• Consultant: US Congress, six Presidents worldwide, UN, NFPs, regulatory agencies: FDA, USP; MHRA; EMA; Turkish; KSA
• Contributor and author of BPCIA
• First guideline to waive animal and efficacy testing (MHRA) of biosimilars
• Civil Award: Star of Distinction
• Coined the terms "bioequivalence," "biosimilar," and "biosimilar RNA Vaccine.
• Consultant to the US Senate on biosimilar legislation
• Founder, first US biosimilar company (TPI to Kashiv) in the US.
• Several FDA biosimilar approved, no no phase 3 data
• Inductee, US Entrepreneur Hall of Fame, raised $500 million+
• First patented SUB-based FDA approval of biologics
• Founder RNA Therapeutics: mRNA vaccines: flu, TB, typhoid, HPV, HIV, diabetes, Alzheimer’s, Parkinson's disease, avian flu.
• Licensed biosimilar Covid-19 vaccine.
• Founder, Novel351k, Inc., biosimilars developer
• Founder, Gensiabiologics, AI-discovery: new and repurpose antibodies--100+ leads identified • University of Illinois Alumni of the Year
• 70+ handbooks and textbooks on biosimilars, biotechnology, bioequi
