News

The IQ Consortium Drug Induced Liver Injury Initiative (IQ DILI) is pleased to announce its newest publication entitled: Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy. IQ DILI collaborated with experts from academia, the FDA, and industry to understand  current  and define new best practices. The publication is available here.

IQ DILI is thrilled to announce the publication of our latest manuscript, Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use. This publication is the work of the Risk Mitigation and Pharmacovigilance Working Group. The manuscript has been published in Drug Safety and is available here. Congratulations to the authors!

On June 15 - 16, 2023 IQ DILI hosted a hybrid meeting in Washington, DC, including both in-person participants and virtual. The meeting included presentations by and participation from IQ DILI working groups, FDA, and academic collaborators. Our next in-person event will be held in November 2023 in Boston, MA around the AASLD Liver Meeting.

IQ DILI hosted a Lunch & Learn webinar for members of the IQ Consortium, IQ DILI’s parent organization. IQ DILI leadership discussed an in depth overview of the IQ DILI portfolio and ongoing activities for those interested in learning and further involvement. Contact us to learn more about joining the IQ Consortium or IQ DILI.

IQ DILI released its 2022 Annual Report. The report details our focus, activities, and initiatives throughout the year and celebrates the continued successes of IQ DILI thanks to the dedication of our members. Contact us to learn more.

IQ DILI has launched a New Gene Therapy Working Group, focused on characterizing hepatic toxicity in emerging gene therapies and develop consensus recommendations for standardized monitoring, assessment, and management for DILI. Contact us to learn more about this working group’s goals and activities, and how to become a member and participate.

IQ DILI members met in-person on November 2 - 3, 2022 in Washington, DC to collaborate on publication and data sharing topics, and to develop a roadmap for addressing new areas in drug-induced liver injury. This meeting seamlessly incorporated in-person and remote participation, marking IQ DILI’s first face-to-face interaction since the COVID-19 pandemic.

IQ DILI has extended its trial membership offer through the end of 2022!

Trial members will be able to participate in all IQ DILI events, working groups, and meetings for one year, with limited access to IQ Consortium events, for only the cost of IQ DILI membership. After one year, trial members can join both IQ and IQ DILI to continue participation.

The trial membership is available to pharma and biotech companies. Contact info@iqdili.org to learn more and begin collaborating with us!

With sadness, IQ DILI offers condolences on the passing of Dr. John Senior. Dr. Senior was a true giant in the field of drug-induced liver injury who made foundational contributions. His engagement, leadership, and lifelong passion in this topic are inspiring for all of us. Read more on Dr. John Senior’s career and legacy.

IQ DILI welcomes Amgen as the newest member of the Initiative. Contact us to learn more about how your company can collaborate to address challenges in drug-induced liver injury.

Join IQ DILI Initiative and the The Forum for Collaborative Research on September 20 for a webinar showcasing IQ DILI publications on cholestatic liver disease, NASH, and causality assessment in DILI. Presenters will include Arie Regev M.D., Judith Hey-Hadavi, and John Marcinak. Register for the webinar here: https://lnkd.in/dvbKtNBM

IQ DILI welcomes Daiichi Sankyo and Mirum Pharma as the newest members of the Initiative. Contact us to learn more about how your company can collaborate to address challenges in drug-induced liver injury.

The IQ DILI Initiative is launching a trial membership available to pharma and biotech companies. Trial members will be able to participate in all IQ DILI events, working groups, and meetings for 1 year, with limited access to IQ Consortium (https://iqconsortium.org) events, for only the cost of IQ DILI membership. After 1 year, trial members can join both IQ and IQ DILI to continue participation.

Trial memberships will only be available through the end of 2021. Contact the Secretariat now at info@iqdili.org to learn more.

The IQ Consortium Drug Induced Liver Injury Initiative (IQ DILI) is pleased to announce its newest publication. IQ DILI collaborated with experts from academia, the FDA, and industry to understand  current  and define new best practices; assess the utility of existing resources; propose a minimal dataset to assess causality, and develop a universal approach to DILI causality assessment for clinical development. Their findings, featured in Drug Safety, are based on extensive literature review and discussions between numerous drug safety & DILI subject matter experts to achieve consensus on common questions related to this crucial topic. The publication is available here.

IQ DILI would like to express its deep gratitude and appreciation for the contributions of Dr. Naga Chalasani (Indiana University School of Medicine), who served as the founding academic chair for the IQ DILI Initiative from 2016-2020. During these 4 years, Dr. Chalasani contributed outstanding leadership, close partnership, and exceptional productivity as the Initiative’s Academic Chair. Dr. Chalasani has contributed significantly to shaping the progress and publications of IQ DILI’s working groups. Dr. Chalasani also helped foster a thriving collaboration among academic and regulatory thought leaders and industry colleagues, which has been a critical element in the development of IQ DILI’ manuscripts and consensus recommendations. IQ DILI is deeply grateful for Dr. Chalasani’s hard work and invaluable contributions.

