XenoGesis is an independent contract research organisation (CRO) based at BioCity Nottingham and Alderley Park in Cheshire.

Start your journey

Find out how the DMPK and in vitro pharmacology team at XenoGesis will advance your research and/or development programme, from hit identification through to designing and identifying the best candidate drug, including predictions of human PK and efficacious dose. We will continue to support you through Phase 1 and Phase 2 clinical trials with regards to understanding PK and dose prediction. We combine our state-of-the-art in vitro, in vivo and bioanalytical capabilities with expert PK/PD data interpretation services to support you in scientific input, design and delivery. We pride ourselves on evaluating and defining only the most appropriate and value-adding set of DMPK, physicochemical and in vitro pharmacology studies for each project.

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Hit identification
& validation

XenoGesis will help you select and profile the best hits and series to understand their relative strengths and weaknesses. Focus will be on overall properties and not just primary potency.

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Lead
identification

XenoGesis can help define the screening cascade and target product profile. Depending on this, project specific relevant DMPK and physicochemical assays will be implemented in the most time and cost-efficient manner to identify the leads to take forward.

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Lead
optimisation

Further refinement of the screening cascade will be recommended and streamlined. Additional DMPK assays will be added and further scientific input provided, including in vitro-in vivo correlation, understanding the mechanism of absorption, clearance mechanism(s), cross-species prediction and drug-drug interactions that will include cytochrome P450 enzymes (CYPs) and transporters. The human pharmacokinetics (PK) and dose will be predicted using modelling and simulation software, GastroPlus™.

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Candidate drug
nomination

XenoGesis will refine the efficacious dosage and human PK predictions and assess if the molecule has any perceived drug-drug interaction liabilities.

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Pre-clinical
development

Further refining the human PK and dose prediction and integrating with available pre-clinical toxicology data, XenoGesis will model potential safety margins with a view to defining the first time in human (FTIH) doses. We work with our contract development and manufacturing organisation (CDMO) partners to assess appropriate dosage technology and product forms depending on the drug loading and any perceived formulation-dependent issues, including half-life extension and improving bioavailability, both pre-clinically and clinically.

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Phase 1

Evaluating the available single ascending dose (SAD) and multiple ascending dose (MAD) clinical PK data, along with any available biomarker data, we refine the PK model in GastroPlus™ to assist in dose setting for Phase 2.

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Phase 2

XenoGesis will continue to support progress through clinical development via DMPK gap analysis, clinical metabolite identification (including MIST guidelines advice) and further refining the human dose prediction.

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Phase 3 &
launch

XenoGesis will continue supporting your project while the drug is investigated in a wider patient population before seeking market authorisation.

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Start your journey.

XenoGesis is a specialist, independent contract research organisation (CRO) based at BioCity Nottingham and Alderley Park in Cheshire.

Our services

XenoGesis is an independent contract research organisation (CRO) based at BioCity Nottingham and Alderley Park in Cheshire. The XenoGesis team has an enviable track record of delivery in drug discovery, specialising in pre-clinical drug metabolism and pharmacokinetics (DMPK), quantitative bioanalysis, pharmacology and expert interpretation.

Our services

XenoGesis can identify the potential ‘winners’ and ‘losers’ in a selection of compounds synthesised in drug discovery campaigns. We provide data-driven iterative feedback to the client, and recommending next steps is a key focus. We combine our state-of-the-art in vitro, in vivo and bioanalytical capabilities with our expert pharmacokinetic/pharmacodynamic (PK/PD) data interpretation services.