Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product lifecycle. Chin is an active member of PhRAM, Combination Product Coalition, and international standard committee. Chin has 20 years of regulatory and quality experience, including strong expertise in combination products and digital health. Prior to joining Genentech, he was with Medtronic and Boston Scientific where he successfully led regulatory submissions and implemented quality management principles that resulted in approvals of IN.PACTTM drug-device coated balloon, TAXUSTM drug-device coated stent, and implantable, programmable drug infusion pumps. Chin graduated from Iowa State University with a Bachelor degree in Industrial and Manufacturing Systems Engineering, a Master of Science in Bioscience regulatory affairs from the Johns Hopkins University, and a Doctorate in Regulatory Policy from the University of Southern California School of Pharmacy.