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2013 Archived Content

SC2 Roadmap for Accelerating Commercialization of Molecular Diagnostics 

 

This short course is focused on development of molecular diagnostics as they make their way from biomarker discovery and initial proof of clinical performance through to commercial launch, partnership delivery and market development. The course will emphasize identification of critical hurdles that when addressed early, can materially accelerate progress. Vital areas to be covered include product pricing, reimbursement strategies, regulatory pathway decisions, provider engagement and key opinion leader development. Examples and case studies of molecular diagnostic companies in will be shared to illustrate a real world roadmap including:

  • Rationale for reimbursement – understanding coverage
  • Regulatory clearance and navigating claims language and timing
  • Maximizing clinical study results while addressing evolving evidence demands
     
 

William Cook, M.B.A., Principal, Strategy and Business Development, Clinical Diagnostics, WECA
Harry GLorikian, Managing Director, Scientia Advisors
Rina Wolf, Vice President of Commercialization Strategies, Consulting & Industry Affairs, Xifin

 

1:00 Introduction/Welcome

1:05 Roadmap for Accelerating Commercialization of Molecular Diagnostics
 

        William Cook, M.B.A., WECA
 

1:45 Route to Commercialization and Revenue Generation
 

       Harry Glorikian, Managing Director, Scientia Advisors
 

2:25 Coffee Break

2:35 Oxford Gene Technology Presentation

3:05 The Impact of the New Realities of Coverage, Coding and Pricing to Your Lab:  An Update
 

        Rina Wolf, Xifen
 

3:45 Q&A with Speakers

4:00 Close of Course

 

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2014 Premier Sponsors:

 Elsevier   

 

NanoString 

 

Quanterix 

 

RemedyMD 

 

Singulex 

 

Thomson Reuters