Tokyo / Barcelona.

Bioinfogate will integrate JADER case reports and pharmacovigilance signals into OFF-X to complement its unique translational view of safety intelligence.

Bioinfogate, a leading healthcare data science organization, today announced it has entered into a global agreement with INTAGE Healthcare (hereafter “INTAGE”) to integrate Japanese pharmacovigilance insights from the JADER database (the Pharmaceuticals and Medical Devices Agency (PMDA) database of spontaneous adverse drug reaction reports in Japan).

Based on its long standing experience managing and curating the JADER and FAERS databases, INTAGE will provide a curated dataset of case reports and derived signals to be integrated with OFF-X’s expertly curated safety data and analytics. INTAGE is the producer of the CzeekV Pro database system, offered since 2010, a curated database of FAERS and JADER spontaneous adverse reports and signals based on well-established methods used by a variety of regulatory bodies worldwide.

By delivering critical integrated target discovery, preclinical toxicity, clinical adverse event intelligence and pharmacovigilance insights coupled to advanced analytics, Bioinfogate OFF-X™ allows safety liabilities to be monitored and anticipated across all phases of drug R&D and post-marketing. OFF-X is updated daily: more than 4,000 expertly curated alerts are added to the portal each week.

Launched in 2016, OFF-X is used across pharma and biotech organizations, in leading research centers and by regulatory bodies around the world, addressing the need for new approaches to enhance safety assessments that can reduce patient burden and avoid costly failures.

About Bioinfogate

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 and investing in emerging projects that align with our core business in the life sciences and data analytics.

About Bioinfogate OFF-X™

The Bioinfogate OFF-X™ portal provides integrated target discovery, non-clinical and clinical adverse event intelligence and pharmacovigilance insights for drugs and targets in all phases of drug R&D and post-marketing. As of October 2020, the portal covers a range of over 15,000 targets and almost 19,500 drugs & biologics, and is populated with more than 875,000 expertly curated safety alerts associated to over 9,000 adverse effects. OFF-X is used across pharma and biotech organizations, in leading research centers and regulatory bodies.

For more information visit www.targetsafety.info

About INTAGE Healthcare

INTAGE Healthcare combines deep knowledge of clinical practice with the INTAGE Group’s abundant resources and strength in consumer insights to provide healthcare consumers, providers, manufacturers, and service companies with the information they need to make healthier decisions.

For more information visit https://www.intage-healthcare.co.jp/

About INTAGE Healthcare CzeekV Pro

The INTAGE Healthcare CzeekV Pro is a system that searches publicly available spontaneously reported adverse event databases for the relationship between drugs and adverse events using statistical analysis methods. The system integrates JADER and FAERS, and calculates and registers score values indicating the relationship between “drugs-adverse events”. The score value is calculated as a statistical method to evaluate significance and adopts the same method as the world’s major regulatory institutions and displays four score values.

It is also equipped with an age-specific histogram, signal distribution map, detailed statistical analysis function by age and gender, and a report list browsing function, which are useful as safety monitoring tools and analysis tools.

For more information visit https://pro.czeek.com/

The Translatability Dashboard supports understanding of how toxicity events derived from experimental assays and animal models translate to the clinic

Bioinfogate is proud to announce the launch of the new OFF-X Translatability Dashboard. The Dashboard supports understanding of how toxicity events derived from experimental assays and animal models translate to the clinic, allowing researchers to prioritize experimental testing and anticipate potential safety issues when designing clinical trials and identify emerging class liabilities.

The translatability dashboard concept has been developed based on the unique and vast array of information in OFF-X, which spans over 14,000 targets of therapeutic interest and almost 800,000 individual alerts manually curated by the Bioinfogate editorial team in the last 5 years. The availability of data from knockout studies, human genetics and pharmacological intervention demonstrate how varying action at the molecular level (e.g. activation, inhibition, inactivation) of the pathway can lead to a benefit for –or in some cases detriment to –patients.

Bioinfogate OFF-X delivers actionable toxicity and safety intelligence to researchers and decision makers in pharmaceutical and healthcare organizations. By delivering critical integrated preclinical toxicity and clinical adverse event intelligence coupled to advanced analytics, Bioinfogate OFF-X allows safety liabilities to be monitored and anticipated across all phases of drug R&D and post-marketing. OFF-X provides integrated information for drugs and targets in all phases of drug R&D, including first-in-class and emerging targets.

The OFF-X Translatability Dashboard can be used in a variety of drug R&D scenarios, including target safety assessments, mechanistic understanding of potential toxicity issues, identifying ways and models that could be used to monitor or assess adverse events, building new panels for off-target assessment, understanding differences in effect between healthy volunteers and diseased patients to support clinical efficacy/safety findings, and analyzing reverse translation from clinical/post-marketing adverse events.

Dr Josep Prous, Jr, Executive Director at Bioinfogate commented: “We are very pleased to add this new functionality in OFF-X and to position the tool as a unique translational safety intelligence portal, from early target discovery to pharmacovigilance needs. This responds to the needs of our customers in pharmaceutical research organizations, regulatory bodies and clinical research organizations who rely on OFF-X as a unique resource in the finding of safer drugs in any therapeutic area of interest.”

About Bioinfogate

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.

Barcelona, December 31, 2019

Bioinfogate is pleased to announce successful completion of the R&D innovation project “DEVELOPMENT OF AN ARTIFICIAL INTELLIGENCE PLATFORM TO ANTICIPATE AND MINIMIZE THE RISKS ASSOCIATED WITH THE SAFETY OF DRUGS FROM THEIR PHASE OF DISCOVERY THROUGH THEIR USE IN CLINICAL PRACTICE”.

The program has been supported by the CDTI (Center for the Development of Industrial Technology) NEOTEC initiative.

The NEOTEC program aims to support the creation and consolidation of technology-based companies (TBCs). A TBC is defined as a company that makes use of products or services that need technologies or knowledge developed from research activity. The business strategy of a TBC requires mastery of scientific and technical knowledge. The most important aspect of the proposals considered for this grant is a business strategy based on technological development (technology must be the company’s defining competitive factor) from the company’s own R&D.

Dr Josep Prous, Jr, Executive Director at Bioinfogate commented: “We are very honored to have been supported by CDTI’s NEOTEC program, and to have successfully completed the surrounding technological and business objectives. This institutional support has proven instrumental in accelerating Bioinfogate’s innovation and growth.”

Details on the specific details of CDTI’s NEOTEC program can be found here.

About Bioinfogate

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.

About CDTI

The Centre for the Development of Industrial Technology (CDTI) reports to the Ministry of Economy, Industry and Competitiveness and fosters the technological development and innovation of Spanish companies. It channels funding and support applications for national and international R&D&I projects. CDTI’s roles include financial and economic-technical assessment of R&D projects, managing and fostering participation in international technological cooperation programs, fostering international business technology transfer and supporting the set-up and consolidation of technological companies.