Manufacturing & Analytical Characterization

Karunakar (Karu) Sukuru, R.Ph., Ph.D
Global Vice President-Pharma Product Development & Head- Scientific Advisory
Catalent
St. Petersburg, Florida
Description: Lifecycle Management (LCM) has become a strategic necessity in a competitive pharmaceutical environment where innovation, speed, and patient relevance drive success. This session explores how softgel and fast-dissolving orally disintegrating tablet (ODT) platforms enable effective LCM strategies that revitalize assets, enhance therapeutic performance, and improve patient experiences. Participants will learn how to integrate development, manufacturing, and supply considerations to accelerate reformulation and streamline scale-up. Real-world case studies will showcase applications that expand patient access, oncology formulations that overcome solubility and tolerability barriers, and lifecycle strategies that maintain market competitiveness. The session highlights how integrating formulation science with scalable technologies and patient-centered approaches supports a proactive model of LCM, ensuring long-term product value and market differentiation.