Pharmaceutical Outsourcing/Insourcing: Managing the Technical Process at a Third Party Organization Sunday,  March 2, 2008
1:00 p.m., Room 260 

Organizer:

Brian P Axe, Eli Lilly & Co.

Speakers:

1:00       Outsourcing Manufacture and Qualification of Pharmaceutical Reference Standards  LOUIS A COURY, Eli Lilly and Company, Margaret M McInerney, Paul F Booth, Cynthia Zajac, Matthew W Borer

1:20       Successful Transfer of an HPLC Method Development Procedure from a Pharmaceutical Laboratory into a Third Party Contract Analytical Laboratory  JON SCOTT KAUFFMAN, Lancaster Laboratories

1:40       Developing Successful Partnerships with Contract Pharmaceutical Organizations  WINONA MATHESON, Aptuit, Inc.

2:00       Accelerating Early Phase Clinical Candidates in Big Pharma   PAUL KEVIN OWENS, Chorus - A Division of Eli Lilly

2:20       Recess

2:35       Making Data Available to Clients Real Time  JON SCOTT KAUFFMAN, Lancaster Laboratories

2:55       Pharmaceutical Outsourcing:  A View from Both Sides  ANDREW CHARLES KOLBERT, Catalent Pharma Solutions

3:15       Challenges for Development, Validation and Transfer of Solid-State Analytical Methods  FIONA C THORLEY, SSCI, An Aptuit Company, Pamela A Smith

3:35       Using Laboratory Workflow Analysis to Determine Critical LIMS Requirements  RANDY HICE, Laboratory Expertise Center

Overview:

Increasing drug prices are a major concern in our current healthcare system and finding innovative ways to bring new medications to market is becoming increasingly challenging.  In the ever scrutinized world of pharmaceuticals, changing the way patients view drugs and drug development is essential to our industry.  Lowering drug development costs continues to be an important goal of many drug manufacturers.  In attempts to reduce the cost of pharmaceuticals, outsourcing / insourcing has become essential and continues to challenge our respective business models.  With increasing analytical development and processes being performed outside the drug manufacturer, the control over information and intellectual property is increasingly limited.  Managing this technical information and interaction is essential to the success of the process.  The goal of this contributed session is to explore some of the analytical technical challenges associated with outsourcing/insourcing and share technical successes and failures.  We want to focus on the technical aspects of these third party interactions and learn from shared experiences amongst our colleagues.  We want to explore trends of insourcing versus outsourcing and discuss what level of technical oversight is considered appropriate.  The topics of this subject may include specific examples of novel testing by a third party, transferring methods or processes to or from a third party organization, the technical oversight needed for certain types of projects, or ways to protect intellectual properties and still provide adequate information.