Post on 24-Sep-2020
transcript
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Access without Excess: Bedaquiline Global Health Policy Forum: “Access to New Medicines”
Myriam Theeuwes, Compound Development Team Leader December 12, 2016
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Overview
• Adult, pediatric drug
sensitive and drug resistant regimens
• WHO prequalified drugs and innovative drugs
• User-friendly diagnostic kits
• Sales to more than 133 countries
• Technical assistance to improve drug management systems
• Pioneered a standard 4-language package global package
Early Access Programs:
Russia & Lithuania
N=57
ATU France
N= 194
Compassionate Use
Global
N=554 N = 760
>800 patients
in 47 countries
Access: When Most Needed
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Access: Where Most Needed
> 80% of the world’s MDR-TB burden has regulatory access to bedaquiline at the end of 2016.
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Access: Janssen Approach
Established markets High burden countries Low to moderate burden countries
< 500 cases / year
500-5,000 cases / year
> 50,000 cases / year
5,000-15,000 cases / year
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Access: Global Drug Facility
• Adult, pediatric drug
sensitive and drug resistant regimens
• WHO prequalified drugs and innovative drugs
• User-friendly diagnostic kits
A UN Operations organization within the STOP TB Department, the GDF is the largest global supplier of quality-assured anti-TB treatments
Administration and oversight of a regulatory waiver process has contributed to an significant advances in patient access to treatments
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Janssen Contributions: Beyond the Pill
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Janssen & South Africa: A New Paradigm in Collaboration
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Questions? Thank you!