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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

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Questions?

Marla A. Phillips, Ph.D.

phillipsm4@xavier.edu

513-745-3073