FDA AND BIOINFOGATE AGREE TO EXTEND 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.

Under this MTA, the FDA has agency-wide access to Bioinfogate’s translational safety intelligence portal, OFF-X. The primary objective of the agreement is to evaluate the potential use of Bioinfogate OFF-X™ as a research tool to anticipate adverse events associated with molecular targets and evaluate its utility in the regulatory review process. In addition and as the collaboration enters its third year extension, the FDA will continue to provide feedback on the utility of the OFF-X database and/or any aspects related to new functions.

Unexpected safety issues constitute one of the most disruptive events in clinical research. A translational approach to drug safety that integrates preclinical and clinical data can significantly reduce patient burden and avoid costly failures. In this context, it is essential to detect as early as possible in the drug R&D process the potential safety liabilities associated with new targets, drugs under development and recently marketed compounds.

About FDA CDER

FDA/CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. FDA/CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients.

About Bioinfogate OFF-X

Bioinfogate, a leading data science organization, is the producer of the OFF-X translational safety intelligence portal (https://www.targetsafety.info/). By delivering critical integrated preclinical toxicity and clinical adverse event intelligence coupled to advanced analytics, OFF-X allows safety liabilities to be monitored and anticipated across all phases of drug R&D and post-marketing. Updated daily with expertly curated safety alerts and as of May 2020, the portal covers a range of close to 15,000 targets and over 16,000 drugs & biologics, and is populated with more than 670,000 expertly curated safety alerts associated to over 8,000 adverse effects. OFF-X covers targets and drugs in all stages of drug R&D from emerging and first-in-class targets to drugs that have reached the market. OFF-X aims to promptly identify toxicology and safety signals and de-risk R&D programs. For more information please contact us at info@bioinfogate.com.

BIOINFOGATE’S OFF-X PROVIDES A DEDICATED “COVID-19” SECTION

The COVID-19 section features the latest safety alerts related to drugs being investigated as potential treatments, vaccinations or supportive care. 

To complement the efforts being made worldwide in the fight against COVID-19, Bioinfogate is pleased to announce that they are providing complimentary access to a dedicated “COVID-19” section in OFF-X, the translational safety information portal. This section features the latest safety alerts related to drugs being investigated as potential treatments, vaccinations or supportive care. 

Updated as soon as new information becomes available, the COVID-19 section provides a compilation of safety alerts derived from recent publications related to COVID-19 as well as previous OFF-X content that may be of interest.

Dr Josep Prous, Jr, Executive Director at Bioinfogate commented: “We are very pleased to be able to contribute to the global efforts being made to tackle this pandemic, by helping optimize pharmaceutical R&D and minimize patient risks in clinical trials and beyond”.

The COVID-19 report can be accessed via the OFF-X home page, from the Selected Daily Alerts section. Content can be sorted and/or filtered by target, drug of interest or date. Clicking on any alert jumps to OFF-X and the full alert details.

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.

BIOINFOGATE’S OFF-X REACHES HALF MILLION SAFETY ALERTS

OFF-X has become the largest translational safety and toxicity intelligence portal for drugs and targets of pharmacological interest.

Barcelona, January 13, 2020

Launched in 2017, OFF-X has now reached 500,000 curated safety alerts corresponding to almost 15,000 targets of pharmacological interest and almost 14,500 drugs and biologics.

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.

On reaching this milestone Dr Josep Prous, Jr, Executive Director at Bioinfogate commented:

“We are very pleased that OFF-X has become an essential tool for all those involved in finding better and safer drugs. Our editorial team – comprised of specialists in multiple biomedical research disciplines – has made an outstanding contribution in producing such a large amount of curated information. 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.

Along with the large amount of information available in OFF-X, a series of advanced analytics allow users to fully exploit the OFF-X dataset.

 

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.

BIOINFOGATE SUCCESSFULLY COMPLETES NEOTEC PROJECT SUPPORTED BY CDTI (CENTER FOR THE DEVELOPMENT OF INDUSTRIAL TECHNOLOGY)

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.