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David Shlaes
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80 followers
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Standard of Care Antibiotics?
One of the major arguments against the use of superiority trials for antibiotics goes as follows. Once a new antibiotic has been shown to be superior to a comparator, the new drug must then become the comparator for all subsequent trials. There are probably...
Standard of Care Antibiotics?
Standard of Care Antibiotics?
antibiotics-theperfectstorm.blogspot.com
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Education for Antibiotic Researchers
The Global Antibiotic Development Partnership ( GARDP ) has teamed up with  CARB-X to provide training to current and future antibiotic researchers and developers. I have been pushing this since 2004 when I recognized that the continued consolidation within...
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Generic Antibiotics on the Edge
Many thanks to Lew Barrett for pointing me to this  article .  In the struggle to control drug prices, the rapid entry of new drugs into the generic marketplace is a key step.  This was emphasized by the National Academies of Science, Engineering and Medici...
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Reflecting on Antibiotic R&D and Pull Incentives
Today I would like to reflect with you on what I have heard from investors, Pfizer, J&J and various biotech company executives concerning antibiotic R&D, the antibiotic marketplace and the potential role of pull incentives.   One major problem is that pull ...
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J&J, Antibiotic Resistance and Pull Incentives
  Before getting into
the topic of today’s blog, I wanted to wish everyone a happy Passover and
Easter. I hope that our thoughts of renewal this weekend will extend to the
impending antibiotic resistance crisis. Today I spoke with Dr. Adrian Thomas, an Aust...
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Duke Margolis FDA Conference on Rare Diseases
Today the Duke Margolis Center and the FDA held a workshop to discuss how to approach clinical trial designs for rare diseases. Full
disclosure – I mainly watched the summary discussion session. Much of the
earlier discussion on the details of Bayesian stat...
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Pfizer, Antibiotics and Incentives
For this blog, I contacted three large pharmaceutical
companies and two agreed to speak about how they view antibiotic research and
development in light of real and potential incentives. This week, I will
discuss my conversation with Patrick Holmes, Head, I...
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Looking Forward
  I wanted to get out a
brief blog just to let you know what I’m doing. As a follow-up to my last blog ,
I am interviewing key executives from large PhRMA to discuss incentives for
antibiotic R&D. I conducted my first interview today – fascinating!   The ne...
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Who cares about pull incentives?
We do. But no one who actually invests in antibiotic R&D
has these incentives high on their priority list or even on their radar
screens. They are not yet real, they may never   come to fruition and they may be
poorly devised such that they would stifle rat...
Who cares about pull incentives?
Who cares about pull incentives?
antibiotics-theperfectstorm.blogspot.com
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Davos and Merck
Its Davos time again – or at least it was last week. During
the Davos meeting, the final DRIVE AB report was released where pull incentives were highlighted. A report from the AMR Industry Alliance was also published focusing on the fight against resistance...
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