Sarfaraz K. Niazi

Niazi was born 10 July 1949, in Lucknow in India, and moved to Karachi with his parents in 1962.[3] His father was Niaz Fatehpuri, a scholar of religion and literature in Pakistan and India.[4]

Niazi earned a bachelor of science degree in pharmacy from the University of Karachi in 1969. In 1970, he moved to the United States, where he obtained his master of science degree in pharmaceutical sciences in 1971 from Washington State University in Pullman, WA, and then moved to Illinois. In 1974, he obtained his doctorate in pharmaceutical sciences from the University of Illinois at Chicago.[3]

From 1972 to 1988 he taught at the College of Pharmacy at the University of Illinois at Chicago,[5] and continues to serve as Adjunct Professor of Biopharmaceutical Sciences. From 1988 to 1996 he worked for Abbott Laboratories as its director of technical affairs;[5] at the same time he was professor of pharmacology at the Aga Khan University Hospital in Karachi.[5] In 1997, he established his own consulting business, known as Pharmaceutical Scientist, Inc.[6][5] In 2003, he founded Therapeutic Proteins, Inc. to develop biosimilar versions of biopharmaceuticals, such as filgrastim, erythropoietin, interferon, Pegfilgrastim, adalimumab, and other monoclonal antibodies. In March 2012, this company became Therapeutic Proteins International, LLC. The company has proprietary single-use bioreactor systems.[7][8] In November 2016, the company changed its name to Adello Biologics.;[9] in January 2019, Adello Biologics assets were purchased by Kashiv Bioscience.[10] In 2018, Niazi went on to establish another start up in biopharmaceuticals called Karyo Biologics.[11][12]

Since 2012 he has served as Adjunct Professor at the College of Pharmacy, University of Illinois, and since 2004 he has served as an adjunct professor at the University of Houston College of Pharmacy. In 2007, he was named as an adjunct professor at the HEJ Research Institute of Chemistry at the University of Karachi. Additionally, since 2013 he has been a NUST Visiting Professor at the National University of Sciences and Technology (NUST) in Islamabad, Pakistan.[10]

In 2002, Niazi published the first complete translation[13] of the ghazals of Mirza Asadullah Baig Khan, known as "Ghalib"[14] and another in 2009.[15] Niazi hosts a show on Voice of America every Sunday, where he recites ghazals.[16]

Niazi has published over 100 research articles, [17][18] and is the creator of a variable volume distribution model to study safety and efficacy of drugs.[19][20]

Niazi has challenged FDA guidance through three Citizen Petitions[21][22][23] that urge FDA to rationalize testing to allow faster entry of generic drugs and biosimilars to the market. In response to Niazi Citizen Petition, the FDA withdrew a pivotal guidance for the approval of biosimilars.[24] Niazi has also challenged the World Health Organization[25] guidance on approving biosimilars as weak on science leading to the possibility of use of unsafe biological drugs in developing countries.[26]

Niazi owns 177 patents[27] in the field of bioprocessing, digital technology, new drugs, new dosage forms and herbal medicines. Niazi is also a patent law practitioner.[28]

On 14 August 2012, the Government of Pakistan announced that President Asif Ali Zardari would be awarded the Sitara-i-Imtiaz in Engineering Science to Sarfaraz.[29] In March 2015, he received Alum of the Year Award from the University of Illinois.[30] In September 2015, he was inducted into Chicago Entrepreneur Hall of Fame.[1]

Niazi has published numerous books;[31] His textbooks are generally made available royalty-free in the developing world.[32]

• Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues. Boca Raton, Florida: CRC, 2002. ISBN 9780849329913.
• Textbook of Clinical Pharmacokinetics and Biopharmaceutics. Bsp, India. 2010. ISBN 9789381075043.
• Handbook of Bioequivalence Testing. Boca Raton, Florida: CRC, 2014. ISBN 978-1482226379.
• Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set 1st Edition. Boca Raton, Florida: CRC, CRC, 2015. ISBN 978-1482298918.
• Fundamentals of Bioprocess Engineering. Boca Raton, Florida: CRC, FL. 2015 ISBN 978-1466585737
• Love Sonnets of Ghalib. Rupa Publications, New Delhi, India, 2017. ISBN 978-8129148520.
• Biosimilarlity—The FDA Perspective. Boca Raton, Florida: CRC, 2018. ISBN 978-1498750394.
• Handbook of Pharmaceutical Manufacturing Formulations Volumes 1–6. Boca Raton, Florida: CRC, 2019. ISBN 978-1138103924.
• Handbook of Preformulation: Drugs, Botanicals and Biological Pharmaceutical Products. Second edition. Boca Raton, Florida: CRC, 2019. ISBN 978-1138297555.

• Official website