The future of in-vitro diagnostics: A regulatory perspective

How can regulators strike a reasonable balance between supporting diagnostic innovation and providing rigorous independent evaluation of new diagnostic tests before they enter clinical practice?

This symposium is aimed at all those involved in development of new diagnostic tests in both academia and industry.

It will consider regulatory developments in two very different contexts: 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. Meanwhile 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.

Programme

13:00 Arrival and registration

13:30 Dr Stuart Hogarth, University of Cambridge – Introductions and opening remarks

14:00 Dr Alberto Gutierrez, NDA Partners – Molecular Diagnostics: Challenging Regulation and Disrupting Medicine

14:50 Robyn Meurant, World Health Organisation – Regulation of IVDs in Low and Middle Income countries, and the role of WHO Prequalification

15:40 Q&A / Panel discussion

16:30 Networking reception

Speaker biographies

Dr Alberto Gutierrez

Alberto Gutierrez, Ph.D., is an expert regulatory consultant with the firm NDA Partners. Dr. Gutierrez recently retired from the FDA after 25 years of working in research and regulation. Dr. Gutierrez was the director of FDA’s Office of In Vitro Diagnostics and Radiological Health for 8 years, responsible for the pre-market review and post-market regulation of in vitro diagnostics and radiology devices, as well as responsible for FDA’s regulation of radiation emitting products and regulation of mammography facilities in the US. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez research experience is in structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, joining management in 2003. Dr. Gutierrez moved up the management chain finally reaching the title of Director in 2009.

Robyn Meurant

For the last 5 years, Ms Meurant has been a Technical Officer in the department of Essential Medicines and Other Health Products (EMP) at the World Health Organization, working in the WHO Prequalification Team: Diagnostics Assessment. She has been responsible for applications, dossiers, changes to prequalified IVDs, and the development of guidance and technical specifications. In addition, she was instrumental in the development of a rapid assessment procedure to be used during a public health emergency of international concern. Before WHO, Ms Meurant worked as a consultant advising Eurogentest on the (then) forthcoming IVD Regulations, as well as to WHO on the design of the programme for WHO prequalification for IVDs. Originally from Australia, she worked as section head in various infectious diseases laboratories for 20 years before joining the Therapeutic Goods Administration of Australia as the regulator of IVDs.

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