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Deliverables
1.   Report A: Technology Evaluation

  • A written technology evaluation report detailing the data and experiences of the participating companies, including:
  • Results and analysis of in-depth interviews of preclinical screening and safety leaders
  • Quantitative summary of key aspects of utility and adoption of new safety screening tools in preclinical safety assessment.
  • A complete assessment of existing processes and technologies at participating client’s companies to understand the current thinking and practice of predictive toxicology
  • The results of survey that asks about the needs and wants for such a tool including user considerations and requirements
  • Concise and actionable conclusions about current and anticipated biomarker efforts

2.   Cell-Based Assay: Actual Screen and Analysis of Compounds

  • CHA in partnership with Cellumen will also include a full screen and analysis of approximately ten (10) test compounds for each participating company, with the ultimate objective using test results to predict toxicity in humans. **

3.   Report B: Compound Screening (Analysis and Summary of Compounds Tested)

  • An additional written report that includes total results of the cell-based assay, including all contributed compounds tested. Report will also summarize the correlation of the high content screening results relative to the known toxicology of the compounds (feedback and data is blinded). Report B will be made available only to those participating companies who have their compounds screened and provided feedback on process. **

4.   Final Web Conference Presentation & Peer-to-Peer Roundtable

  • In addition the two roundtables held throughout the project (noted in Project Stages below), CHA will also host a final project findings presentation and lead a facilitated discussion of the implication of findings in both the Technology Evaluation (Report A) and Analysis/Summary of Compounds Tested (Report B). The presentation and peer-to-peer roundtable (via teleconference) will discuss:
  • the findings from the technology report
  • results of all compounds tested during the actual screen
  • leverage the shared knowledge of the participating members across the total data set
  • determine the most appropriate modifications to the cell-based assay used in the screening (please note all compounds specific information, like compound structures, will be kept blinded).

5.   Rights to Discounts on Future Cell-Based Assay Screens for Predicative Toxicology

  • Participating clients receive 50% in discounts over each of the next three years, up to a total of $75,000 ($25,000 per year). This discount opportunity expires after three years from the date of the Final Web Conference Presentation.

6.   Updates, Analysis

  • CHA will provide interim written updates and analysis and, upon request, make formal presentation of the evaluation’s findings to the client company.

** Participants who take advantage of the complimentary screen of ten compounds will be asked to provide feedback on the technologies process and results through a brief, thirty minute interview. Summary of feedback will be provided via the written Report B described above.

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