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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.

Course Schedule:
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

  • Larry Mimms, Ph.D., Chief Executive Officer, ProciseDX
  • Tammy Brach, MBA, Director Program Management, Dexcom
  • Valerie Day, MBA, Vice President, Product Development, ProciseDX
  • Damon Getman, Ph.D., Chief Scientist, Diagnostics Scientific Affairs, Hologic
  • Al Maderazo, VP, Quality Assurance and Regulatory Affairs, GenMark Diagnostics

Note: 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.

Course Number: BIOL-40244
Credit: 2.00 unit(s)

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