Diarmuid Cahalane

Co-Founder and Director of Regulatory Affairs Metabolomic Diagnostics

Diarmuid Cahalane is the co-founder and director of Regulatory Affairs at Metabolomic Diagnostics, an innovative IVD company based in Cork, Ireland. The company's main focus is on developing screening tests to enhance maternal health, including its flagship screening test for Preeclampsia, "PrePsia."  A serial entrepreneur, Diarmuid has been working in regulatory affairs since 1996. He participated in the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF) which subsequently became known as the GAMP Forum a n industry body established to assist companies implement computerised and automated systems in a compliant manner. He has spoken at Regulatory and Life Science Compliance Seminars in Ireland, the US, and Europe. He is a recognised leader in the field of digital health and software as a medical device and was instrumental in developing regulations governing this area with the FDA and the European Commission.

Since 2011, he has worked to assist Enterprise Ireland Life Science Early Stage Companies as a member of the Enterprise Ireland Mentor Network. He is also a member of the International Society of Biological and Environmental Repositories (ISBER) and has striven to demonstrate how a "digital biospecimen" can be equivalent to a physical specimen. He participated in the ISO Technical Committee which developed standards for Biobanking and Biostorage. He is a member of an international biomarker consortium representing patient advocacy groups the FDA, manufacturers and clinicians which is working to improve patient outcomes for patients affected by Preeclampsia. He has also assisted early stage IVD companies in navigating the regulatory environment in Europe and the United States and participated in the EU-USA regulatory forum in Dublin during the Irish Presidency of the European Union. He is also an adviser to the CODEX4SMEs EU Interreg Programme whose aim is to assist EU companies involved in developing companion diagnostics


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