IQ-DILI Initiative: Pharmacovigilance & Risk Mitigation Working Group
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1 IQ-DILI Initiative: Pharmacovigilance & Risk Mitigation Working Group Frank S. Czerwiec, M.D., Ph.D. Co-Chair Vice President, Global Clinical Development Otsuka Pharmaceutical Development & Commercialization, Inc. 1
2 Working Group Objectives Identify academic/industry/regulatory consensus for realworld best practices for medicines with an identified DILI risk Illustrate (with examples) the principles for determining when routine labelling (contraindications/warnings/precautions) is inadequate to communicate DILI risk and for which: a US Risk Evaluation and Mitigation Strategy (REMS) is required and additional Elements To Assure Safe Use (ETASU) are needed the EU Risk Management Plan (RMP) may require Additional Risk Minimization Measures (ARMM) Examine current approaches and tools used to assess, mitigate and monitor (PV) DILI risk with respect to effectiveness and burden 2
3 Literature Survey, Data Sources for Proposed White Paper Search PubMed literature for DILI risk evaluation, mitigation & PV outcomes Review Regulatory Guidance for risk mitigation (DILI or general) & PV practice Review academic/collaborative databases of DILI associated therapies Review recent drug applications and approvals describing liver injury or DILI Medical Review/Advisory Committee minutes Labels, Medication Guides & SmPC REMS with or without ETASU RMP with or without AARM Survey experience on effectiveness and burden of established practices for DILI risk evaluation, mitigation and PV monitoring among: IQ-Consortium Industry members Academic members Regulatory members Patient advocacy groups Outline best practice for risk assessment, mitigation, and monitoring of DILI from late development to real-world use 3
4 White Paper Objectives Review: 1. Current best practices in characterizing DILI risk including: 1. its potential mechanisms 2. its characteristic presentation (seriousness and temporal nature) 3. its incidence in the intended treatment population 2. Approaches for assessing the unmet need (the treated disease s seriousness and incremental benefit of new drug) 3. Evaluation of controllable and uncontrollable risks: 1. extent of exposure (treatment duration and population size) 2. risks for unintended use/misuse of new drug 4. Likelihood of effective mitigation relative to expected burden 4
5 Key Elements of Risk Management Implement & assess effectiveness vs burden Identify & Analyze Risk Collect & analyze data to identify & characterize risk Predictable, dose-dependent mechanisms vs. idiosyncratic risk Subpopulations with greater/lesser risk Determine relative benefit of intervention Subpopulations with greater/lesser benefit Potential scope of intervention s use/misuse Formulate benefit-risk (B-R) balance Formulate & select plan Evaluate B-R & potential modifiers Evaluate potential for risk mitigation (modifying B-R balance) Select optimal risk minimization tools (considering burden) Implement evaluation plan to assess effectiveness & compliance Iterate to adjust risk minimization tools to improve effectiveness Determine Benefit 5
6 Risk Management & PV Monitoring Tools Routine Labeling Risk Management Dosage & Administration, Contraindications, Special Populations Labeling Risk Communication Adverse Drug Reaction Tables, Warnings & Precautions, Boxed Warnings (USPI) PV Monitoring Spontaneous reports, mining external databases, signal detection and PSUR Enhanced Risk Management Special Communications (Dear HCP letters, patient alert cards, press releases, etc.) Special Training (Registered users, HCP certification) Special Testing (Lab & Treatment Protocols) Controlled Access (Specialty Pharmacy, HCP certification, patient registry) Frequent Assessment/Reporting of risk mitigation effectiveness PV Monitoring Post-approval safety studies/registries 6
7 IQ-DILI PV-RM Working Group Members Frank S. Czerwiec MD, PhD (Otsuka) Co-chair Loreta Marquez MD (Janssen, Johnson & Johnson) Co-chair Ananya Bhattacharya PhD, CMPP (Bristol Meyers Squib) May Chan-Liston PharmD, MPH (Celgene) Alvin Estilo MD (Otsuka) Reem Elbekai PhD, DABT (Otsuka) Liliam Pineda Salgado MD, PhD (Otsuka) Teresa Hines BS (Otsuka) Haifa Tyler MT, MA, PMP (Otsuka) John Marcinak MD (Takeda) Lisa Hawley RN, BSN, MSM (Takeda) Ann Marie Stanley, PhD (IQ Consortium Secretariat, DBR) 7
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