Mieke Jansens

Scientific integrator for projects in early and late development

• Apalutamide pill burden reduction
  Development of a FC tablet with >80% of SDP
  Development and execution of a CRC strategy where tablets with crystalline material were tested with BE results facilitating a broader dissolution spec for commercial purposes.
  Investigation of the variability in PBDT testing for APA, where we tried to find the root cause of this variation.
  Successful transfer to the commercial site (which was a new site for R&D)
• RSV prep BU
  Close collaboration with discovery pharmaceutics to define in early stage of the project the tox manufacturing site and DP manufacturing site.
  Started up a thorough solid state/polymorph screen to select the best form at LLO
• Covid-19
  Data driven decision was taken on the composition of SDP for FIH (based upon stability data, PBDT, dog studies).
• mGlu2Pam
  Introduction of modelling for granulation in the project to reduce the number of upscale experiments for fluid bed granulation.
• FGFRi pediatrics
  I worked out a strategy with CPU, the P&LG group and the quality organization to perform a taste study for a liquid that was executed in a lean way without the need of mock-runs upfront
• RSV678
  formula selection out of multiple formulation platforms (bead coating, spray drying, powder in bottle,…).
• Recently started
  PPDS SI lead for the ASD expert group and RDFA,

due diligence project

Yeti

• Simultaneously managed several complex projects, meeting all pertinent milestones as OSD lead for different projects like Capsid, RORgT, RSV678, esketamine solid, GMCSF, PTG200, VE202, NIK,…
• Evaluated and implemented new technologies like extrusion spheronization, silica loading,...
• Performed experiments and conducted research to formulate compounds in early development making use of enabling technologies like spray drying, bead coating, silica loading,…

• Team leader for start-up and implementation of automated dissolution technology in daily routine of the stability lab to improve on analysis throughput time
• Performed complex troubleshooting and lead initiatives to solve challenging scientific and technical problems with instrumentation.
• Design of sample cup for palpal
• Introduction of camera system to monitor visually automated testing during absence
• Introduction of ergonomic system to compound large quantities of dissolution medium
• Conducted experiments in laboratory environment for product development purposes.
• Co-promotor of thesis “Method transfer from HPLC to UPLC™ for dissolution samples in stability testing of medicins”

• Introduced ALims system for R&D labs in close collaboration with Operations, data processors and LabSystems
• Lead the first instrument qualifaction initiative in AD labs
• Lead the selection of preferred vendor for UV-measurements and dissolution systems
• Lead initiative to consolidate deviations of different departments into one system.
• Evaluated and implemented new technologies and laboratory techniques to improve quality and robustness of sample analysis like NIR, TOC, online UV measurements in dissolution systems