Strategic medical affairs in pharma and medical devices outlines key drivers influencing the growing role of medical affairs functions. Regulatory requirements, demand for local excellence, and the need for transparency are pushing medical activities to expand in areas like medical strategy, clinical operations, and regulatory submissions. Medical affairs contributes throughout the product lifecycle by collecting and disseminating knowledge to internal and external audiences, and can help integrate products into healthcare systems from drug development to reimbursement.

1. Strategic medical affairs in pharma and medical devices
Dr Anjan Banerjee DM, MBA
Medical Safety Solutions Ltd
Copyright Medical Safety Solutions Ltd. 2015 1

2. Environmental and Internal Drivers influence the growing
need for Medical Affairs
Continued need to address
medical data gaps
Regulatory requirements
and scrutiny
Increasing demand
for local functional
excellence
Increasing need
to optimize use
of resources
Personalized medicine
Global networking of
regulators / payers
Growing need for
transparency &
alignment
Implications:
Pipeline diversity
Economic environment - focus
on value/effectiveness
• Importance
• Volume
• Complexity
• Diversity
Efficiency initiatives
Medical activities
growing in:

3. Medical
Strategy
Therapeutic area
Medical Plans, medical
input to key global teams
Clinical Operations and
Biometrics
Global study
implementation, data &
medical systems
management
Regulatory submissions
Training, Quality, Compliance
Safety, Training,
Compliance processes
Scientific Relations/Pubs
• Publications/Ad Boards
• Medical information
• Scientific collaborations
Market Access/Commercial
Conduit between GMA &
Commercial/ Reimbursement
Types of activities
Audience
InternalExternal
Knowledge collection &
management
Knowledge dissemination
Medical Affairs Contributes Throughout the Product Lifecycle…..

4. Copyright Medical Safety Solutions Ltd. 2015
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…and can facilitate horizontal and vertical integration products into healthcare systems
DRUG DEVELOP +B2B
REGULATORS ( Approval +
use as surrogates)
KOL/HCP PRACTICE,
PUBLICATIONS
REIMBURSEMENT
↑Mkt size(new mkts, new indications)
SYNERGY WITH OTHER BUS
QUALITY,COMPLIANCE
• PREDICT
• DIAGNOSE
• INFORM
• TREAT