Institute for International Research

About our Distinguished Advisory Board:

Eugen Koren, MD, PhD, Director, Bioanalytical Development, ABBOTT LABORATORIES

Eugen Koren received his MD and PhD degrees at The University of Zagreb, Croatia and his post-doctoral training in biochemistry and immunology at The University of Uppsala, Sweden and Wistar Institute in Philadelphia. He came to US in 1979 and joined the faculty of The Oklahoma Medical Research Foundation and The OU School of Medicine where he held Associate Professorship of Medicine. He was hired by Genentech in 1994 as a Sr. Scientist where he worked until 2001 and in 2002 he became Associate Director of Clinical Immunology at Amgen. In November of 2005 Dr. Koren joined Scios as a Director of Bioanalytical Development. He published over a hundred research papers and holds 7 patents. During his academic career, Dr. Koren studied atherosclerosis role of pathogenic antibodies in autoimmune disease.  Over the last 12 years, he devoted most of his work to immunogenicity of biologics and served as an Immunogenicity Task Force leader at Genentech and Amgen. He is also coordinator of the AAPS/FDA immunogenicity focus group responsible for the white papers that are being published.  

Michel Awwad, Associate Director, WYETH

Michel has a broad base knowledge and experience in many fields including a PhD in Parasitology, postdoctoral studies in Cancer Immunology and Immunotherapy, and worked in Transplantation Immunology. He worked in one instance to boost the immune response to destroy tumors and in the others to destroy the immune response to allow the survival of transplanted organs (not any organ, pig organs) into NHP, enotransplantation. During my years of industry experience worked (>65% of my efforts) in preclinical development, mainly developing and running immunological and biochemical assays and some times developing animal models.

Shalini Gupta, PhD, Director, Clinical Immunology, AMGEN

Shalini Gupta has a PhD degree in Biochemistry, obtained in 1988 from Lucknow University, India.  Dr. Gupta did postdoctoral work at Cornell University, Ithaca and at UCLA studying signal transduction mechanisms in mammalian cell systems.  In 1994, she joined Athena Neurosciences where she developed and validated potency bioassays for manufacturing support.  In 1996, Dr. Gupta joined Amgen where she has the responsibility of developing and validating cell-based bioassays capable of detecting anti-drug neutralizing antibodies in biological matrices within a GLP environment.  Dr. Gupta currently chairs an AAPS Immunogenicity sub-committee that is working on compiling White Papers that describe the approach used by industry to develop and validate cell-based assays for the detection of anti-drug neutralizing antibodies.

Holly Smith,  Research Scientist, Biomolecular Interactions, ELI LILLY AND COMPANY

Holly Smith is currently a Research Scientist with Eli Lilly and Company in the Investigative Toxicology Division.  She has over 20 years of experience in the immunotoxicology field, performing immunocompetence and immunogenicity evaluations for preclinical toxicology studies.  She has extensive expertise in the development of immunoassays for the assessment of potential immunogenicity of over 40 biotechnology products.  Ms. Smith received her BA degree in Microbiology at Miami University (Oxford, Ohio).