Innovation Capabilities

Combining the best of two worlds – our fully integrated R&D and networked approach

Grünenthal  Innovation is a fully integrated, capable and agile R&D organization. Through our networked approach, we interlink and supplement our R&D expertise with external knowledge.

Our in-house expertise includes, but is not limited to:

Drug Discovery: linking target to disease to create innovation

  • Selection and identification of validated targets based on niche disease strategy and portfolio fit
  • Creation of relevant biological screening cascades and rapid testing cycles
  • Proficient in multidimensional optimization strategies to deliver target modality or technology

Focused pre-clinical development – bringing new therapeutic options safely to patients

  • Support of candidate selection and optimization of modalities
  • Specialized pharmacology offering a unique platform of respective models in order to select and profile molecules in pain/pain sub-indications and focused indications
  • Delivery of robust pre-clinical data package
  • Support of clinical development

Strategic translational science – building the bridge to humans

  • Innovative in vitro / in vivo models and biomarkers
  • Novel biomarkers and pharmacodynamic models in healthy volunteers
  • Innovative pharmacology and proof of concept clinical trial design, including outcome measures

Solution-focused clinical development

  • Holistic clinical trial strategy and planning
  • Full clinical trial operations
  • Experienced CRO management
  • Best-in-class data management, data analysis and modeling and simulation

CMC – bringing compounds to life

  • Capabilities to develop sophisticated formulations for pre-clinical and first-in-human trials
  • Full analytical development services for drug development
  • Capabilities to develop cutting edge formulations for our patients, e.g., capsules, liquid solutions, patches, or suppositories
  • Fast upscaling to serve large, worldwide clinical trials and initial market entries while maintaining the highest quality standards
  • Own engineering capabilities for development of customized equipment beyond standard technologies.

Regulatory Affairs – adding value from the beginning

  • Excellent reputation with regulatory authorities in EU and beyond
  • At forefront of new regulatory trends to shape and prepare for new standards
  • Global capabilities and network to ensure worldwide marketing authorizations and their mainenance

 

Innovation Capabilities