IXICOchief executive Derek Hill is giving an invited talk and joining an expert panel at The Coalition Against Major Diseases regulatory workshop in Washington today alongside representatives of the pharmaceutical industry and regulators from the FDA, EMA and PMDA.
Hill will be presenting the challenges associated with the inclusion of wearable biosensors in pharmaceutical company sponsored clinical trials, and discussing how IXICO is addressing these challenges through its ongoing biosensor programmes.
He will be highlighting the issues in relation to ethics, privacy and security, data validation and ensuring clinical meaningfulness of data.
IXICO is collaborating with Withings/Nokia Digital Health on implementation of their devices in a regulatory compliant environment, and has established a collaboration addressing the correct clinical interpretation of biosensor sleep data with Professor Yves Dauvilliers of the Sleep Medicine Centre at Centre Hospitalier Universitaire de Montpellier, France.
Hill will be presenting some of IXICO's initial data from healthy elderly subjects and patients with dementia and Parkinson's disease recruited from hospitals in France and the UK, including from the previously announced Cygnus project, to illustrate the potential of biosensors to impact drug development.