February 10, 2015
11 a.m. to 12:00 pm EST

Sponsored by

Webinar Description:

During IVD assays’ life cycle, they often undergo modifications during the performance validation process and more often in the post-marketing setting. This webinar will discuss two types of bridging studies: 1) The pre-launch performance validation bridging studies required by FDA for changes made to the IVD, and 2) The post-launch analytical validation of changes made to an IVD to optimize reagents or procedures.

Learning Objectives:

• Understanding the timing of when bridging studies could occur.
• Understanding how to ask the right questions related to the product change in order to create the associated task checklist.
• Understanding the decision tree analysis of the product change and the types of testing required.
• Understanding bridging study design.

Who should attend:

• IVD Regulatory Affairs and Clinical Affairs Executives
• IVD Regulatory Affairs and Clinical Affairs Professionals
• IVD Quality Assurance Professionals
• Pharmaceutical/Companion Diagnostic Regulatory Affairs and Clinical Affairs Executives

Speakers:

Kennon Daniels, Ph.D.

Senior Consultant, In Vitro Diagnostics Regulatory Affairs
Translational and Regulatory Sciences
Precision for Medicine

Dr. Daniels has over 11 years of R&D and US Regulatory Affairs experience with in vitro diagnostic (IVD), medical device and pharmaceutical products. She has extensive expertise with IVDs and specializes in the development of regulatory strategies and submissions for a wide range of IVD assays (>30 products) including assays for oncology, genetic disorders, women’s health issues, cardiac biomarkers, infectious diseases, microbes, sepsis and diabetes. She is also responsible for the design of analytical and clinical protocols for the performance validation of these IVD assays to generate data for the regulatory submissions. Dr. Daniels is skilled in serving as the client representative during face to face meetings and teleconferences with FDA (CDER/CBER/CDRH/OIR).

Dr. Daniels received a BS in Biology from Mary Baldwin College and her Ph.D. in Human Genetics from Virginia Commonwealth University.

Judi Smith, M.S., MT(ASCP)

Vice President, In Vitro Diagnostics and Quality
Translational and Regulatory Sciences
Precision for Medicine

Ms. Smith has worked in the medical products regulatory, quality, and clinical trial areas for over 30 years. In that time, she has been responsible for the regulatory submissions and approvals of a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays, and for the establishment of quality systems for diagnostic products. She has also developed and implemented clinical trials for these products that were used to generate data for the regulatory submissions. She also is on the faculty of the Regulatory Affairs Professionals Society (RAPS) University as an in vitro diagnostic Subject Matter Expert. As a member of the FDA/Industry Roundtable, Ms. Smith was awarded the FDA Group Recognition Award. She has served as President of the Association of Medical Diagnostics Manufacturers (AMDM) since 2006. This organization is dedicated to the in vitro diagnostic industry and provides educational programs with FDA’s Center for Devices and Radiological Health’s (CDRH) Office of In Vitro Diagnostics and Radiological Health (OIR). Ms. Smith also serves on the Board of the Regulatory Affairs Professional Society.

Ms. Smith received her BS from Temple University and her MS from Medical College of Pennsylvania.

Jared R. Kohler, PhD

Managing Director, Analytics
Precision for Medicine

Jared has led scientific operations that delivered on over 150 efforts in clinical drug development and IVD development, specializing in the analytics of personalized medicine and providing strategic guidance in biomarker research. He has authored or co-authored various peer-reviewed manuscripts in the space of personalized medicine and significantly contributed to over 200 confidential technical documents such as statistical analysis plans (SAPs), clinical study reports (CSRs), and other FDA and EMA submission documents. Jared completed his PhD in human genetics with a concentration in statistical genetics at The Johns Hopkins University School of Medicine.

Cost: No cost!

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