Technology Transfer

Drug repurposing: how to protect your asset by an integrated regulatory strategy

by Michael Firgens

Drug repurposing is an alternative cost-effective approach to drug development which builds on already approved drugs and compounds. However, the actual commercial success of a repurposed drug depends on achieving effective protection against competitors such as generics and other products with the same active pharmaceutical ingredient. In this article, Michael Firgens explains the key strategies for the protection of a repurposed drug.

Technology Transfer: What you need for a successful transfer

Technology transfers are frequently conducted throughout the product lifecycle. They require substantial resources, technical know-how, and organizational skills in both sending und receiving units. The transfer of biopharmaceuticals is particularly challenging and should be planned and executed by an experienced and skilled team.  

Michael Firgens, Senior Consultant at Biopharma Excellence, summarizes why the following factors are pivotal for the success of technology transfer projects:

  • Sending unit and receiving unit work closely with each other.
  • Clear understanding of roles and responsibilities of both sending unit and receiving unit team members.
  • Complete technology transfer package.
  • Quality Risk Management.
  • Effective knowledge transfer and training.
  • Stage Gate Approach