The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives. Join an informative webinar focused on in vitro diagnostic development to meet this need, ranging from assay design, the use of bioinformatics in identifying emerging pathogens and optimizing assays, and securing the necessary regulatory approvals that support market access.
Advancing novel, highly sensitive diagnostic assays for infectious diseases requires extensive research and development experience. In a post-pandemic world, as consumers expect these technologies available at point-of-care, this experience has never been more valuable. Because the symptoms of diseases like influenza, RSV and SARS-CoV-2 can be very similar, there is significant benefit in a single diagnostic that tests for the presence of multiple respiratory pathogens.
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Defining the market pathway for an in vitro diagnostic device is a critical activity that should be started as early as possible in the process. Engagement with regulatory authorities can help identify special requirements that may be considered during design and verification and validation study planning, including for clinical comparator testing. Doing so can help clarify the submission and review process as well as the regulatory requirements for quality management, labeling and analytical and clinical testing that are necessary to demonstrate safety and efficacy of the diagnostic assay.
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Join this webinar to learn how to effectively take an infectious disease diagnostic assay from initial design stages through regulatory approvals that support market access.
Speakers
Jennifer Stone, MS, Principal Scientist, MRIGlobal
Jennifer Stone has decades of experience leading complex, multi-disciplinary programs focused on the design, development, optimization and validation of PCR assays for the characterization of biothreat agents and clinically relevant pathogens. Her experience includes leading efforts focusing on the integration of chemistry and hardware technologies to develop and deploy devices for use in field forward labs that have specific time, space and resource constraints. Her specialized molecular assay development skills include early-stage research and development of de novo assay designs, in silico specificity testing, multiplexing and transitioning assays to analytical verification and clinical validation.
Message Presenter
Joe Russell, PhD, Principal Scientist, Group Leader — Applied Biology & Bioinformatics, MRIGlobal
Dr. Joe Russell is a Principal Scientist in the Integrated Health Surveillance and Diagnostics Division at MRIGlobal. Dr. Russell is experienced in genomics-based methods for clinical diagnostics, biosurveillance, biosecurity and forensic applications. His work includes use of emerging hand-held molecular hardware and development of integrated mobile platforms to push genomics and metagenomics into the field, at the point-of-need.
Message Presenter
Yvette Girard, MPH, PhD, Principal Science Advisor, MRIGlobal
As Principal Investigator for in vitro diagnostics (IVD) development programs, Dr. Yvette Girard leads technical teams for analytical study execution and collaborates with clients on protocol development, study design and preparation of documentation for regulatory submissions. The MRIGlobal Regulatory Affairs team supports commercial and US government clients with a variety of regulatory needs including FDA EUA, De Novo and 510(k) premarket notification submissions for IVD products.
Message PresenterWho Should Attend?
This webinar will appeal to Managers/Senior Managers/Directors/Specialists in the following fields:
- Assay development
- Bioinformatics
- Infectious disease diagnostics
- Public health/Epidemiologists
What You Will Learn
Attendees will gain insights into:
- The importance of expertise at all stages of infectious disease diagnostics development
- The value of bioinformatics in the development of infectious disease diagnostics
- How to successfully navigate regulatory pathways to gain market access
Xtalks Partner
MRIGlobal
MRIGlobal improves the health and safety of people everywhere by addressing some of the world’s greatest threats and complex biological, chemical, and engineering challenges. Founded in 1944 as an independent, not-for-profit organization, MRIGlobal provides customized research and development services to health and defense-focused organizations in need of innovative and multidisciplinary solutions. This includes expertise in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. To learn more, visit mriglobal.org.
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