Sarfaraz K. Niazi, Ph.D.
Biosimilars Pioneer, Inventor, Teacher, Author and Founder, Therapeutic Proteins, a Biosimilars Company
Sarfaraz K. Niazi, Ph.D. is globally recognized as a pioneer of affordable biosimilars and interchangeable biosimilars. He has written the first and the largest number of books on biosimilars, bioprocess engineering, pre-formulation and formulation practices, bioequivalence testing, single-use manufacturing, freedom-to-operate analysis, and PK/PD testing. These landmark books (50 ISBNs) and 100+ research contributions of Niazi help many product developers and regulatory agencies in creating guidelines and evaluation of submissions. Dr. Niazi has also authored several consumer books and translations of Urdu and Persian poetry into English, among many others. Dr. Niazi is the most prolific solo biotech inventor with 100+ patents, inventions to reduces the COGS of biosimilars, improve the lot-to-lot variability, allow ISO9 GMP manufacturing, and conduct creative, analytical similarity testing. His other inventions encompass a wide variety of technologies helping millions worldwide, to acknowledge this, he received one of the highest civil awards, Star of Distinction in Engineering. Niazi has practiced his inventions to develop and secure regulatory approvals of the major biosimilar products globally. He is the founder of Therapeutic Proteins Inc., which later became Adello Biologics, LLC, a pure-play, fully integrated US biosimilar products company. He is an inductee into the Chicago Entrepreneur Hall of Fame for his entrepreneurial leadership, having raised hundreds of millions of dollars. As a patent law practitioner, he expertly creates Freedom-to-Operate dossier and encourages scientists in the developing countries by helping them secure US patents on a free basis. He also serves on the faculty of major universities.
Niazi is widely written about for his technical expertise and passion in the 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 include The Chicago Tribune, Crain's Business, The Express, and Diagnostico Brazil, In 2015, Niazi became honored as the Alumnus of the Year by the University of Illinois.
Niazi 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. His blogs deal with the resolution of contemporary issues from a scientific, philosophic and rational viewpoint.
Niazi is an avid photographer, guitarist, and music composer. He lives in Illinois and Wisconsin.