BIOINFOGATE’S OFF-X REACHES ONE MILLION SAFETY ALERTS
Launched in 2017, OFF-X has now reached 1,000,000 safety alerts corresponding to over 15,000 targets of pharmacological interest and more than 21,000 drugs and biologics.
This represents the largest collection of data correlating toxicity and safety findings surrounding targets of pharmacological interest and their associated drugs, from early discovery up to pharmacovigilance.
Unexpected safety issues still constitute one of the major challenges in drug R&D and clinical practice. It is therefore essential to rapidly identify these issues and react accordingly to minimize risks in pharmaceutical programs.
To help in this endeavor, Bioinfogate has developed OFF-X, the translational safety intelligence portal, which provides integrated preclinical toxicity and clinical adverse event intelligence for drugs and targets in all phases of R&D, including first-in-class and emerging targets.
The database is updated daily with information deriving from biomedical literature, congresses and scientific conferences, company communications, major clinical trial registries, pharmacovigilance data and regulatory agencies, and includes data from the last 50 years.
These continued efforts have been paralleled with the incorporation of analytics to navigate and take full advantage of the OFF-X dataset. In that regard, recent enhancements in the OFF-X portal include the OFF-X Translatability Dashboard (supports understanding of how toxicity events derived from experimental assays and animal models translate to the clinic), the Secondary Pharmacology Section (an integrated view outlining relevant secondary pharmacology insights commonly used to delineate the safety profile of investigational drugs), updates to the OFF-X Chemistry Dashboard (assessment of potential compound- vs target-related liabilities), the Drug Combination Area (supports the discovery of potential synergistic adverse effects observed only in combination therapies), and the Adverse Event / SMQ view (allows users to navigate adverse events classified following Standardized MedDRA Queries).
On reaching this milestone Dr Josep Prous, Jr, Executive Director at Bioinfogate commented:
“We are very pleased that OFF-X has reached this milestone driven by the translational research needs for all those involved in finding better and safer drugs. Our team of analysts – comprised of specialists in multiple biomedical research disciplines – has made an outstanding contribution in reaching this milestone. We look forward to further developing the platform to help optimize pharmaceutical R&D and minimize patient risks in clinical trials and beyond”.
By enabling translational research, OFF-X allows safety liabilities to be monitored and anticipated across all phases of drug R&D and postmarketing. OFF-X is used across a wide range of departments in pharmaceutical research organizations, public health institutions and regulatory agencies.
Bioinfogate is a forward thinking, private company working to solve unmet medical needs. Our innovative data science products support the discovery and development of better and safer drugs. We are committed to building industry-leading solutions and identifying / investing in emerging projects that align with our core business in the life sciences and data analytics.
Our passion and capabilities stem from more than 60 years of experience creating and managing biomedical knowledge, first at Prous Science (1958-2007), acquired by Thomson Reuters in 2007 (now Clarivate Analytics), and then at Prous Institute for Biomedical Research. Bioinfogate is the latest initiative within the Prous family group of companies embracing a long tradition and expertise in scientific knowledge management.
CLARIVATE ACQUIRES BIOINFOGATE, REINFORCING POSITION AS PREMIER PROVIDER OF END-TO-END RESEARCH INTELLIGENCE SOLUTIONS FOR LIFE SCIENCES
Expanding and integrating drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle, allowing customers to make more informed decisions
Aug 04 ,2021
FDA AND BIOINFOGATE AGREE TO EXTEND FOR 2 ADDITIONAL YEARS THE MATERIAL TRANSFER AGREEMENT (MTA) TO PROVIDE AGENCY-WIDE ACCESS TO THE OFF-X TRANSLATIONAL SAFETY INTELLIGENCE PORTAL
The agreement aims to evaluate new approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets, supporting the FDA’s mission of protecting public health.
May 12 ,2021
EXTERNAL VALIDATION OF BIOINFOGATE’S OFF-X FAERS CURATION PROCESS & STATISTICAL SIGNAL EXTRACTION TO BE SUPPORTED BY INTAGE HEALTHCARE’S CZEEKV PRO
Bioinfogate has established an agreement with INTAGE Healthcare to perform an external validation of their methodologies to curate information from FAERS and extract safety signals using well-established statistical methods with the CzeekV Pro database system.
Mar 22 ,2021