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June 28-30, 2016

Palm Springs, California

Workshop 1
Tuesday June 28th 2016

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09:00 - 12:00

Strategic Device Development Programs & the Seamless Transition of Drug Delivery Systems into Commercialization
Workshop Leader: Scott Arra, Device Technology Lead, Respiratory, Injectables,, and Topical Delivery Systems, North America, GSK

Ensuring efficient collaboration and teamwork between all members of the combination product ecosystem is essential to executing
injectable device development programs. In this interactive workshop session, our leader Scott Arra will holistically address the
device development, manufacture and commercialization process, leading in-depth discussion around the following topics:

  • Ensuring compatibility of potential commercial delivery systems with biologic product safety
  • Incorporating existing product life-cycle management into innovative technology programs
  • Intelligent creation and management of drug developer-manufacturing partnerships
  • Managing commercialization of a drug delivery device to meet regulation requirements from numerous international regulatory agencies
  • Intuitive approaches to deciding where and when to invest in device and biologic product development
  • Assessing the whole financial picture: what does it cost to develop an injectable delivery device in parallel with the drug product
  • Evaluating execution of combination product development and commercialization: streamlining timelines and costing

Scott Arra, Device Technology Lead, Respiratory, Injectables,, and Topical Delivery Systems, North America, GSK

Scott Arra