Q. Melody Dai, Ph.D.

Biotech executive with 20+ years leading global regulatory affairs, CMC development, and cross-functional product strategy across gene therapy, antisense oligonucleotides (ASO), rare diseases, oncology, and biologics. I bring a unique blend of scientific depth, strategic thinking, and operational leadership that accelerates development and helps organizations scale with clarity and confidence.I have advanced therapies from discovery through IND/CTA submissions, early-phase development, pivotal studies, and global approvals—building high-functioning regulatory and CMC organizations and guiding teams through complex technical and regulatory environments. My experience spans major therapeutic modalities, including gene therapy, antisense oligonucleotides (ASO), and biologics (enzymes and antibodies), integrating deep scientific understanding with disciplined development execution.My leadership is characterized by clarity, thoughtful collaboration, and empowering teams to deliver high-quality, impactful work. I am committed to aligning science, clinical development, regulatory strategy, and technical operations to create cohesive, forward-looking development plans that strengthen organizational decision-making and enable sustainable growth.Expertise: Product Development Strategy • ASO/Oligonucleotide Development • Regulatory Affairs • CMC Development & Innovation • Gene & Cell Therapy • Rare Diseases • Oncology • Global Submissions (IND, CTA, BLA, MAA) • Program Leadership • Technical Operations • CDMO Oversight • Organizational Scale-Up • Cross-Functional Leadership