Dr. Susan Kirshner received a M.Sc. from University of North Carolina School of Public Health in the field of environmental toxicology. She received a Ph.D. in Immunology from the Weizmann Institute of Science, where she worked on the development of a biological therapeutic. Dr. Kirshner’s post-doctoral training was at the National Cancer Institute in the area of transcriptional regulation of MHC class I genes. Dr. Kirshner worked both in the government and industry before joining the Division of Therapeutic Proteins in the Office of Biotechnology Products at the US FDA over 8 years ago. She is currently the Associate Chief of the Laboratory of Immunology at the FDA. In her talk, she will give an update on U.S. regulatory guidance and participate on a panel discussion, “regulatory expectation regarding immunogenicity assessment.”
Dr. Jack A. Ragheb is a Senior Regulatory Research Officer and Principal Investigator in the Division of Therapeutic Proteins/OBP/
Dr. Amy Rosenberg is a graduate of the Albert Einstein College of Medicine. Following medical residency training, she was a post-doctoral fellow in the laboratory of Dr. Alfred Singer at the NCI, where she focused on the cellular mechanisms of allograft rejection. In 1988 she moved to CBER, FDA, progressing from Staff Fellow to Director of the Division of Therapeutic Proteins in 2000. While maintaining a research program in immunology, her main regulatory focus is on the immunogenicity of therapeutic protein products, including product and patient factors that impact immunogenicity, and immune tolerance induction to preclude immune responses that abrogate product efficacy. Her talk will explore immune tolerance induction: novel approaches for novel clinical indications
Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology of the Center for Biologics Evaluation and Research of the FDA before joining the Laboratory of Immunology of Division of Therapeutic Proteins and eventually becoming its Chief. Dr Verthelyi’s laboratory, established in 2002, studies innate immune response modulators in several disease models. She has authored over 50 peer reviewed articles, chairs the NIH/FDA Cytokine interest Group, and received of the FDA's ‘Excellence in Laboratory Sciences Award, among other honors. The focus of her presentation is on immunogenicity considerations in the approval of generic Enoxaparin in the US.
In addition to the FDA presentations, CHI’s Immunogenicity Summit 2012 includes an
extensive 2-part event covering developments in assay technologies, risk assessment, regulatory guidance and means of predicting and avoiding immunogenicity. Other highlights include 3 short courses, roundtable discussion groups, panel discussions, networking reception, and poster & exhibits viewing. This year’s summit is conveniently co-located with the inaugural PK/PD of Novel Constructs conference enabling delegates to track-hop to that conference’s sessions.
Read more about CHI’s Immunogenicity Summit 2012 and register at: http://www.ImmunogenicitySummit.com.
To inquire about sponsoring and/or exhibiting, contact Tim McLucas, 781-972-1342, firstname.lastname@example.org.
Writers and editors are encouraged to attend. To request a press pass, contact Lisa Scimemi at email@example.com.
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