Albert Yehaskel, MS., MBA

Mr. Yehaskel has been in the pharmaceutical industry for over 50 years, working across a number of large and small pharmaceutical companies which included: Schering-Plough, American Cyanamid, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, and Indigo Pharmaceuticals. He has devoted over 37 years to Regulatory Affairs, and honed his expertise in managing and directing domestic and international Regulatory Submissions, orchestrating key FDA meetings and conducting Pharmaceutical Research and Development. He has built and led teams in the successful filing of two electronic NDAs and several partial NDAs (both 505(b)(1) and 505(b)(2)), scores of INDs in 14 therapeutic areas, has filed several Orphan Drug Designations and interacted with many different Divisions at FDA (CDER, CBER, CDRH, OODP); 

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Albert holds two master’s degrees — an MBA in economics and finance from Fairleigh Dickinson University and an M.S. in organic chemistry from Queens College, City University of New York. He brings a breadth of his drug development, project management and regulatory experience to Onconox.

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Mr. Yehaskel has been in the pharmaceutical industry for over 40 years, working for companies including Schering-Plough, Lederle Laboratories (part of American Cyanamid, now known as Wyeth), Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, and Indigo Pharmaceuticals. He has devoted over 33 years to Regulatory Affairs, and honed his expertise in managing and directing domestic and international Regulatory Submissions, orchestrating key FDA meetings (pre-IND, EOP2, pre-NDA and general guidance meetings) and conducting Pharmaceutical Research and development.

 

He has built and led teams in the filing of two electronic NDAs and several partial NDAs (both 505(b)(1) and 505(b)(2)), scores of INDs in 14 therapeutic areas, has filed several Orphan Drug Designations and interacted with 14 different Divisions at FDA (CDER, CBER, CDRH, OODP); he has also reviewed a plethora of INDs, NDAs, ANDAs, DMFs across the 5 eCTD Modules and has CMC expertise in writing the QOS (Module 2) and Module 3 (Drug Substance, Drug Product). He has two master’s degrees — an MBA in economics and finance from Fairleigh Dickinson University and an M.S. in organic chemistry from Queens College, City University of New York. He brings breadth of his drug development, project management and regulatory experience to Onconox.