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Zynteglo Could Be Gene Therapy Test Case For Viability Of Outcomes-Based Contracts – UHC Exec

 
• By Cathy Kelly

Outcomes and disease progression could be clear cut, lending the rare disease treatment to innovative contracting. But the amount of money at stake is likely to complicate things.

Outcomes-Based Contracts May Be Harder With Future Gene Therapies • Source: Shutterstock

bluebird bio is actively pursuing outcomes-based contracts for its Zynteglo gene therapy for beta thalassemia in the US, if cleared for marketing, which could serve as an important precedent for the feasibility of outcomes-based contracts for such cutting edge therapies, according to UnitedHealthcare Pharmacy director of emerging therapeutics and outcomes-based contracting Erik Schindler.

Prospects for outcomes-based, risk-sharing contracts for cell and gene therapies in general “are promising, are moving forward, and this is...

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Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

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Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
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• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

More from Advanced Technologies

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

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