rx-360 anniversary conference: celebrating 5 years of...

Rx-360 An International Pharmaceutical Supply Chain Consortium

Rx-360 Anniversary Conference:

Celebrating 5 Years of Protecting

Patient Safety

Protecting patients worldwide

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Welcome

Linda Evans O’Connor

Vice President, Supplier Quality Management

Teva

Scott Watson

Vice President, Sales & Marketing

Codexis, Inc.

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Overview

• Welcome

• Conference Objectives

• Acknowledgements

• Housekeeping

• Introduction to Conference

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Conference Objectives

Is this slide needed?

If so, what are your thoughts on objective for the conference.

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Acknowledgements

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Special thanks to our Sponsors!

http://www.sigmaaldrich.com/safc.html

http://www.bayer.com/

Acknowledgements

Speakers Dr. Janet Woodcock, FDA

Gerald Heddell, MHRA

Patrick Costello, EMA

LDCR TJ Christl, FDA

Chuck Forsaith, Purdue Pharma

Roger Bate, American Enterprise

Institute

Allan Coukell, The Pew Charitable

Trusts

Rx-360 Speaker Martin VanTrieste, Amgen

Rick Calabrese, Sartorius Stedim

Ben Mills, Amgen

Lew Kontnik, Amgen

Janice Berman, Takeda

Matt Anderson, Merz

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Moderators Brian Johnson, Pfizer

Guy Villax, Hovione

Lynne Byers, Novartis

Housekeeping

• Please turn off cell phones.

• Presentations will be posted on the Rx-360

website after the Conference.

• Questions about Rx-360 – See Rx-360

Representatives at Posters and Table

Poster Session breaks

• 10:00 – 10:15 AM

• During Lunch Break 11:45 AM – 1:00 PM

• 4:00 – 4:15 PM

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Thanks for attending!

Interactive Polling: Question #1

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Do you represent:

A. Pharmaceutical Company

B. Supplier

C. Contract Research Organization

D. Regulatory Authority

E. Academic

F. Other


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What is your role/function within your company? (Please check all

that apply.)

A. Quality

B. Procurement

C. Sales/Marketing

D. Operations

E. Other

Agenda - Morning

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9:00 – 9:10 AM Welcome & Opening

Conference Organizing Committee Co-Chairs

n Linda Evans-O’Connor, Vice President, Supplier Quality Management, Teva

n Scott Watson, Vice President, Sales & Marketing, Codexis, Inc.

9:10 – 9:40 AM Key Note Address: Securing the Global Pharmaceutical Supply Chain

n Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, US Food

and Drug Administration

9:40 – 10:00 AM Rx-360 – Where We Came From and Where We Are Going

n Martin VanTrieste, Senior Vice President, Amgen; Founding Chair, Rx-360

10:00 – 10:15 AM BREAK and Poster Session

10:15 – 11:45 AM Supply Chain Security Risks

Moderator: Brian Johnson, Pfizer, Rx-360 Chair

n Charles Forsaith, Chairman, Pharmaceutical Cargo Security Coalition; Director of

Supply Chain Security, Purdue Pharma

n Roger Bate, Visiting Scholar, American Enterprise Institute

n Allan Coukell, Senior Director, Drug and Medical Devices, The Pew Charitable Trusts

11:45 – 1:00 PM LUNCH and Poster Session

Agenda - Afternoon

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1:00 – 2:30 PM Overview of Rx-360 Initiatives (complimented by Poster Session)

n Update on Rx-360’s Supplier-Led Efforts Rick Calabrese, Global Corporate Director of Quality Systems, Sartorius

Stedim North America Inc.

n Rx-360’s Audit Programs Ben Mills, Lead, Supplier Audit Program, Amgen

n Rx-360’s Supply Chain Security Programs Lew Kontnik, Director, Global Product Protection, Amgen

n Rx-360 Asia Working Group Janice Berman, Vice President, Quality Assurance, Takeda Pharmaceuticals U.S.A.,

Inc.

n Rx-360 Medical Device Working Group Matt Anderson, Vice President, Quality & Business Excellence, Merz

North America, Inc.

2:30 – 4:00 PM Regulatory Efforts to Strengthen the Global Pharmaceutical Supply Chain

Moderator: Guy Villax, Chief Executive, Hovione, Rx-360 Vice Chair

n Patrick Costello, Scientific Administrator, Manufacturing & Quality Compliance, Compliance and Inspections

Department, European Medicines Agency (EMA)

n Gerald Heddell, Director of Inspection, Enforcement and Standards, Medicines and Healthcare products

Regulatory Agency (MHRA)

n Thomas J. Christl, Director, Office of Drug Security, Integrity, and Recalls, US Food & Drug Administration (FDA)

4:00 – 4:15 PM BREAK and Poster Session

4:15 – 5:00 PM What More Can Industry Do to Secure the Global Supply Chain?

Moderator: Lynne Byers, Global Quality Head, Novartis

n Summary of interactive polling

n Open discussion with panelists from earlier panels

5:00 PM Closing Remarks

n Linda Evans-O’Connor, Vice President, Supplier Quality Management, Teva

n Scott Watson, Vice President, Sales & Marketing, Codexis, Inc.


