Sarfaraz K. Niazi

About the Speaker
  • Profession
    Founder
  • Company
    Karyo Biologics, Adello Biologics and Pharmaceutical Scientist, LLC
  • Web Sites

Sarfaraz K. Niazi, Founder at Karyo Biologics, Adello Biologics and Pharmaceutical Scientist, LLC

Sarfaraz K. Niazi (1), Adjunct Professor of Biopharmaceutical Sciences, University of Illinois College of Pharmacy, University of Houston and several other academic institutions, is the founder of Karyo Biologics (www.karyobio.com), Adello Biologics (www.adellobio.com) and Pharmaceutical Scientist, LLC (www.pharmsci.com). Sarfaraz is globally recognized as a pioneer of biosimilars having developed novel technology and regulatory plans to take dozens of biosimilars to the market over a period of over 30 years.

In 2014, the Forbes Magazine’s recognized him as “The Most Interesting Man Revolutionizing The Health World” (2), for his lifetime efforts in making high cost essential drugs, biosimilars and complex generics, accessible across the globe.

In 2018, the Forbes magazine reported him as “Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening” (3), for his efforts to convince the US FDA to adopt a more rational approach to approve biosimilars reduce the cost of development. He is now advising the US FDA in defining the structure of their new Biosimilars Action Plan (BAP) (4) that was issued by the US FDA after Sarfaraz filed a citizen petition against the FDA (5) (FDA-2018-P-1876). The FDA has also shared the progress made in collaboration with Sarfaraz on the US government portal (6, 7). Sarfaraz’s efforts in changing the FDA approval process are widely acclaimed to be the most pivotal move to make biological drugs affordable (8-24).

To promote faster adoption of biosimilars, Sarfaraz has written dozens of major books (25), including the first book on biosimilars and coined the phrase “biosimilar” in his first biosimilars guidance advise to FDA. Other major books of Sarfaraz include the first book on single-use bioprocessing, a textbook on bioprocessing, a two-volume book on biosimilars, a six-volume set of cGMP manufacturing encyclopedia, the largest book on bioequivalence testing and the first book on preformulation of biologics and botanical drugs. He has also authored 100+ research papers and hundreds of blogs. His most recent book, Biosimilarity: The FDA Perspective, published July 2018 is dedicated to Dr. Janet Woodcock, Director, CDER at the FDA. His other books have been dedicated to Dr. James Watson, Nobel Laureate, who discovered DNA structure and President Barack Obama with White House approval, among other notable personalities.

Sarfaraz has also authored a large number of internationally published blogs on topics ranging from contemporary scientific ideas to philosophy, poetry and ironies of life.

Sarfaraz has been a keynote speaker on the topic of biosimilars including presenting the FDA viewpoints before the industry audience (26). He is a fellow of several learned societies and a widely sought-after speaker with over 500 talks across the globe. In his capacity as an academician, Sarfaraz has trained 50+ graduate students and scores of FDA inspectors.

A few notable contributions of Sarfaraz include:

  • Contributed to BPCIA as advisor to the US Congress and President Obama.
  • Received first waiver of in-patient testing of a biosimilar candidate under 351(k).
  • Developed a fourth-dimension analytical similarity testing to achieve fingerprint-like similarity for biosimilars.
  • Developed an ISO 9 bioreactor used to file the first BLA of a biosimilar.
  • First book authored by Sarfaraz and FDA on the topic of biosimilarity (27) and dedicated to Dr. Janet Woodcock, Head, CDER, FDA.
  • Published advise to the US FDA and the industry to identify and obviate the impediments to slow entry of biosimilars in the US markets (28,29).
  • Filed citizen petition on the subject of changing evaluation of biosimilars by the FDA (30).
  • Trained FDA inspectors on cGMP compliance.
  • Coordinated dozens of FDA audits of generic and biological manufacturers, particularly managing consent decrees.
  • Consultants to investment bankers, VC groups and private investors on value proposition analysis in the field of pharmaceutical and biopharmaceuticals.
  • Served as expert witness in IP and pharmaceutical cases.
  • Trained scientists on behalf of the USP.
  • Translated love poems of famous Asian and Persian poets into English.
  • Taught thousands of primary and secondary care physicians in the US on the regulatory pathways and safety features of biosimilars.

Sarfaraz is the largest solo inventor of bioprocessing inventions with over 100 inventions (31), additionally including new drugs, new dosage forms, bioequivalence testing methods and a large number of other patient-related inventions that are widely used across the globe. His patented invention of demonstrating analytical similarity methods (32) was accepted by the FDA to allow waiver of patient trials of biosimilar products.

Sarfaraz is also a licensed practitioner of the patent law at the United States Patent Office, an expertise he has used to create the FTO boundaries for biosimilars to avoid litigation under the BPCIA (33, 34). Sarfaraz provides this service free of charge to the Third World scientists and has secured over 400 patents for his clients.

The President of Pakistan conferred the high civil award, Start of Distinction (35), upon him in the field of engineering sciences, as his 100+ inventions are helping a large population around the world with more affordable drugs, clear water, new drugs, new devices, and novel disease management systems.

Sarfaraz is working with global biosimilar companies to help them secure faster approval of biosimilars as well as working with the US Congress, the FDA and the media to avoid impediments to adoption of biosimilars; recently, Sarfaraz and Pfizer have joined and advised the FDA to adopt the policies that will prevent companies like Amgen to differentiate biosimilars (36). Sarfaraz is also teaching physicians in the US on behalf of the largest biosimilar companies on the safety and regulatory paths to approvals.

