& SERVICES CAPABILITIES

Our goal for clients is two-fold

• To identify high quality clinical candidates.
• To ensure that chemical processes are in place to provide enough material to enable IND filing.

We strive to do this in as cost-effective manner as possible by identifying key risks in molecules and mitigating them early. We tend to avoid screening cascades, using them as a way to ensure we have the correct toolkit, but not as a proscriptive set of instructions as to how to use the tools.

Compound design and synthetic route design is led by Dr Nigel Ramsden (based on The Babraham Research Campus, Cambridge, UK) and Dr David Fox (based at The Chemistry Department, Warwick University, UK).

Our in silico design team provide modelling and computational chemistry support for both small molecules and biomolecules. They have accelerated numerous drug discovery projects. For example, a directed virtual screen for a client led to the selection of 300 compounds and yielded 2 unoptimised hits with in vivo efficacy leading to Series A funding and a clinical candidate and a back-up 6 months later.

Compound synthesis is performed via the optimal combination of in-house work in our laboratories at Warwick University and outsourcing to a small number of preferred and “road tested” CROs. Our lab at Warwick enables us to react rapidly and locally as and when issues emerge, to develop routes to more complex molecules and to trial non-standard chemistry before engaging our CROs on a project, The lab also allows us to access Warwick Scientific Services  on behalf of clients and provide a broader range of analytical services. Our lab at Warwick is equipped to work on scales of up to 250g and we will typically produce early batches of clinical candidates here as well as trouble shoot any issues at CMOs

RxCelerate can also offer full logistical support to projects with compound storage (solids and solutions at temperatures to -80OC), shipping and inventory management. We will routinely build and maintain project databases for clients.

THE PHASES OF DRUG DEVELOPMENT

DISCOVERY

Target validation*

Screening assays*

In vitro pharmacology*

Enzyme assays*

Functional cell assays*

Medicinal chemistry*

PK/PD studies*

Animal disease models*

ADME/Bioanalysis*

Mechanistic biomarkers*

Systems Biology*

Metabolomics*

Proteomics*

PheWAS*

GWAS*

REGULATORY PRE_CLINICAL

Scale-up chemistry*

Preformulation

Analytical Meth Dev*

Bioanalytical Meth Dev*

Toxicology

Toxicokinetics*

GLP*

CLINICAL

Phase 0

Phase I SAD and MAD

Phase IIa

Multi-objective designs*

Data management*

Biostatistics*

Biomarker profiling*

GCP*

Key strategic studies are carried out in-house by experienced RxCelerate scientists (*)

These include all parts of discovery into regulatory preclinical tracking through to the clinic

This process is not linear and so value can be added by RxCelerate’s involvement in the whole program

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