Specialty Sponsorships

Charles River would like to thank the Society, as well as all of those who serve on special-interest groups.
We all benefit from your contributions, and we are proud to sponsor many for these groups.

 

Our Presence at SOT

Poster Presentations

Below is our preliminary list of posters to be presented by our attending scientists.
Further presentation details will be added once available. We also have a collection of collaborative posters. Contact us for more information.

  • Monday, March 11

    Validation of an In Vitro Test Battery to Evaluate Smokeless Tobacco Products
    Presented by: L. Stankowksi

    Abstract Number/Poster Board Number: 1565/P702
    Session Title: Genetic Toxicity
    Presentation Date and Time: Monday, March 11, 9:15 a.m. – 4:30 p.m.

    Identifying the Mode of Action of Potential Genotoxicants Using Nuclear Biomarkers in TK6 Cells

    Presented by: D. Roberts

    Abstract Number/Poster Board Number: 1566/P703
    Session Title: Genetic Toxicity
    Presentation Date and Time: Monday, March 11, 9:15 a.m. – 4:30 p.m.

  • Tuesday, March 12

    Validation of an In Vitro Test Battery to Evaluate Smokeless Tobacco Products

    Presented by: Martin Guillot

    Abstract Number/Poster Board Number: 2118/P511
    Session Title: Safety Assessment Pharmaceutical: Drug Development
    Presentation Date and Time: Tuesday, March 12, 9:15 a.m. – 4:30 a.m.

    Micro-CT and Histopathology Characterization of Atherosclerotic Plaque in Aorta from High Fat Diet-Fed Ovariectomized Apolipoprotein E Knockout Mice
    Presented by: M. Guillot

    Abstract Number/Poster Board Number: 2119/P512
    Session Title: Safety Assessment Pharmaceutical: Drug Development
    Presentation Date and Time: Tuesday, March 12, 9:15 a.m. – 4:30 p.m.

    Development of a Large Animal* Vaccination Model to Assess CD8-Specific Responses
    Presented by: M. Piche

    Abstract Number/Poster Board Number: 2304/P715
    Session Title: Immunotoxicity
    Presentation Date and Time: Tuesday, March 12, 9:15 a.m. – 4:30 p.m.

    Capture Compound® Mass Spectrometry: Elucidating Off-Target Binding to Deconvolute Drug
    Presented by: S. Almond

    Abstract Number/Poster Board Number: 3070/P607
    Session Title: Emerging Technologies
    Presentation Date and Time: Wednesday, March 13, 9:15 a.m. – 4:30 p.m.

    *Titles have been modified due to their sensitive nature.

  • Wednesday, March 13

    Contractility, Can a Rodent Model Be Utilized as a Suitable Alternative to Large Animal Telemetry to Assess Potential Inotropic Effects of Novel Compounds?
    Presented by: K. Norton

    Abstract Number/Poster Board Number: 3353/ P142
    Session Title: Late-Breaking 2: Carcinogenesis; Cardiovascular; Immunotoxicity; Inflammation
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Reliable Method for Intravenous Dosing in Guinea Pigs
    Presented by: C. Jenkins

    Abstract Number/Poster Board Number: 3356/P145
    Session Title: Late-Breaking 2: Carcinogenesis; Cardiovascular; Immunotoxicity; Inflammation
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Validation of an In Vitro Test Battery to Evaluate Smokeless Tobacco Products
    Presented by: B. Roche

    Abstract Number/Poster Board Number: 3357/P146.
    Session Title: Late-Breaking 2: Carcinogenesis; Cardiovascular; Immunotoxicity; Inflammation
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    The Assessment of Alveolar Toxicity and Fibrotic Potential In Vitro Using the MatTek EpiAlveolar/Macrophage Co-Culture Model
    Presented by: C. Roper

    Abstract Number/Poster Board Number: 3379/P169
    Session Title: Late-Breaking 3: Model Systems; Nanotoxicology
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Development of LC-MS/MS Assays to Measure Thyroid Hormones in Rat Serum
    Presented by: P. Coder, E. Grober

    Abstract Number/Poster Board Number: 3441/P236
    Session Title: Late-Breaking 6: Metals; Pesticides; Biomarkers
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Congential Heart Defects Are Not Increased in Rats Exposed in Utero to Trichlorethlylene in Drinking Water
    Presented by: P. Coder

    Abstract Number/Poster Board Number: 3470/P266
    Session Title: Late-Breaking 8: Liver; Reproductive and Developmental Toxicology
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. – 11:30 a.m.

    Immunotoxicology Evaluation in the Juvenile Göttingen Minipig
    Presented by: L. Allais, A. Perbet, F. Condevaux, A. Hoberman

    Abstract Number/Poster Board Number: 3471/P267
    Session Title: Late-Breaking 8: Liver; Reproductive and Developmental Toxicology
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    What to do with Unwanted Inflammation: Dealing with the Impact of Delayed Downstream Immunomodulation Induced by Test Article Administration
    Presented by: G. Wilson, B. Roche

    Abstract Number/Poster Board Number: 3525/P321
    Session Title: Late-Breaking 11: Safety Assessment: Pharmaceutical and Non-Pharmaceutical; Natural Products; Epigenetics
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Intrathecal Administration by Direct Lumbar Injection in the Rat and Nonhuman Primate
    Presented by: C. Voyer

    Abstract Number/Poster Board Number: 3527/P322
    Session Title: Late-Breaking 11: Safety Assessment: Pharmaceutical and Non-Pharmaceutical; Natural Products; Epigenetics
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Successful Application of Automated Liquid Handlers in Bioanalysis to Meet the Increasing Demand of Faster Timelines in Support for Toxicology Studies
    Presented by: K. Colletti

    Abstract Number/Poster Board Number: 3527/P323
    Session Title: Late-Breaking 11: Safety Assessment: Pharmaceutical and Non-Pharmaceutical; Natural Products; Epigenetics
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Distinct Carbon Sources Determine the Response of Induced Pluripotent Stem Cell-derived Cardiomyoctyes to Hypoxia 
    Presented by: A. Bruening-Wright

    Abstract Number/Poster Board Number: 3519/P315
    Session Title: Late-Breaking 11: Safety Assessment: Pharmaceutical and Non-Pharmaceutical; Natural Products; Epigenetics
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Re-evaluation of Discordant Results in Related OECD TG471 Tester Strains
    Presented by: C. Farabaugh

    Abstract Number/Poster Board Number: 3554/P351
    Session Title: Late-Breaking 12: Gene Regulation; Genotoxicity; Stem Cell Toxicology; Systems Biology; Emerging Technologies
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Comet Assay in 3D HepaRG Spheroid Model: A Promising Tool to Evaluate DNA Strand Breaks Using Human Liver Cells
    Presented by: R. Cardoso

    Abstract Number/Poster Board Number: 3555/P352
    Session Title: Late-Breaking 12: Gene Regulation; Genotoxicity; Stem Cell Toxicology; Systems Biology; Emerging Technologies
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Application of a 3D Model of Human Liver Cells Co-Cultured with Human Lymphoblast in the Evaluation of Comet and Micronucleus
    Presented by: R. Cardoso

    Abstract Number/Poster Board Number: 3556/P353
    Session Title: Late-Breaking 12: Gene Regulation; Genotoxicity; Stem Cell Toxicology; Systems Biology; Emerging Technologies
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Comparison of TK6 Micronucleus Data Generated by Flow Cytometry and Microscopy 
    Presented by: V. Kwok

    Abstract Number/Poster Board Number: 3557/P354
    Session Title: Late-Breaking 12: Gene Regulation; Genotoxicity; Stem Cell Toxicology; Systems Biology; Emerging Technologies
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. - 11:30 a.m.

    Ambulatory Intraveneous Infusion in the Large Animal* 
    Presented by: J. Douville

    Abstract Number/Poster Board Number: 3569/P366
    Session Title: Late-Breaking 12: Gene Regulation; Genotoxicity; Stem Cell Toxicology; Systems Biology; Emerging Technologies
    Presentation Date and Time: Thursday, March 14, 8:30 a.m. – 11:30 a.m.

    *Titles have been modified due to their sensitive nature.

  • Exhibitor-Hosted Sessions

    Visit Booth #3942 to connect with our presenters after the session.
    Watch for recordings of these sessions on The Source, our secure portal for technical,
    scientific, and educational resources.

  • The Expanded Role of Flow Cytometry in PK/PD Studies in Nonhuman Primates—What Can We Learn Early
    Within Biotherapeutic Drug Development Programs?

    MONDAY, MARCH 11

    10:30 – 11:30 a.m.

    Location

    Baltimore Convention Center
    Room 340

    SPEAKERS

    Marie Soleil-Piche, PhD
    Scientific Director, Immunology

    Christina Satterwhite, PhD
    Sr. Director, Global Laboratory Sciences

    ABSTRACT

    Flow cytometry quantitation of biotherapeutics and receptor binding assessments has become an integral tool in supporting investigative toxicology, preclinical and clinical programs. Comprehensive PK/PD studies in nonhuman primates provide valuable information used to design non-clinical and clinical programs. Charles River will present an overview of pharmacology and pharmacodynamic capabilities in nonhuman primates, strategies for implementing these endpoints on studies, and options for expediting reporting of key data.

    OBJECTIVEs

    The rationale and advantages to using flow cytometry methodologies, compared to traditional large molecule quantitation approaches, will be explored.
    Case studies will be presented which illustrate the use of these techniques to obtain valuable information, which ultimately impacts interpretation of preclinical data.

    BIO

    Dr. Marie-Soleil Piche obtained her BSc in microbiology and immunology from McGill University, her MSc in immunotoxicology from the Armand Frappier Institute and her PhD in experimental medicine at the University of Montreal in 2009. She is an immunologist by training who specifically studied the role of autoantibodies in autoimmune disorders such as lupus. While pursuing her doctoral degree, she learned a diverse set of skills including protein expression and purification, antibody generation, cell culture, molecular biology, flow cytometry and immunoassay development.

    Marie-Soleil joined Charles River in early 2009 as an immuntoxicology scientist, in which her primary role was to development flow cytometry assays. She progressively took additional responsibilities and is now the Scientific Director of the immunology group at the Charles River Montreal site where she manages a group of over 25 scientists. Her group works mainly on pre-clinical and clinical programs for small molecules, biotherapeutics, cell therapies, and vaccines. During her time at Charles River, Marie-Soleil has overseen, developed, and validated hundreds of bioanalytical methods including nonclinical and clinical immunogenicity assays, nAb assays, biomarker, qPCR, cell based and flow cytometry assays.

    Marie-Soleil previously worked at Biophage Pharma where she worked jointly with the Canadian army in high security laboratories. Marie-Soleil is an active member of the ILSI/HESI Immunotoxicology Technical committee with which she has contributed to the writing of papers on good practices to perform TDAR and CRA assessments.

    Dr. Christina Satterwhite has over 15 years of experience in biologic drug development. The breadth and number of compounds she has worked on is extensive, as she has worked for Charles River in the areas of pathology, toxicology (emphasis in immunotoxicology studies), analytical chemistry, and immunobiology. Her experience in toxicology, as well as preclinical and clinical assay support, has given rise to a comprehensive understanding of biologic drug development.

    Christina joined Charles River as a study director in 2002 as an associate research scientist, having received her PhD in cellular and molecular pharmacology and physiology at the University of Nevada, Reno, School of Medicine in the same year. Christina’s area of scientific expertise was in the study of ion channels and their role in cardiovascular disease.

    The biologics focus in her career at Charles River has allowed her to work with multiple types of compounds such as monoclonal antibodies, bispecific antibodies, antibody drug conjugates, enzymes, peptides, and oligonucleotides. Christina has direct experience in study directing general toxicology and immunotoxicology studies in non-human primates.

    Today Christina has had overall responsibility for successful interactions with regulatory authorities and Sponsors, interpretation and reporting of study data, as well as the conduct, management and regulatory compliance of assigned nonclinical and clinical studies. She has also directed the Nevada Safety Assessment laboratory sciences group starting in 2006 to 2017 and recently started a new role for the global Laboratory Sciences groups.

