Newsroom/Press Releases/EdjAnalytics Partners with U.S. FDA to Provide Predictive Analysis for Pharmaceutical Site Inspection

EdjAnalytics Partners with U.S. FDA to Provide Predictive Analysis for Pharmaceutical Site Inspection

LOUISVILLE, KY (June 24, 2019) – EdjAnalytics (Edj), a data science firm providing artificial intelligence, machine learning and advanced analytics for life sciences, announces it has developed a predictive model to support the FDA’s decision-making process to select sites for inspection. The model provides the likelihood of a facility having an inspection outcome of an OAI (Official Action Indicated), VAI (Voluntary Action Indicated) or NAI (No Action Indicated). Additionally, the model produces information about what factors most influence a particular outcome.

Edj began its contract with the FDA’s Center for Drug Evaluation and Research to produce novel advanced analytics related to the drug supply chain in September 2018. After completing the modeling earlier this month, Edj is currently working to assist the FDA in integrating the results of its analysis. 

“We are grateful for the unique opportunity to work for the FDA to produce innovations using data science to improve the pharmaceutical facility inspection process. The FDA is on the cutting edge of technology in life sciences by exploring decision support using predictive analytics,” said Susan Olson, Ph.D., COO, who leads Edj’s healthcare and life sciences business.

To achieve its goals, Edj trained machine learning models on historical inspection outcomes to create a predictive model. Features related to facilities, their associated products and their historical inspection outcomes were used as model inputs. Model development was guided by predictive error, implementation feasibility and the interpretability of findings to stakeholders.

Edj is also researching this and other life sciences applications for commercial pharma companies. Risk mitigation, predictive ARBM, HEOR, patient-centric risk/benefit analysis and pharmacovigilance are a few of Edj’s areas of work. 

Edj will be presenting at the DIA Global Annual Meeting on Monday, June 24 to discuss how machine learning is being used in the real world to mitigate and manage risk in the pharmaceutical manufacturing sector. For more information on DIA Global, visit www.diaglobal.org.

About EdjAnalytics

EdjAnalytics was founded on the premise that a team of expert data scientists working on a diverse array of complex problems creates a breadth of experience that is valuable across multiple industry verticals. Today, EdjAnalytics empowers smarter decision making with analytical models and custom software solutions in verticals such as life sciences, healthcare, workforce intelligence, education and sports. EdjAnalytics’ approach helps organizations support evidence-based decisions by unlocking the predictive power of data. For more information, visit www.edjanalytics.com.

About U.S. Food and Drug Administration (FDA)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. For more information, visit www.fda.gov.

# # #