The Safety
of our Drugs and Devices
The Complex Reality
Marla A. Phillips, Ph.D.
Xavier University
June 10, 2013
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Xavier University
•
Founded in 1831
•
85 majors
•
7,019 total students
•
334 fulltime faculty
•
4,368 undergraduates
•
Chem, Bio, Physics, Math
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Xavier University - Mission
Our mission is to educate each
student intellectually, morally,
and spiritually
…for a world that is increasingly
diverse, complex and
interdependent
…as they cultivate lives of
reflection, compassion and
informed action
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Xavier Health
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Making a Difference
FDA/Xavier
PharmaLink
FDA
National
Forum
QARA
Institute
Emerging
Leaders
FDA/Xavier
MedCon
Making a Difference
4
Tell me…..and I'll forget;
show me…..and I may remember;
involve me…..and I'll understand
- Chinese Proverb
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Not if……but When and Where
FDASIA
Bioterrorism
Act
FDA Global
Engag. Rpt.
1.4 million fake antimalaria drug packets
seized in Angola
Africa from China
Tainted cough syrup
kills 21 in Panama
Falsified
Medicines
Directive
Pew Rpt
After
Heparin
FSMA
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Integrity of Supply Initiative
Name
Title
Company
Pete Beckerman
Office of the Commissioner
FDA
Steve Solomon
Office of the Commissioner
FDA
Rafiqah Williams
Vice President
Eli Lilly
Gwyn Murdoch
Director
Eli Lilly
Dale Huff
Director
Merck
Mark Paviglianiti
Director
Merck
Tedd Green
President
Cook Pharmica
Tom Roberts
Vice President
Cook Inc.
Mike King
Director
J&J – Ethicon
Hank Llamas
Vice President
J&J
Tamima Itani
Vice President
Boston Scientific
Todd Jackson
Vice President
Boston Scientific
Susan Rolih
Senior Vice President
Meridian Bioscience
Michelle Smith
Senior Director
Meridian Bioscience
Payton Pruett
Vice President
Kroger
Sarah Geisert
Senior Director
General Mills
Creating
Best
Practice
IMDRF
FSMA
FDASIA
Industry
After
Heparin
Xavier
Rx-360
Regulators
Congress
IPEA
GFSI
FDA Strategic
Priorities
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Integrity of Supply Initiative
Mission Statement:
To determine true root causes related to the challenges of improving
Integrity of Supply, and to identify sustainable solutions that can be tied
to Return on Investment – returns related to increased safety, decreased
cost, improved reliability, or all three.
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What causes you the greatest concern
related to your supply chain and
suppliers?
(initial focus on in-coming materials)
9
Kick-off Meeting
August 2012
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Top Themes by Vote
Theme
Votes
Theme
Votes
Supplier and Supply Change
33
Cultural Impacts
8
Certification and Database
30
Benchmarking
8
Harmonization of Requirements
29
Manage Small Suppliers
3
Culture of Company/Supplier
18
Cost of Quality (ROI)
2
Risk Management
16
Co-Location
0
Keep it Simple
14
Diverse Perspectives (include all
Stakeholders)
0
Supplier Expectations
11
R&D Integration
0
Understand Legal Implications
10
Supplier Leverage
9
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Top Themes by Vote
Desire
Agility
Change Control
Reliability
Leverage
R&D Integration
Small Suppliers
Culture
Legal
Implications
Certification
Risk
Management
Stakeholder
Involvement
Visibility
Harmonization
Database
Communication
Keep it
Simple
Co-Location
Benchmarking
ROI
Supplier
Expectations
Enablers
12
Pre-Initiative Assessment
January 2012 – August 2012
13
Pre-Initiative Data
• Interviewed approx. 50 people
− FDA: each of the industry regulator groups
− Companies (6): cross-functional representation
