Our Presence at SOT
Below is our preliminary list of posters to be presented by our attending scientists.
Developmental and Reproductive Toxicology
Our exceptional team of scientists regularly designs and performs safety programs ranging from acute through chronic toxicity and carcinogenicity studies.
Toxicology POSTER Presentations
28-Day Somatic Gene Mutation Study of 1-Bromopropane in Female Big Blue® B6C3F1 Mice via Whole-Body Inhalation
Presented by: M. Steljes, SLR International Corp (Co-Authored by: J. Weinberg at Charles River)
Abstract Number/Poster Board number: 2255/P613
Session Title: Genetic Toxicity
Presentation Date and Time: March 14th, 2017 1:15 to 4:30 PM
Presentation Location: CC Exhibit Hall
A Comparison of Selected Organ Weights and Clinical Pathology Parameters in Male and Female CD-1 and CByB6F1 Hybrid Mice 12-14 Weeks in Age
Presented by: L. Dhiel
Comparison of the Long-Term Effects on Survival, Body Weight, and Food Consumption in Two Strains of Rats Used in Toxicology Studies Given Diets of 14% or 18% Protein Content
Presented by: A. Viau
The Incidence of Rodents Rejected from Non Clinical Toxicology Studies due to Ophthalmology Findings
Presented by: P. Mansell
Comparison of Early Morning Versus Overnight Pan Collection for Urine Assessment in Large Animals*
Presented by: M. Guillot
Triple Cannulation Approach for Biodistribution Studies of Neurologically Active Compounds in the Large Animals*
Presented by: J. Douville
Urine Collection for Group-Housed Mice in Toxicology Studies Using the LabSand® Techniques—An Alternative Method
Presented by: A. Varela
Abstract Number/Poster Board number: 1717/P169
Session Title: Pharmaceutical Safety: Drug Development
Presentation Date and Time: March 14th, 2017 9:30 AM to 12:45 PM
Presentation Location: CC Exhibit Hall or Hall A
Reversible Fur and Skin Pigmentation Changes in Large Animals and Long Evans Rats Following the Administration of AZD3293, a Novel β-Secretase Inhibitor*
Our immunology groups provides fully integrated services to support toxicology and clinical studies that determine the safety of compounds, and define immunological endpoints and alterations of cellular function induced by test compounds.
ImmunoToxicology POSTER Presentations
Abstract Number/Poster Board number: 1986/P656
Session Title: Immunotoxicology
Presentation Date and Time: March 14th, 2017 9:30 AM to 12:45 PM
Presentation Location: CC Exhibit Hall or Hall A
In Vitro Toxicology
Our scientists have been leading the way in the development, validation and acceptance of various animal-free models. Many of our assays are direct replacements for tests or screenings done on animals.
In Vitro Toxicology POSTER Presentations
Laboratory Sciences Support
Our Laboratory Sciences team balances scientific integrity, cost-effectiveness and regulatory compliance within the most stringent of time frames to deliver comprehensive support throughout the drug development process. We believe in remaining at the forefront of laboratory technology and have made significant investments in highly trained chemists, facilities and instrumentation to produce rapid and reliable data.
Laboratory Sciences Support POSTER Presentations
These sessions will be recorded and made available for those unable to attend on The Source℠,
our secure portal for technical, scientific and educational resources.
All Exhibitor Sessions will be presented in Room 340 at the Baltimore Convention Center.
Make sure to come by our booth (Booth 1825) to discuss further with our presenters after the session.
Recent changes to REACH legislation and its guidance, the substance identity focus, etc., make it challenging to meet the 2018 deadline, and to register new substances. Companies should consider a global approach to testing of industrial chemicals, including regions such as China or USA with its updated TSCA requirements.
This presentation discusses the cost-effectiveness of taking a more global approach to REACH program designs by including endpoints and studies to fulfill a wider range of regulatory requirements. Recent changes to REACH will be reviewed alongside alterations to other guidelines, such as TSCA.
Mr. Newton’s main duties include analysis of and advocacy on legislative and regulatory affairs related to chemical risk management policies, primarily the Toxic Substances Control Act (TSCA). He also manages PMNPro, SOCMA’s consulting service for companies complying with TSCA, specializing in the premanufacture notification (PMN) process for new chemicals entering the US marketplace. Before joining SOCMA, Mr. Newton served as an environmental analyst for an EPA contractor. Prior to that, he worked as an analytical chemist.
Dr. Paulussen is the head of the Regulatory Affairs Department at the Charles River Den Bosch facility. She leads the 20+ person Regulatory Affairs team, which provides support for the registration of chemicals, biocides, agrochemicals and pharmaceutical products. After obtaining her PhD at the Faculty of Pharmacy at the University of Utrecht, she moved into regulatory affairs, providing legislative support with a background in human risk assessment for the agrochemical/chemical industry.
