Expertise: 

Development and implementation of regulatory and quality strategies for drug and biologic products, and global pharmacovigilance intelligence.  Implementation of drug and biologic products risk management process. Writing biologic regulatory applications (IND, BLA) and medical device application (510k).  Cellular therapeutics research and quality/regulatory systems.

Experience: 

Over 25 years of corporate and academic experience. Her research experience is in cell biology, genetics and immunology and her business experience includes extensive work in pharmacovigilance, regulatory strategy and regulatory intelligence.

Other: 

Member AAAS, American Association of Immunology, DIA.  Adjunct Assistant Professor, University of Illinois, Chicago.  Adjunct Professor at Rosalind Franklin University.  Editorial board of Transplantation and ad hoc reviewer of various peer reviewed journals.