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Company with no US commercialization experience created strategic partnerships to manufacturer, distribute and market a lab-based diagnostic. Case Study:  EU Diagnostic Company (Co. A) ,[object Object],[object Object],[object Object],Co. A invested in a product that had no commercial value in the US due to reimbursement and payment issues and scrapped the project.  “ Look Before You Leap” - Consider the commercial reimbursement landscape before investing!  Results & Lessons Learned
Company with some US commercialization experience launched a lyo-formulated SQ injectable biologic for a chronic disease into a very crowded market. Case Study:  Mid-size Biotech (Co. B) ,[object Object],[object Object],[object Object],Co. B could have considered a pro-active risk management program to mitigate concern with patient education and altered the label pre-approval.  “ Consider The Label” – nuances in the label can have drastic repercussions on the future reimbursement scenario!  Results & Lessons Learned
Well respected medical device manufacturer had challenges with spinal surgeon utilization of artificial disc replacement due to negative US coverage policies (CMS NCD) and technology assessments (BCBS TEC) Case Study:  Medical Device Firm (Co. C) ,[object Object],[object Object],[object Object],Co. C saw increased utilization of product due to lower administrative burden on the spine surgeon’s office.  Additionally, patients who may have been denied the procedure obtained approval and were treated. Results & Lessons Learned

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BIOTECH 2011 NJ/PA/DE Case Studies

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