VHIO AND BIOINFOGATE PARTNER TO ENHANCE SAFETY ASSESSMENT IN CLINICAL RESEARCH

Announced today, the Vall d´Hebron Institute of Oncology – Bioinfogate collaboration will validate the utility of the OFF-X translational safety intelligence portal in the design of novel clinical trials, including first-in-human studies.

Barcelona, June 17, 2019

The Vall d´Hebron Institute of Oncology (VHIO) and Bioinfogate have launched a collaborative agreement to analyze new opportunities in optimizing safety assessment and minimizing patient risk in oncology clinical trials. This partnership will seek to establish how integrating preclinical toxicity and clinical safety intelligence facilitates a translational research approach and increases understanding of the safety profile of new treatments.

The agreement involves the use of publicly available information published in Bioinfogate’s OFF-X translational safety intelligence portal to more quickly and precisely identify potential adverse events resulting from treatment with new therapies that are either about to enter clinical trials or are under current clinical development.

A first milestone of the collaboration will be to assess the value of the new OFF-X Score system to identify the degree of association between targets/drugs and adverse effects in the corpus of more than 340,000 alerts available in OFF-X.

Throughout this collaboration, VHIO will bring its renowned expertise and know-how in pioneering early clinical drug development to evaluate and advise on newly introduced functionalities of the OFF-X platform. These efforts focus on advancing and accelerating the development of more effective and safer anti-cancer therapies, set firmly within the context of precision medicine in oncology.

“Only by factoring in important preclinical insights into clinical study design will we be better equipped to predict, ameliorate and alleviate side effects experienced by patients participating in clinical trials, now and in the future” commented Elena Garralda, Director of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – “la Caixa”, and Principal Investigator of its Early Clinical Drug Development.

“Toxicity and safety assessment represent, along with a deeper understanding of disease processes, next generation experimental models and biomarkers, one of the cornerstones of finding and developing new anticancer therapies. We are very pleased to partner with VHIO, a leading research organization in the field, to demonstrate the usefulness of OFF-X in the clinical setting” commented Josep Prous, Jr., Executive Director, Bioinfogate.

 

About Vall D’Hebron Institute of Oncology

Established in 2006, the Vall d´Hebron Institute of Oncology (VHIO) is a leading comprehensive cancer center of excellence where scientists and research physicians adopt a purely translational research model and work together as multidisciplinary teams to accelerate and advance personalized and targeted therapies against cancer. Undertaking one of Spain’s most dynamic cancer research programs, VHIO is dedicated to delivering on the promise of precision medicine in oncology – turning cancer discovery into more effective treatments and better practice for the care of their patients. Located within the Vall d’Hebron Barcelona Hospital Campus, translational science and clinical research are tightly connected and promote the necessary interaction and teamwork to accelerate the bench-bedside-bed cycle of knowledge. VHIO’s pioneering model and programs, coupled with its belief in combining strengths through cross-border collaborations, continue to spur advances in reversing cancer resistance, halting metastatic cell spread, and more effectively treating even the most undruggable tumor types.

 

About Bioinfogate OFF-X™

Bioinfogate, a leading data science organization, is the producer of the OFF-X translational safety intelligence portal (www.targetsafety.info). 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. Updated daily with expertly curated safety alerts, as of June 2019, the portal covers a range of 7,700 targets and more than 10,000 drugs & biologics, and is populated with more than 340,000 alerts associated to 5,000 adverse effects. OFF-X covers targets and drugs in all stages of drug R&D development from emerging and first-in-class targets to drugs that have reached the marketplace. OFF-X aims to promptly identify toxicology & safety signals and de-risk R&D programs.

For more information please contact us at media@bioinfogate.com

BIOINFOGATE EXHIBITING AT WORLD PHARMA WEEK IN BOSTON, MA (JUNE 17-20, 2019)

June 14, 2019  

Bioinfogate will be showcasing some of their recent developments at World Pharma Week in Boston, MA, June 17-20 2019.

At the exhibition (booth 133, shared with Chemotargets), the latest version of the translational safety intelligence portal OFF-X will be presented, including new features like the OFF-X Score – a tool to identify the degree of association between targets/drugs and adverse effects in the corpus of more than 340,000 alerts available in OFF-X.

Since its launch in 2017, Bioinfogate OFF-X has been providing 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. OFF-X allows prompt identification of toxicology and safety signals and de-risking of R&D projects. As of June 2019, the portal covers a range of 7,700 targets and 10,000 drugs & biologics, and is populated with more than 340,000 expertly curated safety alerts and 500,000 references of interest associated to 5,000 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).

A series of case studies will be presented to demonstrate OFF-X’s utility for a wide variety of professionals including:

  • Biologists and Bioinformaticians, to perform new target safety assessment
  • Medicinal Chemists, to identify potential toxicophores and optimize hit compounds
  • Data Scientists, to build predictive and AI models using OFF-X’s high quality curated and structured dataset
  • Toxicologists and Non-Clinical Safety Researchers, to analyze data for regulatory endpoints of interest, assess secondary pharmacology and potential off-target liabilities
  • Clinical Researchers, to optimize clinical trial design, understand mechanistic toxicity of adverse events observed in clinical trials and to benchmark competitors’ safety profiles
  • Pharmacovigilance teams to discover unknown adverse events and support understanding of safety alerts
  • Regulatory professionals, to facilitate mandatory reporting requirements of regulatory bodies
  • Business Development Analysts, to enhance due diligence of potential in-licensing opportunities

For further information or to schedule a meeting during the conference, please contact info@bioinfogate.com.

