Better Practices in Developing Effective Contract Manufacturer and Supplier Partnerships

Session 405
Manufacturing Operations Track

The competition for highly capable contract manufacturers and suppliers has become fierce. It is imperative that existing and new relationships between pharma companies be strengthened to benefit both companies and ultimately drive compliant, reliable, cost-effective supply to patients around the world.

Session Description

The goal of this session will be to create a dialogue on how to effectively select CMOs and suppliers for strategic partnerships while driving value for both parties. Recent years have seen significant rationalization of internal manufacturing and packaging facilities at big pharma in favor of contracting these services with 3rd party providers worldwide. Presenters representing big pharma, contract engineering firms, and CMOs will provide perspectives on the following topics.

Selection process for CMOs and suppliers including due diligence, audits, etc.
Approaches to technology transfer and start up of processes and packaging operations.
Use of contract engineering firms to assist third party CMOs with capital projects.
Driving win-win components into supply contracts and quality agreements.
Change control, compliance and ongoing oversight needs.

At the conclusion of this session, participants will be able to:

Understand what steps can be taken to optimize relationships with suppliers
Effectively select a supplier for partnership
Develop tools and systems to enable the effective oversight of suppliers

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom