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Four FDA Thought-Leaders to Present at CHI’s Immunogenicity Summit 2012

With representation by Susan Kirshner, Jack Ragheb, Amy Rosenberg, and Daniela Verthelyi.

Aug. 1, 2012 - PRLog -- Cambridge Healthtech Institute (CHI) has announced the participation of the CDER/FDA at the upcoming Immunogenicity Summit 2012 to be held October 10-12, 2012, at the DoubleTree by Hilton Hotel in Bethesda, Maryland: Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology; Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic Proteins; Amy Rosenberg, M.D., Director, Therapeutic Protein; and Daniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins.

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/OPS/CDER/FDA and an Attending Physician on the Allergy Immunology Service, NIAID, National Institutes of Health, Bethesda, MD. A graduate of the Johns Hopkins University and School of Medicine, he performed his clinical training at the Johns Hopkins Hospital and National Institutes of Health. A recipient of numerous research awards, his work and publications has spanned the fields of retrovirology, gene therapy, immune activation, and clinical trials in immune tolerance. He is actively investigating the use of humanized mouse models to predict the immunogenicity of therapeutic proteins. In his talk, he will describe the nature, limitations, utility, and predictive value of in vitro and in vivo model systems. Case studies will illustrate how pre-clinical data and a risk-based assessment may help inform the probability of immunogenicity in humans.

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, tmclucas@healthtech.com.

Writers and editors are encouraged to attend. To request a press pass, contact Lisa Scimemi at lscimemi@healthtech.com.

About Cambridge Healthtech Institute (www.chicorporate.com)

CHI is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHI’s Media Group, which includes news websites and e-newsletters including Bio-IT World and eCliniqua. Founded in 1992, CHI strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments.


James Prudhomme
Cambridge Healthtech Institute

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