Xenovium identified and engaged a CRO that specialised in bespoke immunology and biomarker identification work...
A virtual biotech was developing a biological for the treatment of autoimmune disease and allergic disorders.
The client challenge:
The Board of Directors needed both strategic and operational leadership for the project. This required integrating a small team of existing consultants and Contract Research Organisations to execute on a pre-existing strategy as well as to review the scientific requirements for progression and identify new collaborative partners and experts as required.
Xenovium co-ordinated a clinical study that would determine the safety and tolerability of the molecule as well as allowing a preliminary assessment of markers of inflammation had previously been designed. A small virtual team, consisting of drug development, manufacturing/CMC and clinical operations experts was established to operationalise the study. Our team conferenced weekly and engaged frequently with various suppliers (e.g. manufacturing company, formulation specialist, release-assay provider, regulatory expert, contract research organisation, principle investigator etc.) to ensure the smooth running of the study. Additionally, a review of existing preclinical data was conducted which suggested that the project would benefit from further translational medicine studies.
Xenovium identified and engaged a CRO that specialised in bespoke immunology and biomarker identification work and a series of mechanistic studies were conducted in human patient cells to further understand how the drug mediated its anti-inflammatory effects particularly in specific diseases.
The client was delighted with the delivery of a well organised and operationalised clinical study. Additionally, insights into the mechanism of the drug in human disease were gained which was the basis for further patent filings. This was important to allow the company to be well positioned for future fund-raising discussions.
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