TranScrip Translational Medicine

TranScrip can play a crucial role in facilitating the selection and progression of drug candidates into clinical studies to proof-of-concept and demonstration of potential value, including, where necessary, securing funding and regulatory approvals.

Expertise
Experience

TranScrip Translational Medicine Experts

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 efficient approaches to achieving proof of mechanism / concept, dose selection for efficacy studies and delivery of clinical pharmacology labeling. TranScrip's Translational Medicine experience covers respiratory medicine, nephrology, neurology, gastroenterology, rheumatology, immunology, endocrinology and cardio-metabolic diseases. TranScrip has extensive experience working with regulatory authorities worldwide, including EMA, FDA and PMDA. TranScrip´s services range from ad-hoc advice to deployment of multifunctional strategic and operational teams of up to 10 people.

Chris Brearley
Head of Translational Medicine

Chris brings experience of more than 20 years working in Translational Medicine to his role as Head of TranScrip’s Translational Medicine team. He has worked across several therapeutic areas, including cardiovascular, metabolic, CNS and inflammation. He has the breadth of knowledge afforded by working with both small molecules and biologicals. He has been responsible for integrating pre-clinical safety and toxicology findings into selecting doses for FIH studies in patients and healthy volunteers, and creating strategies for Proof of Concept and for PK/PD modelling to support rational dose selection in efficacy studies. He has wide experience in the review of in-licensing opportunities, and in all roles he has prepared regulatory documents and successfully defended safety, translational medicine and clinical pharmacology positions with regulatory agencies.

Case Study

This case study outlines the wide and important role which TranScrip has played in Translational Medicine.

Challenge
A small company with novel biological candidates needed to design a development programme to start phase I trials.
Solution
TranScrip Partners 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 support the clinical trial application.
Result
Pre-clinical development was completed, clinical development plan designed and phase I study started.

TranScrip Partners provide Translational Medicine support across various therapeutic areas, including:

Development guidance during lead optimisation

Support through pre-clinical pharmacology to first-into-man

Designing effective phase II programmes to demonstrate value

Insightful efficacy and safety measurement assessments

Applying years of experience & knowledge to the client’s portfolio evolution

Creating new approaches, taking advantage of advances in technology and study design whilst aligning with emerging Regulatory Agency disease and device guidelines

Working on MAA and NDA submissions for preparation of the clinical pharmacology modules and their defence