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Please describe your level of awareness of Rx-360 before

attending the 5 Year Anniversary Conference:

A. Never heard of Rx-360 (none)

B. Vaguely Aware

C. Aware

D. Involved

E. Highly Aware

F. Highly Involved

Rx-360

Where We Came From

And Where We are Going

Martin VanTrieste

Senior Vice President, Quality

Amgen

Founding Chair, Rx-360

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Contents

• The Problem

• The Organization: Rx-360

• 2013 Status/Accomplishments

• 2014 Goals

14 The Value of Rx-360 is in the Engagement

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The Problem

• Criminal Profits

• Complex Supply Chains

• Global Trade

• Internet

• Weak Controls

FDA Asked the Industry

to Collaborate for

Patient Safety

Illicit Activity Impacts All Stages of the

Supply Chain From:

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Raw materials

Excipients

APIs

Components

Drug Products

Packaging & Labeling

Storage

Distribution

Anti-Counterfeiting Technologies

Rx-360 Mission

Protect patient safety by sharing

information and developing processes

related to the integrity of the healthcare

supply chain and the quality of materials

within the supply chain.

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Patient safety should never be compromised as a

competitive advantage

“Rx-360s current members are pioneers that are building the type

of global, all embracing industry group of the 21st century. Rx-

360 is working to ensure that patients everywhere can enjoy the

benefits of globalization safely.”

Guy Villax, Chief Executive Officer, Hovione

Rx-360: Bringing Industry and Regulators

Together to Protect Patients Worldwide

• Exchange public information to allow firms to

adopt best practices across industry

• Bring industry experts together to develop

responses and action when the supply chain is

threatened

• Act as a clearinghouse for suspicious supply

chain information

• Share individual audits and conduct joint audits

• Consider joint technological development for

securing supply chain and detecting adulteration

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Broad and Inclusive Membership

• Global

• Small and large companies

• Suppliers and manufacturers

• Branded and generic

• Regulatory agencies, standard setting

bodies, and industry organizations

participate as Observers

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Operating Model

• Formed in mid-2009

• 501(c)(6) nonprofit organization

• Volunteer based

• Companies are members not individuals

• Not intended to replace regulatory systems or oversight

• Designed to meet competition law requirements; on-going and comprehensive antitrust compliance

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Current Rx-360 Membership

Manufacturers (27) • AbbVie

• Amgen

• AstraZeneca

• Baxter

• Bayer

• Bend Research

• Biogen Idec

• Boehringer Ingelheim

• BMS

• Daiichi Sankyo Co., Ltd.

• Eli Lilly

• Forest Laboratories

• Roche/Genentech

• GSK

• Impax Laboratories Inc.

• Johnson & Johnson

• Merck & Co.

• Merz Aesthetics

• Mylan Inc.

• Novartis

• Pfizer

• Pharmaceutics International, Inc.

• Procter & Gamble

• Sanofi-Aventis

• Takeda

• Teva

• UCB Pharma S.A.

Suppliers (32) • AMPAC Fine Chemicals LLC

• Ash Stevens

• Aurisco

• Avantor Performance Materials, Inc.

• BASF

• Cambridge Major Laboratories, Inc.

• Cardinal Health

• Codexis

• Doe & Ingalls

• DKSH International

• DSM Nutritional Products Ltd.

• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

• GE Healthcare

• Hikal

• Hovione

• Imperial Health Sciences

• Labochim

• LifeConEx

• Life Technologies Corp.

• Ligand

• Merck KGaA

• Myoderm

• Neuland Laboratories Limited

• Novozymes

• OSO BioPharmaceuticals Manufacturing LLC

• Sartorius AG

• Sigma Aldrich

• Spectrum Chemical Mfg. Corp.

• TempTime

• VWR

• West

• York Container

Members Observers

Auditors (13) • Auckerman Consulting

• blue inspection body GmbH

• BSI Supply Chain Solutions

• MPC Consulting LLC

• PharmaPact Consulting Services

• PSC Biotech Corp.

• Regulatory Compliance Associates

• Rephine Ltd.

• RMC Pharmaceutical Solutions Inc.

• Safis Solutions LLC

• SQA Services Inc.

• STS Consulting

• The Weaver Group, Inc.

Associations (18) • ANSI-ASQ National Accreditation Board

• APIC

• Bulk Pharmaceutical Task Force

• Consumer Healthcare Products Association (CHPA)

• Council for Responsible Nutrition

• European Fine Chemicals Group (EFCG)

• European Generic Medicines Association (EGA)

• EXCiPACT

• Health Distribution Management Association (HDMA)

• International Society for Pharmaceutical Engineering (ISPE)

• IPEC Americas

• IPEC Europe

• NSD Bio Group

• Parenteral Drug Association (PDA)

• Pharmaceutical Quality Group (PQG)

• Pharmaceutical Research & Manufacturers of America (PhRMA)

• Pharmaceutical Supply Chain Initiative (PSCI)

• Rx Response

This is Where Rx-360 is Currently

Engaged

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Supply Chain Security Incident Management

Illegal Diversion

Serialization

Drug Shortages

Cargo Theft

SCS Programs

Audit

Operations Joint Audits

Shared Audits

Auditor Qualification

Licensing

Database

Intelligence and

External Affairs Monitoring & Reporting

Flash Reports

Alerts

Supply Chain Threats

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Collaboration on Supplier Audits Will Increase

Compliance, Quality and Efficiency

“Rx-360 is a one-stop venue for understanding the issues, solutions,

and emerging regulations around the pharmaceutical supply chain.

