Human Antibody Factory Ltd
Human Antibody Factory 

  • Design of the clinical programme including a strategy for patient access and study size requirements to generate statistically meaningful data sets
  • Preparation and delivery of documentation and approvals for the trial
  • Exploration of patient recruitment sites and engagement of clinical centers, all of which are now actively recruiting
  • Training and monitoring of staff at these sites to capture data appropriately and within the approval guidelines
  • Identification, contracting and monitoring of sample processing CROs who produce biochemical, metabolic and clinical pathology data
  • Design and implementation of study databases and capture of all study data
  • Management of company operations and budget, collaborations and outsourcing activities
Unravel MGUS

CASE STUDY

Human Antibody Factory (HAF) is a clinically focused biotechnology company investigating a common haematological condition, Monoclonal Gammopathy of Unknown Significance (MGUS). As a result of this condition, clonal plasma cells accumulate that produce high levels of a single immunoglobin known as a paraprotein. The primary goal at HAF is to provide a comprehensive data set that will improve the clinical management of MGUS patients and discover tools that will identify patients where disease is most likely to progress to Multiple Myeloma. In addition, as a result of assessing the paraprotein-self antigen interaction, HAF hope to identify novel biological pathways implicated in particular clinical phenotypes. This work may lead to the design of novel targeted therapies for diverse indications.

Working closely with the company founders, RxCelerate is enabling progression of the clinical programme and parallel research projects in the following ways:

  • Design of the clinical programme including a strategy for patient access and study size requirements to generate statistically meaningful data sets
  • Preparation and delivery of protocols, clinical documentation, ethical review and HRA approval for the trial
  • Exploration of patient recruitment sites and engagement of clinical centers, all of which are now actively recruiting
  • Training and monitoring of staff at these sites, continuous data quality checks throughout the study
  • Identification, contracting and monitoring of CROs who will process samples and produce biochemical, metabolic and clinical pathology data
  • Design and implementation of study databases and capture of all study data

RxCelerate has enabled the completely virtual HAF Ltd secure financing for the UnravelMGUS clinical trial (unravelmGUS.org), design a clinical trial and set up and maintain healthy recruitment. The trial is due to complete in 2018.