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Sarfaraz K. Niazi

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Sarfaraz Khan Niazi (Urdu: سرفراز خان نیازی; born 1949 in Lucknow, India) migrated to Karachi, Pakistan in 1962, and to the United States in 1970. He is an expert in biopharmaceutical manufacturing and has worked in academia, industry, and as an entrepreneur. He has written books in pharmaceutical sciences, biotechnology, consumer healthcare, and poetry. He has translated ghazals (love poems) of the Urdu poet Ghalib.[1]

Sarfaraz K. Niazi
سرفراز خان نیازی
Sarfaraz_K._Niazi
Sarfaraz K. Niazi
Born (1949-07-10) 10 July 1949 (age 75)
Lucknow, Uttar Pradesh, India
NationalityAmerican
Alma materUniversity of Illinois, Washington State University, and Karachi University.
Known forBiopharmaceuticals
Biosimilars
MRNA vaccine
Ghazals
Ghalib
AwardsSitara-i-Imtiaz (2012)
Inductee, Chicago Hall of Entrepreneurs (2015)
Scientific career
FieldsPharmaceutical sciences
Biopharmaceuticals
Recombinant manufacturing
InstitutionsUniversity of Illinois at Chicago
Aga Khan University Hospital
Higher Education Commission of Pakistan
University of Houston College of Pharmacy

Personal life

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Niazi was born on 10 July 1949 in Lucknow in India, and moved to Karachi with his parents in 1962.[2] His father was Niaz Fatehpuri, a scholar of religion and literature in Pakistan and India.[3]

Education

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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.[2]

Employment

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From 1972 to 1988, he taught at the College of Pharmacy at the University of Illinois at Chicago,[4] 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;[4] at the same time, he was a professor of pharmacology at the Aga Khan University Hospital in Karachi.[4] In 1997, he established his own consulting business, known as Pharmaceutical Scientist, Inc.[5][4] 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.[6][7] In November 2016, the company changed its name to Adello Biologics.;[8] in January 2019, Adello Biologics assets were purchased by Kashiv Bioscience.[9]

Honorary teaching

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Since 2012, he has served as an 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 an NUST Visiting Professor at the National University of Sciences and Technology (NUST) in Islamabad, Pakistan.[9]

Poetry

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In 2002, Niazi published the first complete translation[10] of the ghazals of Mirza Asadullah Baig Khan, known as "Ghalib"[11] and another in 2009.[12] In 2023, Niazi published the first complete English translation of Ghalib's Persian love poems with Mariam Tawoosi[13] Niazi had hosted a show on Voice of America every Sunday, where he would recite ghazals.[14]

Research

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Niazi has published over 100 research articles,[15][16] and is the creator of a variable volume distribution model to study the safety and efficacy of drugs.[17][18]

Biosimilars

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Niazi has shared his knowledge in several publications in the field of biosimilars.[19] He has published multiple books [20][21][22][23][24][25] on the subject and peer-reviewed research papers [26][27][28][29][30][31] that advise developers on how to secure a faster approval of biosimilars by the FDA and EMA and suggest changes to harmonize approval guidelines. He has also introduced the concept of biosimilar mRNA vaccines.[32][33] He has also created biosimilar whiskies[34] Forbes magazine has for the third time recognized and reported his work on biosimilars, recently on his lifetime contributions.;[35] he was also listed as the Most Interesting Man Revolutionizing Healthcare by the Forbes Magazine also.[36] Forbes also recognized his work on advising the FDA on making changes to regulations.[37]

Politics

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Niazi has recently challenged the Biosimilars Council,[38] disreputing the Congressional Bill intended to reduce the cost of drugs to Medicare patients as a price control measure that will hurt the industry. In a line-by-line analysis in a peer-reviewed journal, Niazi stated that these oppositions are merely political as all Republicans opposed the Bill.[39]

FDA/WHO

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Niazi has challenged FDA guidance through three Citizen Petitions[40][41][42] that urge the FDA to rationalize testing to allow faster entry of generic drugs and biosimilars to the market. In response to Niazi's Citizen Petition, the FDA withdrew pivotal guidance for approving biosimilars.[43] Niazi has also challenged the World Health Organization's[44] guidance on approving biosimilars as weak on science leading to the possibility of the use of unsafe biological drugs in developing countries.[45] He has suggested harmonizing the guidelines for approval of biosimilars removing the animal and phase 3 studies that will significantly reduce the cost of biosimilars.[29] Niazi also contributed to Senate Bill introduced by Senator Lee recognizing his recommendations to remove the interchangeability status of biosimilars.[46] The FDA has awarded a grant of $2 million to Niazi working with Professor Anna Schwendeman to develop new analytical technologies to reduce the testing of biosimilars and remove clinical efficacy testing.[47] A citizen petition filed by Niazi in September 2023 demands that the FDA modify its biosimilars approval based on new scientific findings and offers a critical analysis of the suggestions by the FDA to use Omics technology to create pharmacodynamic markers for monoclonal antibodies, an exercise that Niazi considers impractical and unnecessary and instead offers alternatives that are readily adoptable.[48]

