Sarfaraz K. Niazi

Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB
20 Riverside Drive, Deerfield, Illinois 60015. USA
Phone: +1-312-298-0000; Fax: +1-312-297-1100; email: sniazi3@uic.edu
https://en.wikipedia.org/wiki/Sarfaraz_K._Niazi
https://www.linkedin.com/in/skniazi/
www.niazi.com; www.therarna.com
• Therapeutic Proteins
• mRNA Therapeutics
• Gene Therapy
• Biotechnology Innovations
• Regulatory Guidelines
• Intellectual Property
• Artificial Intelligence

Vision: Invent and reinvent biologicals
Education:
• 1974: Ph.D., Pharmaceutical Sciences, University of Illinois, Chicago, IL
• 1970: MS, Pharmaceutical Sciences, Washington State University, Pullman, Washington
Professional:
Patent Agent, US Patent and Trademark Office, 2002-present. He prosecuted 500+ patents.
Positions:
Academic:
• 1972-1988: Instructor to Tenured Associate Professor at the University of Illinois College of Pharmacy, Chicago, Illinois.
• 2012-Present: Visiting Professor, University of Houston College of Pharmacy.
• 2015-Present: Adjunct Professor of Biopharmaceutical Sciences, University of Illinois College of Pharmacy
Corporate:
• 1988-1995: Director of Technical Affairs, Abbott International.
• 1993-Present: Founder and CEO, Pharmaceutical Scientist, Inc., Chicago, IL.
• 2003-2017: Founder and CEO, Therapeutic Proteins, Inc. Chicago, IL
• 2023-Present: CEO, RNA Therapeutics, Inc., Deerfield, IL
• 2024-Present: CEO, Chicago University, Inc., Chicago, IL
Professional
• 2002-present: United States Patent and Trademark Office, Patent Agent.
Recognitions, Awards, Achievements and Contributions
• Civil Award by the President of Pakistan (Sitara-e-Imtiaz) for contribution to engineering sciences.
• Fellowship of Royal Society of Biology, Pakistan Academy of Medical Sciences, American Society of Clinical Biochemistry, Abbott Volwiler Society.
• Forbes Magazine’s Cover Pages:
• “The Most Interesting Man Revolutionizing the Health World” 2014
• “Scientist Invented a New Pathway To Approve Biosimilars, And The FDA Is Listening.” 2019.
• What’s Next in Biologics? Biosimilar Expert Predicts Big Fall Change., 2023.
• Invited contributor to BPCIA as an advisor to the US Congress.
• Established the first biosimilar company in the US; secured multiple FDA approvals.
• Secured the most significant funding for a biotechnology start-up in the US for biological drugs: $500 Million.
• Invited advisor to President Obama on the Affordable Healthcare Act and several other heads of state.
• Advisor to all SRA regulatory agencies, as well as developing countries.
• Consultant to the Governments of Uzbekistan, Turkey, Pakistan, the US, Canada, Japan, and Saudi Arabia on regulatory guidance development.
• Advisor to the US Senate; helped introduce FDA Modernization Act 2.0 and placed bills to remove interchangeability and patent dance.
• Consultant to investment bankers, VC groups, and private investors on value proposition analysis in pharmaceutical and biopharmaceuticals.
• FDA grant of $2 million to develop methods for establishing biosimilarity.
• Served as an expert witness in IP and pharmaceutical legal cases.
• Advisor and Teaching Faculty, The US Pharmacopoeia.
• Wrote the first and most books about biopharmaceutics, clinical pharmacokinetics, biosimilars, mRNA technology, and poetry translations.
• An inductee of the US Entrepreneur Hall of Fame.
• University of Illinois Alumni of the Year
• TOKTEN Fellow for US Aid under the PL-480 program.
• March of Dimes grant reviewer.
• Co-investigator and creator of the first NIH grant in 1977 to create a self-paced full-degree teaching program; implemented at the University of Illinois.
• Editorial boards of scientific journals, including Nature.
• Radio host for Voice of America; 2008-2016.
• Advisor to Higher Education Commission of Pakistan on intellectual property management since 2012
• Invited keynote speaker to 500+ engagements worldwide.
• Innovation of the Year, Sponsored by Honeywell; Global Generics and Biosimilars Awards 2014: https://www.generics-bulletin.com/media/19636/Winners-for-Website1.jpg
• Finalists Best Upstream Technology Application 2012: TPI Single-use technology for production of bacterial proteins, Bioprocess International (http://www.bioprocessintl.com/bioprocess-international-2016-awards/past-winners-of-bioprocess-international-awards/).
• Coined “bioequivalence” and “biosimilar.”
• Created the first line of generic products for Abbott Laboratories, solid dosage forms, suspensions, and liquids.
• Created the first patented biosimilar whiskey.
• Assisted 10+ companies worldwide in establishing biosimilar manufacturing.
• Trained new hires as FDA inspectors in cGMP compliance.
• Trained 46 graduate students: MS. Ph.D.
• 100+ US patents; largest solo inventor of bioprocessing patents; NCE, NBE, drug delivery, natural products, drug testing, wine aging, automobile safety, disease management, and other technologies.
• Developed a fourth-dimension analytical similarity testing to achieve fingerprint-like similarity for biosimilars.
• Created volume of distribution as a function of time PK parameter for PD correlation.
• Developed a biodistribution PK model recommended by the FDA in 2019 to establish interchangeability (May 2019, 2023)
• Developed an ISO 9 bioreactor to file the first BLA of a biosimilar in the US.
• Created the first exhaust-free bioreactor for the US Military.
• Coordinated dozens of FDA audits of generic and biological manufacturers and secured the first FDA approval of a product from the MENA region.
• Secured first waiver from the FDA for in-patient testing of biosimilars.
• Taught physicians in the US about the regulatory pathways and safety features of biosimilars on behalf of large pharma companies.
• Chicago Marathon runner 2014.
• Translated with an explication of the entire Mirza Ghalib and Bedil divan from Urdu and Persian to English.
Books

