Rx-360 Symposium: Supplier Audits and Supply Chain Security Meeting Increasing Expectations and Escalating Regulatory Requirements

October 29, 2014 Cologne, Germany

WELCOME David Walker, Bayer HealthCare

SYMPOSIUM OVERVIEW Brian Johnson, Pfizer

Overview • Welcome • Acknowledgements • Housekeeping • Introduction to Symposium

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Acknowledgements Speakers/Panelists

Rx-360 Speakers

Vivian Leung, MHRA

Guy Villax, Hovione

Rainer Gnibl, Govt of Upper Franconia Luísa Paulo, Hovione Klaus Gritschneder, EAMSP

Janice Berman, Takeda

Lindsey Rodriquez, BSI

Paul Gibbons, Amgen

Stefan Karl, Sandoz

Carmen Wolf, Boehringer Ingelheim

Andrew Cotter, Mylan

Lynne Byers, Novartis

David Hatt, Teva

Ben Mills, Amgen

Moderators  Brian Johnson, Pfizer  Martin VanTrieste, Amgen  Linda Evans O’Connor, Teva

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Housekeeping • Please turn off cell phones. • Presentations will be posted on the Rx-360

website after the Symposium. • Questions about Rx-360? – See Rx-360 Representatives at Registration Table or ask any Rx-360 Presenters.

Thank you for attending! 6

Agenda - Morning I.

Welcome (8.30 – 8.35 CET) David Walker, Bayer HealthCare

II.

Opening (8:35 – 8:40) Brian Johnson, Pfizer, Rx-360 Chair

III.

Rx-360 – Progress Report: Where We Came From and Where We Are Going (8.40 – 8.55) Linda Evans O'Connor, VP, Supplier Quality Management, Teva

IV.

Reasons for Rx-360’s Success and 2015 Goals (8.55 – 9.10) Guy Villax, Chief Executive, Hovione, Rx-360 Vice Chair

V.

Regulatory Panel: Regulators’ Views on Supply Chain Security Issues (9.10 – 10.55) Moderator: Martin VanTrieste, Senior Vice President, Amgen; Founding Chair, Rx-360 Vivian Leung, GMDP Inspector, MHRA (9:10 – 9:55) Dr. Rainer Gnibl, Pharmacist, GMP-Inspector, Government of Upper Franconia (9:55 – 10:40) Q&A Session (10:40 – 10:55)

10.55 – 11.10 BREAK VI.

Protecting Patients from Falsified Medicines Online (11.10 – 11.40) Klaus Gritschneder, Vice President and Secretary General, European Association of Mail Service Pharmacies (EAMSP)

VII.

Rx-360 Supplier Assessment Questionnaire (SAQ) (11.40 – 12.05) Luísa Paulo, Compliance Senior Director, Hovione

VIII. Rx-360 in Asia (12.05 – 12.30) China: Janice Berman, Vice President, Quality Assurance, Takeda Pharmaceuticals U.S.A., Inc. India: Guy Villax, Chief Executive, Hovione, Rx-360 Vice Chair Q&A Session

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Agenda - Afternoon 12.30 – 13.30 PM LUNCH IX.

Supply Chain Security (13.30 – 15.00) Cargo Theft/ Dealing with Armed Robbery Paul Gibbons, Director EMEA, Amgen Global Security, Amgen Upstream Supply Chain Carmen Wolf, Head of Supply Network Quality Management, Boehringer Ingelheim Good Distribution Practice in Africa Lynne Byers, Global Quality Head, Novartis

X.

The Rx-360 Audit Program (15.00– 15.45) Ben Mills, Supplier Audit Program, Amgen Lindsey Rodriquez, Business Development Manager, BSI

15.45 – 16.00 BREAK XI.

Benefits of Rx-360 Membership for Generic Manufacturers (16.00 – 17.00) Moderator: Linda Evans O'Connor, VP, Supplier Quality Management, Teva Panelist: Stefan Karl, Head Audit & Compliance Europe, Sandoz International GmbH Andrew Cotter, Senior Manager, Global Operations Audit Group, Mylan David Hatt, Director Quality Business Development, Teva

XII.

