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Software and services to advance dose-response modeling in chemical risk assesment

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41TR002567-01A1
Agency Tracking Number: R41TR002567
Amount: $300,130.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NCATS
Solicitation Number: PA19-029
Solicitation Year: 2018
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-15
Award End Date (Contract End Date): 2019-12-15
Small Business Information
Bloomington, IN 47401-8017
United States
DUNS: 080461222
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (812) 856-2725
Business Contact
Phone: (412) 651-7452
Research Institution
BLOOMINGTON, IN 47405-1223
United States

 Nonprofit College or University

PROJECT SUMMARY Chemical risk assessment has been widely applied in chemical industry as a necessary step to get new commercial chemicals registeredand in governmental agencies as a critical procedure to evaluate the toxicity of chemicals in order to properly regulate them to protect human health and the environmentThe Lautenberg Chemical Safety Act further strengthens the importance of chemical risk assessment on both regulatory and industrial sidesThe acceptance of the benchmark doseBMDmodeling method to replace the traditional No or Lowest Observed Adverse Effect LevelNOAEL LOAELapproach as a default method for dose response assessmenta key component in quantitative risk assessmentis an important step forward in analyzing and interpreting dose response dataThe BMD method has a number of important advantages over the traditional approachhoweverthe substantial potentials of the BMD method have been significantly limited by current practices and outdated dose response modeling strategies represented by existing softwaresuch as US EPAandapos s BMDS and RIVMandapos s PROAST softwareThereforein this STTR projectwe will explore and demonstrate the feasibility and credibility of integrating existing toxicological information into dose response modeling for BMD estimation through a web based Bayesian BMD modeling systemTo accomplish this objectivetwo specific aims will be pursueddevelop an online dose response modeling system with the capability to use toxicologically plausible informative priors for parameters to model common endpointsanddemonstrate the utility of employing toxicology based informative prior in enhancing the precision of BMD estimates and reducing the number of animals used in toxicity studiesThe three person teamincluding the project PICOO of Dream Tech and an industry expertwill utilize the I Corp program to discover potential customers of the dose response modeling system being developed and develop a viable business plan to commercialize it in the next phaseThe success of this project may revolutionarily change how dose response modeling is conducted in chemical risk assessment and other relevant fieldse gpre clinical evaluation in drug developmentand create new horizons of research andquot This innovative strategy will have significant impact on chemical safety evaluation and regulation which is critical to protect hundreds of millions of peopleandapos s health from chemical exposure PROJECT NARRATIVE This STTR project aims at developing an advanced dose response modeling system featuring the use of Bayesian framework to incorporate toxicologically plausible informative prior of model parameters to enhance the reliability and credibility of benchmark doseBMDestimationwhich will be a major step forward in chemical risk assessment and regulation for protecting public health from chemical exposure

* Information listed above is at the time of submission. *

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