Fundamentals of Clinical Outsourcing Agenda at a Glance

DAY ONE PROGRAM AGENDA: Thursday, October 22, 2009

WORKSHOP:

8:30	Workshop Registration & Morning Coffee	12:30	Workshops Concludes; Luncheon for Workshop Participants
9:00	Workshop Begins	1:00	Registration for Main Conference Only Participants
10:30	30-Minute Networking & Refreshment Break

WORKSHOP DETAILS:
Contract Approach and Development: Key Terms and Negotiating Strategies

Workshop Faculty
Kathleen Greenough
Manager Clinical Business Analysis,
BIOGEN IDEC

Donna Saligan, MBA, MT (ASCP)
Senior Associate
RH BOUCHARD & ASSOCIATES INC

Michelle Rosen
Corporate Counsel,
VERTEX PHARMACEUTICALS INCORPORATED

Who Should Attend This Workshop
Pharmaceutical and Biotech Executives with roles in
Outsourcing, Contracts, Procurement, Vendor Management

DAY ONE PROGRAM AGENDA: Thursday, October 22, 2009

1:30	Main Conference Begins - Chairperson’s Opening Remarks Rikki Hansen Bouchard President & CEO RH BOUCHARD & ASSOCIATES, INC.
1:45	Map the Clinical Development Outsourcing Process Graeme Currie, PhD Vice President, Clinical Operations SEPRACOR INC
2:30	Understand the Different Outsourcing Models Rikki Hansen Bouchard President & CEO RH BOUCHARD & ASSOCIATECIATES, INC.
3:15	30-Minute Networking Break
3:45	Create a Corporate Outsourcing Strategy Anthony J. Carita Director, Clinical Outsourcing OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATIATION
4:30	KEYNOTE ADDRESS: Tracking the Transition from Transactional to Portfolio-Based Relationships Ken Getz, MBA Senior Research Fellow TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
5:15	Day One Concludes

DAY TWO PROGRAM AGENDA: Friday, October 23, 2009

7:45	Morning Coffee
8:15	Chairperson’s Opening Remarks
8:30	The Benefits of a Establishing a Governance Committee David Reasner Senior Vice President, Clinical Operations and Data Analysis SEPRACOR INC
9:15	Relationship Management: The “Rules of Engagement” Larry Blankstein Senior Director, Clinical Research GENZYME Karen L. Wolf Senior Director, Clinical Operations MILLENNIUM PHARMACEUTICALS Shantal Feltham President and CEO STIRIS RESEARCH
10:00	Networking & Refreshment Break
10:30	External Service Provider Identification, Assessment and Selection Heidi Shea Manager, BMRA Outsourcing GENZYME CORPORATIATION
11:15	Budget Basics and Outsourcing Tools and Content of Templates
12:00	Luncheon
1:30	Developing Scope of Work for a Solid Project Foundation and Minimal Project Setbacks Lynn McGovern Director, Strategic Sourcing MILLENNIUM PHARMACEUTICALS
2:00	Adhere to Timelines and other Measures of Success Lauren Goldsmith Senior Manager, Strategic Outsourcing MANNKIND CORPORATIATION
2:30	Refreshment and Networking Break
3:00	FDA ADDRESS: What Does FDA Expect Regarding Quality Oversight of Third Parties? Michael Marcarelli Director, Office of Bioresearch Monitoring, CDRH FDA
3:45	Conference Concludes