Precision Medicine and Companion Diagnostic
BIOL-40398
Dive into the cutting-edge world of precision medicine with our advanced course on Companion Diagnostics (CDx). This dynamic program offers a deep dive into the development pathways, regulatory landscapes, and the intricate business relationships between pharmaceutical and diagnostic companies. Through an in-depth exploration of FDA regulatory frameworks, real-world case studies, and a critical analysis of recent industry collaborations and market trends, students will gain a comprehensive understanding of how CDx is revolutionizing patient care. Whether you're a future scientist, healthcare professional, or business leader, this course is your gateway to mastering the essential tools and knowledge needed to succeed in the rapidly evolving field of personalized medicine.
This course is a live online experience conducted through Zoom. You'll need to log in at the scheduled time to join discussions and complete assignments.
What you'll learn
- Define companion diagnostics and articulate their significance in personalized medicine
- Navigate the regulatory landscape for companion diagnostics, particularly FDA requirements
- Analyze the technical aspects of CDx development from biomarker discovery to clinical implementation
- Evaluate business models and partnerships between pharmaceutical and diagnostic companies
- Assess current market trends and future directions in companion diagnostics
Course Information
Course sessions
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All course materials are included unless otherwise stated.
Policies:
- No refunds after: 2/10/2026
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Instructor:
Larry Mimms, Ph.D.
Chief Scientific Officer, Prometheus Laboratories
Larry Mimms, Ph.D. is chief scientific officer at Prometheus Labs. Previously he served as head of product development for Human Longevity. From 2009 to 2014, Dr. Mimms served as vice president R&D Quidel Corp., a world leader in development of point of care and rapid tests. Prior to his work at Quidel, Dr. Mimms founded VDx LLC in 2008 to develop rapid, point of care HIV diagnostic tests.
From 1994 to 2007 Dr. Mimms held a number of executive positions at Gen-Probe including executive vice president, research and development from 2005-2007 and vice president of development, and vice president of strategic planning and business development. Dr. Mimms initiated and headed up the Gen-Probe blood bank program from 1996 to 2002. In 1996, he and his colleagues won a National Institutes of Health (NIH) contract to develop blood screening assays to detect HIV and HCV nucleic acid. This work and later contracts led to FDA licensure and market introduction of Procleix HIV-1/HCV, Ultrio HIV-1/HCV/HBV assay and the Procleix West Nile Virus assay. As a result of this work, Gen-Probe won the 2004 National Medal of Technology, the highest U.S. honor for technological innovation, for “development and commercialization of new blood testing technologies and systems for the direct detection of viral diseases.” Dr. Mimms served as a member of the Blue Ribbon R&D Panel for the American Red Cross from 2006-2007.
Prior to joining Gen-Probe, Dr. Mimms held various positions in the Hepatitis/AIDS Business Unit at Abbott Laboratories. He was an NIH postdoctoral fellow at Harvard University in cellular and developmental biology prior to joining Abbott Laboratories. He earned a Ph.D. in biochemistry from Duke University and a B.S. in chemistry from Davidson College. In 2014 Dr. Mimms received an honorary doctorate in science from Davidson College for his work on HIV, HCV and HBV.