Triple helix expertise exchange workshop on modeling drug-device interaction
Regulatory science related to in-silico technologies is receiving more and more attention. Testimony to this are the ASME V&V40 standard for medical devices and the collaborative work ongoing to establish guidelines for the use of in-silico models (beyond the pharmacometrics models) in the drug development context.
A triple helix format refers to the active participation of academia, regulators and industry.
The workshop “Triple helix expertise exchange workshop on modeling drug-device interaction” (Friday 30 April 2021, 15:00 – 17:00 CEST) is organised and promoted by the Virtual Physiological Human Institute (VPHi) and focuses on in-silico models of drug-device combinations. In this context, speakers from academia and industry will present the work they are doing in this space, while regulators will subsequently present the regulatory perspective on the evaluation of drug-device combinations and the open questions related to the credibility establishment of in-silico models. At the end of the workshop, a discussion between the presenters and participants will address these questions and identify additional challenges.
The workshop agenda includes:
- 15:00: Liesbet Geris, VPHi (BE): Introduction & goals
- 15:03 – 15:21: Yu Feng, Oaklahoma State University (USA): Respiratory drug delivery
- 15:21 – 15:39: Roberta Bursi, InSilicoTrials (NL): Nasal inhaler
- 15:39 – 15:57: Maria Christina Gagliardi, CNR NANO (IT): Drug eluting stents
- 15:57 – 16:15: Marc Horner, Ansys (USA): Wearable insulin pump
- 16:15 – 16:40: Ine Skottheim-Rusten, NMA (N) & Flora Musuamba Tshinanu, FAGG (BE): Regulatory perspective & questions in drug-device interaction
- 16:40 – 17:00: General discussion
Register here to take part in this interactive workshop and share your inputs and perspectives!