Translational Development Services
All indications from Oncology to CNS
- Non-clinical risk assessments
- Non-clinical gap analysis
- Non-clinical strategy
- Study design, User requirement specifications and CRO engagement
- Pivotal GLP study monitoring
- Advice on proof of concept (POC) and efficacy studies
- Due diligence reports
Modalities
- Small molecules including oligonucleotides (ASO, siRNA) and peptides
- Biologics – monoclonal antibodies (nanobodies, bispecific constructs, antibody drug conjugates (ADC), proteins (and conjugates)
- Vaccines – attenuated viral and mRNA
- Oncolytic Viruses
- Cell Therapies
- Gene Therapies
- Combined ATMPs
- Medical Devices
Advice, guidance and support
- Regulatory meetings
- Biopotency CMC including route cause analysis (RCA)
- Support with method development
- Support with ADME, PK/PD, biodistributions, Toxicology, Tumorigenicity studies
- General toxicology, data checking, due diligence reporting and problem solving.