Speakers

Arlene Wolny, PhD

Global Head of Regulatory Affairs
Biocon Biologics Ltd.

Arlene Wolny is the Global Head of Regulatory Affairs at Biocon Biologics since 2023. Prior to Biocon Arlene was the US head of Biosimilar Regulatory Affairs at Sandoz, and before this worked at Novartis in the development of Oncology medicines to advance therapeutic options for cancer patients. My focus is working towards international convergence of streamlined development. This will maintain the high-quality standards needed for agency approvals but reduce the time and costs required to develop affordable biologics for patients. Arlene holds a PhD in Pharmacology from the Basel University Switzerland and an MBA at Columbia University NY.

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