Virology

Virology Header

TRN's Virology team brings pharmaceutical R&D virology expertise together with the broad-based skills of chemistry, toxicology, pharmacokinetics and formulation within TRN. Our team understands the specific needs of the antiviral drug R&D process including strategic development for specific patient populations, efficacy models, resistance generation and monitoring, screening strategies, clinical sample analysis and regulatory studies. In addition we have consultants with specific expertise in combination toxicology and formulation strategies common to new generation antiviral regimens. With our network of CRO partners, we can design and deliver innovative studies to move your projects forward effectively and efficiently. The team have worked closely with a range of global CROs and understand their capabilities and services. TRN’s unique resource of skilled pharmaceutical professionals and its CRO network provides significant value for their clients. 

 
Pre-Clinical Drug Discovery
We can partner to deliver full data packages as part of a project team or offer consultancy services as needed. 

  • Target Validation studies 

  • Assay design and development

  • Screening cascade and triage consultancy and implementation

  • Hit-to-lead and candidate virology profiling

  • Generation of resistance

  • Clinical Viral Isolate profiling

  • Impact of Human Serum binding studies

  • Generation of virology data packages for IB's 

  • Design and delivery of in vivo toxicity studies

  • Drug formulation consultancy including drug combination

The Clinical Virology team supports candidate antiviral drugs from candidate selection through regulatory approval and beyond:

  • Ensure pre-clinical virology packages are adequate for supporting first-in-human studies and develops this package in parallel with clinical studies to meet regulatory requirements.

  • Provide virology input for the regular updates to Investigator Brochures and INDs.

  • In collaboration with pre-clinical and clinical pharmacologists, provides advice on initial dose requirements for first-in-patient studies. 

  • Advise and support the preparation of a clinical development plan and its presentation to regulatory authorities, including obtaining scientific advice from agencies.

  • Provide the virology/CRO interface for defining and implementing the clinical virology element of clinical operations in studies with patients.

  • Provide virology expertise in problem solving during the course of clinical trials.

  • Ensure the appropriate clinical samples are analysed using appropriate, validated assays and collaborates with data managers to ensure all clinical virology data is deposited in the clinical database.

  • Provide a virology analysis plan for implementation by statisticians and programmers.

  • Prepare reports and virology sections for regulatory submissions.

  • Provide or support representation to regulatory authorities as required, including Advisory Committees, meetings to seek scientific advice and other ad hoc meetings.

  • Provide virology representation to advisory boards seeking key opinion leader advice on development strategy.

See our virology flyer

Meet the virology team.