Workshop

1:00pm
Standard of Care: What is SOC and How do you Determine what Procedures Fall within its Scope?
Holly Squires, Senior Vice President, TTC, LLC
Malcolm Bohm, President, Trialytics

Main Conference

9:05am
The Impact of the FDA Amendments Act (FDAAA) – Comply with Federal Regulations to Avoid Potential Liability
Priya Mannan, Senior Counsel, BAXTER INTERNATIONAL, INC.

1:00pm
Intellectual Property Rights: Practical Ways of Negotiating High Disputed Provisions
Paul Fehlner, Partner, BAKER BOTTS, LLP
Allan M. Cohen, Director, Legal Services, CELTIC PHARMA DEVELOPMENT

2:00pm
Creating a Win-Win Relationship: A Systematic Approach to Investigator Contracting and Grant Payment Management
James M. DiCesare, Director of Pharmaceutical Services, CLINICAL FINANCIAL SERVICES, LLC
Kevin T. Williams, MS, MBA, Director of Contracting and Client Services, CLINICAL FINANCIAL SERVICES, LLC

10:30am
Streamlining Accruals and Contract Management with Earned Value Analysis
Kristin Lucas, Senior Director, Clinical Services, CLEARTRIAL, LLC
Alan Stowe, Director, Financial Planning and Analysis, PDL BIOPHARMA, INC.