51st Annual Meeting & ToxExpo - Society of Toxicology

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Society of Toxicology 2012 Exhibitor Hosted Sessions Exhibits TUESday Development Challenges for Antibody Drug Conjugates (ADCs) Tuesday, March 13, 8:30 AM–9:30 AM Presented by: MPI Research ADCs combine the targeting potential of mAbs with the pharmacology of small molecules. These are significant challenges in the development of ADCs such as lot variation as well as the need to simultaneously determine safety margins for intact ADC, drug-free mAb, and small molecules that are released in vivo. Human Induced Pluripotent Stem Cell Technology in Predictive and Mechanism-Based Drug Discovery and Toxicity Testing Using Photometric- Based Assays Tuesday, March 13, 8:30 AM–9:30 AM Presented by: Promega Corporation Human iPSC-technology and photometric assays provide rapid and predictive assessments of viability/toxicity and ADME properties during drug development. This tutorial will highlight recent developments in human iPSC-derived cell types from CDI and reporter assays from Promega while demonstrating the advantages of these technologies in accurate assessment of drug-induced cellular responses. Current Strategies for Juvenile Toxicity Testing Tuesday, March 13, 9:45 AM–10:45 AM Presented by: Charles River Since issuance of the pediatric rule 14 years ago, we have conducted over 300 juvenile toxicity studies in rodent and nonrodent animals for numerous therapeutics (large and small molecule) and chemicals. This seminar will cover what we have learned, current global regulatory expectations, and program designs including species, dose routes, and evaluation. Experience Results: Lessons Learned Developing New Anticancer Drugs and Biotherapeutics Tuesday, March 13, 9:45 AM–10:45 AM Presented by: Accelera Srl Case stories from the direct experience of safety assessment for different drug development programs, including some marketed products, are presented with special emphasis on anticancer drugs and biotherapeutics. Challenges, key issues, and lessons learned are described in the context of scientific and regulatory requirements. Developing a Novel Gene Therapy Product for the Treatment of Rare X-Linked Disease Tuesday, March 13, 9:45 AM–10:45 AM Pathology Peer Review: Who, What, When, Where, Why, and How Tuesday, March 13, 8:30 AM–9:30 AM Presented by: Vet Path Services This presentation will cover pathology peer review in the industrial, GLP setting, with discussions of who does a peer review, what the peer review achieves, when it is performed, why should a peer review be done, and how a pathologist goes about a peer review. It will highlight current common practices in the current regulatory environment. Presented by: Huntingdon Life Sciences Safety assessment of gene therapy products is a complex business with multiple safety risks. Standard paradigms do not exist and approaches must be designed on a case-by-case basis. A case study will be discussed that highlights considerations for a gene therapy to treat an x-linked disease. Innovative Models and Techniques for the Investigation of Nanotoxicity Tuesday, March 13, 11:00 AM–12:00 Noon Presented by: Fraunhofer ITEM The session will focus on the state of the art and future of in vivo inhalation tests, innovative in vitro and ex vivo models as significant tools in inhalation toxicology, and sensitive methods to detect lung damage potentially induced by nanoparticles including carbonanotubes. 118 SOT’s 51 st Annual Meeting
San Francisco, California Exhibitor Hosted Sessions Searching for Drug Safety, Efficacy, and Performance: Scientific and Regulatory Perspectives New Capabilities of Noninvasive Telemetry Used for Cardiovascular Respiration and CNS Assessments Tuesday, March 13, 11:00 AM–12:00 Noon Presented by: PointCross Life Sciences Nonclinical scientists and regulatory reviewers are increasingly confronted with the need to assess safety, efficacy, and performance of drug candidates across study data, reports, chemical structures, and other artifacts. This session focuses on practical ways to search and navigate disparate information from the perspective of R&D and US FDA reviewers. ADME Studies in Knockout Rats Lacking Key Drug Transporters Tuesday, March 13, 12:15 PM–1:15 PM Presented by: SAGE Labs Advances in genetic engineering have enabled the generation of targeted knockout rats. We will discuss the technology used to develop Mdr1a, Bcrp, and Mrp2 drug transporter knockouts. Data from these models demonstrate they may serve as more relevant and specific tools for the elucidation of compound efflux and DMPK studies. Dermal Drug Development Tuesday, March 13, 12:15 PM–1:15 PM Presented by: CiToxLAB The session will present the toxicology studies to support the development of a dermal drug, covering early screening assays, IND-enabling package, and full development. In addition the session will cover the skin histology in laboratory animals and issues relating to broken skin and wound healing. Tuesday, March 13, 1:30 PM–2:30 PM Presented by: emka TECHNOLOGIES INC. The presentation will explain how the new features of emka TECHNOLOGIES’ latest generation of noninvasive telemetry and associated software allow for a significant increase in power and efficiency of preclinical investigations. The focus will be on blood pressure and respiration analysis, subject-specific QT correction and arrhythmia detection, and EEG signal collection and use in sleep or epilepsy studies. The Key Role of Experience in Toxicological Study Design and Data Interpretation Tuesday, March 13, 1:30 PM–2:30 PM Presented by: RTC, Research Toxicology Centre S.p.A. RTC senior science experts in different areas of toxicology will share some special cases for which practical experience played an important role during preclinical development. In fact, for an effective translational approach, it is important to define appropriate study designs and apply a critical interpretation of equivocal results. Utility of Primary Stem Cell Colony Assays in Drug Development Tuesday, March 13, 1:30 PM–2:30 PM Presented by: STEMCELL Technologies, Inc. A potential side effect of anticancer and some novel inhibitor drugs is damage to stem cells, including those of the hematopoietic (blood) system. Impairment of proliferation and differentiation can result in neutropenia, anemia, or thrombocytopenia. This talk outlines the value of hematopoietic in vitro clonogenic assays for prediction of hematotoxicity. Exhibits up-to-date information at www.toxicology.org 119
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Monday, March 12 8:00 AM-9:00 AM PL
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9:00 AM-12:30 PM Poster Sessions
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Scientific Posters SNACK BAR 016 11
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