Sree Katikaneni

I am a pharmaceutical quality and stability leader with 17 years of experience across biologics (including ADCs), vaccines, small molecules, and mRNA — from Phase I through commercial launch.

My career began on the bench at Catalent Biologics, where I progressed from analytical scientist to quality program leadership, managing GMP stability programs for clients including Merck and Johnson & Johnson. I went on to lead global stability strategy at GlaxoSmithKline, overseeing programs that supported the commercial approvals of Sotrovimab and Dostarlimab. At Takeda Pharmaceuticals, I served as Associate Director and Head of Global Stability, managing a portfolio of 30+ commercial (90% Small Molecules and Adcetris ADC) and late-phase products — including Exkivity — across an outsourced CDMO network. Most recently, at the Gates Medical Research Institute, I built the GMP stability quality infrastructure from the ground up for an institute-wide IMP portfolio spanning biologics, vaccines, small molecules, and mRNA.

I bring deep hands-on expertise in stability program design, ICH-compliant regulatory submissions, CDMO oversight, OOS/OOT investigations, and GMP compliance — and I have done this work at every stage of development, at every scale, across every major drug modality.