[BioTimes] Council for Advanced Regenerative Medicine Successfully Concludes the 3rd Advanced Regenerative Medicine Development Strategy Forum

Held under the theme “Changes in the Domestic and Global Environment and Development Trends in Advanced Regenerative Medicine and Advanced Biopharmaceuticals”
Forum Explores the Direction of the U.S. Biotechnology Executive Order and Response Strategies
Discussions Also Address Regulatory Improvements for Approvals and Licensing in Advanced Regenerative Medicine

[BioTimes] The 3rd Advanced Regenerative Medicine Development Strategy Forum, hosted by the Council for Advanced Regenerative Medicine (CARM) and chaired by Kang Kyung-sun, was successfully held on the 8th in Seminar Room A at COEX Hall B1 in Seoul.

The forum was held as part of KOREA LIFE SCIENCE WEEK 2022, a major exhibition and conference for Korea’s life sciences industry.

Moderated by Noh Kyung-hwan, Executive Director at Kangstem Biotech, the forum was held under the theme “Changes in the Domestic and Global Environment and Development Trends in Advanced Regenerative Medicine and Advanced Biopharmaceuticals.” It consisted of three sessions: the U.S. Biotechnology and Biomanufacturing Initiative and strategies for responding to the related executive order; linkage between advanced regenerative medicine clinical research and regulatory review of advanced biopharmaceuticals; and trends in the development of exosome-based therapeutics. Each session featured presentations followed by panel discussions.

In his welcoming remarks, CARM Chairman Kang Kyung-sun said, “As economic conditions have weakened both domestically and globally, and the United States has stepped up efforts to strengthen its domestic bioindustry following President Biden’s executive order on the National Biotechnology and Biomanufacturing Initiative, Korean biotechnology companies are facing increasing challenges.”

He added, “I hope today’s forum will provide an opportunity to review recent developments in advanced regenerative medicine and advanced biopharmaceuticals, and to exchange diverse views with experts on changes in the industry environment, regulatory reform, and other measures needed to advance Korea’s regenerative medicine sector.”

The first session, “U.S. Biotechnology and Biomanufacturing Initiative: Current Status, Direction, and Response Strategies,” was chaired by Kim Tae-ho, CEO of Cure Therapeutics. Presentations included strategies for responding to President Biden’s executive order on biotechnology and biomanufacturing by Yoo Seung-ho, CEO of Youth Bio Global; key issues in U.S. biotechnology policy and implications for Korea by Kim Hyun-soo, Team Leader at the Korea Research Institute of Bioscience and Biotechnology; and strategic directions for Korea’s advanced bioindustry, including cell and gene therapy (CGT) by Kim Tae-ho.

Kim proposed that Korea’s cell and gene therapy industry respond to the U.S. biotechnology initiative through biofoundries and decentralized manufacturing. He cited traditional manufacturing methods and shortages of skilled production personnel as key challenges facing Korea’s CGT sector, adding that decentralized manufacturing could also be suitable for therapies such as CAR-T.

The second session, “Linking Advanced Regenerative Medicine Clinical Research with Regulatory Review of Advanced Biopharmaceuticals,” included a presentation on the review process and current status of advanced regenerative medicine clinical research by the Secretariat of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee under the Ministry of Health and Welfare.

This was followed by a panel discussion on ways to connect advanced regenerative medicine clinical research with regulatory review of advanced biopharmaceuticals. Panelists included Hwang Yoo-kyung, CEO of YUYA Bio Consulting; Jung Mi-hyun, Executive Director at Medipost; Yoo Jong-man, CEO of Organoid Sciences; Joo Ji-hyun, CEO of Y iPSCELL; Choi Byung-hyun, Secretary General of CARM; and Joo Wan-seok, Executive Director at CLIPS BnC.

The third session, “Development Trends in Exosome-Based Therapeutics,” was chaired by Na Gyu-heum, CEO of Primoris Therapeutics. Presentations included “Cell and Gene Therapy Reimagined by BioDrone Platform Technology” by Oh Seung-wook, CSO and Executive Director of MDimune; “Promoting Clinical Research on Stem Cell-Derived Exosome Therapeutics” by Geun-Ho Kang, Team Leader at StemExOne; and “ASC-Exosome Based Regenerative Therapeutics Using EXOSCRT Platform Technology” by Lee Jun-ho, Director at ExoCoBio.

Oh Seung-wook said, “Exosome development began in earnest in Korea around 10 years ago, and many exosome-based companies have emerged over the past seven to eight years. Korean companies have also established strong competitiveness in the global exosome market.”

He added, “Through sustained efforts, companies have developed technologies for large-scale production and overcome hurdles related to CMC, regulatory approval, and stability. However, scaling these technologies to pharmaceutical manufacturing remains a major challenge.”

Geun-Ho Kang of StemExOne presented an overview of the global exosome market and compared domestic and international trends related to special legislation governing advanced regenerative medicine.

He said, “Korean exosome-based biotech ventures currently have a total of 53 pipelines, with the largest share involving mesenchymal stem cell-derived exosome therapeutics targeting autoimmune diseases, inflammatory diseases, and cancer.”

Kang emphasized, “A clear regulatory classification for exosome therapeutics within the advanced biopharmaceutical framework is needed. In addition, regulatory improvements are required, including enhanced coordination with the Ministry of Food and Drug Safety’s cell therapy task force and clearer pathways for non-cell-based therapies, so that innovative technologies can enter the market at the appropriate time.”

Meanwhile, CARM operated an Advanced Regenerative Bio Promotion Pavilion throughout KOREA LIFE SCIENCE WEEK 2022 to support the promotion of its member companies and help visitors better understand the advanced regenerative medicine industry.

Participating companies included Young Science, which distributes Lonza’s cell and gene therapy products as well as Steris disinfectants, cleaning agents, and built-in VHP sterilization systems for cleanrooms; GC Cell, which has pipelines based on NK cells, T cells, and stem cells and operates CGT-focused CDMO and specimen testing businesses; ENCell, a Samsung Medical Center spin-off and one of Korea’s CGT-focused CMO/CDMO companies capable of one-stop production of cells and viruses; Xcell Therapeutics, which developed a GMP-grade chemically defined serum-free medium for stem cells and operates a GMP manufacturing facility with annual production capacity of 100,000 liters; and Daewoong Pharmaceutical, which has been expanding its CDMO business after obtaining authorization for a cell processing facility.

[BioTimes, Reporter Kim Soo-jin]

Source: BioTimes