  • Auditory Safety in Toxicology: Discussions on Current Trends

    TUESDAY, MARCH 12

    10:30 – 11:30 a.m.

    Location

    Baltimore Convention Center
    Room 340

    SPEAKERS

    Rachel Tapp, MS
    Senior Study Director, Neurobehavioral Sciences, Ototoxicity, Charles River – MWN

    Ken Schafer, DVM, PhD, DACVP
    Senior Pathologist
    Vet Path Services, Inc.

    Christopher Toscano, PhD, DABT
    Division of Neurologic Products, Center for Drug Evaluation and Research, FDA

    ABSTRACT

    Evaluation of sensory systems in toxicity studies has historically been only a priority for directly administered compounds and those in classes of risk. We will discuss the necessary considerations for compounds that may be in a class of risk for ototoxicity, those directly administered to the ear, those targeting the ear, and considerations for future screening and inclusion of these specialty system evaluations in standard toxicity studies.

    OBJECTIVEs

    Give historical summary of available guidelines, endpoints, and study types necessary to support potential ototoxicants. Offer insight into the necessary considerations for endpoints and study preparation/design for ototoxicity studies. Give examples of types of pathology to include in the studies and how they apply across these different compounds. Discuss options for screening compounds for potential ototoxicity.

    BIO

    Ms. Rachel Tapp, is a senior study director in neurobehavioral sciences at Charles River. As an expert with more than 20 years of experience, she ensures high level performance of regulatory and non-regulatory contracted neurobehavioral ototoxicity studies, focusing on study management, communication, and fostering Sponsor relationships. Rachel joined Charles River (then MPI Research) in 2003 as a research associate and was promoted to Study Director in 2005. Before joining the company, Rachel worked as a field research technician at the National Audubon Society and as a laboratory assistant in the Aquatic Toxicology Laboratory at Michigan State University. She obtained her BS in zoology from Michigan State University in Michigan in 2002, and her MS in pharmacology and toxicology from Michigan State University in 2016. She has authored many auditory safety posters and articles and is an active member of the Association for Research in Otolaryngology, the American College of Toxicology, and the Safety Pharmacology Society.

    Dr. Kenneth Schafer received his DVM and PhD in veterinary pathobiology from Purdue University. The thesis work for his PhD was performed at Lovelace Respiratory Research Institute in Albuquerque, NM. Dr. Schafer has been engaged in toxicologic pathology for about 20 years at Wyeth Research, Lilly Research Laboratories, and Vet Path Services. He is the past Secretary/Treasurer and past President of the Society of Toxicologic Pathology (STP) and served as chair of the STP’s Scientific and Regulatory Policy Committee. Dr. Schafer has an interest in ocular and otic pathology and has co-authored 4 book chapters on these topics with three more chapters currently in press. He has been a member of the American College of Veterinary Pathologists since 1996. At Vet Path Services, Dr. Schafer provides GLP-compliant contract histopathology and consulting services to pharmaceutical, animal health, medical device, and chemical companies worldwide.

    Dr. Christopher D. Toscano received a BS in biology from Manhattan College in The Bronx, NY, an MS in toxicology from St. John’s University in Queens, NY, and a PhD in toxicology from the Department of Environmental Health Sciences in the Bloomberg School of Public Health at The Johns Hopkins University in Baltimore, MD. His Masters and PhD theses focused on the molecular mechanisms of the neurotoxicity of lead. As a postdoctoral fellow in the Brain Physiology and Metabolism Section of the National Institute on Aging at the National Institutes of Health, Dr. Toscano assessed the involvement of cyclooxygenase in models of central nervous system neurotoxicity. Dr. Toscano became a Diplomate of the American Board of Toxicology just prior to joining the Division of Neurology Products in the Office of New Drugs at the Center for Drug Evaluation and Research in 2008. As a pharmacologist in the Division of Neurology Products, he is currently involved in the review of nonclinical studies performed to support the development of therapeutics to treat neurological diseases.

  • Pre-IND Research Opportunities to Accelerate Rare/Orphan Disease Trials

    TUESDAY, MARCH 12

    3:00 – 4:00 p.m.