− Industry Associations (4): PhRMA, MDMA, GPhA, IPEC
− Outside experts: (5) Pharma/Device, (2) Food, (2) General – authors of 12 books
• Research
− Meetings with Congress – Senate HELP and House Energy & Commerce Committees
− New Legislation
− Newly released and relevant books and articles
• Data Analysis
1. Comparison of the three industry supply chain characteristics from interviews
2. Interview data in SWOT format
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SWOT Analysis
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SWOT Analysis
Threat
Weakness
F
P
Do not know or calculate the cost benefit of
Supply Integrity
X
X
Do not communicate and collaborate across
internal business units well about Supply
Integrity methods/approaches/resources
X
X
D
F P D
Upstream tiers can cause problems, are not transparent, often
X
Tend to use “one size fits all or nothing” relationship
X X X
lower margins
approach to all suppliers
Broker and distributor effect on traceability
X and Trace systems spotty
Track
X X X
supply
complex, more frequent)
Strength
P Global
D
Insular – “not invented here” or “we Fare different”
X chains
X (long,
X
industry mentality (regulators too)
Risk
methodologies
used
X
X
X
Far upstream R&D/Product Design
notcategorization
aware of
X
X
Explosion of new global suppliers – opportunism and cultural
on-going supply and logistics in supply chain
Secretive with suppliers about material use in product
X X
issues
Supply Integrity and Safety integrated into company processes,
X
X
X
and job expectations in
functions
Tend not to share supplier problems/excellence
X many X
X companies incapable of significant supply
Small
X X X
with rest of industry, and with regulators only if
integrity investment (although pharma has a bigger
Regulatory inconsistency – states, countries, federal (FDA,
Linkage between strategic (important) suppliers and need for
required
X
X USDA,
X
“small”)
NOAA, other laws)
strong long term relationships
Resources to do this work viewed as cost center
X
X
X
Opportunity
Current system works vast majority of the time (problems are
not revenue protector
X
X
X
generally at a less than 6 Sigma level)
Establish Industry-wide Standards through 3rd Parties that suppliers
Focused primarily on Tier 1 suppliers not
X
X
X
must meet to supply FDA industries
FDA and Industry relationship is generally cooperative (however
upstream
X
X
X
inspector level can be exception, hard to receive an official “ok”)
Establish supplier data base for selection and on-going
Specifications not well developed/maintained
X
X
X
management
Good supplier qualification programs
X
X
X
Opportunity
F
P
D
Modify FDA requirements
to allow for “change” over product F
Threat
P
Measure suppliers – have basic metrics in place (Cost, Quality,
lifecycle
X
X
X
Third party audits – industryDelivery)
certification of auditors included
X
X
X
Low volume reduces leverage with suppliers (especially those not interested
X
and standardize the Supplier Qualification Program –
industries) Improve
Broader regulatory agency collaboration
on this
issueChain groups exist
X (e.g.
X MDSCC,
X in FDAPSCI)
Specific industry
Supply
X
X
including disqualification
Change
control
processes
at suppliers (especially upstream tier items)
X
X
Develop upstream suppliers that are interested in this sector
X
X
Develop better metrics for suppliers on integrity and upstream
Legacy suppliers andsupply
chainstiers
coupled with regulatory hurdles to change
X
Other regulations are included in risk assessment (e.g. social
X
X
X
Risk categorization model includes guidelines for management
responsibility, etc.)
Change is risky and expensive (FDA interest, cost, PR, etc.)
X
Use industry supply chain associations that focus more on
Supplier education program on FDA industry needs (e.g.
