Author: Sarfaraz Niazi
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Fingerprint-like Non-inferiority Similarity Demonstration–A New Invention
The FDA, now now EMA, emphasize analytical similarity as the pivotal step to minimize residual uncertainty, but creating a plan to demonstrate fingerprint-like similarity has been difficult because of improper use of testing methods, testing protocol, statistical modeling and the knowledge of the variability within and between lots. I have addressed this issue in my…
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Making Alcoholic Beverages Unique and Affordable–New Patent Issued 29 August 2017.
The alcoholic beverage industry is bigger than the pharmaceutical industry, over $1.5 Trillion worldwide, yet the technology for aging alcohol, letting it sit in a barrel, dates back thousands of years. While I have developed many technologies with dozens of patents to make biological drugs more affordable, and these technologies are used to reduce the…
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A Biosimilar Delayed is a 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). I am inviting all of my friends (and I have many) to join me at this…
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Making Biosimilars Accessible Requires Intelligent Partnership
Later in the year, I will be speaking on the topic of improving accessibility of biosimilars.
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Thermodynamic Equivalence to Demonstrate Bioequivalence
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Why do we exist?
About 80,000 years ago, a variant of the Homo genus, the Sapiens, came out of East Africa and spread across the globe, annihilating other Homo genus title holders, many large animal species and now finally devouring the environment that supports his existence. The renewal of species is a common occurrence in the mega plan of…
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Amorphous Scalia And The New USA
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On Being an Inventor
With around 100 inventions, I can talk about the experience of being an inventor. The simile of light bulb for an idea is not far fetched. Owning patents in a variety of fields, some farthest away from my professional field, is the fun part of inventing. An invention is: A “process” is defined as a process, act,…
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On the Death of Moore’s Law
Moore’s law refers to an observation made by Intel co-founder Gordon Moore in 1965. He noticed that the number of transistors per square inch on integrated circuits had doubled every year since their invention. The prediction repeated so well for so many years that we began calling it a law, an immutable set of observations.…
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The Sweet Tooth Syndrome
Racing past our evolution, we need to fool the instinct, not fight them for things sweet.
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