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FDA Perspective on IVD Clinical Trial Descriptions, Data Analyses, and Data Presentations in FDA Submissions

(Recorded on January 21, 2015) | Access Today  

Sponsored by 
Precision for Medicine 

Symposium Course Description:



The quality of a submission to FDA in support of marketing authorization (pre-submission, 510k, special 510k, PMA, or de novo) has a significant impact on the timeline to commercialization. This webinar will discuss the key issues on how to present information to FDA on the clinical trial, data analysis, and presentation of the data from two perspectives, representing different backgrounds, specifically IVD FDA submission, clinical trials, statistical analysis, and FDA feedback expertise. The three experts have over 25 years’ experience with IVDs in industry and/or consulting.

Learning Objectives:

  • Understanding the importance of organization, presentation, transparency, and accuracy.
  • Describing analytical studies, clinical validation studies, and pivotal studies validating cutoffs.
  • Presenting data and performance claims.
  • Communicating with FDA to resolve issues and concerns.
  • Asking FDA questions to obtain the best possible response.

Who Should Attend:

  • Regulatory Affairs and Clinical Affairs Executives
  • Investigators, Study Coordinators and Trial Center Managers
  • Clinical and Regulatory Affairs Professionals


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.

Teresa Hedrick, MT (ASCP), CCRA, CCRC, CCRP

Director, Clinical Trial Services
Precision for Medicine

Teresa D. Hedrick MT (ASCP), CCRC, CCRP, CCRA, is Director of Clinical Trials for Precision for Medicine. In her role at Precision, she is responsible for leading the quality management of teams on multiple concurrent trials by providing development and coaching to optimize the skills of functional teams to ensure efficiency and accuracy throughout the project duration. She is also responsible for the financial management of the clinical trials. She has more than 29 years of combined clinical laboratory and investigational trial experience conducting clinical research across a wide variety of therapeutic areas. Teresa serves as a subject matter expert in laboratory testing and management, clinical trial coordination, clinical trial monitoring, and clinical trial management of in vitro diagnostic (IVD) clinical trials. Prior to joining Precision, she was the Director of Clinical Research Services at Beaufort. Teresa provides our clients with advice and guidance in designing, planning, and implementing clinical trials. Teresa is an active member of the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SoCRA), the American Society of Clinical Pathology (ASCP), and the Association for Molecular Pathology (AMP). Teresa received her Bachelors of Science in Medical Technology from Atlantic Christian College. In addition, she holds certifications as an ASCP Certified Medical Technologist, HHS Certified Clinical Laboratory Scientist, SoCRA Certificated Clinical Research Professional, ACRP Certified Clinical Research Coordinator, and ACRP Certified Clinical Research Associate.

Scott L. Marshall, Ph.D.

Managing Director, Analytics
Precision for Medicine

Scott Marshall, PhD, is a Managing Director of Precision Analytics at Precision for Medicine. He has extensive industry experience in a leadership role, consulting in the pharmaceutical, biotechnology, and biodefense industries, specializing in the analytical component of personalized medicine, biomarker R&D, analytical methods and strategy development, as well as medical device/diagnostic development. Prior to joining Precision for Medicine, Scott served as the Head of Bioanalytics at a statistical consulting company serving the pharmaceutical, biotechnology, and biodefense industries. In addition to his scientific role, his responsibilities included helping develop the company’s business and analytical R&D strategies, as well as the organizational structure and operational system. Scott’s expertise spans multiple spaces, with a specific emphasis in precision medicine-guided efforts, and strategy development focused on patient selection. He has authored, coauthored, and presented analytical strategies and methods for use in precision medicine in various publications, including The Pharmacogenomics Journal, Pharmacogenomics, Biometrics, and the Journal of Pharmacogenomics and Personalized Medicine. Areas of focus include genomic region-based testing (method and strategy manuscript) and the estimation of molecular signatures toward patient stratification. In addition, he has authored or coauthored more than 150 confidential technical documents, such as statistical analysis plans, statistical analysis reports, and other US Food and Drug Administration (FDA) and European Medicines Agency submission documents. Scott completed his PhD in Biostatistics at the Medical College of Virginia, Virginia Commonwealth University. As a trainee on a National Institute of Environmental Health Sciences grant, Scott developed novel methodologies for the evaluation of complex chemical mixtures. Scott earned a Bachelor of Science in Applied Mathematics from the University of Tennessee at Chattanooga.

(Recorded on January 21, 2015) | Access Today  


For reprints and/or copyright permission, please contact Terry Manning, 781.972.1349.