Dr Gill Morgan
An internationally experienced professional in the IVD industry with particular expertise in:
- Product registration in the USA, Canada and Europe
- Registration strategies including clinical registration programmes
- Data and submission reviews
- Implementation of ISO 13485 quality systems for IVD manufacturers
- Conducting quality systems gap audits
- Product clinical development and marketing strategies
- Due diligence of partnering opportunities
25+ years of diagnostic industry experience, including executive management, in North America and Europe. Created Good Clinical Practice compliant clinical departments, and implemented ISO compliant quality systems for small companies (5- 40 employees). Directed clinical and regulatory departments in multinational companies, and completed global registration trials and product registrations for a diverse portfolio of diagnostic products, including the highly regulated complex molecular diagnostics. Due diligence reviews of potential acquisitions and co-development opportunities. Strategic planning, project management and business development experiences ensure a perspective on most aspects of product development, commercialization and product partnering.
Gill completed a chemistry and education degree at London University (Chelsea College) graduating with First Class honours. Her PhD thesis, entitled Chemical and Radiochemical studies of Technetium containing Complexes, was successfully defended in 1988 and resulted in a research fellowship for one year at Harvard Medical School pursuing research into neutral Technetium complexes suitable for neuroimaging. Industry appointments at IRE-Medgenix in Belgium, Amersham International (UK) and Guilford Pharmaceuticals (Baltimore, MD USA) continued the scientific interest in neuroimaging diagnostics and clinical applications in neurology and psychiatry. At Guilford, Gill held the position of Associate Director, Clinical Research and Business Development and Project Team Leader for a novel neuroreceptor imaging agent managing a global clinical studies programme. In 1998, Gill moved to the in vitro diagnostics field as the Senior Director, Regulatory Affairs and Clinical Research, Visible Genetics in Toronto Canada, which was acquired by Bayer Healthcare in 2003. Gill served with Bayer in the USA initially as clinical and regulatory head of their molecular diagnostics division, ending up as their global head of clinical affairs for Bayer Diagnostics. Returning to the UK in 2008, Gill held executive operational positions in diagnostic biotech companies in the UK and Ireland.
Since 2012, Gill, a Director of Sestria Ltd., has consulted for companies in the US and Europe.