Quantitation of Biotherapeutics by LC/MS: Finding Its Groove in Preclinical Toxicology
LC/MS quantitation of biotherapeutics has evolved as a differentiated tool supporting investigative toxicology. Research demonstrates that this methodology 1.) satisfies FDA criteria for TK assessments; 2.) addresses limitations of ligand binding assays techniques related to selectivity of endogenous analogs and metabolites; and 3.) mitigates reagent generation issues.
The rationale and advantages to using LC/MS-based quantitation methodologies, compared to traditional large molecule quantitation approaches, will be explored. Case studies will be presented that illustrate complementary results obtained by using parallel LC/MS and standard assay methods. Considerations for LC/MS quantitation in preclinical toxicology will be discussed.
Dr. Elizabeth Groeber is currently a director of bioanalytical chemistry at Charles River Laboratories. Her 20-year career spans contract research organizations and innovator pharma, including nine years with Pfizer in development and discovery roles.
Dr. Scott Fountain is currently executive director of North American laboratory sciences and clinical support at Charles River Laboratories and chair-elect for the AAPS BIOTEC Section. Dr. Fountain received his PhD in analytical chemistry from the University of Michigan, and went on to work for Waters Corporation in a technical client-facing role following graduation. He interacted with his next employer, Pfizer, which was a client of Waters. During his career at Pfizer, he established a quantitative biomarker implementation group in Michigan and later a biotherapeutics and translational research group in California. He is the past chair of the Biomarkers in Translational Medicine Focus Group. Dr. Fountain has established and relied on a durable network of professional friendships to shape a professional career of over 20 years.
Quantitative Measures Associated with DNA and RNA Therapeutics
Increasing interest in the development of oligonucleotide therapeutics among biotech and large pharma companies has been recently fuelled by the approval of mipomersen. Sensitive and selective bioanalytical methodologies are key to the development process. Chromatographic and hybridization ELISA approaches will be reviewed, compared and contrasted.
An overview of oligonucleotide therapeutics in multiple clinical stages will be given. The available bioanalytical platforms for quantitation of oligonucleotide therapeutics will be discussed, with a focus on the hybridization ELISA assays.
Dr. Reeves has been with Charles River since 2006. He holds a PhD in cell biology from the University of Liverpool, and spent 6 years at the University of Glasgow and the Beatson Institute for Cancer Research gaining experience developing ELISA-based and immunohistochemical ligand binding assays. Following his postdoctoral work, he moved to Canada and worked for Procyon Biopharma in Montreal developing novel ELISA methodology for prostate cancer screening tests.
Trends, Trials and Triumphs in In Vitro Toxicology
In vitro alternatives for toxicology screening and animal testing are increasing in variety. While validation against animal tests is costly and may result in false rejection, human clinical and/or mechanistic data is revolutionizing our acceptance and understanding of these tests. Such knowledge will serve to guide our future testing strategies.
We will explore some of the complexities and successes met in the validation and acceptance of in vitro toxicology tests, highlighting how strides in adverse outcome pathways stand to benefit toxicology and drug development. In addition, we will discuss the advantages of in silico technologies in TK/PK studies.
Dr. Warren Casey is director of the U.S. National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), National Institutes of Environmental Health Sciences (NIEHS). He received his undergraduate degree in biochemistry and his PhD in microbiology from North Carolina State University, where he now serves as an adjunct associate professor in the Department of Microbiology. Prior to joining NICEATM, he was the manager of pharmaceutical microbiology at Glaxo, Inc.; head of biomarker development at GlaxoWellcome, Inc.; and a senior scientist for discovery and investigative toxicology at GlaxoSmithKline, Inc. He has authored and co-written more than 28 publications in peer-reviewed journals, presented at numerous scientific meetings, and holds three patents. Dr. Casey is a Diplomate of the American Board of Toxicology (DABT).
Dr. Clive Roper is the head of in vitro sciences at Charles River’s Edinburgh facility. He is an expert in skin penetration, especially for safety testing of cosmetics and agrochemicals and for formulation selection for topical pharmaceuticals. He also has a strong personal interest in dermal metabolism. In his current role, he manages genetic toxicology, in vitro safety pharmacology (hERG), in vitro toxicology (e.g., skin and eye irritation and lung toxicology), skin penetration and bespoke and technology transfer testing. Dr. Roper has published many abstracts and posters and a number of peer-reviewed papers.
Dr. Leon Stankowski is the scientific director of genetic and in vitro toxicology at Charles River in Skokie, IL. He is responsible for guiding research and development for new service offerings, and providing guidance on all aspects of toxicology to help clients reach their goal of regulatory approval for new products. He is responsible for evaluating and addressing adverse toxicology issues when they arise, as well as designing specialized protocols and mechanistic studies to resolve them. He regularly reviews study results and adverse outcomes for compounds being developed by various pharmaceutical and other companies. Dr. Stankowski has authored multiple publications.
