Others have taken note of Dr. Niazi’s extensive work, and through published articles and awarded accolades, celebrated his accomplishments. Find below examples of the kind words that have been shared on Dr. Niazi’s feats and endeavors. And also, the talks Dr. Niazi has given.
Pharmaceutical Scientist, Inc.: FDA Calls For Public Comments On Bioequivalence Testing
In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel dissolution methods, to allow biowaivers for all types of drugs. The call comes in response to a Citizens Petition filed by Dr. Sarfaraz K. Niazi, Executive Chairman, Pharmaceutical Scientist, Inc., and Adjunct Professor of Biopharmaceutical Sciences at the University of Illinois at Chicago College of Pharmacy and author of dozens of books and research papers on the subject (www.niazi.com).
Dr. Niazi would like to speed the approval process for generic drugs to get medicine to patients as quickly and cost-effectively as possible by using a faster process called thermodynamic equivalence. The FDA has agreed to the validity of Niazi’s argument, in theory at least. In a response letter to Dr. Niazi’s petition, Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research at the FDA, wrote that her department “is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence…Therefore, your Petition is granted….” “It has taken years of communication with FDA to reach this stage,” said Niazi.
The focus of expanding biowaivers in the petition calls for establishing a new parameter—thermodynamic equivalence, to obviate the need for blood level studies that significant biologic variability that confounds true differences between products. The suggested change fits well within the purview of the Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 and other measures taken by the FDA to allow faster approval of generic chemical and biosimilar drugs. Thermodynamic equivalence demonstration requires identifying dissolution conditions that can discriminate differences in chemical potential, a process created by Dr. Niazi. Thermodynamic equivalence can be used to assure life-cycle clinical equivalence of a generic product and provide a critical measure of GMP compliance.
Now Dr. Niazi is calling on the scientific community to send their feedback to the FDA. “I am encouraging scientists to respond to this challenge and help reduce the cost and time to approval for both chemical and biologic drugs,” said Dr. Niazi. To participate in the public comments, go to https://www.regulations.gov/comment?D=FDA-2007-P-0055-0004 and the correspondence between FDA and Pharmaceutical Scientist, Inc., a global science-driven idea company (www.pharmsci.com).
At the 4th Annual Biomanufacturibg Summit, Dr. Niazi analyzes the major hurdles, never fully recognized, that have caused delays in approvals and escalated cost of development of biosimilars in USA and offers clear solutions. Read the presentation here.
Title: Bioinnovation of Future for Cost Optimization. Dr. Niazi discloses a complete plan, from facility design to upstream and downstream manufacturing in ISO9 environment, continuous processing and a cost-optimized manufacturing platform that is a subject of dozens of US and worldwide patents owned by Dr. Niazi.
Safaraz K. Niazi, Founding Executive Chairman, Therapeutic Proteins International
As the conference chair for the 2015 Bioproduction Summit in San Francisco, California, Dr Niazi lead discussion around the manufacturing and development of biosimilars.
For three decades, the Chicago Area Entrepreneurship Hall of Fame has been honoring local entrepreneurs that have left their mark on the business community and the city of Chicago
IBM Research and the Accelerated Discovery Forum invited Dr. Niazi as Distinguished Speaker at the IBM Research Distinguished Seminar Series on 9th April 2015. Dr. Niazi spoke of the changes in biological processing hat are coming to accommodate the new types of biological drugs and the need to develop these drugs on a faster path. A copy of his presentation is provided here.
Dr. Niazi speaks at the Bisimilar 2015 Conference. Click here to see the presentation titled A Pure play Perspective
Each year, the UIC College of Pharmacy recognizes alumni who have distinguished themselves through their research and service and who embody the highest values...
CEO da Therapeutic Proteins International, o indiano Sarfaraz Khan Niazi é um defensor da popularização dos biossimilares como alternativa aos custos crescentes na saúde
The Epress, Pakistan.
He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors...
CEO of Therapeutic Proteins International, the Indian Sarfaraz Khan Niazi is a defender of the popularization of biosimilars as an alternative to rising health costs...
The 2010 Affordable Care Act created a shorter licensing path for lower-cost versions of cell-derived drugs called biologics. Sarfaraz Niazi is working to get among the first of these substitute drugs called biosimilars approved...
Sarfaraz Niazi grew up in India and, as a pharmaceutical consultant later, visited impoverished countries where families sometimes had to choose between buying medicine for one child or food for them all...
Illinois Governor Pat Quinn congratulated Dr. Sarfaraz K. Niazi, a long-time Illinois resident, for being awarded the Pakistani civil award Sitara-i-Imtiaz (Star of Excellence) announced on Pakistan's Independence Day...
26 June, 2013