Truly Translational

Truly Translational Sweden AB
Karin von Wachenfeldt, CEO
+46 723 11 15 89
www.trulytranslational.com

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?

Strategic plans

  • Project plans
  • Target Product Profile (TPP)
  • Translational Medicine plans

Project management

  • Strategic and operational

Second opinion

  • 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

Outsourcing

  • Identify and evaluate contract research labs
  • Set up specifications, coordinate activities and evaluate data