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Wednesday, June 29 • 10:30am - 11:45am
#311: Outsourcing: Assessing CRO Performance and Challenges

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Outsourcing has been a major topic in the pharmaceutical industry over the last decade. As drug development costs increase, trial complexity grows, and work in emerging markets becomes more important, the industry has looked toward outsourcing to help combat these challenges. But what impact has the rising proportion of outsourcing had on operational performance? How is the effect being measured or tracked? This panel will explore the dynamic between CROs and sponsors and their expectations, the operational benefits of outsourcing, as well as the challenges from outsourcing. It will examine performance and the crucial factors that influence internally-conducted trials versus outsourced trials, how these differences are being managed, and what changes have occurred over time.

Learning Objectives

Recognize the operational benefits and challenges of outsourcing clinical trials; Classify the different approaches to outsourcing and the strategic trade-offs.

Chair

Scott R Martin, JD

Speaker

Creating an External Alliances Structure
John F. Kurtz

How Real World Research Challenges Outsourcing Strategies
Michael George Minor

Controlling Study Level Budgets with CROs
Michael Williamson, MSc



Chair
avatar for Scott Martin

Scott Martin

Principal, KMR Group Inc.
Scott Martin is a Principal of KMR Group a firm specializing on biopharmaceutical R&D performance, information and analytics. Among Scott’s areas of expertise are: clinical development performance, resource management, assessing efficiency and productivity in R&D, and implementing... Read More →

Speakers
avatar for John Kurtz

John Kurtz

Senior Director, External Alliances, Janssen R & D, LLC
John is Senior Director, External Alliances for Janssen Pharmaceutical Companies of Johnson & Johnson. His primary focus is to drive value creation and R&D effectiveness by optimizing collaborations with Key R&D Strategic Suppliers. John has over 25 years’ experience building and... Read More →
avatar for Michael Minor

Michael Minor

Senior Vice President, Global Head Operations and Strategic Planning, ICON Peri-Approval and Observational Research
Michael Minor is SVP, Global Head, Peri-Approval & Observational Research at ICON. Mike has >30 years’ experience leading Phase I-IV and non-interventional research, and as outsourcing professional in pharma companies and CROs giving him a balanced perspective of sponsor/provider... Read More →
avatar for Michael Williamson

Michael Williamson

Associate Director Outsourcing and Contracts Management, UCB Biosciences, Inc.
Mike has been with UCB for over seven years serving as a sourcing and procurement professional implementing innovative sourcing models, vendor strategic partnering arrangements, and spending improvement analysis focused on clinical research. Mike is currently Associate Director and... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Session