Andrew Luk, PhD

Dr. Andrew Luk has over 30 years of experience in the MedTech industry, covering a variety of therapeutic areas in both pharmaceuticals and devices. He has held leadership roles in new product development, project management, and GMP manufacturing. He served as the Senior Director of New Technology and Project Management at CooperVision, a leading contact lens and eye care company. Prior to CooperVision, he was the Senior Director at Cordis, a world leader in drug-eluting stents, which was later acquired by Johnson & Johnson (J&J). Before that, he was an Engineering Fellow at ALZA, the top polymer-based drug delivery company, also acquired by J&J.

Dr. Luk has extensive expertise in new technology development, technology translation, and cross-functional alliance management. He has led cross-functional R&D teams to drive product sub-concepts from rapid prototyping to clinical proof-of-concept testing for over 50 clinical trials and 100+ invention disclosures. He has guided technical teams to operate in compliance with Design Control, GXP, ICH, USP/EP/JP, and ISO guidelines. He has authored CMC sections in IND/IDE/PMA submissions and crafted successful comprehensive responses to global regulatory questions, facilitating the transition to clinical trials and regulatory approvals.

Dr. Luk received his PhD in Chemical Engineering from the University of Delaware.