Designing and Establishing Supply Networks (Track 1)

Track Leader

• John Donaubauer, Project Leader, Scientific Affairs, Abbott Laboratories, USA

Session 1 - Current Challenges and Threats to Developing an Efficient Supply Network - Joint Session

Creating a Sustainable Advantage in Pharmaceutical Source Development
Thomas Eckrich, Director, Chemical Product Research and Development, Eli Lilly & Co., USA

How Well Connected is the Pharma Supply Chain Network?
Nick Davies, CEO & Principal Consultant, NDA Consultants, USA

Roundtable Discussion

Session 2 – Panel Discussion: Emerging Technologies – Opportunities and Challenges in Registration, Tech Transfer, Regulatory, Supply Chain, & Quality Systems

Panel Discussion Moderators:

• Mike O'Brien, Head of Innovation & Technology Strategy, Pfizer, Inc., USA
• Shanthi Sethuraman, PhD, Director of Chemical Products R&D, Eli Lilly & Co., USA
• Peter Bigelow , President, SHA Consultants, LLC, USA
  
• Bryan Wright, ISPE International Regulatory Advisor, UK
  
• Rick Spencer, Engineering Consultant, Eli Lily & Co., USA

Session 3 – Quality Expectations and Challenges in the Global Supply Network - Joint Session

Managing CMOs from a Customer's Perspective
Bill Connell, Vice President & Supply Chain Practice Leader, Maxiom Group, USA

Incentives for Local Manufacture: The Regulatory and Business Landscape
Guy Villax, CEO, Hovione, USA

Question & Answer Session

Session 4 – Local Manufacturing Impact on Global Supply

Pharmaceutical Industry Trends in Emerging Markets
Angelica Wong, Vice President, Emerging Markets, Pfizer, Inc., USA

Case Study of Emerging Market Technology Transfer Process
Matt Roberge, PE, Director, Emerging Market Support, Pfizer, Inc., USA 

Panel Discussion

Session 5 – Supplier Integration and Third Party Quality Assurance

Quality Assurance Oversight Strategies of CMOs
Erik Roggeman, Associate Quality Consultant, Eli Lilly & Co., USA

New Challenges for the Pharmaceutical Supply Chain
Hans Engels, PhD, President & CEO, DSM Pharmaceuticals, Inc. USA

Question & Answer Session

Session 6 – Regulatory Challenges in a Global Supply Network

Managing Regulatory and Quality Challenges in an Outsourcing Environment
Eda Ross Montgomery, Senior Director, Technical Steward, Global Pharmaceutical Technology, Shire Pharmaceuticals, USA

Regulatory Challenges in a Global Supply Network
Francis Godwin, Compliance Officer FDA/CDER/DMPQ, USA

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