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Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
Session Chair(s)
Anupama Ramkumar, MD
Consultant, Clinical Development
Dr. Reddy's Laboratories Ltd., India
Insourcing to India: The Real Politics of Building a Dynamic partnership between US and Hyderabad Regulatory Professionals
Learning Objective : Identify the unique challenges related to the outsourcing of clinical trials of biologics/biosimilars; Analyze the differentiators and the medical and project management issues related to these trials; Describe current partnering trends and the paradigm shift from mono-centric to poly-centric, frugal innovation models; Explain how to go beyond basic cultural and management issues and use more advanced strategies for integrating diverse skills around operational deliverables.
Speaker(s)
Clinical Trials in Biosimilars or Follow-on Biologics: Outsourcing Strategies and Challenges
Anupama Ramkumar, MD
Dr. Reddy's Laboratories Ltd., India
Consultant, Clinical Development
Global Licensing and Co-development Models: Innovative Route to Faster Commercialization
Nidhi Saxena, MBA
Karmic Lifesciences, Inc., India
Founder and CEO
Insourcing to India: The Real Politics of Building a Dynamic partnership between US and Hyderabad Regulatory Professionals
Raffy H. Chilingerian, PhD, MS
Novartis Pharmaceuticals Corporation, United States
Senior Regulatory Operations Manager
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