Animal rights

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Niazi has strongly opposed animal testing of biosimilars in the prestigious Science magazine;[39] he has also referred to the new FDA perspective that even new biological drugs need not be tested in animals, all because animals do not have the receptors for the biological drugs to bind and thus show pharmacology or toxicology.[49][50] Niazi assisted US Senate in the drafting of the FDA Modernization Act 2.0, convincing the Senators to remove animal testing of generic and biological drugs; it became law in 2023 [51][31][52]

Inventions

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Niazi owns 177 patents[53] in the field of bioprocessing, digital technology, new drugs, new dosage forms, and herbal medicines. Niazi is also a patent law practitioner.[54]

Awards

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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.[55] In March 2015, he received the Alum of the Year Award from the University of Illinois.[56] In September 2015, he was inducted into the Chicago Entrepreneur Hall of Fame.[57][58]

Textbooks and professional handbooks

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Niazi has published dozens of books;[59] His textbooks are generally made available royalty-free in the developing world.[60]

  • 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 978-0367705640.
  • Future of Pharmaceuticals. A Nonlinear Analysis. Boca Raton, Florida: CRC, 2022. ISBN 978-1138297555.
  • mRNA Therapeutics--A Fast to Market Strategy. CRC Press, Boca Raton, Florida. ISBN 9781032163444
  • Biopharmaceutical Manufacturing, Volume 1 Regulatory processes. Professor Sarfaraz K. Niazi, Sunitha Lokesh. Bristol, UK 2021. ISBN 978-0750331739.
  • Biopharmaceutical Manufacturing, Volume 2 Unit Operations. Professor Sarfaraz K. Niazi, Sunitha Lokesh. Bristol, UK 2021. ISBN 978-0750331777.
  • Wine of Love, Persian Ghazals of Ghalib, Translations, and Explications by Sarfaraz Niazi and Maryam Tawoosi[61] Ghalib Academy of America ISBN 978-0-9714746-2-8.