 

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.

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), 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.

FDA AND BIOINFOGATE AGREE TO EXTEND THE MATERIAL TRANSFER AGREEMENT (MTA) TO ACCESS THE OFF-X TRANSLATIONAL SAFETY INTELLIGENCE PORTAL

Barcelona, May 21, 2019.

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. Under the recently extended agreement, the FDA will continue to provide feedback on the utility of the OFF-X database and/or any aspects related to its functioning and use.

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 to both new targets and drugs under development.


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-XTM

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. Updated daily with expertly curated safety alerts and as of June 2019, the portal covers a range of 7,600 targets, close to 10,000 drugs & biologics, and is populated with more than 315,000 expertly curated safety alerts associated to 5,000 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.

NEW ALLIANCE BETWEEN CLARIVATE ANALYTICS AND BIOINFOGATE TO DELIVER SAFETY & TOXICITY INTELLIGENCE TO PHARMA AND HEALTHCARE RESEARCHERS AND DECISION MAKERS

Philadelphia / Barcelona, February 28, 2019

Bioinfogate will cross-link the OFF-X translational safety intelligence portal with the Cortellis suite of solutions from Clarivate Analytics to enable enhanced insights for targets and drugs of interest

Bioinfogate, a leading healthcare data science organization, today announced it has into a global agreement with Clarivate Analytics to cross-link the OFF-X safety intelligence portal with Cortellis preclinical intelligence. In addition, Clarivate will leverage its commercial footprint to expand OFF-X usage to life science professionals who are benefiting from Cortellis, its suite of life sciences data and analytics solutions. The agreement makes it easier for customers to integrate, access and apply toxicity and adverse events intelligence across all phases of drug research and development (R&D).

Toxicity and adverse events cause more than 30% of drugs to fail during the R&D process, which costs the industry approximately $35 billion each year. 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 early safety assessments that can reduce patient burden and avoid costly failures. Updated daily, OFF-X enables safety liabilities to be monitored and anticipated across all phases of drug R&D.

In this partnership, both organizations have also agreed to identify, develop and deploy new capabilities, including additional platform cross-linking, content syndication, and API-enabled integration to ensure interopability. Cortellis drug and target ontologies are used within OFF-X to provide platform linkages, which pave the way for enhanced data delivery.

“We are pleased to partner with Clarivate Analytics to expand and accelerate the reach of our safety and toxicology data assets,” commented Josep Prous, Jr., Executive Director, Bioinfogate. “We look forward to expanding the OFF-X value proposition by giving researchers and regulators access to complementary data, analytics and insights in Cortellis.”

“Ensuring drug safety is of vital importance to our industry, and enabling the interoperability between Cortellis and the OFF-X platform will help to advance this goal,” said Mukhtar Ahmed, President, Life Sciences, Clarivate Analytics. “Through this partnership, we’ll be able to significantly expand the reach – and utility – of critical drug efficacy and safety information to researchers around the world.”

 

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.

Our passion and capabilities stem from more than 60 years’ experience creating and managing biomedical knowledge, first at Prous Science (1958-2007, acquired by Thomson Reuters in 2007), and then at Prous Institute for Biomedical Research. Bioinfogate is the latest initiative within the Prous Group of companies to embrace a long tradition and expertise in scientific knowledge management.

For more information visit www.bioinfogate.com

 

About Bioinfogate OFF-XTM
The Bioinfogate OFF-XTM portal provides integrated preclinical toxicity and clinical adverse event intelligence for drugs and targets in all phases of drug R&D, including first-in-class and emerging targets. OFF-X allows prompt identification of toxicology & safety signals and de-risking of R&D projects. As of February 2019, the portal covers a range of 15,000 targets and 10,000 drugs & biologics, and is populated with more than 260,000 expertly curated safety alerts and 500,000 references of interest associated to 4,000 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 Cortellis
Cortellis gives life to science by unlocking the hidden insights in data. This industry-leading solution curates the broadest and deepest sources of intelligence to enable precise, actionable answers to specific questions across the R&D lifecycle — from discovery and clinical development through regulatory submission and commercialization. By supporting data-driven decisions, Cortellis helps pharmaceutical companies, biotech and medical device/diagnostic firms accelerate innovation. In 2017, 80% of U.S. companies filing NMEs, 91% of companies achieving breakthrough therapy status and 70% of the top licensing deals were informed by Cortellis intelligence.

To learn more, visit www.Clarivate.com/Cortellis

 

About Clarivate Analytics
Clarivate Analytics is a global leader in providing trusted insights and analytics to accelerate the pace of innovation. Building on a heritage going back more than a century and a half, we have built some of the most trusted brands across the innovation lifecycle, including the Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet. Today, Clarivate Analytics is a new and independent company on a bold entrepreneurial mission, to help our clients radically reduce the time from new ideas to life-changing innovations.

For more information, please visit www.clarivate.com.

 

Forward-Looking Statements
This press release and oral statements made with respect to information contained in this release may contain forward-looking statements regarding Clarivate Analytics. Forward-looking statements provide Clarivate Analytics’ current expectations or forecasts of future events and may include statements regarding anticipated synergies and other future expectations. These statements involve risks and uncertainties including factors outside of Clarivate Analytics’ control that may cause actual results to differ materially. Clarivate Analytics undertakes no obligation to update or revise the statements made herein, whether as a result of new information, future events or otherwise.

 

Media Contacts:
BioInfogate
info@bioinfogate.com

Clarivate Analytics
media.enquiries@clarivate.com

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