X
X
X
operational actions (not legislative)
change notice/control)
Single/Sole source suppliers
X
X
Reapply best practices from non-FDA industries
Solutions needed for small companies incapable of significant
supply integrity investment (although pharma has a bigger
“small”)
F
P
D
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Weakness
X
X
X Third party auditing groups do not certify auditors and can be expensive for
smaller companies – exception: IPEA
Small suppliers/non strategic suppliers often cause the problems
F
X
D
X
X
X
P
D
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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SWOT Analysis
Strength
F
P
D
Risk categorization methodologies are being used
X
X
X
Supply Integrity and Safety integrated into company processes,
and job expectations in many functions
X
X
X
Linkage between strategic (important) suppliers and need for
strong long term relationships
X
X
X
Current system works vast majority of the time (problems are
generally at a less than 6 Sigma level)
X
X
X
FDA and Industry relationship is generally cooperative
X
X
X
Good supplier qualification programs
X
X
X
Measure suppliers – have basic metrics in place (Cost, Quality,
Delivery)
X
X
X
17
SWOT Analysis
Weakness
F
P
D
Do not know or don’t calculate the cost benefit of Supply
Integrity
X
X
X
Do not communicate and collaborate across internal
business units well about Supply Integrity
methods/approaches/resources
X
X
X
X
X
Far upstream R&D/Product Design not aware of on-going
supply and logistics in supply chain
Tend not to share supplier problems/excellence with rest
of industry, and with regulators only if required
X
X
X
Resources to do this work viewed as cost center not
revenue protector
X
X
X
Focused primarily on Tier 1 suppliers not upstream
X
X
X
Specifications not well developed/maintained
X
X
X
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SWOT Analysis
Opportunity
F
P
D
X
X
X
X
Modify FDA requirements to allow for “change” over product
lifecycle
X
X
Improve and standardize the Supplier Qualification Program –
including disqualification
X
X
Establish Industry-wide Standards through 3rd Parties that suppliers
must meet to supply FDA industries
Establish supplier data base for selection and on-going
management
X
Develop better metrics for suppliers on integrity and upstream
supply tiers
X
X
X
Risk categorization model includes guidelines for on-going
management
X
X
X
X
X
Develop upstream suppliers that are interested in this sector
19
SWOT Analysis
Threat
Upstream tiers can cause problems, are not transparent, often
lower margins
F
P
D
X
X
X
X
X
Low volume reduces leverage with suppliers (especially those
not interested in FDA industries)
Global supply chains (long, complex, more frequent)
X
X
X
Change control processes at suppliers (especially upstream tier
items)
X
X
X
Regulatory inconsistency – states, countries, federal (FDA,
USDA, OUS, other laws)
X
X
X
X
X
Change is risky and expensive
20
Themes Supported by Data
Associations
Experts
Core Team
Agility, Reliability, Visibility
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Root Cause Identification
Agility, Reliability, Visibility
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Agility Team Objective
Improve supply chain agility in the Medical Device, Pharma and
Food/Beverage industries by leaning the supplier/materials change
process and reducing inherent industry barriers.
 First confirm the Key Change Process Areas that require the largest amount of
time in Supply Change Management
 Second validate root cause of the pain/barrier
Can we
include you on
the survey?
23
Agility – Regulatory Barriers
The regulatory barriers currently in place hinder
the agility we need to manage our supply chain in
a way that would improve the Integrity of Supply.
• So even if we streamline our own processes, we often
cannot act as quickly as needed to resolve or prevent
issues.
Do you feel barriers
are due more to:
• Companies often choose to stay with substandard practices
or suppliers due to the hurdles involved in change –
internally and with regulatory authorities.
• Complexity
• Requirements
• Bottlenecks
24
Reliability Team:
Inputs by Process Step
Select Potential
Supplier/
Supply Chain
RFQ
Define Business/
Quality Rqmts.
Select/Approve
Supplier/Supply
Chain
What do you feel are the main
root causes related to the
concern of reliability?
Your response can be associated
with any part of the process
Manage
Supplier /
Supply Chain
25
Reliability Team: Top 6 Votes
Select Potential
Supplier/
Supply Chain
RFQ
Define Business/
Quality Rqmts.
Select/Approve
Supplier/Supply
Chain
Manage
Supplier /
Supply Chain
26
Is there Hope?
It starts with YOU
We have already identified “Opportunities” through SWOT
Next steps include benchmarking other industries
Global regulators are working together
Industry is working together
It ends with EVERYONE
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Questions?
Marla A. Phillips, Ph.D.
phillipsm4@xavier.edu
513-745-3073
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