8th Annual Immunogenicity for Biotherapeutics
Meet the 2007 Advisory Board
Eugen Koren, MD, PhD, Director, Bioanalytical Development
SCIOS , A JOHNSON & JOHNSON COMPANY
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 where he is currently working. He published over a hundred research papers and holds 7 patents. During his academic career, Dr. Koren studied atherosclrosis 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, PhD, Associate Director, DSM
WYETH
Michel has a broad base of knowledge and experience in many fields; he holds a PhD in Parasitology, did his postdoctoral studies in Cancer Immunology and Immunotherapy, and worked in Transplantation Immunology. Dr. Awwad has worked in one instance to boost the immune response to destroy tumors while in others, worked to destroy the immune response to allow the survival of transplanted organs (not any organ, pig organs) into NHP, xenotransplantation. Over 65% of his efforts have been in preclinical development (mainly developing and running immunological & biochemical assays and sometimes developing animal models).
Shalini Gupta, PhD, Associate 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 subcommittee 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.
Wolfgang M. Klump, PhD, Principal Scientist, Analytical Biochemistry & Formulations
SEATTLE GENETICS, INC.
Wolfgang Klump has worked in analytics in biotech companies the last 14 years. Currently, he is heading the bioanalytical development group at Seattle Genetics, Inc. responsible for the development of PK and immunogenicity assays, including ligand binding assays and cell based neutralization assays, for antibody and antibody drug conjugate therapeutics. Prior to joining Seattle Genetics, he headed assay development for several gene therapy companies including Targeted Genetics Corporation and Viagene, Inc.Wolfgang Klump received his Ph.D. in Biochemistry at the Ludwig Maximilian University in Munich, Germany.
Holly Smith, Research Scientist
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).
Frederick Holtsberg, PhD, Manager, Contract Research
BIOVERIS CORPORATION
Frederick Holtsberg has over 17 years experience in pharmaceutical and biotechnology drug development. He currently directs the contract research at BioVeris Corporation responsible for assay development, validation and sample analysis. Prior to joining BioVeris, Dr. Holtsberg headed the product development of novel anticancer drugs using enzyme therapy. There he developed pK, immunogenicity and neutralization assays for preclinical and clinical studies. Dr. Holtsberg received his Ph.D. from the University of Kentucky in Molecular and Cellular Biology.
SCIOS , A JOHNSON & JOHNSON COMPANY
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 where he is currently working. He published over a hundred research papers and holds 7 patents. During his academic career, Dr. Koren studied atherosclrosis 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, PhD, Associate Director, DSM
WYETH
Michel has a broad base of knowledge and experience in many fields; he holds a PhD in Parasitology, did his postdoctoral studies in Cancer Immunology and Immunotherapy, and worked in Transplantation Immunology. Dr. Awwad has worked in one instance to boost the immune response to destroy tumors while in others, worked to destroy the immune response to allow the survival of transplanted organs (not any organ, pig organs) into NHP, xenotransplantation. Over 65% of his efforts have been in preclinical development (mainly developing and running immunological & biochemical assays and sometimes developing animal models).
Shalini Gupta, PhD, Associate 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 subcommittee 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.
Wolfgang M. Klump, PhD, Principal Scientist, Analytical Biochemistry & Formulations
SEATTLE GENETICS, INC.
Wolfgang Klump has worked in analytics in biotech companies the last 14 years. Currently, he is heading the bioanalytical development group at Seattle Genetics, Inc. responsible for the development of PK and immunogenicity assays, including ligand binding assays and cell based neutralization assays, for antibody and antibody drug conjugate therapeutics. Prior to joining Seattle Genetics, he headed assay development for several gene therapy companies including Targeted Genetics Corporation and Viagene, Inc.Wolfgang Klump received his Ph.D. in Biochemistry at the Ludwig Maximilian University in Munich, Germany.
Holly Smith, Research Scientist
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).
Frederick Holtsberg, PhD, Manager, Contract Research
BIOVERIS CORPORATION
Frederick Holtsberg has over 17 years experience in pharmaceutical and biotechnology drug development. He currently directs the contract research at BioVeris Corporation responsible for assay development, validation and sample analysis. Prior to joining BioVeris, Dr. Holtsberg headed the product development of novel anticancer drugs using enzyme therapy. There he developed pK, immunogenicity and neutralization assays for preclinical and clinical studies. Dr. Holtsberg received his Ph.D. from the University of Kentucky in Molecular and Cellular Biology.
Bottom menu
Copyright 2003-2006 IIR Holdings, Ltd. All rights Reserved