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Agenda at a Glance

Clinical Trial Cost & Contract Management Agenda at a Glance

Monday, November 9 • Day One

Workshop - For full Description please click here.
8:30 AM	Workshop + Conference Registration
9:00 AM	AM Workshop Begins WORKSHOP: Contract Approach and Development: Key Terms and Negotiating Strategies Workshop Faculty: Frederick Dorey Special Counsel COOLEY GODWARD KRONISH LLP Who Should Attend: Pharmaceutical and biotech executives with roles in contracts, outsourcing, procurement, vendor management
10:30 AM	30-Minute Networking & Refreshment Break
12:30 PM	Workshop concludes; Luncheon for Workshop Participants
1:00 PM	Registration for Conference Only

1:30 PM	Chairperson’s Opening Remarks Kenneth Wu, MS, MBA Consultant, KENNETH WU & ASSOCIATES, LLC
1:45 PM	Gauging the Downstream Impact of Consolidation and Turbulent Economic Conditions on Sourcing Agreements Kenneth Wu, MS, MBA Consultant, KENNETH WU & ASSOCIATES, LLC
2:30 PM	Achieving Compliance by Reconfiguring Payment and Contracting Strategies in Light of Fair Market Value (FMV) Darren Hart Clinical Outsourcing Director, GENENTECH
3:15 PM	Networking & Refreshment Break
3:45 PM	Site Management Contracting: How to Best Define Responsibilities Between Sponsors and CROs to Avoid Accountability Disputes Mary R. Lee, JD, Contract Officer, Clinical Trial Agreements, STANFORD UNIVERSITY Sandra Friborg Director, Clinical Operations, Elan Pharmaceuticals Shantal Feltham President, Stiris Research Inc
4:30 PM	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
5:30 PM	Day One Concludes

Tuesday, November 10 • Day Two

8:30 AM	Chairperson’s Opening Remarks Kenneth Wu, MS, MBA Consultant, KENNETH WU & ASSOCIATES, LLC
8:45 AM	Morning Problem Solving: Innovative Methods for Contracting & Budgeting in the New Sponsor/CRO/Site Paradigm Moderators:Sue Liao Associate Director, Clinical Contracts and Finance, GILEAD SCIENCES Kenneth Wu, MS, MBA Consultant, KENNETH WU & ASSOCIATES, LLC
9:15 AM	Methods for Staying on Budget When Dealing with Ad Hoc Items Outside of Initial Contracts Linda Rodriguez Senior Manager, Clinical Finance & Contracts, ARENA PHARMACEUTICALS
10:00 AM	Networking & Refreshment Break
10:30 AM	Budget Basics and Outsourcing Tools and Content of Templates Deborah Dwyer Associate Director of Clinical Outsourcing, CEREXA Daniella Ajib, MBA Manager, Clinical Outsourcing, CEREXA
11:15 AM	Developing Scope of Work for a Solid Project Foundation and Minimal Project Setbacks Jessica Y. Kaman Senior Director, Development Outsourcing, EXELIXIS*Join co-located Fundamentals of Clinical Outsourcing room
12:00 PM	Luncheon
1:15 PM	Payment Structure Analysis – Contrasting the Benefits and Drawbacks of Milestone and Unit Cost Payment Structure Mark J. Milberg Contract Manager, Clinical Contracts & Alliance Management, MEDTRONIC VASCULAR
2:00 PM	FDA Address: What Does FDA Expect Regarding Quality Oversight of Third Parties? Michael Marcarelli Director, Office of Bioresearch Monitoring, CDRH, FDA
3:00 PM	End of Cost & Contract Management for Clinical Trials

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