Fundamentals of Clinical Outsourcing

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November 01 - 02, 2007 | Marriott Long Wharf in Boston, Boston, MA

DAY ONE

Chairperson's Opening Remarks and Review of Audience Objectives
Rikki Bouchard, President & CEO, RH BOUCHARD & ASSOCIATES
Mapping the Clinical Development Outsourcing Process
Mike Sullivan, Senior Contracts Manager, Clinical Trial Logistics, WYETH
Cassandra Kelly, Senior Outsourcing Manager, VERTEX PHARMACEUTICALS
Michael Breton, Sr. Director, Business Operations, PAREXEL INTERNATIONAL CORP.
Understanding the Different Outsourcing Models
Nicholas Kenny, Executive Director, Oncology, INC RESEARCH
External Service Provider Identification, Assessment and Selection
Karen A. Zuklie, Director, Planning & Outsource Management, PURDUE PHARMA LP
Jon Lee, Senior Director, Strategic Operations, CEREXA
Julia Santos, Worldwide Associate Director, Strategic Sourcing, JOHNSON & JOHNSON
Budget Basics
Anthony J. Carita, Director, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION
Outsourcing Tools and Content of Templates
Jon Lee, Senior Director, Strategic Operations, CEREXA
PANEL DISCUSSION: Creating a Corporate Outsourcing Strategy
Kelly Blackburn, Vice President, Clinical Development Operations, VERTEX PHARMACEUTICALS
Linda Carlson, PhD, MBA, Vice President, Medical Operations, EMD SERONO, INC
David Reasner, Senior Vice President, Clinical Operations and Data Analysis, SEPRACOR

Developing Scope of Work for a Solid Project Foundation and Minimal Project Setbacks
Maureen Hynes, Associate Director, Strategic Sourcing, MILLENNIUM PHARMACEUTICALS
Contract Management
Lynn Newbould, Senior Associate, BioPharma/Clinical Research Consulting, RH BOUCHARD & ASSOCIATES
Michele Gause, Contracts Manager, Clinical Trial Logistics, WYETH
Contract Approach and Development: A Non-Legal Approach to Contract Basics and Terminology
Kenneth Krisko, Partner, COOLEY GOWARD KRONISH LLP
Allan Cohen, Director, Legal Services, CELTIC PHARMA Effective Project Closure
Larry Blankstein, Senior Director, Clinical Research, GENZYME
INTERACTIVE ROUNDTABLE:Moderator: Christine Sahagian, Associate Director, Outsourcing, VERTEX Outsourcing Metrics: What is Valuable to Track and What to Do Once You Have the Data?
PANEL DISCUSSION: Relationship Management: The "Rules of Engagement"
Kathleen Findlen, Executive Director, Clinical Operations, SYNDAX PHARMACEUTICALS
David Reasner, Senior Vice President, Clinical Operations and Data Analysis, SEPRACOR
Shantal Feltham, President, STIRIS RESEARCH INC.