Short Course - Guidelines for Commercial Launch of Novel Diagnostics

Tuesday, April 17 | 6:30 – 8:30 pm

Guidelines for Commercial Launch of Novel Diagnostics 

This short course is focused on development of molecular diagnostics as they make their way from identification of a medical need through to commercial launch. The course will emphasize identification of critical hurdles that when addressed early, can materially accelerate progress. Vital areas to be addressed include disease management, validation, reimbursement strategies including provider engagement, regulatory pathway decisions and education of the medical community. Examples and case studies of diagnostic companies will be shared to illustrate a real world roadmap including:

• Disease Management
• Assay Validation
• Regulatory Pathways and Considerations
• Reimbursement
• Acceptance and Adoption

Instructors:
Bill Cook, Principal, WECA
Dwight Denham, MBA, Director, Clinical Research, Health Economics &. Reimbursement Affairs (CHRA), Beckman Coulter, Inc.

*Separate Registration Required