Sarfaraz K. Niazi, Ph.D., is the Founding Executive Chairman of Adello Biologics, LLC (ABL, formerly Therapeutic Proteins International), a global developer and manufacturer of biosimilar biologics, one of the most prominent new categories of life-altering drugs. The ABL manufactures biosimilars in Chicago, IL and Cashel, Ireland and develops products in Chicago and Piscataway, NJ.
As an entrepreneur, Niazi has raised hundreds of millions of dollars, and for these accomplishments, he received induction into Chicago Entrepreneur Hall of Fame.
Niazi is a pharmacist, who received his MS degree in biopharmaceutics from Washington State University (1971) and Ph.D. degree (1974) from the University of Illinois, where he began his career teaching pharmacy (1972-1988) and received tenure at the age of 27. He trained dozens of graduate students, published a vast volume of refereed research articles, managed research grants, wrote the first textbook on clinical pharmacokinetics, formulated many pharmaceutical products, developed mathematical and statistical models in pharmacokinetics, and taught FDA inspectors. In 2015, Niazi became honored as the Alumnus of the Year by the University of Illinois.
In 1988, Niazi left his teaching position, but not teaching, and joined Abbott International, where he established a new line of consumer and generic products and introduced many novel manufacturing technologies to reduce the COGS substantially. He became a tenured Volwiler Fellow at Abbott.
In 1995, Niazi established his consulting company. He managed FDA and EMA submissions and approval of both chemical and biological drugs; Niazi coordinated the development and commercial launch of cytokines, monoclonal antibodies, and insulin, managing budgets of hundreds of millions of dollars worldwide, on behalf of his clients. Niazi also coordinated regulatory filing of alternative medicines, a new category of drugs at the FDA. He continues to provide consulting to many regulatory agencies worldwide. He had also served in the development of the US legislature, Affordable Care Act, more particularly the BPCIA.
In 2003, Niazi established ABL with vision to make lifesaving biological drugs affordable. Realizing that starting a biological development and manufacturing operation requires hundreds of millions of dollars, a resource that he did not have, he went on to reinvent the bioprocessing technology platform from the ground up. His technology earned scores of patents for his inventions, making him the largest single owner of bioprocessing technology patents in the world. The bioprocessing technology created by Niazi significantly reduces capital investment and operational cost with potential of improving quality. His inventions are widely recognized globally. ABL utilizes some of Niazi’s technology to manufacture cost-competitive biosimilar drugs.
He is widely renowned for his technical expertise and passion to reduce cost to patients in world press; the Forbes Magazine lists him as the most interesting man in the world for his efforts in making high-cost drugs affordable across the globe; other recent mentions of Niazi include The Chicago Tribune, Crain's Business, The Express, and Diagnostico Brazil,
With over 50 ISBNs under his name, Niazi has authored many landmark books: the first textbook in the field of clinical pharmacokinetics that remains a primary teaching tool for 40 years, the longest running edition of any book in the pharmaceutical sciences; a 6-volume series of pharmaceutical manufacturing formulations, the largest such book ever published on the topic; the first book on biosimilars; the most comprehensive book on bioequivalence testing; a handbook of pre-formulation; online filing of patents; a textbook on bioprocessing; a number of consumer books, and translations of Urdu and Persian poetry into English, among many others.
He currently serves as an ad hoc faculty at the University of Houston, Texas, HEJ Research Institute, Karachi, and National University of Science and Technology, Islamabad. He has also served as a Foreign Professor at the HEJ Research Institute, Karachi. He serves on the editorial board of the journal MOJ Proteomics & Bioinformatics (MOJPB) and starting 2017, as Chief Editor of International Journal of Biosimilars. He also serves as Member of National Advisory Board of the College of Pharmacy, University of Illinois. He is a Fellow of the Pakistan Academy of Medical Sciences, Fellow National Academy of Clinical Biochemistry and Institute of Biology. He served as a TOKTEN Fellow to India (Transfer of Knowledge Through Expatriate Nationals ( UNDP, 1983-84). In 2013, he received the one of the highest civilian awards, Star of Distinction in Engineering, from the Pakistani President. He has hosted a radio show at Voice of America (US State Department) on a weekly basis for more than 5 years with audience into billions. He is an avid musician (guitar), a street photographer and a marathoner.
Niazi lives with his family in Chicago.