The Future of In-Vitro Diagnostics: A Regulatory Perspective
Research Seminar with Stuart Hogarth, Alberto Guiterrez and Robyn Meurant
Thursday 15 February 2018, 1-5.30pm
The Cambridge Academy of Therapeutic Sciences is delighted to invite you to a research seminar on the Future of In-Vitro Diagnostics. The event will offer an afternoon of discussion on how regulators can strike a reasonable balance between supporting diagnostic innovation and providing rigorous independent evaluation of new diagnostic tests before they enter clinical practice.
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This symposium was aimed at all those involved in development of new diagnostic tests in both academia and industry. Speakers of the day were Prof Stuart Hogarth of the University of Cambridge, Dr Alberto Gutierrez of NDA Partners and Robyn Meurant from the World Health Organisation. The event also featured an introductory address by Dr Paula Frampton on the work of CATS in providing a strong cross-University framework with and point of access for researchers and companies working in the development of therapeutics, biomarkers and diagnostics in Cambridge.
The speakers considered regulatory developments in two very different contexts. Dr Alberto Gutierrez outlined the challenges faced by the Food and Drug Administration in the USA responding to the genomic revolution in biomedicine and the World Health Organisation’s role in ensuring the safety and effectiveness of diagnostic tests used in low and middle-income countries. In the USA, the existing regulatory paradigm has been challenged by successive waves of technological change: the growing use of companion diagnostics and multi-marker prognostic signatures in oncology; the development of next-generation sequencing and liquid biopsy; and the emerging fields of metabolomics and proteomics. Robyn Meurant then discussed how the World Health Organisation has a growing role in helping countries with limited clinical laboratory infrastructures and little or no regulatory expertise for the evaluation of diagnostic tests.
Agenda
13.00 | Arrival and Registration
13.20 | Paula Frampton – Welcome and introduction to CATS
13.30 | Stuart Hogarth – Introductions and opening remarks
14.00 | Alberto Gutierrez – Molecular Diagnostics: Challenging Regulation and Disrupting Medicine
14.50 | Robyn Meurant - Regulation of IVDs in Low to Middle Income countries, and role of WHO Prequalification
15.40 | Panel Discussion and Q&A
16.30 | Networking Reception
Click here to listen to the full audio recording of the event.
