2014 ISPE CMO Conference
Conference Program
Conference Highlights
Exhibit Hall

START-UP - SELECTION -
GOVERNANCE - DELIVERY
Participate in 2 days of high-level discussions around CMO challenges and expectations at every phase of operation.

Representatives from Contract Manufacturing and Development Organizations, Owner Companies, and the FDA, will assemble at the CMO Workshop to discuss regulatory and operational challenges associated with four phases of contract manufacturing operations. Through open discussion and debate, key activities covered at this workshop will include CMO related challenges such as roles and responsibilities and quality contracts.

  • Examine every phase of the Owner-CMO relationship throughout the product lifecycle:
    Start-up ♦ Selection ♦ Governance ♦ Delivery
  • Explore roles and responsibilities of all parties involved in CMO activities
  • Contribute to an ongoing dialogue facing all partners and constituents committed to successful manufacture and delivery of quality products
  • Discuss challenges experienced by both Pharma and Generics Companies
  • Understand important components of Quality Contracts being included in upcoming FDA guidance
  • Interact in a workshop setting with Regulators and other executives from CMO and Owner Companies

Conference Chairs

Tim Tyson
 Photo
Chairman and CEO, Aptuit, Inc.

Steve Leonard
 Photo
Sr VP of Global Operations, Catalent Pharma Solutions

Paula Katz, JD
 Photo
Branch Chief (A), Regulatory Policy & Collaboration, FDA/CDER/OC/OMPQ

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Announcements:

MAKE SURE YOUR COMPANY'S VOICE IS HEARD!  

Discussions from the workshops will be collated for the development of a white paper to inform the development of guidance on this topic.

Featured KEYNOTE Speakers

Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions

Thank you to our PROGRAM COMMITTEE!

Tim Tyson, Chairman and CEO, Aptuit, Inc. – Chair

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions – Co-Chair

Paula Katz, Branch Chief (A), Regulatory Policy & Collaboration, FDA/OMPQ - Co-Chair

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson - Co Chair

Joachim Del Boca, Apotheker, Vetter Pharma-Fertigung GmbH & Co KG