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The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold?
Session Chair(s)
Patty Leuchten
Founder and CEO
Diligent Pharma, United States
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 Objective : Discuss how consortia and industry collaboratives can provide benefits in drug development.
Speaker(s)
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
The Avoca Group, United States
Executive Director, Quality Consortium
Change Management Requires Processes, Technology, AND PEOPLE: A New Paradigm in Innovative Workforce Development Through Previously Unused Forms of Collaboration
James Kremidas
Wake Forest Clinical Research, United States
Adjunct Graduate Faculty Member
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
GlaxoSmithKline, United States
Director, Written Standards and Governance, Third Party Resourcing
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