HLB Innovation announced on Wednesday that its U.S. subsidiary, Verismo Therapeutics, has officially appointed Dr. Dennis Williams as Vice President of Regulatory Affairs.
Dr. Williams is a seasoned expert with over 25 years of experience spearheading regulatory strategies in the global oncology and cell therapy sectors. He has a proven track record of developing and overseeing global and country-specific regulatory strategies throughout the entire drug development lifecycle, from early-stage clinical trials to late-stage studies, submission processes, and regulatory approvals.
At Adaptimmune, a British global cell therapy company, Dr. Williams led the late-stage clinical development and regulatory strategy for Tecelra, a T-cell receptor (TCR) gene-modified cell therapy. His efforts culminated in the U.S. Food and Drug Administration (FDA) approval for solid tumor indications, paving the way for the therapy’s commercialization.
Tecelra has made history as the first gene-modified cell therapy to receive FDA approval for solid tumor indications, demonstrating both clinical efficacy and commercial viability.
Dr. Williams holds a Bachelor of Pharmacy from Temple University and a Pharm.D. from the University of Florida. His impressive career includes senior regulatory positions at pharmaceutical giants Teva and GlaxoSmithKline (GSK), where he spearheaded major product approvals and indication expansions.
With Dr. Williams on board, Verismo aims to bolster its global regulatory strategy capabilities and accelerate the clinical development of its Chimeric Antigen Receptor T (CAR-T) cell therapy pipeline, which is based on the company’s proprietary KIR-CAR platform.
Brian Kim, Chief Executive Officer (CEO) of Verismo, commented that Dr. Williams brings a wealth of experience in both late-stage development and global regulatory strategies. His firsthand experience in shepherding a solid tumor TCR-T cell therapy through FDA approval will be invaluable in advancing Verismo’s CAR-T pipeline.
Kim added that as they ramp up development for the KIR-CAR platform-based therapies, SynKIR-110 and SynKIR-310, they’re poised to systematically enhance the global development strategy. Its goal is to maximize the chances of success from clinical development through to commercialization.
