Safety Assessment of Cosmetic Ingredients

Opportunity: Conduct ingredient safety assessments leveraging next generation tools. Fill data gaps for new ingredients lacking existing literature for assessing safety. Apply next generation approaches appropriately and proficiently to inform on potential safe use of new ingredients. Challenges: Perform systematic review for data and literature [...]

Safety Assessment of Cosmetic Ingredients2018-10-23T18:06:46+00:00

Optimized tissue collection to yield quality RNA for expression profiling

Opportunity: Perform toxicological assessments with cerebral spinal fluid (CSF) collected at termination Challenges: Ensure that RNA from CSF and tissue samples are of high quality and free of hemolysis, and that tissues have an RNA integrity number (RIN) greater than 8.5. Weigh and preserve eight [...]

Optimized tissue collection to yield quality RNA for expression profiling2018-01-08T21:48:12+00:00

Investigational toxicology – challenging route of administration

Opportunity: Conduct in vivo studies involving submandibular injections of a gel-forming product. Previous efforts by the incumbent CRO had not met client expectations, specifically related to the quality and reproducibility of the results. The client was also confronted with a broad inability among providers to [...]

Investigational toxicology – challenging route of administration2018-01-08T23:03:20+00:00

Literature search to identify toxicity data

Opportunity: Conduct thorough search of publicly available literature to identify data that could impact human health or environmental risk assessments for genetically modified organisms. Submit evaluation results in the proper format and within the time requested. Challenges: Develop evaluation strategy that would meet client expectations. [...]

Literature search to identify toxicity data2018-01-08T21:48:40+00:00

Expedited in vivo micronucleus/comet assay supporting combined OECD 474/489

Opportunity: Conduct an expedited micronucleus (MN) assay in mice and comet assay in rats. Challenges: Accelerate timeline to accommodate a meeting between the client and the FDA, leading up to NDA filing, leaving little room to deal with any unanticipated events. Work around effects induced [...]

Expedited in vivo micronucleus/comet assay supporting combined OECD 474/4892018-01-08T22:12:21+00:00

Interpreting and leveraging Tox21 high-throughput data

Opportunity: Evaluate Tox21 and/or ToxCast high-throughput screening data for food-use chemicals using computational toxicology methods and in-house expertise. Clearly communicate data and analyses in reports and presentations. Identify, highlight, analyze and explain the most important findings from within a broad data set. Challenges: Identify and [...]

Interpreting and leveraging Tox21 high-throughput data2018-09-18T14:13:50+00:00

Pathological review of genetically modified mouse lung tissue

Opportunity: Thoroughly document and interpret the histopathologic effects resulting from exposure of an emerging occupational hazardous agent in wild type and genetically modified mice, focusing on the potential of the agent to induce both neoplastic and nonneoplastic lesions following long-term exposure. Deliver a clear, concise [...]

Pathological review of genetically modified mouse lung tissue2018-01-08T21:49:10+00:00

RNA extraction from FFPE tumor tissues

Opportunity: Extract RNA from human FFPE tumors to support development of novel chemotherapeutic agents. Accurately and thoroughly identify neoplastic cells in submitted tissue samples to recover sufficient RNA. Challenges: Process a large number of submitted samples with very short lead time. Adhere to extremely tight [...]

RNA extraction from FFPE tumor tissues2018-01-08T21:49:18+00:00

OECD 487: in vitro micronucleus assay using TK6 cells to investigate mechanism of action

Opportunity: Test whether the genotoxicity observed following administration of a commonly used herbal supplement (reference extract) to mice and rats was potentially related to folate deficiency induced by the supplement. Use an in vitro micronucleus assay to investigate a possible mechanism of action for a [...]

OECD 487: in vitro micronucleus assay using TK6 cells to investigate mechanism of action2018-01-08T22:59:44+00:00

A toxicogenomics approach to assess MOA using next-generation sequencing

Opportunity: Design a study to assess the mode of action (MOA) that leads to tumor development in rodents exposed to acrylamide. Publish data in the peer-reviewed literature. Provide data for use by international regulatory agencies as part of risk assessments. Challenges: Design an experiment identifying [...]

A toxicogenomics approach to assess MOA using next-generation sequencing2018-01-08T23:00:54+00:00