Dr. Michael Noderer, AstraZeneca - Qepler's Drug/Device Combination Products Summit 2018

Dr. Michael Noderer

Associate Principal Scientist
AstraZeneca
Manchester, United Kingdom
AstraZeneca

Michael Noderer is an Associate Principal Scientist within the AstraZeneca Device Development group. Michael holds a Diplom Ingenieur degree in Mechanical Engineering and a MEng. He spent the last 15 years of his career in device development. During this time, he led projects through all phases of product design, from early feasibility studies to design transfer and regulatory submissions. Michael was the technical lead in the development of Sanofi’s Lyxumia/Adlyxin and Toujeo devices before he joint AstraZeneca where he completed the development activities for Bydureon autoinjector which was successfully launched in US 2018.

Related Sessions:

DRUG/DEVICE COMBINATION
PRODUCTS SUMMIT 2018

  • 4-December-2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday 4, December 2018
BLOCK: REAL LIFE SOLUTIONS FOR YOUR COMBINATION PRODUCT.
CASE STUDY: Life Cycle Management: Exenatide case study.
  • Life Cycle Management journey from discovery of Exenatide to recently launched Bydureon Bcise
  • Four generations of device design used to administer exenatide in the last decade
  • Analysing the key drivers for device decisions along the way:
    • Regulatory pathways
    • Clinical data and studies
    • Changes in patient/market acceptance/Human Factors
    • Outside world, competitor products
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