DIA 2017 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Describe how new techniques for formulation and product manufacturing will modernize the delivery of products to patients.

Chair

Christine M. V. Moore, PhD

Speaker

Potential Regulatory Challenges for Worldwide Approval of Continuous Manufacturing
Christine M. V. Moore, PhD

Translational Pharmaceutics and Integrating GMP Manufacture and Clinical Testing: A Game Changer for R&D Productivity
Peter Scholes, PhD, RPh

FDA Perspective on 3D Printing: A New Frontier in Pharmaceutical Drug Development
Akm Khairuzzaman, PhD, MS