My name is Sudha Babu, founder and principal consultant of GeneBio Consulting LLC. I am a biopharmaceutical professional with a Ph.D. in Genetics and have 18+ years of industry experience, including 11 years in regulatory CMC (Biologics and Gene Therapy). I am passionate about cell, gene, and biologics therapeutic development and offer innovative regulatory CMC solutions to the clients.

Prominent Accomplishments

• Regulatory CMC strategy development for several biologics and gene therapy products with approved INDs / CTAs

• Briefing book authoring with positive outcomes

• Developed several successful CMC comparability strategies

• Managed authoring and review of the BLAs for Opdivo and Empliciti (BMS)

• Successfully managed commercial product lifecycle without supply chain disruption (Luxterna, Spark Therapeutics)

• Supported several global health authority inspections