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Epstein Syndrome

The people who were close to Jeffrey Epstein
included princes, Nobel Prize winners,
presidents of state, financiers, cultural icons,
and some of the most prominent men in
modern public life. A single criminal scandal
has hardly ever crossed so many levels of
symbolic power simultaneously. The tale
wasn’t just a narrative about money. It was a
story about being close to power in almost
every area that affects public trust.

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The Power of Belief

Life is our most precious asset; taking life of others or giving our own for the sake of others is the final frontier of our expression of belief.

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A Biosimilar Delayed is Biosimilar Denied

After decades of experience in taking biosimilars from cell line to market and after facing both success and failures, I feel qualified to talk about what not to do when it comes to making biosimilars accessible (available and affordable).

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Thermodynamic Equivalence to Demonstrate Bioequivalence

The 1980s saw emergence of generic drugs in the US that has saved hundreds of billions of dollars to patients and improved accessibility to drugs. The statute that created this abbreviated pathway for approval of generic drugs stated that therapeutic equivalence means same concentration of active drug at the site of action, an evaluation that was neither possible nor practical. So, the FDA recommended using blood level studies as a surrogate test demonstrating bioequivalence.

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Hubris

Originally the intentional use of violence to humiliate or degrade others, Hubris has evolved–an overweening presumption that leads a person to disregard the divinely fixed limits on human action in an ordered cosmos.

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