Understanding the FDA’s LDT Rules and Their Impact
Join us for an important episode of DCN Dx’s Expert Insights series as we discuss the significant changes in the regulatory landscape for laboratory-developed tests (LDTs). With the FDA’s recent rule redefining LDTs as regulated medical devices and the implications of the Supreme Court’s Chevron decision, this episode is a must-listen for professionals in the diagnostics industry.
Why Listen?
This episode offers a comprehensive discussion on the FDA’s new regulations for LDTs, highlighting the phased enforcement plan and its impact on the industry. Our expert panel explores the challenges and opportunities these changes present, especially in ensuring compliance and maintaining high standards. Additionally, we examine the broader implications of recent legal battles and regulatory shifts, providing valuable insights for navigating this evolving issue and its impacts to your organization.
Note that this is an evolving issue and this recording was made on July 3, 2024; some details may have changed.
Expert Panelists
Mitzi Rettinger, Chief Revenue Officer at DCN Dx; Episode Host
Mitzi Rettinger, Chief Revenue Officer at DCN Dx, is a dynamic force in the life sciences industry, with more than 25 years of experience fueling innovation and growth across various sectors, including diagnostics, pharmaceuticals, and biotechnology. Her expertise lies in driving sustainable revenue growth, market development, and digital transformation, leveraging her deep understanding of the scientific commercial landscape.
At DCN Dx, Mitzi has been instrumental in shaping strategic initiatives that enhance customer engagement and drive market leadership. Her tenure at MilliporeSigma was marked by transformative leadership where, in her role as Sr. Director, she proposed and led the commercial organization through a digital transformation by translating the value that data and technology bring to the business. With an entrepreneurial spirit and a focus on modernization of strategy, process, and tools, she drove innovation in sales and delivered significant year-over-year growth on a revenue base of over $300M.
A trained scientist with hands-on laboratory experience, Mitzi’s leadership extends beyond revenue generation to include building cross-functional teams that deliver solutions aligned with the scientific community’s needs.
Elliot Cowan, Principal and Founder at Partners in Diagnostics, LLC
Elliot Cowan, Ph.D., is principal and founder of Partners in Diagnostics, LLC, providing consulting on the regulation of in vitro diagnostics to IVD manufacturers, as well as to international public health agencies, procurement organizations, regulatory harmonization efforts, governmental bodies, and philanthropic foundations. This followed a 20-year career at the US Food and Drug Administration, where he was responsible for leading the regulation of all blood donor screening tests and retroviral diagnostics used in the US, including the first over-the-counter HIV test system, approved in 2012.
Dr. Cowan was also a member of the Laboratory Technical Working Group for the President’s Emergency Plan for AIDS Relief (PEPFAR), providing technical assistance for laboratory quality assurance issues in PEPFAR focus countries, and advised the World Health Organization on the development and restructuring of its Prequalification of Diagnostics Programme.
Dr. Cowan received a B.A. from Williams College and a Ph.D. in Biology and Biomedical Sciences from Washington University in St. Louis.
Emily Friedland, VP of Clinical Research at DCN Dx
Emily Friedland is a seasoned professional in the field of clinical research with a special focus on in vitro diagnostic (IVD) and traditional medical devices. She has held several prestigious roles throughout her career, each contributing to her extensive knowledge and experience in the medical and diagnostics sector.
As the Vice President of Clinical Research at DCN Dx, Emily leads and fosters growth within the clinical operations teams. She excels in fast-paced and challenging environments, coordinating and overseeing various clinical research projects.
Prior to her role at DCN Dx, Emily was the Director of Global Clinical Operations at Teleflex Incorporated. She also spent several years at Singulex, initially serving as the Director of Clinical Affairs, then progressing to the position of Sr. Director, Clinical and Regulatory Affairs. During her tenure at Singulex, Emily managed the execution of clinical trial programs, including the implementation and execution of FDA registration trials and additional post-marketing clinical trials of CE-marked and FDA registered products.
Before Singulex, Emily worked at Grifols Diagnostic Solutions as the Associate Director of Clinical Affairs, where she led clinical trials and ensured cross-functional alignment in their execution. Her earlier roles include serving as Manager of Clinical Affairs at Celera and Manager of Clinical Research at Roche Molecular Systems.
Emily’s specialties span IVD, infectious diseases, women’s health, genetic testing, immunodiagnostics, blood safety, medical devices, and clinical operations. Her track record highlights her ability to tackle complex problems with effective solutions and her strong collaboration skills. Her peers describe her as a wealth of knowledge and a pleasure to work with.
Emily holds a Bachelor of Science in Biology from Virginia Tech. Throughout her career, Emily has demonstrated an unwavering dedication to her field and continues to contribute to advancements in clinical research and diagnostics.
