Truly Translational Sweden AB
Karin von Wachenfeldt, CEO
+46 723 11 15 89
Truly Translational provides drug development consultancy with an emphasis on biology and translational science. The three founders have long experience with drug research & development and previously worked at AstraZeneca R&D Lund, Sweden, with a focus on lung biology, respiratory disease and inhalation projects.
Our experience in relation to inhalation includes:
- biologicals and small molecules
- preclinical in vitro studies and animal models
- LPS models rodents and human
- local and systemic PK/PD
- lung irritancy
- biomarker strategies
- clinical study outline and management
We offer a broad range of services to help our customer´s translate their preclinical research into successful clinical development plans.
Evaluation of project ideas
- Is the mechanism suitable for inhalation?
- Is there a business case for an inhalation approach?
- Project plans
- Target Product Profile (TPP)
- Translational Medicine plans
- Strategic and operational
- Feedback on project plans, presentations and experimental protocols
Pre-clinical and clinical study design
- In vitro and in vivo study protocols
- Regulatory pre-clinical development plans and documentation
- Clinical study outline and protocols
Coordination of biomarker activities
- Analytical and clinical validation
- Implementation in clinical studies
- Identify and evaluate contract research labs
- Set up specifications, coordinate activities and evaluate data