Pharmacovigilance and Drug Safety Track AN INDUSTRY PERSPECTIVE

1. Pharmacovigilance and Drug Safety Track AN INDUSTRY PERSPECTIVE Amrit Ray, MD, MBA, FCMI Vice President, Medical Safety - Global Pharmacovigilance & Epidemiology Bristol-Myers Squibb Company

2. Role of QP-PV (responsibilities for QP and MAH) Implementation of Risk Minimization Plans Partner Agreements Increase data sources for PV assessments Formalized, auditable Signal management Increase transparency with Agencies Stricter enforcement of regulations Notification of new safety concerns Single global Quality Mgt System Efficient Routine PV, focus effort on proactive safety Top 10 Pharmacovigilance Issues Chris Holmes, Principal, WCI Consulting Ltd

3. KEY ISSUE: Implementation of Globalized, Proactive Risk Minimization Planning Maintiainng a globalized RM strategy despite locally unique situations and requirements Proactive risk planning requiring assessment earlier on where less data is available Evaluation of risk includes evaluation of meta-analyses and of inter- and intro- organization combined data Rapidly changing regulatory landscape for RM planning (e.g., FDAAA REMS, EU-RMP) Formalized, auditable signal management and integration of findings into Risk Planning KEY ISSUE: Modern trends in risk identification Pharmacogenomics and risk identification Elegant signal detection tools but rely on antiquated adverse event reporting system Extrapolation of surrogate safety endpoints to supplant primary mortality and morbidity endpoints Health authority and industry seeking “personalized medicine” approach to optimizing drug delivery Top Pharmacovigilance Issues – An industry perspective Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb

4. KEY ISSUE: New Approaches to Risk Communication Technological world expects immediate and flawless notification of risk; industry and health authorities aren’t there yet Spontaneous reporting underreporting and reporter bias vs confidentiality issues and other detractors of identifying true incidence/prevalence Blogs, internet massmailings, personal websites and other secondary channels for communicating risk KEY ISSUE: Increased transparency of safety communications and increased potential for post hoc data evaluations “Bystander” meta-analyses Pros/cons of combined (industry-industry; health authority-industry, health authority cross-collaborations) collaborations Top Pharmacovigilance Issues – An industry perspective Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb

5. KEY ISSUE: Increased industry R&D and marketing collaborations Complexities in proactive safety reporting Complexities in early identification of risks Heightened need to stipulate single point accountability for safety reporting KEY ISSUE: Polypharmacy and increasing difficulty in identifying safety risk of individual compounds E.g., Increasing incidence of acute allergic reactions and difficulties in ascribing causality in multi-drug settings Overprescribing of drugs (e.g., antibiotics) and untoward secondary safety effects Top Pharmacovigilance Issues – An industry perspective Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb