tranScrip plays a crucial role in facilitating the selection and progression of client drug candidates into Phase 1 and proof-of-concept clinical studies to demonstrate their potential value including, where necessary, securing funding and regulatory approvals.
tranScrip’s Translational Medicine team has worked with big pharma and small biotech companies providing support in the Translational Medicine, Experimental Medicine and Clinical Pharmacology space, focussing on achieving proof of mechanism/proof of concept, dose selection for efficacy studies and delivery of clinical pharmacology labelling. tranScrip's Translational Medicine experience covers a large spectrum of therapy areas and diseases. tranScrip has extensive experience working with regulatory authorities worldwide, including EMA, FDA and PMDA.
Optimal design and execution of translational studies are critical for de-risking of clinical development programmes and achieving regulatory success.
The services that tranScrip provides include, but are not limited to:
- Planning of early clinical development programmes, from preclinical research through to the proof of concept studies
- Design of early clinical trials, e.g. dose escalation studies in healthy volunteers and patients, drug-drug interaction studies, food interaction studies, etc
- Review and interpretation of translational studies data (safety, PK and PD)
- Acting as members of independent safety boards
- Preparation for Pre-IND meetings
- Preparation of IND filings
- Development of biomarker strategies
- Development of PK/PD models
This case study outlines the wide and important role which tranScrip has played in Translational Medicine.
A small company with novel biological candidates needed to design a development programme to start phase I trials.
tranScrip worked with the company to establish candidate selection criteria, develop a toxicology programme, support agency meeting for review of pre-clinical plans, secure funding grants and prepare the clinical trial application.
Pre-clinical development was completed, the clinical development plan designed and a phase I study started.