As Dr. Chalasani completes his term as academic chair this month, IQ DILI is very pleased to announce and welcome Dr. Jim Lewis (Georgetown University Hospital) as the incoming 2021-2022 Academic Chair for IQ DILI. IQ DILI looks forward to Dr. Lewis’s leadership and IQ DILI’s continued collaboration with DILI thought leaders outside of industry to continue to advance the development of best practices for the detection, monitoring, management and prevention of DILI in clinical trials and post-marketing pharmacovigilance programs, in order to positively impact the drug development process and enhance patient safety.

The IQ Consortium Drug Induced Liver Injury Initiative (IQ DILI) is pleased to announce its newest publication. IQ DILI collaborated with experts from academia, the FDA, and industry to develop comprehensive consensus recommendations for monitoring for, diagnosing, and managing potential DILI events during clinical trials in patients with Hepatitis B, Hepatitis C, and cirrhosis from viral hepatitis or NASH.  This is part of an ongoing effort by IQ-DILI to develop guidelines for clinical trials in which many or all individuals enter with abnormal baseline liver tests. Previous papers published by IQ-DILI that are part of this workstream have focused on clinical trials in non-cirrhotic NASH, and in cholestatic liver diseases such as PSC and PBC.  The guidelines and recommendations of the IQ DILI Abnormal Baselines working group featured in the journal Drug Safety are based on an extensive literature review and review of multiple industry sponsored clinical trials in these indications with iterative discussions between clinicians and subject matter experts from academia, industry, and the FDA to arrive at consensus. The publication entitled, “Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Non-alcoholic Steatohepatitis” is available here. 

IQ DILI welcomes Merck & Co. as the newest member of the Initiative. Contact us to learn more about how your company can collaborate to address challenges in drug-induced liver injury.

The IQ Consortium Drug Induced Liver Injury Initiative (IQ DILI) collaborated with DILI experts from across academia, industry and US FDA to develop comprehensive guidelines addressing best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development. Despite increased awareness of this unique type of live injury, there has been lack of uniform recommendations regarding its detection, diagnosis, monitoring and management during clinical trials for development of new drugs. The guidelines and consensus statements of the IQ DILI Immunotherapy Working Group , featured in the Journal of Auotimmunity, are based on extensive literature review and discussions among numerous drug safety & DILI subject matter experts to achieve consensus on common questions related to this important topic. The publication entitled: “Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development” is available here.

Congratulations to Sharin Roth (Otsuka), Phil Sherratt (BMS), and the Biomarkers Workers Group, whose publication “Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development” was recognized as one of the top 10% most downloaded papers in Clinical Pharmacology & Therapeutics among work published in 2018-2019!

At the 2020 SOT Conference on March 15th - 19th IQ DILI member Sharin Roth (Otsuka) will present a poster based on the IQ DILI manuscript “Next Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development” published last year in Clinical Pharmacology and Therapeutics.

At the 2019 FDA - AASLD Hepatotoxicity Conference IQ DILI member Melissa Palmer (Takeda) presented the poster “Position Paper from IQ DILI Consortium: Best Practices for Detection, Assessment and Management of Suspected Acute Drug Induced Liver Injury During Clinical Trials in Adults with Chronic Cholestatic Liver Disease.”

Arie Regev (Eli Lilly, IQ DILI Co-Chair Emeritus) also gave a plenary presentation at the Conference on “Industry Perspectives and Initiatives to Fill Key Gaps in the Guidance.”

IQ-DILI welcomes Sanofi as a member of the Initiative. Contact us to learn more about membership opportunities.

IQ-DILI held a meeting on October 19 with two plenary sessions and breakouts for all six working groups. Over fifty participants attended, including member company representatives and academic and regulatory experts.

IQ-DILI welcomes AbbVie as a new member of the Initiative.

Contact us to learn more about membership opportunities.

 The IQ-DILI Initiative Newsletter (Volume III) is now available. Read more about our recent events and collaborations.

On June 5, the IQ-DILI Initiative hosted a successful in-person meeting with academic and regulatory experts in drug-induced liver injury for a deep dive into the efforts and questions, and topics being addressed by the six IQ-DILI working groups. Dozens of stakeholders attended the meeting and make valuable contributions to advancing the prevention, mitigation, and treatment of DILI.

On March 27, the IQ-DILI Initiative hosted a webinar with academic experts to discuss collaboration on vital questions to address DILI in clinical trials and post-marketing pharmacovigilance programs.

Dr. William Treem, Co-Chair of the DILI initiative, presented an update on the Initiative's activities at the IQ Consortium Board of Directors meeting in early March. The presentation was well-received and the Board commended the group for the significant progress it has made.

The IQ-DILI Initiative held a successful in-person meeting on February 7 - 8, 2017 to hear updates from working groups, allow working groups to meet and make significant progress on their efforts, and to discuss potential collaboration with representatives from academia, regulatory authorities, and other stakeholders.

The IQ-DILI Newsletter Volume II was released in December 2016. Read more about our initiative and progress.

Read more about the background and goals of this initiative in the IQ-DILI Newsletter Volume I.