Biography:
Bhasker Sambar is a Senior Manager of External R&D and Technical Services at Alvogen Inc., NJ, with over 15 years of pharmaceutical industry experience spanning formulation development, CMC regulatory authorship, and commercialization of sterile injectable and combination products. He has successfully led prefilled syringe, autoinjector, and complex injectable suspension programs through NDA approval, with expertise in QbD, DoE, media-milling technology, CDMO management, and eCTD module authorship. He holds a Master's degree in Pharmaceutics from Kakatiya University, India.
Title : Artificial intelligence and digital twins in drug product development: A regulatory science perspective