In Vitro Diagnostics Product Development
BIOL-40244
In Vitro Diagnostics Product Development
As biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the skills required to be effective in a biological product development environment will increase. In this course, learn the requirements for moving an IVD product from concept to regulatory approval and market launch. Topics include planning for success by setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and composition of the product development team, risk analysis, and IVD clinical and regulatory issues including compliance and complaint handling. Specific product development cases will be discussed.
Who Should Attend
This course is geared towards managers, entrepreneurs, investors and scientists seeking an overview of the regulatory, clinical, scientific and business aspects of In Vitro Diagnostic product development.
Course Agenda
Due to circumstances stemming from COVID-19, this course will be offered in a live- online format. This course will use Zoom conference call technology instead of traditional classroom meetings. Please see below for course dates and times.
Session 1
- Introduction to the IVD World
- Package Insert – Begin with end in mind
- Product Development Process
- Resource Planning
Session 2
- Design Control
- Customer Input, PRD
- Product Risk Analysis
- Case Study 1- DNA Sequencing
Session 3
- Group Assignment and Breakout
- Business Case (NPV, IRR, Standard Costs)
- Case Study 2 – COVID
Session 4
- Principles of Assay Development
- Companion Diagnostics
Session 5
- Group Assignment and Breakout - Companion Diagnostics
- Instrumentation/ Software in IVD
Session 6
- Design and Conduct of Preclinical and Clinical Trials
- Regulatory Overview
- Exam Review
Speakers:
- Larry Mimms, Ph.D., Principal, LTM Enterprises
- Valerie Day, MS, MBA, Medical Device Consultant
- Damon Getman, Ph.D., Scientific Director, Medical and Scientific Affairs, Hologic, Inc.
- Al Maderazo, VP, Quality Assurance and Regulatory Affairs, GenMark Diagnostics
Course Information
Course sessions
Section ID:
Class type:
Textbooks:
All course materials are included unless otherwise stated.
Policies:
- No refunds after: 4/7/2025
- Early enrollment advised
Schedule:
| Date | Day | Start | End |
|---|---|---|---|
| 4/1/2025 | Tue | 4:00 p.m. | 7:00 p.m. |
| 4/3/2025 | Thu | 4:00 p.m. | 7:00 p.m. |
| 4/8/2025 | Tue | 4:00 p.m. | 7:00 p.m. |
| 4/10/2025 | Thu | 4:00 p.m. | 7:00 p.m. |
| 4/15/2025 | Tue | 4:00 p.m. | 7:00 p.m. |
| 4/17/2025 | Thu | 4:00 p.m. | 7:00 p.m. |
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.