    Location

    Baltimore Convention Center
    Room 340

    SPEAKERS

    Keith Sutton, PhD
    Principal Scientist, Safety Assessment

    Lauren Black, PhD
    Distinguished Scientist, Scientific Advisory Services

    Julie Douville, PhD
    Director, IPN

    David Fischer, PhD
    Executive Director of Biology, DMPK

    ABSTRACT

    Approval and clinical efficacy of AAV-based gene therapies, as well as the advent of CRISPR, promise many new therapies that might reverse monogenic disease, and possibly modify many other diseases including cancers, neurodegenerative, cardiovascular, and autoimmune disease. Many of these diseases are inherited or start in utero from naturally occurring mutations, so the key target population for therapy is young infants. How do we accelerate entry into these trials, before significant or irretrievable loss of abilities has occurred?

    OBJECTIVEs

    1. Point out “hard” and “soft” guidance which can save time and costs in preclinical research
    2. In vitro pathway/cell-based systems for looking at human disease activity/potential benefit
    3. Lean preclinical plans focused on mainly on rodents save cost and enable human dose extrapolation
    4. Biomarker and genetic technology to screen for on and off target effects of gene therapy

    BIOs

    Dr. Keith Sutton joined Charles River in 2016, and works in the Immunobiology group within safety assessment at our Edinburgh site. At Charles River, he has worked with a broad variety of therapeutic modalities covering a range of cell based therapeutics and gene therapies using both viral and non-viral delivery methods. Keith holds a degree in Immunology and PhD in virology. Prior to joining Charles River he worked at Research Institutions in the US, UK and Australia, including time at UMass Medical school and MD Anderson Cancer Center. During his research career, he worked across a number of physiological systems, deploying a wide range of molecular and cell biology techniques.

    Dr. Lauren Black provides strategic consultation for drug, cellular therapy, gene therapy and vaccine development. Prior to joining Charles River, Dr. Black served as a reviewing pharmacologist at the FDA’s Center for Drug Evaluation and Research (CDER) within the Division of Antiviral Drugs where she assessed pharmacology and toxicology data for pre-INDs, initial first-in-human INDs and applications of antisense, antiviral and immunosuppressant drugs. She also served as a reviewer at the FDA’s Center for Biologics (CBER) during which time she focused on biologics such as monoclonal antibodies, cellular therapies, and vaccines/adjuvants. Over the course of her career at the FDA, she reviewed over 400 INDs and 12 BLAs and contributed to 8 guidance articles. Dr. Black received her doctorate degree in pharmacology and toxicology from the Virginia Commonwealth University Medical School and was awarded an IRTA postdoctoral fellowship at NIH/NINDS. She is an invited panelist for numerous pharmaceutical safety advisory boards and currently serves as a scientific advisor for the California Institute for Regenerative Medicine (CIRM) Translational Center, which provides funding and scientific guidance to developers of stem cell-based therapeutic candidates.

    Dr. Julie Douville obtained her PhD in 2006 and spent the following year as a postdoctoral fellow studying breast cancer stem cells. She started her career at Charles River in 2007 as study director in general toxicology. She then transferred to the Infusion group and focused on conducting neurological safety studies, specializing in cerebrospinal delivery, serial CSF collections, and studies using Alzheimer's disease mouse models. She is actively involved in the development of novel approaches and validation of new techniques in this field and she is the main scientific point of contact for neurological safety studies.

    Dr. David Fischer joined Charles River in October 2005 and is responsible for the target discovery and primary cell-based screening activities. During six years of postdoctoral fellowships at the Netherlands Institute for Neuroscience in Amsterdam (an Institute of the Royal Netherlands Academy of Arts and Sciences) and the Free University Amsterdam, he focused on neurodegenerative diseases, with focus on Alzheimer’s and Huntington’s disease. He has published over 50 patent applications and peer-reviewed papers in the fields of neurodegenerative disease, oncology, gene regulation, and RNAi screening.

  • Molecular Imaging in Preclinical Drug Development

    WEDNESDAY, MARCH 13

    10:30 – 11:30 a.m.

    Location

    Baltimore Convention Center
    Room 340

    SPEAKERS

    Tuulia Huhtala, PhD
    Lead Scientist, Nuclear Imaging, Charles River Discovery Research Services, Kuopio, Finland

    Aurore Varela, DVM, MSc, DABT
    Scientific Director, Musculoskeletal Research & Imaging, Charles River, Montreal, Canada

    Scott Haller
    Director of Imaging, Charles River, Mattawan

    ABSTRACT

    Current in vivo imaging modalities offer unique sensitivity, specificity, and resolution to longitudinally evaluate drug metabolism, efficacy endpoints, physiological, pathological and molecular changes, and off-target effects. Morphological and functional imaging methods are becoming an integral part of drug development as early and translational biomarkers in drug discovery and safety assessment.

    OBJECTIVEs

    1. Principles of imaging modalities
    2. Use of imaging biomarkers to improve preclinical drug development
    3. Experience and recognition of the important information provided by in vivo molecular imaging
    4. Review major applications of imaging in different therapeutics areas
    5. Opportunities for decision making in preclinical phase

    BIOs

    Aurore Varela has more than 15 years of experience in preclinical imaging, bone biomarkers, biomechanics, study design and conduct in musculoskeletal research and toxicology. She received her DMV in France, her MSc from the University of Montreal, and she is also a Diplomate of the American Board of Toxicology. She plays a key role in designing and executing studies, and interpreting data relevant to musculoskeletal research, musculoskeletal and metabolic toxicology, and imaging. She has co-authored several research papers in peer-reviewed scientific journals and contributed to chapters in several books related to musculoskeletal research and bone pathology and is editing a book on bone toxicology.

    Scott Haller, MS, is Director of Imaging at Charles River. With over 18 years of experience, Mr. Haller is responsible for providing strategic leadership for scientific advancement, business development, and integration of service offerings. Mr. Haller has a diverse research background, including experience in preclinical and clinical development, in vitro and in vivo cellular and molecular biology applications, and various facets of imaging applications in drug development. Before joining Charles River (then MPI Research) in 2006, Mr. Haller was an associate scientist at Pharmacia & Upjohn in Kalamazoo, Michigan, where he served as a research scientist/director of the imaging core and medical device research laboratories at the Borgess Research Institute. He received his BS in 1996 and his MS in virology and immunology in 2001, both from Western Michigan University. Mr. Haller is well published in many peer-reviewed journals and continues to serve as a visiting scientist at his alma mater

  • Education / Career Development

    Members of Charles River's scientific staff are participating in the following
    CE course during this year's SOT Annual Meeting.

  • AM 03 Morning Course
    Assay Development Principles and Good Research Practices for Rigor and Reproducibility in In Vitro Toxicology

    SUNDAY, MARCH 10

    8:15 a.m. to Noon

    LOCATION

    Baltimore Convention Center

    Characterizing Reproducibility and Optimizing Value of In Vitro Screening Methods

    Viswanath Devanarayan, University of Illinois at Chicago, Chicago, IL

  • AM 05 Morning Course
    Developmental Toxicity of the Skeletal System: Interpretation of Findings in DART Studies and Implications for
    Risk Assessment

    SUNDAY, MARCH 10

    8:15 a.m. to Noon

    LOCATION

    Baltimore Convention Center

    Case Studies of Common Skeletal Findings in Developmental Toxicity Studies

    Donald Stump, Charles River

  • SEND Breakfast Forum

  • Overcoming SEND Challenges | Expert Panel Discussion

    Tuesday, March 12

    7:30 - 8:30 a.m.

