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Wednesday, June 27 • 4:00pm - 5:15pm
#385: Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-676-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this provocative session, executives from various sponsor organizations will react to the 2017 industry report on risk in clinical trials. They will share its 2017 industry findings on the state of clinical outsourcing, risk assessment, and risk-based approaches to managing quality and oversight in the context of a changing regulatory landscape. With a near equal balance of respondents identifying as using primarily FSP or primarily Full-Service models, they will shed light on what the data says about the impact of sourcing model on quality, relationships, and risk-based approaches.Forward-thinking executive leaders from pharma and CRO respondents will respond to the findings with their own interpretations, describe strategies where threats and opportunities may be addressed, and promote their own unique view.

Learning Objectives

Assess the impact of clinical outsourcing model on quality, relationships, and risk-based approaches; Describe strategies addressing threats and opportunities in the changing regulatory landscape.

Chair

Mitchell A. Katz, PhD

Speaker

Panelist
David M. Johnston, PhD

Panelist
John Oidtman

Panelist
Jeremy G. Chadwick


Speakers
JC

Jeremy Chadwick

Group Vice President, Clinical Development Operations, Shire
DJ

David Johnston

Executive Vice President, Clinical Development, PPD
Serves as EVP and global head of clinical development for PPD. Responsible for project delivery and provides strategic direction to the company’s Phase II-IV organization in the Americas, Europe, Middle East and Africa (EMEA), and Asia-Pacific. Previously, Dr. Johnston oversaw PPD... Read More →
avatar for Mitchell Katz

Mitchell Katz

Head of Clinical Research and Drug Safety Operations, Purdue Pharma L.P.
Dr. Mitchell Katz is Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. In this position, he is responsible for leading all operational activities across Purdue’s multinational clinical programs. Dr. Katz has 28 years’ experience in the pharmaceutical and... Read More →
avatar for Mitchell Katz

Mitchell Katz

Vice President, Development Operations, Ferring Pharmaceuticals
Dr. Mitchell Katz recently joined Ferring Pharmaceuticals, Inc. as Vice President, Development Operations. In this position, he is responsible for providing strategic direction and operational excellence in running Ferring’s clinical stage programs. Dr. Katz has over 25 years... Read More →
avatar for John Oidtman

John Oidtman

Senior Vice President, Head of Global Clinical Operations, EMD Serono, Inc.
John Oidtman is a seasoned Clinical Operations leader with almost 30 years in the global pharmaceutical industry. He has a keen focus on accelerating drug development and strongly believes in fostering a global culture that is reflective of being inclusive and collaborative. Prior... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm EDT
Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session