ISPE Delaware Valley
The Changing Environment of the Pharmaceutical Industry! Jim Breen
VP WW Engineering & Technical Operations
Johnson & Johnson Supply Chain
March 30, 2015
Agenda:
1.
2.
3.
4.
5.
Welcome
Industry / Economic Trends
Johnson & Johnson
ISPE
Questions
Back to the Future
March 30 20 15 1 7 32
March 30 20 20 1 7 32
March 30 2050
1 7 22
May 2013
Welcome to the
2014
Facility of the
Year Awards
Banquet
Honorable Mention:
WuXi AppTec Biopharmaceutical Co.
cGMP Bulk Cell Culture Production
Facility
• Location: Wuxi City, China
• Designer/Architect: Sino Pharmengin
Corporation, Wuhan China
• Engineer: NNE Pharmaplan, Shanghai,
China
• Construction Manager: Chen Ze,
Shanghai, China
• Major Equip Supplier: Sartorius-Stedim
Biotech
Cutting Edge Technologies in R&D
Organ on a Chip
Stem Cell Organs
3D Printed Organs
Largest and Most Diversified Health Care Company in the World
70%
31 52
Consecutive
years of
adjusted earnings
increases*
Consecutive
years of
dividend
increases**
AAA RATED
* Non-GAAP measure; excludes special items
** Inclusive of the April 2014 dividend declaration
~
70% ~25%
~
of sales from
#1 or #2 global
market share
position
of sales from
products launched
in
past 5 years
of 10 year Free
Cash Flow
returned to
shareholders
Strategic Framework
OUR FOUNDATION
Our Credo
Our Aspiration
OUR STRATEGIC PRINCIPLES
Broadly Based
in Human
Health Care
Managed
for the
Long Term
Decentralized
Management
Approach
OUR GROWTH DRIVERS
Creating Value
through
Innovation
Global Reach /
Local Focus
Excellence in
Execution
Leading
with Purpose
Our People
and Values
Global Update
New Senior ISPE Leadership
John Bournas
ISPE President & CEO
Former CEO / Executive Director, World Federation of Hemophilia
Senior Director, International, American College of Cardiology
Senior Director, Cardinal Health
Diplomat
45
Some Drug Shortage Facts
• Number of Medically Significant drugs on US Shortage
List steadily increased thru 2011 and peaked in 2011.
• Approximately 75% of drugs on list have been
injectables.
• Overall number of new shortages has come down.
• However, many of the ongoing shortages are not
being resolved and new ones are being added.
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE Is Focused On Preventing
Drug Shortages
2012
2013
2014
• ISPE Drug
Shortage Team
formed
• Survey
developed
• Results shared
across industry
and with
regulators
• Drug
Shortage
Prevention
Plan
developed
2015
• Build
capability
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Summary of ISPE Survey Findings
• Clear Corporate goal to avoid drug shortages
• Dedicated Resources focused on preventing
shortages
• Strong Quality Systems for regulatory compliance
• Metrics defined around drug shortages
• Ability to quickly react to drug shortages
• Strong relationship and communications with
Regulatory Authorities
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Quality Metrics
Quality metrics can be useful
 Surveillance using both leading and lagging indicators
Considering two major buckets of QMs
 Risk rank sites and products
 Better structure inspections
Russ Wesdyk, FDA,
June 2013, ISPE GMP
Conference
FDASIA Title VII a potentially useful regulatory mechanism
 Sec. 706 allows FDA to collect information that would have been
available on inspection “in advance or in lieu of an inspection”
 Sec. 705 requires FDA to do risk based inspection (i.e. site
stratification schedule)
 Potential regulatory mechanism
 Identify data under 704
 Collect it under 706
 Utilize for 705 and 706, etc…
51
Timeline – Quality Metrics Industry Pilot
April‐June 2014
Finalize metrics and timelines

▪

▪

▪

▪

▪
Participate in Brookings meeting to discuss FDA direction
Finalize metrics and definitions
Prepare data collection templates and surveys
Outline analysis methodology
Announce pilot details
June 2014 ‐ Mar. 2015
June 2nd
ISPE‐FDA CGMP Conference Workshop to explain and launch pilot approach
Pilot: Wave 1 ▪
▪
▪
▪

Formal check‐in with FDA
▪
▪
▪
2015+
Potential Wave 2


Confirm pilot participants
Launch data collection
Complete data collection, clean/validate data Share initial findings and correlations
Individual report‐outs to all pilot participants
Issue ISPE report on Wave 1
Plan for Wave 2

52
Diverse sample: 18 participating companies with 44 sites/technologies
By technology
By type of product
28
18
8
6
Solids Sterile Bio DS
4
API
By region
8
Other
5
Rx
Gx
6
5
Cons.
health
CMO,
Labs
By company size
39
18
16
3
NA
EMEA
LA
7
Asia
5
Small
Large
Note: If a site has more than 1 technology we count the number of separate templates they will fill, usually 1 per technology
Initial Quality Metrics Pilot Debrief with FDA
Questions ?