References

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  1. ^ "About the Ghazals - A Desertful of Roses". www.columbia.edu. Retrieved 9 March 2022.
  2. ^ a b Express News, Pakistan. 2 Oct 2014 ڈاکٹر سرفراز خان نیازی ؛ دنیائے طب میں انقلاب لانے والے پاکستانی سائنس دان English version via Google translate
  3. ^ Sarfaraz K. Niazi. Love Sonnets of Ghalib. Rupa & Co. (10 January 2009) ISBN 978-8171675968, see back flap.
  4. ^ a b c d "Sarfaraz K. Niazi". Linkedin.com. Retrieved 5 March 2022.
  5. ^ "Pharmsci.com". Pharmsci.com. Retrieved 5 March 2022.
  6. ^ "Medicine or food? Both, is this startup's mission". Crain's Chicago Business. 28 May 2014. Retrieved 5 March 2022.
  7. ^ Kate MacArthur, 17 June 2014, Q&A: How an inventor's trying to cut the cost of making biological drugs, Chicago Tribune
  8. ^ LLC, Adello Biologics. "Therapeutic Proteins International Renames Company to Adello Biologics, LLC; Relocates Corporate Headquarters to Piscataway, New Jersey". Prnewswire.com (Press release).
  9. ^ a b "Kashiv Pharma Acquires Adello Biologics and Becomes Kashiv BioSciences". Businesswire.com. 3 January 2019.
  10. ^ "Love Sonnets of Ghalib". Goodreads.com.
  11. ^ Gulzar for India Today. 25 February 2002 Ghalib in love. Book review: Love Sonnets of Ghalib, translated by Sarfaraz K. Niazi
  12. ^ Jamaluddin Aali, quoted in Sarfaraz K. Niazi. Wine of Passion. Lahore, Pakistan: Ferozsons Publishing, 2009
  13. ^ "Wine of love".
  14. ^ Nicole Fisher for Forbes. 30 August 2014 The Most Interesting Man Revolutionizing The Health World
  15. ^ "niazi s - PubMed - NCBI". Ncbi.nlm.nih.gov.
  16. ^ "Google Scholar". scholar.google.com.
  17. ^ Niazi, Sarfaraz (1976). "Volume of Distribution as a Function of Time". Journal of Pharmaceutical Sciences. 65 (3): 452–454. doi:10.1002/jps.2600650339. PMID 1263103.
  18. ^ "distribution volume niazi s - PubMed - NCBI". Ncbi.nlm.nih.gov.
  19. ^ "Sarfaraz K. Niazi, PhD | Center for Biosimilars®".
  20. ^ "Biosimilars and Interchangeable Biologics: Tactical Elements".
  21. ^ "Fundamentals of Modern Bioprocessing".
  22. ^ "Biosimilarity: The FDA Perspective".
  23. ^ "Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues".
  24. ^ "Biosimilars and Interchangeable Biologics: Strategic Elements".
  25. ^ "The Future of Pharmaceuticals: A Nonlinear Analysis".
  26. ^ Niazi, S. K. (2019). "Comment on "The End of Phase 3 Clinical Trials in Biosimilars Development?"". BioDrugs. 33 (1): 121–123. doi:10.1007/s40259-018-0330-1. PMID 30604391. S2CID 57426983.
  27. ^ Niazi, Sarfaraz K. (2022). "The Coming of Age of Biosimilars: A Personal Perspective". Biologics. 2 (2): 107–127. doi:10.3390/biologics2020009.
  28. ^ Niazi, Sarfaraz K. (2022). "Biosimilars: A futuristic fast-to-market advice to developers". Expert Opinion on Biological Therapy. 22 (2): 149–155. doi:10.1080/14712598.2022.2020241. PMID 34913776. S2CID 245219573.
  29. ^ a b Niazi, Sarfaraz K. (September 2022). "Biosimilars: Harmonizing the Approval Guidelines". Biologics. 2 (3): 171–195. doi:10.3390/biologics2030014.
  30. ^ Niazi, Sarfaraz K. (2022). "No two classes of biosimilars: Urgent advice to the US Congress and the FDA". Journal of Clinical Pharmacy and Therapeutics. 47 (9): 1352–1361. doi:10.1111/jcpt.13743. PMC 9796791. PMID 35869625. S2CID 250990026.
  31. ^ a b Niazi, Sarfaraz K. (2022). "End animal testing for biosimilar approval". Science. 377 (6602): 162–163. Bibcode:2022Sci...377..162N. doi:10.1126/science.add4664. PMID 35857557. S2CID 250378579.
  32. ^ "Biosimilar mRNA Vaccines, Part 1: Regulatory Revolution!".
  33. ^ "Biosimilar mRNA Vaccines, Part 2: Fast-to-Market Approach!".
  34. ^ "Column: CFB Board Member Creates "Biosimilar" Whiskey".
  35. ^ Roberts, Nicole F. "What's Next In Biologics? Biosimilar Expert Predicts Big Fall Changes". Forbes. Retrieved 18 October 2023.
  36. ^ Roberts, Nicole F. "The Most Interesting Man Revolutionizing The Health World". Forbes. Retrieved 18 October 2023.
  37. ^ Roberts, Nicole F. "Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening". Forbes. Retrieved 18 October 2023.
  38. ^ 978-0-9714746-2-8
  39. ^ a b Niazi SK. End animal testing for biosimilar approval. Science. 2022 Jul 8;377(6602):162-163. doi: 10.1126/science.add4664. Epub 2022 Jul 7. PMID 35857557.
  40. ^ "Regulations.gov". Regulations.gov.
  41. ^ "Regulations.gov". Regulations.gov.
  42. ^ "Regulations.gov". Regulations.gov.
  43. ^ Fisher, Nicole. "Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening". Forbes.
  44. ^ "WHO Guidelines on evaluation of similar biotherapeutics (SBP)" (PDF). Who.int. Retrieved 5 March 2022.
  45. ^ "WHO Biosimilar Guidance Is Based on Weak Science". The Center For Biosimilars. Retrieved 5 March 2022..
  46. ^ "Sen. Lee Introduces Biosimilar Red Tape Elimination Act". 17 November 2022.
  47. ^ "Professors Anna Schwedenman¹ and Sarfaraz Niazi² awarded a $2 Million FDA grant to create novel analytical methods to reduce the cost of developing biosimilars".
  48. ^ "Regulations.gov". www.regulations.gov. Retrieved 18 October 2023.
  49. ^ "Biosimilars | Science and Research". FDA. 6 March 2023.
  50. ^ Li J, Florian J, Campbell E, et al. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies. Clin Pharmacol Ther. 2020;107(1):40-42. doi:10.1002/cpt.1653. Accessed 23 March 2022.
  51. ^ "No More Animal Testing – President Biden Signs Bill Meeting Professor Niazi's Recommendations". 30 December 2022.
  52. ^ "Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA".
  53. ^ "Espacenet – search results". Worldwide.espacenet.com. Retrieved 5 March 2022.
  54. ^ "United States Patent and Trademark Office". Oedci.uspto.gov. Retrieved 5 March 2022.
  55. ^ "Abida Parveen, Aleem Dar among winners Posthumous awards for Manto, Mehdi Hassan". Dawn.com. 14 August 2012. Retrieved 5 March 2022.
  56. ^ "Catalyst - Spring 2015 by UIC College of Pharmacy - Issuu". Issuu.com. Retrieved 5 March 2022.
  57. ^ "Hall of Fame Members | Institute of Entrepreneurial Studies". Archived from the original on 2 February 2016. Retrieved 1 February 2016.
  58. ^ "Hall Of Fame Members | Institute of Entrepreneurial Studies". 1 October 2019. Archived from the original on 1 October 2019. Retrieved 9 March 2022.
  59. ^ "ISBN Search - sarfaraz niazi". Isbnsearch.org. Retrieved 5 March 2022.
  60. ^ University of Illinois College of Pharmacy National Advisory Board: Profile of Sarfaraz K. Niazi Page accessed 23 April 2015
  61. ^ "Wine of Love: Persian Ghazals of Ghalib Translated and Explicated by Sarfaraz K. Niazi, Ph.D. - Issuu".
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