Date/TimeAugust 24, 2023
Imagine the future of infectious disease where testing is completed at home and treatment is available at the click of a button. A drone delivers your therapeutic drug allowing you to recover in the comfort and privacy of your home. A telehealth visit supports your recovery and checkups can be as easy as a self-administered test.
The COVID-19 Pandemic transformed the healthcare industry, removing many obstacles to at home testing. During this critical time, the diagnostic industry excelled in creating respiratory tests designed to support at home users.
Despite breaking down barriers between testing designed for the laboratory and at home use, multiple items still need to be unpacked to support the “Big Move.” And what is the “Big Move” for IVD? It is the movement of a test out of the laboratory or care setting and into the home environment. What are the considerations? What are the drawbacks? How could this move potentially impact our healthcare system?
Attendees can expect as we discuss these questions and more with our panel of infectious disease experts. Our team will draw on their experience working for or with infectious disease industry leaders to pack up the following boxes:
- Box 1: Looking at our past, would past pandemics have benefited from at home tests? What have we learned from COVID-19 that could be applied to this move?
- Box 2: What must be packed up to support the “Big Move?” User environment, testing accuracy, pivotal trial design and global regulatory requirements (at a minimum) must to be considered.
- Box 3: Should Infectious Disease Diagnostics move out of the care setting and into the home, just because it can? Our panel will discuss the pros and cons of the big move.
Christele Perrin-EastSenior IVD Regulatory Consultant
Christèle is an experienced professional with a strong background in the in-vitro diagnostics (IVD) industry, focusing on infectious diseases, immunohistochemistry, and immuno-oncology. With over 20 years of industry experience and a decade specifically dedicated to IVD, she has worked in various roles, in which she contributed to IVD product development and innovative biological tools for microbiology laboratories. Her recent projects involved IVDR multi-geographic regulatory assessments, addressing weaknesses in the technical documentation and developing technical documentation for the IVDR and US submission.
Paul Steven, MSPrincipal Biostatistician, IVD
Paul Steven joined the NAMSA in 2021. Focused solely on In Vitro Diagnostics (IVDs), Paul has experience with companion diagnostics (CDx), oncology, infectious disease, women’s health, automated and manual quantitative polymerase chain reaction (qPCR), high resolution melting (HRM), enzyme-linked immunoassay (ELISA), lateral flow and next generation sequencing (NGS). He brings extensive experience in research and development (R&D) and consulting arena with a focus on early and late phase clinical trial reporting. Paul is an expert at helping Sponsors navigate the statistical complexity of their studies while providing necessary outputs for regulatory submissions.
He received his Bachelor of Science (BSc) in mathematics and statistics with first class honours and his Master of Science (MSc) in statistics at Lancaster University (Lancaster, UK).
Wendy SchroederPrincipal Strategy Consultant, Clinical
Wendy Schroeder has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites. She has supported medical device product development including device risk classification, pre-clinical testing and design controls and clinical strategy interactions with the FDA.
Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.
Carol BuchertSenior Manager, N.A. Regulatory & Quality Consulting
Carol Buchert is a highly experienced professional in the MedTech industry with over 25 years of experience. She has expertise in clinical diagnostics, in vitro diagnostics (IVDs) and medical devices. Carol has managed various aspects of quality, regulatory affairs, manufacturing, sales and marketing within the industry. She has also provided strategic guidance on developing quality management systems and regulatory pathways for medical devices. Additionally, Carol has experience in managing clinical studies, authoring regulatory submissions, conducting audits and providing training in laboratory settings.