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Tuesday, June 20 • 4:00pm - 5:15pm
#283: The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold?

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000199; RN 1.25

It takes $2.6 billion in capitalized costs to develop a new drug. Only one in 10 new drug applications is approved, and cycle times are not faster compared to the mid-90s. Many companies continue to spend time and energy on addressing challenges that do not bring competitive differentiation. The Avoca Quality Consortium along with other industry consortia have enabled sponsors, CROs, and specialty providers to leapfrog solution development through common, collaboration platforms. In this forum, we will discuss the process for driving change through industry collaborations, and we will explore the challenges and opportunities for making a meaningful impact in an industry that is slow to change. Two case studies, one involving workforce development and one involving oversight, will be covered.

Learning Objectives

Discuss how consortia and industry collaboratives can provide benefits in drug development.

Chair

Patricia Leuchten

Speaker

Industry Consortia are Propelling Collaborative, Creative Solutions in Drug Development: How Have we Enabled Partnering Between Sponsors, CROs, and Other Industry Stakeholder Groups to Foster Change and Create Streamlined Solutions?
Steven B. Whittaker

Change Management Requires Processes, Technology, AND PEOPLE: A New Paradigm in Innovative Workforce Development Through Previously Unused Forms of Collaboration
James Kremidas

Industry-Based GCP, GLP, GMP, and Nonregulated Outsourcing Oversight Maturity Model: Partnering on Solutions to Reduce the Gap Between Sponsors and CROs
Barbara Kristina Beck, MS


Moderators
avatar for Patricia Leuchten

Patricia Leuchten

President and Chief Executive Officer, The Avoca Group
Patricia Leuchten is Founder and CEO of The Avoca Group, a consulting and research firm focused in clinical outsourcing and the first company to measure the health of sponsor-CRO relationships. In 2012, Ms. Leuchten founded the Avoca Quality Consortium, a division of Avoca that provides... Read More →

Speakers
avatar for Barbara Beck

Barbara Beck

Director, Written Standards and Governance, Third Party Resourcing, GlaxoSmithKline
Barbara Beck is currently with GlaxoSmithKline (GSK), and in her role she is helping to support outsourcing activities within GSK Pharma R&D. One particular area of interest is in building internal capability in the oversight space. This desire led to the collaboration with the AQC... Read More →
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →
avatar for Steven Whittaker

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  08: StratPlan-Exec-Partnershps, Forum