Sarfaraz was born in Lucknow, India. He received as MS degree in pharmacy from the Washington State University, and a PhD in pharmaceutical sciences from the University of Illinois, where he began his academic career and continues as Adjunct Professor of Biopharmaceutical Sciences at the University of Illinois College of Pharmacy and additionally at the University of Houston and several other academic institutions around the world. Sarfaraz became a tenured professor at the age of 28, a position he left to join Abbott Laboratories International, where he was tenured as Volwiler Fellow. He left Abbott to develop biosimilars to make them accessible globally.

Sarfaraz is an avid photographer, a musician, a poet, a radio broadcaster (Voice of America, US State Department) with audience of over a billion, on literary and philosophic topics. He is also a translator of Asian love poems into English; he resides in Deerfield, Illinois.

References

  1. niazi.com
  2. https://www.forbes.com/sites/nicolefisher/2014/08/30/the-most-interesting-man-revolutionizing-the-health-world/#4fad94cd20ba
  3. https://www.forbes.com/sites/nicolefisher/2018/07/25/one-mans-mission-to-fix-the-fdas-biosimilar-problem/#7945680b2380
  4. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf
  5. http://www.fdalawblog.net/2018/05/biosimilar-approval-better-stronger-faster/
  6. https://www.regulations.gov/document?D=FDA-2018-P-1876-0003
  7. https://www.regulations.gov/document?D=FDA-2018-P-1876-0004
  8. https://www.prnewswire.com/news-releases/fda-withdraws-its-pivotal-biosimilar-products-testing-guideline-after-sarfaraz-niazi-founder-of-pharmaceutical-scientist-files-the-first-citizen-petition-challenging-its-clinical-relevance-300675168.html
  9. https://www.biospace.com/article/fda-withdraws-draft-guidance-on-biosimilar-development
  10. https://seekingalpha.com/news/3367537-fda-withdraws-draft-guidance-related-biosimilar-development
  11. https://www.forbes.com/sites/nicolefisher/2018/07/25/one-mans-mission-to-fix-the-fdas-biosimilar-problem/#402daf2e2380
  12. https://www.biosimilardevelopment.com/doc/fda-withdraws-its-pivotal-biosimilar-products-testing-guideline-after-sarfaraz-niazi-0001
  13. http://www.fdalawblog.net/2018/05/biosimilar-approval-better-stronger-faster/
  14. https://www.europeanpharmaceuticalreview.com/article/70987/obstacles-success-biosimilars-us-market/
  15. https://www.bigmoleculewatch.com/wp-content/uploads/2018/05/Citizen_Petition_from_UIC_ollege_of_Pharmacy.pdf
  16. http://www.erienewsnow.com/story/38684328/fda-issues-new-biosimilar-action-plan-bap-accepting-recommendations-made-by-sarfaraz-niazi-ceo-of-pharmaceutical-scientist-to-modernize-regulatory
  17. https://www.mmm-online.com/home/channel/regulatory/pfizer-petitions-fda-for-biosimilar-communications-guidelines/
  18. https://www.jdsupra.com/legalnews/fda-to-hold-public-hearing-on-67759/
  19. http://gabi-journal.net/potential-changes-to-the-fda-approach-to-biosimilars-have-a-global-impact.html
  20. https://static1.squarespace.com/static/5891331d8419c227312ee2ca/t/5a60d138e2c483a5c287ab56/1516294469587/16-1-Biosimilars-eBook.pdf
  21. https://exlevents.com/fda-12. withdraws-biosimilar-draft-guidance-after-public-outcry/
  22. https://www.epmmagazine.com/news/fda-is-asking-for-public-comments-on-bioequivalence-testing-/
  23. https://www.rdmag.com/article/2014/10/biosimilars-market
  24. http://www.smartbrief.com/branded/D4C8EBAD-9C67-4D55-869C-CC2C8F893F9E/8F6CA12E-FE53-449F-B181-D9E3E11EEDCF
  25. https://www.niazi.com/scholar/
  26. https://karyobio.com/news/2017/11/6/dr-niazi-invited-as-keynote-speaker-at-the-fdacms-conference
  27. https://www.amazon.com/Handbook-Bioequivalence-Testing-Pharmaceutical-Sciences/dp/1482226375/ref=dp_ob_title_bk?dpID=41GrUD9hA7L&preST=_SY291_BO1,204,203,200_QL40_&dpSrc=detail
  28. https://www.barnesandnoble.com/w/biosimilarity-sarfaraz-k-niazi/1125939292
  29. http://www.bioprocessintl.com/wp-content/uploads/2018/01/16-1-Biosimilars-eBook.pdf?submissionGuid=ba89dcc5-a456-4ef0-849d-bceda94f16a3
  30. https://www.europeanpharmaceuticalreview.com/article/70987/obstacles-success-biosimilars-us-market/
  31. http://www.fdalawblog.net/2018/05/biosimilar-approval-better-stronger-faster/
  32. https://sarfaraz-niazi.squarespace.com/s/biomolecule-patent.pdf
  33. https://patents.google.com/patent/US20180024137A1/en?oq=US20180024137A1
  34. https://www.law.cornell.edu/uscode/text/42/262
  35. https://en.wikipedia.org/wiki/Category:Recipients_of_Sitara-i-Imtiaz
  36. https://www.regulations.gov/document?D=FDA-2018-P-3281-0003