Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the European Medicines Agency (EMA), will give an European regulatory update at the Chief Medical Officer Summit East at the Colonnade Hotel, Boston, MA on 12th May. Steffen Thirstrup, Former Director of NDA’s Regulatory Advisory Board, will also be attending the summit.

Thomas will present along with Jonathan Helfgott, Coordinator for Regulatory Science Program at Johns Hopkins University in the session “FDA & European Regulatory Update” were they will discuss:

  • Update on breakthrough designations and lessons learned in 2015
  • Are phase 2 trials still necessary?
  • POV on basket trials
  • Oncology trials jumping from phase 1 to phase 3?
  • Combination development of two investigational drugs
  •  Insights on what they deem challenging for CMOs

The CMO conference is an annual event for senior physicians. The objective of the conference is to bring together CMO executives to address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors, and strategising for appropriate exits. As well as to create a network of CMOs from small to midsize life science companies to share ideas, solutions and support.

As well as presenting at the event, NDA Group is ‘Associate Sponsor’ of the “CMO Summits”, demonstrating its commitment and support towards the CMO community.

To find out more about the event click here.



Dr Thomas Lönngren

Strategic Advisor

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