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New Frontiers in Pharmaceutical Manufacturing
Session Chair(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
This session explores novel and disruptive approaches to pharmaceutical formulation development and manufacturing. Translational pharmaceutics is the emerging practice of integrating formulation development, real-time manufacturing, and clinical testing within early phase drug development. We explore the utility and potential of this approach to provide optimal formulations to take forward into later phases of clinical testing. We also explore the potential of 3D printing and how this may be integrated to provide personalized medicine within clinical trials and on the market. We consider cost, utility and benefits of these approaches, and implications on the regulatory requirements.
Learning Objective : Describe how new techniques for formulation and product manufacturing will modernize the delivery of products to patients.
Speaker(s)
Potential Regulatory Challenges for Worldwide Approval of Continuous Manufacturing
Christine Moore, PHD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Translational Pharmaceutics and Integrating GMP Manufacture and Clinical Testing: A Game Changer for R&D Productivity
Peter Scholes, PHD, RPH
Quotient Clinical, United Kingdom
Chief Scientific Officer
FDA Perspective on 3D Printing: A New Frontier in Pharmaceutical Drug Development
Akm Khairuzzaman, PHD, MS
FDA, United States
Branch Chief (Acting), Office of Process and Facilities, OPQ, CDER