Proprietary

and confidential
do not distribute
Proprietary and confidential do
not distribute

Achieving Potential Through the Power of Health | September 6, 2016 2

Proprietary and confidential

do not distribute
Proprietary and confidential do
not distribute

Achieving Potential Through the Power of Health | September 6, 2016 3

Proprietary and confidential

do not distribute
Proprietary and confidential do
not distribute

Achieving Potential Through the Power of Health | September 6, 2016 4

Proprietary and confidential do not distribute

Proprietary and confidential

do not distribute
Proprietary and confidential do
not distribute

Achieving Potential Through the Power of Health | September 6, 2016 6

Regulation
Draft

Serialization of pharmaceuticals

Lighter color denotes phased approach

D=Draft

D
2010

2011

2012

2013

Proprietary and confidential do not distribute

2014

2015

2016

2017

2018

D
2019

D
2020

2021

Achieving Potential Through the Power of Health | September 6, 2016 7

Requirements
High level regulatory requirements
and interpretation
Sufficient time to implement
Standards vs. proprietary
Barcodes
Encoded data
Data exchange

To aggregate or not aggregate

Logistical container marking

Achieving Potential Through the Power of Health | September 6, 2016 8

Cross-functional Teams
Functions

Who owns the program?

Operations: Manufacturing,
distribution, TPM, CMO, 3PL

Regulatory

Quality: IT and operations

Business operations

Supply chain

Regulatory, New product introduction,

Labeling, Master data, Equipment
Engineering , IT
Brand protection, commercial, finance
Vendor management

Achieving Potential Through the Power of Health | September 6, 2016 9

Enterprise cost leverage

ENTERPRISE APPROACH
Harmonized global model with consistent business process
Ensures interoperability while reducing complexity
Streamlined information exchange allows scalability
Coordinated approach
Achieve lower total cost of ownership over time

LOCAL APPROACH
Everyone talks to everyone in various localized formats
Communication changes from simple Batch to complex
and large amounts of information hierarchies
Data management will have to become a core
competency for all groups involved
Disparate hardware systems require more attention

Achieving Potential Through the Power of Health | September 6, 2016 10

BIG Data
50,000 units /batch
50 batches per year

PER YEAR
50 batch records

600 records / year

500 pallet records

3600 records 6 year retention

50 shipment notices
PER WITH SERIALIZATION
50 batch records
500 pallet records
50 shipment notices
2,500,000 serialized unit records

~5MM records / year

~30 MM records 6 year retention

25,000 case records

~2,550,000 hierarchy records
Proprietary and confidential do not distribute

Achieving Potential Through the Power of Health | September 6, 2016 11

Global
Global network of sites
and suppliers
Distributed, de-centralized
teams, time zones
Language translation
Mergers & acquisitions
New product introduction
Shared packs and over-labeling

Achieving Potential Through the Power of Health | September 6, 2016 12

Recommendation
Design and build for
flexibility and scalability
Modularize functionality
Partnership vs. vendor
Standards, stanDARDS,
STANDARDS!
Evolve with requirements
Strong governance

Achieving Potential Through the Power of Health | September 6, 2016 13