00:00 Introduction
01:13 Presentation ‘An Aim to Standardize Breath Analysis – Developing Respiratory Science Tools’
15:00 Q&A
Talk Abstract:
Geographic isolation and poverty are barriers to disease diagnosis in United States and many parts of the globe due to high cost and complexity of instruments needed to perform analysis. Supporting development of field instruments by having accurate databases of healthy breath and disease biomarkers is an important step towards an improved and equitable healthcare system[1]. Breath analysis is a promising technique that uses the biological information in exhaled breath to monitor, diagnose, and study human health while having the potential of decreasing turnaround times and providing real time analysis. A systematic approach in breath sample collection and biomarker confident identification can aid in establishing a web-based software tool to analyze mass spectrometry data. Development of relevant assessment approaches and Regulatory Science Tools (RST) can then be utilized by the in vitro diagnostics industry to help accelerate innovation and standardize identification of disease through breath [2,3].
Acknowledgements:
The authors would like to acknowledge the Bill & Melinda Gates Foundation for their support of this study.
References:
1. Ferrandino, G., et al. High-quality identification of volatile organic compounds (VOCs) originating from breath. Journal of Clinical and Translational Hepatology. 2023;11(3),638–648
2. Regulatory Science Tool Catalog – Catalog of Regulatory Science Tools to Help Assess New Medical Devices | FDA
3. FDA – OSEL – CDRH OSEL
Speaker Biography:
BA.Sc. Chemical Engineering, University of Ottawa, CANADA (Cum Laude- 1991). M.A.Sc. Chemical Engineering, University of Ottawa, CANADA (1993). Chemical Engineer, Atomic Energy of Canada, CANADA (1993 – 1995), Ph.D. Physical Chemistry, Carleton University, CANADA (1999). Postdoctoral Fellow, Polymer Physics– NSERC Scholar, National Research Council of Canada, CANADA (1999 -2000). Associate Scientist– National Research Council of Canada, CANADA (2000 – 2007). JSP Fellow – Young Scientist Award, Tsukuba Science City, JAPAN (2006). Corporate Scientist – Sealed Air Corporation, USA (2007 – 2017). Principal & lead Consultant – AP Chem4 Solutions LLC, USA (2018 – 2021). Council Member – Gerson Lehrman Group (GLG), USA (2019 – 2021), Assistant Director – FDA, DBCMS, USA (2021 – Present). Executive MBA, University of Texas at Austin – McCombs School of Business, USA (May 2022).
Empathic and experienced thought leader with 27 years of knowledge in product development from infancy through commercialization. Working for organizations globally has given me the opportunity to effectively apply my scientific expertise and resolve technical challenges while building lasting relationships with my managers, peers, direct reports, and collaborators.
My passion for science and its application to solve exacting business issues gives me the capacity to constantly learn, self-improve, and apply my knowledge to effectively bridge business and science concepts for a more strategic and effective management approach (Winner of 2022 POETS & QUANTS – Best and Brightest Executive MBA, 2024 FDA Honor Award for External Partnership).
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