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Wednesday, June 21 • 10:30am - 11:45am
#313: New Frontiers in Pharmaceutical Manufacturing

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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



Speakers
avatar for Akm Khairuzzaman

Akm Khairuzzaman

Branch Chief (Acting), Office of Process and Facilities, OPQ, CDER, FDA
Dr. Khairuzzaman is a pharmaceutical scientist by training and currently serving as an Acting Branch Chief at FDA’s Office of Process & Facility, OPQ where he is leading a group of review scientists responsible for the assessment of chemistry, manufacturing, controls (CMC) of i... Read More →
avatar for Christine Moore

Christine Moore

Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
Christine Moore is the Global Head and Executive Director of CMC Policy at Merck. She joined Merck in 2016 after 11 years in various positions at FDA, including Acting Office Director of the ONDQA and OPF. Throughout here career, Christine has been at the forefront of development... Read More →
avatar for Peter Scholes

Peter Scholes

Chief Scientific Officer, Quotient Clinical
Peter read Pharmacy at Nottingham University gaining his PhD in 1993. He joined Quotient in 2007 and was instrumental in driving integration of pharmaceutical development and clinical testing in early research. Peter was appointed CSO in 2013. He has served on the UK CRS and APS... Read More →


Wednesday June 21, 2017 10:30am - 11:45am
S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616