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The Safety of our Drugs and Devices
The Complex Reality
Marla A. Phillips, Ph.D.
Xavier UniversityJune 10, 2013
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Xavier University
• Founded in 1831
• 7,019 total students
• 4,368 undergraduates
• 85 majors
• 334 fulltime faculty
• Chem, Bio, Physics, Math
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Xavier University - Mission
Our mission is to educate each student intellectually, morally, and spiritually
…as they cultivate lives of reflection, compassion and informed action
…for a world that is increasingly diverse, complex and interdependent
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Xavier Health
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Making a Difference
Not bound by our
own research goals
Not bound by
structure
Not defined by a building
Solution tailored to the need
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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
Tainted cough syrup kills 21 in Panama
1.4 million fake anti-malaria drug packets seized in Angola Africa from China
FDASIA
FSMA
Bio-terrorism
Act
Pew Rpt After
Heparin
Falsified Medicines Directive
FDA Global Engag. Rpt.
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Integrity of Supply Initiative
Creating
Best
Practice
Xavier
Industry
CongressRegulators
FSMAIMDRF
FDASIA
Rx-360
IPEAGFSI
AfterHeparin
FDA StrategicPriorities
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
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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)
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Kick-off Meeting
August 2012
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Top Themes by Vote
Theme Votes
Supplier and Supply Change 33
Certification and Database 30
Harmonization of Requirements 29
Culture of Company/Supplier 18
Risk Management 16
Keep it Simple 14
Supplier Expectations 11
Understand Legal Implications 10
Supplier Leverage 9
Theme Votes
Cultural Impacts 8
Benchmarking 8
Manage Small Suppliers 3
Cost of Quality (ROI) 2
Co-Location 0
Diverse Perspectives (include all Stakeholders)
0
R&D Integration 0
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Top Themes by Vote
Agility Reliability Visibility
HarmonizationLeverage
R&D IntegrationSmall Suppliers
CommunicationRisk
Management
Culture
Change Control Certification Database
Desire
Enablers
ROIStakeholder Involvement Co-Location
Keep it Simple
SupplierExpectations
LegalImplications Benchmarking
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Pre-Initiative Assessment
January 2012 – August 2012
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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 Analysis1. 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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Threat F P D
Upstream tiers can cause problems, are not transparent, often lower margins
X X X
Broker and distributor effect on traceability X X X
Global supply chains (long, complex, more frequent) X X X
Explosion of new global suppliers – opportunism and cultural issues
X X X
Regulatory inconsistency – states, countries, federal (FDA, USDA, NOAA, other laws)
X X X
SWOT Analysis
Weakness F P D
Do not know or 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
Far upstream R&D/Product Design not aware of on-going supply and logistics in supply chain
X X
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
Weakness F P D
Tend to use “one size fits all or nothing” relationship approach to all suppliers
X X X
Track and Trace systems spotty X X X
Insular – “not invented here” or “we are different” industry mentality (regulators too)
X X X
Secretive with suppliers about material use in product
X X
Small companies incapable of significant supply integrity investment (although pharma has a bigger “small”)
X X X
Opportunity F P D
Establish Industry-wide Standards through 3rd Parties that suppliers must meet to supply FDA industries
X X
Establish supplier data base for selection and on-going management
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
Develop better metrics for suppliers on integrity and upstream supply tiers
X X X
Risk categorization model includes guidelines for management X X X
Use industry supply chain associations that focus more on operational actions (not legislative)
X X X
Reapply best practices from non-FDA industries X X X
Threat F P D
Low volume reduces leverage with suppliers (especially those not interested in FDA industries)
X X
Change control processes at suppliers (especially upstream tier items) X X X
Legacy suppliers and chains coupled with regulatory hurdles to change X X
Change is risky and expensive (FDA interest, cost, PR, etc.) X X
Single/Sole source suppliers X X X
Third party auditing groups do not certify auditors and can be expensive for smaller companies – exception: IPEA
X X X
Small suppliers/non strategic suppliers often cause the problems X X X
Strength F P D
Risk categorization methodologies 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 (however inspector level can be exception, hard to receive an official “ok”)
X X X
Good supplier qualification programs X X X
Measure suppliers – have basic metrics in place (Cost, Quality, Delivery)
X X X
Specific industry Supply Chain groups exist (e.g. MDSCC, PSCI) X X
Opportunity F P D
Third party audits – industry certification of auditors included X X X
Broader regulatory agency collaboration on this issue X X X
Develop upstream suppliers that are interested in this sector X X
Other regulations are included in risk assessment (e.g. social responsibility, etc.)
X X X
Supplier education program on FDA industry needs (e.g. change notice/control)
X X X
Solutions needed for small companies incapable of significant supply integrity investment (although pharma has a bigger “small”)
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
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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
Far upstream R&D/Product Design not aware of on-going supply and logistics in supply chain
X X
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
Establish Industry-wide Standards through 3rd Parties that suppliers must meet to supply FDA industries
X X
Establish supplier data base for selection and on-going management
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
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
Develop upstream suppliers that are interested in this sector X X
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Threat F P D
Upstream tiers can cause problems, are not transparent, often lower margins
X X X
Low volume reduces leverage with suppliers (especially those not interested in FDA industries)
X X
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
Change is risky and expensive X X
SWOT Analysis
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Themes Supported by Data
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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?
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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.
• Companies often choose to stay with substandard practices or suppliers due to the hurdles involved in change – internally and with regulatory authorities.
Do you feel barriersare due more to:
•Complexity•Requirements•Bottlenecks
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Reliability Team: Inputs by Process Step
Select Potential Supplier/
Supply Chain RFQ
Define Business/ Quality Rqmts.
Select/Approve Supplier/Suppl
y Chain
Manage 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
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Reliability Team: Top 6 Votes
Select Potential Supplier/
Supply Chain RFQ
Define Business/ Quality Rqmts.
Select/Approve Supplier/Suppl
y Chain
Manage Supplier /
Supply Chain
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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
