in Post COVID-19 Era.” This Conference is aimed to share knowledge and productive opinions related to various GMP assessment approaches in post COVID-19 era such as case studies of remote GMP inspections of biopharmaceuticals manufacturers and current status of GMP assessment based on mutual reliance among regulatory authorities.

Program

Time	Program	Speakers
Opening
14:00~14:05	Opening remarks	Dr. Seogyoun Kang (MFDS)
14:05~14:10	Introduction and announcements	Facilitator (MFDS)
II. GMP Assessment Based on Mutual Reliance
14:10~14:30	GMP inspection reliance from a PIC/S perspective	Mr. Boon Meow Hoe (PIC/S Immediate Past Chairman)
14:30~14:50	Status of GMP assessment based on mutual reliance - Korea	Ms. Mija Park (MFDS)
14:50~15:10	Introduction of ASEAN Mutual Recognition Arrangement on GMP inspection and Listed Inspection Service(LIS)	Belinna Abu Bakar (NPRA, Ministry of Health Malaysia)
15:10~15:30	Status of GMP assessment based on mutual reliance - ASEAN Member States : Singapore	Prof. Chong Hock Sia (Singapore HSA)
15:30~16:00	Q&A	Facilitator (MFDS)
16:00~16:20	Break
III. Various GMP Assessment Approaches in Post COVID-19 Era (Panel discussion)
16:20~16:50	⚫Challenges in remote inspection and how to overcome them ⚫Information sharing between regulatory authorities based on mutual reliance : benefits, challenges, etc.	Moderator (MFDS) Day 1: Speaker (Industry) Day 2: Speaker (Regulator)
Closing
16:50~16:55	Closing remarks	Ms. Young-ah Kang (MFDS)
16:55~17:00	Closing	Facilitator (MFDS)

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