The Orphan Drug Act

The Orphan Drug Act Jeff W. Bailey MS Senior Regional Business Manager Shire Human Genetic Therapies June 2009

References/Data Source ,[object Object],[object Object],[object Object],[object Object]

Table of Contents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

The Orphan Drug Act ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Provisions of the Orphan Drug Act: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Governmental Entities Implementing the Orphan Drug Act ,[object Object],[object Object],[object Object]

Has the Orphan Drug Act Met It’s Objectives? ,[object Object],[object Object],[object Object],[object Object]

Findings: ,[object Object],[object Object],[object Object],[object Object]

Findings: Total Orphan Designations and Approvals 68 79 67 55 60 56 58 65 56 80 89 75 73 59 33 48 41 1 D E S I G N A T E 14 20 20 19 23 11 11 13 13 12 12 12 11 9 6 7 3 2 A P P R O V A L S 00 99 98 97 96 95 94 93 92 91 90 89 88 87 86 85 84 83 Y E A R

Conclusion: ,[object Object],[object Object],[object Object]

What Does This Mean To You?: Managed Care Vision Today & Beyond ,[object Object],[object Object]

Trends & Concerns (Abroad & Here) ,[object Object],[object Object],[object Object],[object Object]

Trends & Concerns: Abroad & Here ,[object Object],[object Object],[object Object]

Trends & Concerns: Abroad & Here ,[object Object],[object Object],[object Object],[object Object]

Trends & Concerns: Abroad & Here ,[object Object],[object Object],[object Object],[object Object],[object Object]

Implications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Implications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object]

The Orphan Drug Act

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