News
Following a successful hybrid members meeting on May 16th to review the IQ DILI Initiative portfolio, the IQ Consortium Drug Induced Liver Injury Initiative (IQ DILI) co-organized an in-person conference on May 17th in Washington DC with speakers and attendees from FDA, NIH, industry, and academia to discuss emerging topics and research on DILI. The conference was successful with 80+ attendees. You can access copies of the presentations available for public sharing here!
May 2024
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.
February 2024
January 2024
IQ DILI is thrilled to announce the publication of our latest manuscript, Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative. This publication is the work of the IQ DILI in Elderly Working Group. The manuscript has been published in Drug Safety and is available here. Congratulations to the authors!
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!
October 2023
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.
June 2023
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.
May 2023
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.
March 2023
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.
February 2023
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.
November 2022
June 2022
IQ DILI was featured in the June 2022 CIOMS newsletter, including information on our working groups, publications, and data sharing efforts. Read more here.
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!
April 2022
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.
February 2022
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.
January 2022
November 2021
The IQ DILI Initiative marks its 5 year anniversary in 2021. In this video, IQ DILI leaders reflect on the impact of the Initiative to drug-induced liver injury and the value of IQ DILI’s collaborative environment.
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
September 2021
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.
June 2021
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.
May 2021
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.
March 2021
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.
November 2020
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.
November 2020
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.
September 2020
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.
August 2020
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!
April 2020
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.
March 2020
February 2020
IQ DILI is thrilled to report that our paper “Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease” was one of the most downloaded papers published in Alimentary Pharmacology & Therapeutics (AP&T) in December 2019. Congratulations to the dedicated authors!
November 2019
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 acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease. Their findings, featured in Alimentary Pharmacology & Therapeutics, 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.
September 2019
In collaboration with the IQ Drug Induced Liver Injury Initiative (IQ DILI), Biomarkers and DILI experts from across academia, industry, and US FDA have collaborated to develop comprehensive guidelines addressing best practices for the collection of bio specimens that are consented for future use. Properly archived bio specimens will aid in the development and qualification of DILI biomarkers, as well as other biomarkers relevant to drug development. Their findings, featured in Clinical Pharmacology and Therapeutics, are based on extensive literature review and discussions between numerous drug safety & DILI subject matter experts to achieve consensus on general practices recommended for adequate collection and storage. This includes the logistics of the sample collection, but also consent documentation and the collection of clinical data that is temporally related to the sample. The publication is available here.
June 2019
IQ DILI welcomes Novartis 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.
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.”
May 2019
May 2019
IQ DILI welcomes EMD Serono and Gilead 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.
April 2019
At the 2019 World Drug Safety Congress Americas, Daniel Seekins (Bristol-Myers Squibb, IQ DILI Co-Chair) and Alexandre Kiazand (AstraZeneca, IQ DILI Co-Chair Elect) gave a podium presentation on “Approaching Drug-induced Liver Injury (DILI): how to build an industry-led effort that focuses on clinical aspects of DILI by defining best practices and addressing regulatory gaps for detection, monitoring, management and prevention.”
March 2019
In collaboration with the IQ Drug Induced Liver Injury Initiative (IQ DILI), nonalcoholic steatohepatitis (NASH) and DILI experts from across academia, industry, and US FDA have collaborated to develop comprehensive guidelines addressing best practices for detection, assessment and management of DILI in clinical trials. Their findings, featured in Alimentary Pharmacology & Therapeutics, 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.
NASH is presently the most common cause of chronic liver disease worldwide, and a leading indication for liver transplantation in the Western world. Over the last decade, there has been an acceleration in the search for new therapies for NASH, and the number of clinical trials enrolling NASH patients is growing rapidly. Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected DILI compared to patients with healthy livers. However, until now, no regulatory guidelines or position papers systematically addressed best practices pertaining to DILI in NASH clinical trials. To address this critical gap, the IQ DILI Initiative developed this consensus paper in collaboration with DILI experts from academia and FDA. The paper focuses on recommended best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH to support safer, more effective trials in this increasingly prevalent disease.
IQ-DILI welcomes Sanofi as a member of the Initiative. Contact us to learn more about membership opportunities.
March 2019
October 2018
IQ-DILI welcomes GlaxoSmithKline as a member of the Initiative. Contact us to learn more about membership opportunities.
August 2018
The IQ-DILI Initiative Newsletter (Volume V) was released in August 2018. Read the newsletter to learn about recent advancements within the initiative.
June 2018
On June 1, 2018, the IQ-DILI Initiative met in-person with collaborating academic and regulatory experts to finalize white paper recommendations and discuss considerations for potential research questions for the next phase of work.
March 2018
The IQ-DILI Initiative held a successful in-person meeting on March 16, 2018 to allow working groups to meet to make further progress on white paper recommendations, and to begin discussing the next stage of the consortium's work.
December 2017
The IQ-DILI Initiative Newsletter (Volume IV) is now available. Read the newsletter to learn more about our recent meeting and collaborative effort.
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.
October 2017
IQ-DILI welcomes AbbVie as a new member of the Initiative.
Contact us to learn more about membership opportunities.
August 2017
The IQ-DILI Initiative Newsletter (Volume III) is now available. Read more about our recent events and collaborations.
July 2017
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.
June 2017
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.
March 2017
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.
March 2017
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.
February 2017
The IQ-DILI Newsletter Volume II was released in December 2016. Read more about our initiative and progress.
December 2016
Read more about the background and goals of this initiative in the IQ-DILI Newsletter Volume I.