AbbVie’s participation allows our shared service audit team to apply

enhanced focus and risk prevention with critical suppliers.”

Wes Schmidt, Divisional Vice President, Operations Quality Assurance,

AbbVie

Rx-360 Audit Programs

Activity Contacts:

Afternoon Presentation by: Ben Mills, Amgen, [email protected]

Robin Kumoluyi, Novartis, [email protected]

mailto:[email protected]

http://inactapp.dbr.com/InterAction/relationship-overview-person?contactId=8592224248&IAContactId=&folderId=&hasFolderId=false&folderClass=&findContactName=&soundsLike=&hasProjectId=false&proxyAccount=

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Sharing of Information and Processes Enhances

Supply Chain Security thereby Protecting Patients

Rx-360 Supply Chain Security

“BASF supports Rx-360 as it contributes to a secure pharmaceutical

supply chain and enables drug manufacturers and their suppliers to

cope with current and future audit challenges without compromising

product safety.”

Dr. Rainer Fendt, Head of Regulatory & GMP Compliance Pharma , BASF

Activity Contacts:

Tim Valko, Amgen, [email protected]

Tim Chesworth, AstraZeneca, [email protected]

Afternoon Presentation by: Lew Kontnik, Amgen,

[email protected]




Asia Working Group

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Activity Contacts:

Afternoon Presentation by: Janice Berman, Takeda,

[email protected]

Zhijian Xiao, AstraZeneca, [email protected]

The awareness and impact of Rx-360 will significantly increase in Asia

through the creation of a regional based team, accelerating our efforts to

improve patient safety and enhance the security of the supply channels

in this critical region.

Janice Berman, VP, Takeda Pharmaceuticals U.S.A., Inc.



Supplier Led Working Group

Supplier-Led forum to collaborate with

manufacturers on developing standardized

solutions

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Activity Contacts:

Gary Perkins, Sigma-Aldrich, [email protected]

Afternoon Presentation by: Rick Calabrese, Sartorius,

[email protected]





Monitoring & Reporting Working Group

Objectives:

Monitor and report on key regulatory, legislative, and policy

developments relevant to supply chain integrity

– Global in scope

– Slide sets summarizing regulatory guidance, proposed

legislation, etc. are posted on Rx-360 public website

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Activity Contacts:

Barb Unger, Amgen [email protected]


Monitoring and Reporting Working Group

Accomplishments

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http://www.rx-360.org/News/Rx360FlashReports/tabid/137/Default.aspx




Additional Work Groups

• Observers – Frithjof Holtz, Merck-Millipore, [email protected]

– Collaborating organizations and regulators through quarterly

briefings

• Membership

– Linda Evans O’Connor, Teva, linda.evans.o’[email protected]

• Communications Team

– Lew Kontnik, Amgen, +1 805 447 4123, [email protected]

• Medical Device Exploratory Group

– Afternoon Presentation by: Matt Anderson, Merz,

[email protected]

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As an Rx-360 Subscriber You are Kept

Informed of Key Developments

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• Information packed

web site

• Over 400 Flash Reports

• Over 100 Summaries of

Legislation, Regulation

or Guidance

• Several important

standards for unmet

needs

Sign up at www.Rx-360.org

• 18 Alerts Issued

• Several White Papers

documenting best

practices

• Over 100 Audits

• Real time advice to

manage crisis, i.e.

Japan Tsunami

http://www.rx-360.org/



How Do Member Companies Benefit?

– Protecting your patients and business!

– “Doing more with less” – leveraging external resource for internal

benefit

– “Seat at the table” with regulators, legislators, etc.

– Influencing practical solutions to major events (risk mitigation)

– Intelligence (risks, regulations, etc.)

– Benchmarking (processes, procedures, etc.) – instead of hiring

consultants – stealing ideas

– Influencing standards - raising the bar

– Offsetting increased audit requirements and costs through

collaboration

– We all have supply chains! We know how our patients will

benefit!

31 We know how our patients will benefit!

Questions?

The Value of Rx-360 is in the Engagement

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Interested in joining or learning more?

Contact

Dede Godstrey, Project Manager, Rx-360

at [email protected] , +1 202 230-5607

We are intent on making sure every patient worldwide has safe medicine.

Rx-360's Mission Is to Protect Patients

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BREAK

and Poster Session 10:00 – 10:15 AM

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Closing

Takeaways

Is there anything else you want to add here?

Keep the discussion going, join

our LinkedIn Group.

Be sure to sign up to receive Rx-

360 news at the website:

www.rx-360.org

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