Transcript Powerpoint

Pharmacovigilance and Drug Safety Track
AN INDUSTRY PERSPECTIVE
Amrit Ray, MD, MBA, FCMI
Vice President,
Medical Safety - Global Pharmacovigilance & Epidemiology
Bristol-Myers Squibb Company
BMS Confidential – for internal purposes only
1
Top 10 Pharmacovigilance Issues
Chris Holmes, Principal, WCI Consulting Ltd
1.
Role of QP-PV (responsibilities for QP and MAH)
2.
Implementation of Risk Minimization Plans
3.
Partner Agreements
4.
Increase data sources for PV assessments
5.
Formalized, auditable Signal management
6.
Increase transparency with Agencies
7.
Stricter enforcement of regulations
8.
Notification of new safety concerns
9.
Single global Quality Mgt System
10.
Efficient Routine PV, focus effort on proactive safety
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BMS Confidential – for internal purposes only
Top Pharmacovigilance Issues – An industry perspective
Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb
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 introorganization 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
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BMS Confidential – for internal purposes only
Top Pharmacovigilance Issues – An industry perspective
Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb
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 crosscollaborations) collaborations
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BMS Confidential – for internal purposes only
Top Pharmacovigilance Issues – An industry perspective
Amrit Ray, MD – VP, Medical Safety GPV&E , Bristol-Myers Squibb
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
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BMS Confidential – for internal purposes only