Early Go / No Go Decisions

Early Go / No Go Decisions

Objective Go / No Go Decision Early

Our customer, a public global pharmaceutical company based in the USA with a therapeutic focus on auto-immune diseases, used a global CRO to conduct a Phase IIb study of its lead product candidate, which involved over 450 randomized patients at over 50 sites. The study did not achieve the primary or secondary endpoints. The Company’s stock price fell nearly 20% the morning after announcing the results.

In repeating the study, the Company wanted a better much more sensitive methodology to differentiate placebo and patient groups, greater visibility of the data in order to make early agile go / no go decisions based on the interim analyses.

IAG’s team has conducted the study and integrated output from the study sites, investigators and various dispersed information systems into a single manageable database within DYNAMIKA, giving the study team members 24/7 visibility into ALL of the data and activities throughout the study.

Furthermore, IAG has designed a new sensitive scoring methodology for the assessment of auto-immune disease manifestations in the imaging data, allowing to make early decisions on the expected treatment efficacy. Our experts also introduced a robust approach to imaging data management and analysis, allowing the Company to make early decisions.

DYNAMIKA provided a single point of access and analysis of live data from numerous internal and external information systems. The Company was able to make informed decisions while conducting the study based on the 11 customized reports, including a Site Performance, Custom Queries Management, Trial Dashboard. At the very start of the study,  IAG’s Trial Solutions team conducted study-specific training which brought together investigators and imaging sites (technologists) with the aim to explain the critical importance of data quality and its direct link to the primary and secondary end points.

The early visibility of clean data enabled the Company to attract a licensing partner who paid an undisclosed amount for the U.S. rights to the drug before the study was completed. The announcement of positive top line results also drove the Company’s share price 150% above its 52 week low.

About IAG

IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. wp1.ia-grp.com