From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases. From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.

1. Critical Importance of
Pharmaceutical Traceability in
the Experience Economy
Ajaz S. Hussain, Ph.D.
Insight, Advice & Solutions LLC
11/6/2017 Ajaz@ajazhussain.com 1
Express Pharma CXO Pharma Summit: Beyond 2017

2. Three new US
laws & the
Experience
Economy
The Experience Economy
The 21st
Century Cures
Act
•13 December
2016
The Drug
Quality and
Security Act
•27 November
2013
The FDA
Safety and
Innovation
Act
•9 July 2012
11/6/2017 Ajaz@ajazhussain.com 2

3. 11/6/2017 Ajaz@ajazhussain.com 3

4. Goods – Services - Experiences
Manufacturer – Provider - Stager
Standardized – Customized- – Personal
User – Client – Guest
Attributes – Benefits – Sensations
Ajaz@ajazhussain.com
Welcome to the Experience Economy: B. Joseph Pine II and James H. Gilmore, Harvard Business Review July–August 1998

5. Experience and The Gold Standard
Ajaz@ajazhussain.com
Why Is the Placebo Effect Exploding in The U.S. But Nowhere Else? Forbes. 7 October 2015

6. Experiencing Automatic Substitution
Annals of internal medicine.
161(2), pp.96-103 (2014)
Burden of Changes in Pill
Appearance for Patients
Receiving Generic
Cardiovascular
Medications After
Myocardial Infarction.
The Washington Post.
14 July 2014.
If Color or Shape of
Generic Pills Changes,
Patients May Stop Taking
Them.
Final Guidance. June 2015
Guidance for Industry.
Size, Shape, and Other
Physical Attributes of
Generic Tablets and
Capsules. Pharmaceutical
Quality/CMC.
Ajaz@ajazhussain.com

7. Value-based
pricing
• Kymriah® $475,000/outcome
Novartis – CMS Agreement
• “We need to eliminate some of the
silos in healthcare systems and
spending, reduce waste, and take
a more holistic approach to
resource allocation, centered on
the value delivered to patients,”
Novartis’ Jimenez
• World Economic Forum's value-
based health project has been in
the works for several years.
11/6/2017 Ajaz@ajazhussain.com 7

8. Totality of Experience
11/6/2017 Ajaz@ajazhussain.com 8

9. Drug Supply
Chain Security
Act (DSCSA)
The DSCSA, passed as part of the Drug Quality Security Act
Immediate purpose of strengthening protections for
patients from receiving diverted or counterfeit product
From a narrow viewpoint, serialization is just a process of
printing an identifying number on products and shipping
cases
From a long-term view, the integration of serialization
numbering systems with the production line as well as the
quality control procedures required to maintain the
integrity of the numbers
Further, the QC team can no longer simply remove an item
from the line for testing — serialization protocols require
additional processes to allow for any sampling or disposal
of products once the number has been applied.
11/6/2017 Ajaz@ajazhussain.com 9

10. How you
approach
serialization
matters!
• We are waiting for FDA Guidance!
• FDA is not likely to enforce it; see
it delayed enforcement again to
Nov 2018!
• What is the minimum we need to
do?
An added
cost of
“compliance”
to meet the
minimal
requirements
• Beyond compliance – how can we
leverage this need to improve our
ability to deliver assurance
patients need today and
tomorrow in the Experience
Economy?
An
opportunity
for systems
improvement
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