Alex Shih-Min Huang

VP & Head of Cell Therapy, BeiGene
BeiGene (Taiwan) Limited
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Dr. Alex Shih-Min Huang joined BeiGene in April 2021 and is the Vice President, Head of Cell Therapy. He is an experienced leader of science and people in pharmaceutical R&D with substantial proficiency in drug discovery and development. Over the span of more than 20 years, he built a command of portfolio oversight and hands-on, proven track record spanning target discovery/validation, hit-to-lead, lead nomination, lead optimization, development candidate selection, early/late development, life cycle management, clinical biomarkers, and forward/reverse translational research, at Novartis, Sanofi, Genentech, BMS, and AbbVie with increasing responsibility. 

Prior to joining BeiGene, Alex was deeply engaged in the clinical development space at Genentech, BMS, and AbbVie. Most recently, he was the Senior Director of Precision Medicine Oncology at AbbVie, leading a group of ~50 seasoned scientific personnel, delivering translational research/clinical biomarker/CDx strategies, critical data packages, and relevant interpretations to facilitate development and commercial decisions from pre-GLP tox to Ph1/2/3 trials and life cycle management, covering >20 pipeline molecules consist of various therapeutic modalities (CAR-T, bispecific, ADC, naked therapeutic antibody, small molecule, etc.) targeting diverse biological space including immuno-oncology, apoptosis, and B cell signaling pathways in both solid tumors and hematological malignancies. Prior to entering the translational medicine space, Alex was a drug discovery program PTL with Novartis Institutes for Biomedical Research (NIBR) and Sanofi Oncology, leading drug discovery teams to advance multiple programs spanning target discovery/validation, hit finding, lead optimization, lead nomination, development candidate selection, and pre-clinical translational research. 

Dr. Huang obtained his doctoral degree in Microbiology and Immunology from the University of Rochester Medical Center and completed his post-doctoral training at the Genomics Institute of the Novartis Research Foundation (GNF) in San Diego.

 

Speech title & Synopsis

Driving the next generation of innovative and affordable cell therapies across indications

As significant as its clinical impact, autologous CAR-T still suffers from the low accessibility and affordability. In addition, not all patient-sourced specimens can be turned into the qualified CAR-T products. Integrating multiple gene edits in a single cell, while maintaining a homogenous therapeutic cell population that harbors all the desired edits has also proven difficult. These issues largely remain with the donor-based allogeneic cell therapy.

Inevitably, the donor-to-donor variations and the burden of maintaining a super-donor pool indefinitely could weigh heavier and heavier on the long-term commercial viability of the donor-based approach, especially when the anticipated doses one can derive from one batch decreases dramatically from the promised thousands to low hundreds or even tens. 
Induced pluripotent stem cell(iPSC) is one of the solutions to provide a sustainable path for cell therapy.  iPSC-derived cell therapy could present minimal product inconsistencies vs that of the autologous or the donor-based approach, as it arises from one single cell clone that harbors all the desired genetic alterations to ensure absolute homogeneity of the gene edits at the single cell level. The subsequent uniformed differentiation and expansion methodologies will further ensure consistency of the therapeutic products and dramatically reduce the cost-of-goods to significantly enhance affordability and accessibility of the cell therapy.  
Since its official inception in 2022, the BeiGene Cell Therapy has already created a wholly owned, globally compliant GMP grade iPSC clone collection that generates desired effectors with high purity and expansion fold, integrated combinatorial genetic edits that enhance the functionality and longevity of the iPSC-derived effector cells, and established highly efficient, but feeder-free differentiation and expansion platforms that will facilitate the streamlined manufacturing process. 
This presentation will aim to stimulate discussions on providing affordable and accessible cellular medicines worldwide in the backdrop of BeiGene’s experience.