Pharmacovigilance and Drug Safety Track

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Pharmacovigilance and Drug Safety Track AN
INDUSTRY PERSPECTIVE
Amrit Ray, MD, MBA, FCMI Vice President,
Medical Safety - Global Pharmacovigilance
Epidemiology Bristol-Myers Squibb Company
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Top 10 Pharmacovigilance Issues Chris Holmes,
Principal, WCI Consulting Ltd

• 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

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Top Pharmacovigilance Issues An industry
perspective Amrit Ray, MD VP, Medical Safety
GPVE , 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 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

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Top Pharmacovigilance Issues An industry
perspective Amrit Ray, MD VP, Medical Safety
GPVE , Bristol-Myers Squibb

• KEY ISSUE New Approaches to Risk Communication
• Technological world expects immediate and
  flawless notification of risk industry and
  health authorities arent there yet
• Spontaneous reporting underreporting and reporter
  bias vs confidentiality issues and other
  detractors of identifying true incidence/prevalenc
  e
• 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

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Top Pharmacovigilance Issues An industry
perspective Amrit Ray, MD VP, Medical Safety
GPVE , Bristol-Myers Squibb

• KEY ISSUE Increased industry RD 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