    LOCATION

    Ravens Room at the Baltimore Marriott Inner Harbor

    Discussion Topics
    • When is SENDIG v3.1 going to be required?
    • How do I know when to use SENDIG v3.0 and when to use SENDIG v3.1?
    • What are the main differences between SENDIG v3.0 and SENDIG v3.1?
    • Can you please describe how VISITDY is handled in SENDIG v3.0 and SENDIG v3.1?
    • SENDIG v3.1 adds an unscheduled flag.  What will this variable do for us?
    • How do I know what study designs are in scope for SENDIG v3.0 and v3.1? (Out of scope studies and datasets – specifically around juvenile studies, immunology, etc.)
    • How should I handle endpoints on a study that are not within the scope of the SEND IG v3.0?
    • Are SEND datasets needed for nonGLP studies?
    • Are SEND datasets required if an audited draft report is submitted?  What about an interim report?
    • Why is it important for me to ensure that all my subcontractors are SEND ready?  If I pick a subcontractor that isn’t SEND ready can you help me?
    • Are the FDA eCTD Technical Rejection criteria in effect yet?
    • Do we still need TS datasets for studies started prior to the SEND mandate?
    • What do I need to submit with my SEND datasets?  (nSDRG and define file)
    • Is the tumor.xpt the same thing as a TF SEND dataset?
    Abstract

    Regardless of whether you have questions regarding current requirements, upcoming standards, or logistical best practices, our panel of experts will be on hand to share SEND knowledge and expertise. Now more than ever, it is imperative that providers have implemented the SEND standards and can prepare submission-ready SEND dataset packages. Our panel of experts will discuss the new standards, challenges, and tips on what you can do to be prepared for submitting your data to agency.  There will also be an opportunity to ask your burning SEND questions and get some expert answers and advice on your SEND submission strategy!

    Panelists: Audrey Walker, Christy Kubin, Marc Ellison (INSTEM), Bill Houser (BMS and current CDISC Lead)

    Facilitator: Pam Walker

  • Succeeding with New SEND Requirements | Expert Panel Discussion

    Tuesday, March 12

    7:30 - 8:30 a.m.

    LOCATION

    Ravens Room at the Baltimore Marriott Inner Harbor

    Discussion Topics
    • When is SENDIG v3.1 going to be required?
    • How do I know when to use SENDIG v3.0 and when to use SENDIG v3.1?
    • What are the main differences between SENDIG v3.0 and SENDIG v3.1?
    • Can you please describe how VISITDY is handled in SENDIG v3.0 and SENDIG v3.1?
    • SENDIG v3.1 adds an unscheduled flag.  What will this variable do for us?
    • How do I know what study designs are in scope for SENDIG v3.0 and v3.1? (Out of scope studies and datasets – specifically around juvenile studies, immunology, etc.)
    • How should I handle endpoints on a study that are not within the scope of the SEND IG v3.0?
    • Are SEND datasets needed for nonGLP studies?
    • Are SEND datasets required if an audited draft report is submitted?  What about an interim report?
    • Why is it important for me to ensure that all my subcontractors are SEND ready?  If I pick a subcontractor that isn’t SEND ready can you help me?
    • Are the FDA eCTD Technical Rejection criteria in effect yet?
    • Do we still need TS datasets for studies started prior to the SEND mandate?
    • What do I need to submit with my SEND datasets?  (nSDRG and define file)
    • Is the tumor.xpt the same thing as a TF SEND dataset?
    Abstract

    Regardless of whether you have questions regarding current requirements, upcoming standards, or logistical best practices, our panel of experts will be on hand to share SEND knowledge and expertise. Now more than ever, it is imperative that providers have implemented the SEND standards and can prepare submission-ready SEND dataset packages. Our panel of experts will discuss the new standards, challenges, and tips on what you can do to be prepared for submitting your data to agency.  There will also be an opportunity to ask your burning SEND questions and get some expert answers and advice on your SEND submission strategy!

     

  • Specialty Sponsorships

    Charles River would like to thank the Society, as well as all of those who serve on special-interest groups.
    We all benefit from your contributions, and we are proud to sponsor many for these groups.

  • Charles River 2019 Society of Toxicology Annual Meeting and ToxExpo Sponsorships

     

    • Platinum Sponsor: Society of Toxicology
    • Reproductive and Developmental Toxicology Specialty Section
    • Ocular Toxicology
    • Dermal Toxicology
    • Toxicologic and Exploratory Pathology Specialty Section
    • SOT 2019 Special Interest Group (SIG) Sponsorships
    • Hispanic Organization of Toxicologists (HOT)
    • Women in Toxicology

© 2019 Charles River Laboratories International, Inc.