•
• The Omega Connection, Esquire Press, Illinois, 1982; ISBN-13: 9780961784102
• Adsorption and Chelation Therapy, Esquire Press, Illinois; 1987. ISBN-9780961784140
• Attacking the Sacred Cows: The Health Hazards of Milk, Esquire Press, Illinois; 1988; ISBN-13: 9780961784119
• Endorphins: The Body Opium, Esquire Press, Illinois; 1988; ISBN 9780961784126
• Nutritional Myths: The Story No One Wants to Talk About, Esquire Press, Illinois. ISBN 9780961784133
• Wellness Guide. Ferozsons Publishers. Pakistan 2002. ISBN 9789690017932
• Love Sonnets of Ghalib: Translations, Explication and Lexicon, Ferozsons Publishers, Lahore, Pakistan 2002 and Rupa Publications, New Delhi, India 2002; ISBN-13: 9788171675968
• Filing Patents Online, CRC Press, Boca Raton, Florida, 2003; ISBN-13: 9780849316241
• Pharmacokinetic and Pharmacodynamic Modeling in Early Drug Development in Charles G. Smith and James T. O'Donnell (eds.), The Process of New Drug Discovery and Development (2nd ed.). New York: CRC Press, 2004; ISBN-13: 978-0849327797.
• Handbook of Biogeneric Therapeutic Proteins: Manufacturing, Regulatory, Testing and Patent Issues, CRC Press, Boca Raton, FL, 2005; ISBN-13: 9780971474611
• Handbook of Preformulation: Chemical, Biological and Botanical Drugs, Informa Healthcare, New York, NY, 2006; ISBN-13: 9780849371936
• Handbook of Bioequivalence Testing. New York: Informa Healthcare, 2007; ISBN-13: 978-0849303951
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 6 Second Edition: Sterile Products, Informa Healthcare, New York, NY, 2009; ISBN-13: 9781420081305
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 1 Second Edition: Compressed Solids, Informa Healthcare, New York, NY, 2009; ISBN-13: 9781420081169
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 2 Second Edition: Uncompressed Solids, Informa Healthcare, New York, NY, 2009; ISBN-13: 9781420081183
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 3 Second Edition: Liquid Products, Informa Healthcare, New York, NY, 2009; ISBN-13: 9780849317484
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 4 Second Edition: Semisolid Products, Informa Healthcare, New York, NY, 2009 ISBN-13: 9781420081268;
• Handbook of Pharmaceutical Manufacturing Formulations, Volume 5 Second Edition: Over the Counter Products, Informa Healthcare, New York, NY, 2009; ISBN-13: 978-1420081282
• Textbook of Biopharmaceutics and Clinical Pharmacokinetics. Hyderabad, India: The Book Syndicate, 2010. ISBN 978-93-8107-504-3
• Wine of Passion: Love Poems of Ghalib, Ferozsons (Pvt) Ltd., Lahore, Pakistan, 2010; ISBN-13: 9780971474611
• Disposable Bioprocessing Systems, CRC Press, Boca Raton, FL, 2012; ISBN-13: 9781439866702
• Handbook of Bioequivalence Testing. Second Edition, New York, NY: Informa Healthcare, 2014 ISBN-13: 9781482226379
• There is No Wisdom: Selected Love Poems of Bedil. Translations from Darri Farsi, Sarfaraz K. Niazi, and Maryam Tawoosi, Ferozsons Private (Ltd), Lahore, Pakistan, 2015 ISBN 978969025036
• Wine of Love: Complete Translations of Urdu Persian Love Poems of Ghalib, Sarfaraz K. Niazi, Ferozsons Private (Ltd), Lahore, Pakistan, 2015. ISBN: TBA
• Biosimilars and Interchangeable Biologicals: Strategic Elements. CRC Press, 2015; ISBN 9781482298918
• Biosimilars and Interchangeable Biologics: Tactical Elements. CRC Press, 2015; ISBN 9781482298918
• Fundamentals of Modern Bioprocessing, Sarfaraz K. Niazi and Justin L. Brown, CRC Press, 2015; ISBN 9781466585737
• Biosimilarity: The FDA Perspective, CRC Press, 2018; ISBN 9781498750394
• Handbook of Preformulation. CRC Press, 2019. ISBN 9781138297555.
• Future of Pharmaceuticals--a Nonlinear View, CRC Press, 2022. ISBN-13: 978-0367705640
• Biopharmaceuticals Manufacturing Unit Process Volume 2. 2022 Institute of Physics Publishing. ISBN: 9780750331777
• Biopharmaceutical Manufacturing Regulatory Processes Volume 1. 2022 Institute of Physics Publishing. ISBN: 9780