2024/7/25 BIO Asia–Taiwan 2024, Day 2

從mRNA、基因療法、CMC到轉譯醫學，臺灣生技發展的四大關鍵趨勢！

From mRNA and gene therapy, to CMC and translational medicine –
Four key trends are driving the development of biotechnology in Taiwan

25 July, 2024

BIO Asia–Taiwan 2024 entered its second day at the Taipei Nangang Exhibition Center, Hall 1 (TaiNEX 1). The day's three Innovation Forum sessions focused on the following industry-prominent topics: The development prospects of new mRNA therapeutic modalities in the post-pandemic era; critical chemistry, manufacturing, and controls (CMC) for biologics development; and translational medicine that bridges laboratory innovations to clinical development, ultimately benefiting patients. Attendees also heard from the winners of this year's Taiwan BIO Awards, who shared their development strategies, technical highlights, and winning innovations.
 

New Post-Pandemic Treatment Prospects: mRNA Therapy and Gene Therapy Usher in the Era of Personalized Medicine

Session 6, entitled ‘mRNA and New Therapeutic Modalities’, focused on the wide-reaching mRNA technology that that came to prominence during the COVID-19 pandemic. The first speaker was Yusuke Nakamura, President of the National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) in Japan, who shared insights on mRNA cancer vaccines designed to target tumor neoantigens for each patient, aiming to overcome the challenges of immunotherapy. John Tsai, former Head of Global Drug Development and Chief Medical Officer at Novartis, currently a Partner at Syncona, discussed the regulatory challenges faced by popular gene therapies and the future development trends in this field.

Eric Huang, Partner at Delos Capital and former General Manager and Chief Scientist of Moderna Genomics, shared insights on mRNA as cancer vaccines, nucleic acid drugs, and the latest global advancements in gene editing therapies. Kevin Chan, Director of Commercial Strategy and Business Development at Kudo Biotechnology, analyzed the practical challenges of mRNA products in process development, quality management, and transportation from a Contract Development and Manufacturing Organization (CDMO) perspective.

In Session 7, entitled ‘Taiwan BIO Awards – Successful Stories,’ the successful companies from this year's Taiwan BIO Awards were invited to give short presentations on their winning development strategies, technological highlights, and latest innovations. These 19 companies included: Lotus Pharmaceutical, PharmaEssentia, Bonraybio, Pharmosa Biopharm, TSH Biopharm, Steminent Biotherapeutics, Onyx Healthcare, BenQ Dialysis, Acepodia Biotechnologies, ImmunAdd, Sunhawk Vision Biotech, Elixiron Immunotherapeutics, BioGend Therapeutics, Braxx Biotech, Protect Biotech, Formosa Pharmaceuticals, TaiGen Biotechnology, HippoScreen Neurotech, and Syngen Biotech. An additional award ceremony will also be held during the opening of the BIO Asia–Taiwan Exhibition tomorrow.

 

From CMC to Translational Medicine: Two Key Elements Essential to Taiwan's Biotech Development.

For the luncheon Session 8, entitled ‘Strategic Insights into CMC Project Design: Advancing Biologics Development Success, four biologics manufacturing experts were invited to share their insights on Chemistry, Manufacturing, and Controls (CMC).

Friedmund Bachman, Vice President of OncoOne Research & Development, Germany, outlined the numerous details to consider in CMC process development during biologics R&D. Hsing-Mao Chu, CEO of T-E Meds, discussed how his company develops complex next-generation antibody-drug conjugates (ADCs) through innovative multi-arm linker and proprietary drug bundle technologies.

GeneQuantum Healthcare Chief Scientist Paul Song shared the development story of his company’s ADC technology and the manufacturing advantages brought by its unique antibody drug conjugation technology. Taron Solutions CEO Alan Chang shared global trends and observations in drug CMC design, pointing out that failed drugs are often due to design issues. Therefore, the earlier problems in drug development are identified and resolved, the higher the success rate of the drugs.

Session 10, entitled 'Translational Medicine: A Journey from Novelty to Commercial Success,' began with Jingrong Jean Cui, President and CEO of BlossomHill Therapeutics, to discuss three oncology drugs she led in development—crizotinib, lorlatinib, and repotrectinib—that were approved by the US FDA, detailing her approach from drug design to commercialization.

Boyu Zhong, President and Chief Scientist of Tyligand Bioscience, shared the company’s process of developing the oral highly-selective c-Met inhibitor Bozitinib from experimental research to clinical trials. He stated that the drug not only shows that c-Met is a promising cancer treatment target but also demonstrates in translational medical research that it can be used to treat non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).

David Chang, CEO of Taiwan Bio-Pharmaceutical Manufacturing Corp. (TBMC), detailed the CMC-related difficulties that new drugs might encounter when transitioning from the preclinical stage. Under the moderation of Hsing-Pang Hsieh, Distinguished Research Fellow and Director of the Institute of Biotechnology and Pharmaceutical Research at the National Health Research Institutes, the three speakers also engaged in a comprehensive panel discussion on patent applications for translational drugs, clinical trials, and practical experiences in GMP manufacturing.