Key Tips for Diagnostics in 2018 and Beyond: Development Success in the Evolving US and EU Landscape

Health Decisions, the leading specialty diagnostics CRO, is offering a webinar to prepare diagnostics developers to meet evolving challenges as the FDA revises and accelerates some review processes affecting diagnostics, and the EU prepares to implement new Device Directives that impose more burdensome requirements. The webinar will address both high-level regulatory strategy and operational challenges in clinical validation studies of investigational diagnostics.

Gail E. Radcliffe, PhD, President of Radcliffe Consulting and a member of the Health Decisions Scientific Advisory Board, will draw on recent experiences representing sponsors with the FDA to address topics, including:

• FDA changes to the 510(k) de novo process
• The 510(k)/CLIA Waiver dual submission
• Processes for development of companion diagnostics

Dr. Radcliffe will also discuss adjusting to the new norm of substantially faster FDA response in a variety of areas. 

In addition, Dr. Radcliffe will analyze the effects of new EU regulations, including more extensive review by Notified Bodies. The European Medical Device Regulations and In Vitro Diagnostic Regulations came into effect on May 26, 2017 and Notified Bodies may be authorized to perform reviews by June 2018. Dr. Radcliffe will discuss the implications of EU changes for developer decisions about whether to seek CE Mark before FDA approval, or the reverse. Dr. Radcliffe will discuss pros and cons of different development pathways for the US and EU markets. In addition, Dr. Radcliffe will address questions about the implications for diagnostics developers of regulatory changes on both sides of the Atlantic.

Health Decisions Project Manager Jessica Kappes, MBA, MT, will advise sponsors on progressing diagnostics programs from early development to subject-based testing. The transition to subject-based testing sometimes presents unexpected challenges, especially for start-up companies with in-house scientific expertise but limited experience in clinical studies. Ms. Kappes, with training as both a medical technologist and a business manager, is a highly experienced project manager for diagnostics studies involving clinical settings.

Ms. Kappes will address topics including how to determine that your product is indeed ready for trials involving collection of samples from subjects in clinical settings, and coordination of internal and external development teams to initiate clinical studies. Her goal is to help diagnostics developers assess development status to justify proceeding with confidence into large subject-based trials to support a PMA, 510(k) or dual 510(k)/CLIA waiver submission.

Above all, she wants diagnostics developers to avoid the shock of discovering after investing in a large subject-based IVD study that the investigational diagnostic is not functioning in a clinical setting as it did in the hands of diagnostics professionals in the lab.

Speakers

Gail Radcliffe, Ph.D., President, Radcliffe Consulting, Inc., Member, Health Decisions Scientific Advisory Board

Gail E. Radcliffe, Ph.D. has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment, marketing and clinical/regulatory issues.  Gail founded Radcliffe Consulting in 1998. Her experience as a molecular biologist includes developing IVD assays for several infectious disease organisms including HIV, CMV, TB and Chlamydia. She has also established a clinical affairs group and forged industry alliances for diagnostics companies. As a consultant, Dr. Radcliffe has assisted start-up and established device companies with market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development and clinical trial support. Consulting engagements have involved cutting-edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, POC and CLIA Waived in vitro diagnostic devices. Dr. Radcliffe holds a Ph.D. in Molecular Biology from Brown and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School.

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Jessica Kappes, MBA, MT, CCRA, Health Decisions Project Manager

Ms. Kappes has nine years of experience as a project manager of diagnostics and interventional trials. Studies have ranged from small early-phase studies to global diagnostics trials enrolling thousands of subjects and have involved domestic and global populations across all age groups.  Ms. Kappes’ experience includes trials of IVDs for influenza A and B, cytomegalovirus, and bacteremia (complicated intraabdominal infections, and complicated urinary tract infections). She has additional experience in studies in endocrinology and oncology indications. Before joining Health Decisions, Ms. Kappes served for four years as a Clinical Operations Study Manager and three years as a Global Project Manager for two multinational diagnostics companies. Ms. Kappes holds an MBA from Indiana Wesleyan University and a Bachelor of Arts in Clinical Laboratory Science from Indiana State University. She received Medical Technology Certification from the American Society of Clinical Pathology and Clinical Research Associate certification through the Association of Clinical Research Professionals (ACRP).

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