USA flag logo/image

An Official Website of the United States Government

Decision support software for cancer drug development

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
88953
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
CA135809
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
PREDICTIVE BIOLOGY ANALYTICS, LLC
PREDICTIVE BIOLOGY ANALYTICS, LLC 48 WILDE RD NEWTON, MA 02468
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2008
Title: Decision support software for cancer drug development
Agency: HHS
Contract: 1R43CA135809-01
Award Amount: $147,672.00
 

Abstract:

DESCRIPTION (provided by applicant): Every year billions of dollars are invested in new drug development in the USA, and over 30,000 patients enroll in National Cancer Institute sponsored clinical oncology drug trials. Economic and health-related risks inh erent in antineoplastic drug development impact both public health and economic stability. The ability to predict antineoplastic drug efficacy and toxicity based on preclinical and early clinical antineoplastic drug data could reduce these risks, resulting in more efficient and robust drug development pipelines. We have developed a drug development forecasting approach that utilizes preclinical data and available early clinical data to predict phase I, II, and III trial outcomes. Our overall hypothesis is t hat integrating pharmacologic data and clinical trial outcomes will yield commercially successful decision support software for drug development. Our objective is to develop novel database integration tools and prototype decision support software that will reduce the risks and costs of developing new antineoplastic drugs. Our unique approach uses pre-clinical and early clinical pharmacologic data to inform decisions for the initial and ongoing financial support of Phase I, II and III clinical oncology trial s. We will accomplish our objective via two Specific Aims: (1) To develop comprehensive and novel database integration tools for pharmacologic data, and clinical trial event data predictive of Phase I/II/III antineoplastic compound outcomes, and (2) to lev erage the database developed in Specific Aim 1 to identify, evaluate and implement Bayesian network models of pharmacologic markers that predict oncology trial events. This project will deliver comprehensive proof-of-concept for prototype software tools th at can (a) integrate diverse data sources, and (b) predict Phases I, II and III clinical oncology trial outcomes, with the ultimate goal of reducing the risk and cost of developing new antineoplastic drugs. Upon successful completion of this project, we wi ll expand the database to include all antineoplastic drugs available for analysis, and we will extend the development and application of the software tools to other disease mechanisms. PUBLIC HEALTH RELEVANCE: Every year billions of dollars are invested in new drug development in the USA, and over 30,000 patients enroll in National Cancer Institute sponsored clinical oncology drug trials. The ability to use early drug development data to predict antineoplastic drug efficacy and safety could reduce these ris ks. We have developed a drug development prediction approach that utilizes preclinical data and available early clinical data to predict trial outcomes. Our overall hypothesis is that integrating pharmacologic data and clinical trial outcomes will yield co mmercially successful decision support software for drug development. Our objective is to develop novel database tools and decision support software that will reduce the risks and costs of developing new antineoplastic drugs. Our unique approach uses pre-c linical and early clinical pharmacologic data to inform decisions for the initial and ongoing financial support of clinical oncology drug trials.

Principal Investigator:

Business Contact:

Small Business Information at Submission:

PREDICTIVE BIOLOGY ANALYTICS, LLC
PREDICTIVE BIOLOGY ANALYTICS, LLC 48 WILDE RD NEWTON, MA 02468

EIN/Tax ID: 126135266
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No