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.
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.”
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.”
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.
The IQ-DILI Initiative Newsletter (Volume V) was released in August 2018. Read the newsletter to learn about recent advancements within the initiative.
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.
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.
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.
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.