Dr. Jeroen Rijk finished his master study in food science at Wageningen University. His PhD thesis research, conducted at RIKILT - Institute of Food Safety in Wageningen, focused on hormone abuse in the veterinary sector. He was later appointed a postdoctoral researcher at RIKILT, and worked for four years in the field of endocrine disruption. Dr. Rijk came to Charles River’s Den Bosch facility in 2013, where his current work in the fields of in vitro ADME and in vitro toxicology focuses on endocrine disruption, skin sensitization and ADME.
Members of Charles River's scientific staff are participating in the following CE course during
this year's SOT Annual Meeting.
Sunrise Mini-Course (SR01) │ Molecular Imaging for Toxicologists
Baltimore Convention Center
Advanced in vivo imaging techniques such as magnetic resonance and nuclear and tomographic imaging are the gold standard in several areas of clinical medicine for diagnosis and guided therapy, and play an increasing role in clinical trials, being an integral part of the drug development process. Imaging sciences have known an incredible development during the last decades, and many techniques, such as MRI, PET, SPECT, and X-ray-computed tomography, have become indispensable.
The applications of in vivo translational imaging are now extending further into drug discovery and development, and have the potential to considerably accelerate the process, reduce the cost, significantly affect the drug development process, and comply with the 3Rs. It is important to understand the technologies and their applications and limitations. Imaging technology includes a range of modalities such as magnetic resonance imaging (MRI), positron emission tomography (PET), single photon emission computed tomography (SPECT), computed tomography (CT), in vivo optical imaging, and ultrasound. These noninvasive and quantitative techniques provide not only anatomical evaluation but also functional and molecular information that can access the mechanisms of drug action or its toxicity.
The future trends will certainly be in multimodality imaging, combining high sensitivity and molecular techniques with high spatial resolution and morphological techniques. Imaging stands out as one of the most promising translational techniques for making early-phase go/no-go decisions by helping to identify compounds that are likely to fail in later phases, so that only the most promising candidates are moved forward. Imaging technologies can improve the drug development process, not only through the development of safer and more effective drugs, but also by reducing timelines. Better prediction of toxicology in an earlier stage will certainly limit the large contribution of drug failure due to adverse effect in later-stage development.
Although imaging has not yet found a major place in safety pharmacology and toxicology studies, several applications exist in cardiovascular, neurology, teratology, and reproductive toxicity. The same technologies and physiological and pathological parameters can be quantified for both pharmacology and toxicology applications, confirming the role of in vivo imaging as a translational biomarker for both efficacy and safety assessment.
This overview provides the opportunity to review fundamentals of molecular imaging and important applications of imaging in different therapeutic areas, discover opportunities for decision-making in the preclinical phase, examine the challenges of GLP validation, and actually integrate imaging approaches into safety assessment in drug development.
The Wonderful World of Molecular Imaging: Understand the Technology. Roger Lecomte, Université de Sherbrooke, Sherbrooke, QC
Imaging Biomarkers for Decision Making in Drug Discovery. Paul J. McCracken, Eisai AiM Institute, Andover, MA
Managing COI and Bias in a CRO Setting
Baltimore Convention Center
Pragati Sawhney Coder
Charles River Laboratories, Ashland, OH
Charges or claims of conflict of interest (COI) are made with increasing frequency with regard to suspicion that personal employment, associations, or funding sources will interfere with the ability of a scientist to objectively conduct or interpret studies, and/or serve on peer review or advisory panels. A frequent concern is funding sources. As public funding for scientific research decreases and becomes more competitive, researchers are seeking funding from other sources (e.g., nonprofit organizations, special interest groups, industry, foundations, and advocacy groups. It is important to recognize possible sources of COI and bias and develop ways to mitigate the potential effects.
This session will provide an opportunity for participants to openly discuss issues regarding conflict of interest, and how COI and bias might affect scientists’ work, as well as their integrity and credibility. It will begin with a philosopher of science examining three philosophical criteria for objectivity in science: transparency, reproducibility, and critical review. This will be followed by scientists from various sectors (government, contract research organization [CRO], academia, private sector, and scientific society) who will reflect upon COI and potential for bias in their professional work (e.g., interpretation and application of their work), and how one might avoid or manage biases and conflicts of interest.
Squeezing more out of iPSC-derived Cardiomyocytes:
Providing better solutions through increased functionality and integrative analyses
Presented by: ACEA Biosciences with Andrew Bruening-Wright from Charles River
This forum showcases practical advances in xCELLigence CardioECR and iPSC-cardiomyocyte-based solutions for toxicity studies. Specifically, data will be presented illustrating increased cardiomyocyte functionality and how integrating electrical and mechanical responses provides mechanistic and translatable results from a variety of chemical classes including small molecule kinase inhibitors and inotropic compounds.
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 2017 Society of Toxicology Annual Meeting and ToxExpo™ Sponsorships