Sarfaraz K. Niazi, Ph.D.
Founding Executive Chairman, Adello Biologics, LLC
Sarfaraz K. Niazi, Ph.D., a well-recognized authority on the contemporary biologic drug industry, is Founder and Executive Chairman of Adello Biologics, LLC, (formerly, Therapeutic Proteins International, LLC), a biosimilar products company located in Chicago, IL, Piscataway, NJ and Cashel, Ireland. Adello Biologics is leveraging his diverse background and decades of hands-on experiences in the development, manufacturing, regulatory approvals and commercialization of biological drugs. His contributions to the science and art of biological drugs make it possible to make these drugs more affordable while optimizing their quality and fast to market opportunities.
As an entrepreneur, Niazi has raised hundreds of millions of dollars and became recognized as an inductee into the Chicago Entrepreneur Hall of Fame.
Niazi began his career teaching pharmaceutical sciences at the University of Illinois, College of Pharmacy where he was tenured before entering the industry at Abbott International. Throughout his experiences at Abbott, he witnessed a global disparity in the affordability of life-saving drugs that fueled his passion for working to soften this humanitarian crisis. He departed Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through the founding a biosimilar products company to supply these life-saving and life-altering products at the most competitive price. He is currently leading Adello Biologics, a pure-play biosimilar products company, to achieve his goals of humanitarian support.
A prolific inventor with scores of patents, most prominently in the field of bioprocessing technology, Niazi is currently the largest single holder of bioprocess technology patents. The technology invented by Niazi reduces capital investment requirement, operational cost, regulatory barriers, time to market and optimization of product quality. His inventions are widely recognized globally. Adello Biologics' proprietary MayaBio®, a single-use bioreactor platform is based off a host of patented inventions. His other inventions span a broad category of technologies, new chemical entities, new formulations, new analytical methodologies, and much more.
He is widely renowned and written about for his technical expertise and passion for reducing 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, In 2015, Niazi became honored as the Alumnus of the Year by the University of Illinois.
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 that has gone through two editions (a third one coming in 2017), the largest such book ever published on the topic and a book that has made development of generic drugs more affordable; the first book on biosimilars before even the name 'biosimilar' was coined--this book opened the field of biosimilar drugs that are poised to save trillions of dollars in healthcare; the most comprehensive book on testing bioequivalence that has gone through two editions and considered a training manual for designing and submitting studies to regulatory agencies; a handbook of pre-formulation; a self-help book online filing of patents; a engineering textbook on bioprocessing; a number of consumer books, and translations of Urdu and Persian poetry into English, among many others.
In his consulting work, he assisted in many complex FDA and EMA submissions and approvals for chemical, biological drugs, and natural product drugs, managing budgets of hundreds of millions of dollars worldwide on behalf of his global clients. He has also assisted regulatory agencies, educational institutions, investment bankers and the writing of the BPCIA as part of the Affordable Care Act.
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). 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. As a newspaper columnist, he has provided health tips that were published as a book. His blogs deal with the resolution of contemporary issues from a scientific, philosophic and rational viewpoint.
Niazi is also an avid photographer, guitarist, and music composer. He lives in Chicago, Illinois.