Clinical Trial Cost & Contract Management Agenda at a Glance

WORKSHOP:
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:
Pharmaceutical and biotech executives with roles in contracts, outsourcing, procurement, vendor management

Chairperson’s Opening Remarks

Sandra Lyons
Senior Contract Administrator, Strategic Sourcing, KING PHARMACEUTICALS

Gauging the Downstream Impact of Consolidation and Turbulent Economic Conditions on Sourcing Agreements

Ian C. Lauf
Manager, Outsourcing Lead, PFIZER

Structuring Contracts for CROs in the Middle East, China and India: Identifying Critical Variations in Responsibility, Liability and Accountability

James Kirwin
Associate Vice President, Global Clinical Operations, WYETH PHARMACEUTICALS

Site Management Contracting: How to Best Define Responsibilities Between Sponsors and CROs to Avoid Accountability Disputes

Priya Mannan
Executive Director and Associate General Counsel, NOVARTIS

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

Measuring the Impact of the Impending Physician Payments Sunshine Act on Your Standardized Disclosure Practices

Brian Annulis
Partner, MEADE & ROACH LLP

Methods for Staying on Budget When Dealing with Ad Hoc Items Outside of Initial Contracts

Scott Jensen
Manager, Global Budgeting & Contracting, ELI LILLY

Sally Teeters
Director, Legal and Business Operations Management, CALISTOGA PHARMACEUTICALS

Panel

Achieving Compliance by Reconfiguring Payment and Contracting Strategies in Light of Fair Market Value (FMV)

Rebecca Miller-Larson
Senior Clinical Contracts Analyst, Clinical Affairs, SHIRE HUMAN GENETIC THERAPIES

Gregg Jewett
Senior Manager, Global Strategic Sourcing, SCHERING PLOUGH CORPORATION

Ian C. Lauf
Manager, Outsourcing Lead, PFIZER

Payment Structure Analysis – Contrasting the Benefits and Drawbacks of Milestone and Unit Cost Payment Structure

Sally Teeters
Director, Legal and Business Operations Management, CALISTOGA PHARMACEUTICALS

Focus on Intellectual Property: Fine Tuning Current Domestic and International Standards and Strategies for Handling Intellectual Property (IP)

FDA Address

What Does FDA Expect Regarding Quality Oversight of Third Parties?

Michael Marcarelli
Director, Office of Bioresearch Monitoring, CDRH, FDA