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US Federal Trade Commission: Ryan

US Federal Trade Commission: Ryan

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Published by: ftc on Jan 21, 2008
Copyright:Attribution Non-commercial

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12/25/2013

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FTCs RoundtablePanel: Policy and New Drug Development
Una S. Ryan, Ph.D., O.B.E.
President & CEO
 
Vaccines are at a Crossroads
New understanding of molecular immunology
Genetic engineering, rather than selection
Adult and adolescent markets, as well as pediatric
Therapeutic as well as preventative
But Issues Remain:
 – 
Irrational public fear – 
Enormous Phase 3’s for safety – 
Plaintiff’s bar – 
Reactogenicity to adjuvants – 
Manufacturing capacity – 
Uncertain regulatory pathways – 
Cumbersome reimbursement
 
The Big Issues
Return on InvestmentIndemnification for ManufacturersRegulatory Predictability

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