Founder and CEO - RegKey
Aruna Dontabhaktuni,Ph.D
Responsibility
-RegKey is a new category of regulatory intelligence platform that unifies agentic AI, proprietary regulatory data, and world-class human expertise to transform how life sciences companies navigate compliance. -RegKey is helping regulatory teams achieve up to 90% efficiency gains, reduce execution risk, and bring life-saving therapies to patients faster.Experience
30+Personal Information
Pharmaceutical and biotech consultant with 30+ years of experience supporting drug development from early discovery through global regulatory approval. I specialize in Clinical Pharmacology, DMPK, and Regulatory Strategy, working across all phases of development. I’ve partnered with leading organizations including Genentech, Roche, Daiichi Sankyo, GSK, SK Life Sciences, and Rafael Pharmaceuticals, and serve as a subject matter expert on DSMBs and Scientific Advisory Boards. My experience spans 20+ assets across biologics, small molecules, and antibody–drug conjugates in therapeutic areas including oncology, immuno-oncology, immunoscience, and rare diseases. I’ve led global regulatory interactions with agencies such as the FDA, EMA, PMDA, and KFDA, and authored key regulatory submissions including INDs, NDAs, BLAs, and eCTD modules. Author of 40+ peer-reviewed publications and frequent keynote speaker at international scientific conferences. Expertise: Clinical Pharmacology • PK/PD • Pharmacometrics • Regulatory Affairs • Biosimilars