Closing Brian Johnson, Pfizer, Rx-360 Chair (17.00)

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RX-360 PROGRESS REPORT: Where we came from and Where we are going Linda Evans O’Connor, Teva

The Problem • • • • •

Criminal Profits Complex Supply Chains Global Trade Internet Weak Controls FDA Asked the Industry to Collaborate for Patient Safety

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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. 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. Rx360 is working to ensure that patients everywhere can enjoy the benefits of globalization safely.” Guy Villax, Chief Executive Officer, Hovione

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Rx-360 Objectives 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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Membership Broad and Inclusive

• 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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Membership Requirements

Any legal entity may join Rx-360 provided that it meets the following criteria: Its activities relate to the research, development, manufacture, or distribution of pharmaceutical, biotechnology, or medical device products, including (i) research-based pharmaceutical companies, generic pharmaceutical companies, biotechnology companies, and medical device companies, (ii) suppliers of ingredients and components of pharmaceutical, biotechnology, and/or medical device products, and (iii) suppliers of services relating to the quality or safety of the pharmaceutical, biotechnology, and/or medical device supply chain, including distributors and wholesalers. Excerpt from Rx-360 Bylaws, Article IV: Membership; Section 4.01 (A): Membership Criteria

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How We Are Organized Operating Model • Formed in 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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Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

• • • • •

Serialization Cargo Theft Data Information Sharing Upstream Supply Chain Africa

Supply Chain Security

• • • • • •

Monitoring & Reporting Flash Reports Alerts Supply Chain Threats Membership Observers

Outreach

• China • Audits • Supply chain • Membership • India

New Regions

• Supplier Working Group • Medical Device

Focused Industry Initiatives 16

Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

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Rx-360 Audit Programs 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

Activity Contacts: Afternoon Presentation by: Ben Mills, Amgen, [email protected] Robin Kumoluyi, Novartis, [email protected]

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Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

• • • • •

Serialization Cargo Theft Data Information Sharing Upstream Supply Chain Africa

Supply Chain Security

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Rx-360 Supply Chain Security Sharing of Information and Processes Enhances Supply Chain Security thereby Protecting Patients “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: Rob Welsh, VWR, [email protected] Joe Newell, Amgen [email protected] Afternoon Presentations by: Paul Gibbons, Amgen, [email protected] Lynne Byers, Novartis, [email protected] Carmen Wolf, Boehringer Ingelheim, [email protected] 20 20

Rx-360 Supply Chain Security Accomplishments - Deliverables Management Systems • Benchmarking, and white paper describing comprehensive supply chain security program

Conveyance Risk Management • Benchmarking, development of risk model, and white paper on using risk based approaches to conveyance security

Market Monitoring • Benchmarking, white paper and framework on good practices/toolstechniques, emerging technologies, to monitor the market for criminal activity

Audits and Assessments of Third Party Providers • Points to Consider for audits/assessments; audit standard methodology; audit tools for LSP’s

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Rx-360 Supply Chain Security Accomplishments - Deliverables

Illegal Diversion • Shared information on illegal diversion and how each company is impacted; identified best practice and current thinking; generated a white paper that highlighted the problem and what can/should be done to address it

Incident Management • Benchmarking, white paper on existing efforts for supply chain incidents response

Drug Shortages • Highlighted risks to the integrity of pharmaceutical supply chains in a white paper

Webinars conducted for all the above • Available at: http://www.rx360.org/Resources/DocumentsGuidelinesPTCWhitePapers/tabid/209/Default.aspx

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Rx-360 Supply Chain Security Accomplishments – Risk Mitigation

Response to Crisis in Japan

• • • • • • • • •

Gathered Japan supply chain experts Shared risk assessments / models Shared regulatory intelligence Monitored the regulatory environment and kept requirements library Monitored the “on the ground” situation in Japan Source of SME knowledge for regulators Contributed to a balanced response We were a service to industry and patients Leveraging external resource

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Rx-360 Supply Chain Security Initiatives Upstream Supply Chain Security • Benchmarking, white paper on security practices and controls that mitigate these threats of economic adulterated raw materials

Cargo Theft in High Risk Areas • Benchmarking, white paper on responses to the escalation of violence in cargo theft incidents in high risk areas

Africa Supply Chain • Organizing and holding GDP workshops in Africa; discussions, knowledge sharing with local organizations

Serialization Discussion Group • Share information, knowledge, experiences and leverage learnings on how companies actually implementing requirements

Traceability Data Exchange Architecture • Discuss standards-based models for choreography of traceability data exchange • Develop concept model best suited for Brazil regulation and for APEC pilot; publish whitepaper

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Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

• • • •

Serialization Cargo Theft Upstream Supply Chain Africa

Supply Chain Security

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Asia Working Group 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.

Activity Contacts: China: Zhijian Xiao, AstraZeneca, [email protected] Afternoon Presentation by: Janice Berman, Takeda, [email protected]

India: Afternoon Presentation by: Guy Villax, Hovione [email protected] 26

Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

• • • • •

Serialization Cargo Theft Data Information Sharing Upstream Supply Chain Africa

Supply Chain Security

• China • Audits • Supply chain • membership • India

New Regions

• Supplier Working Group • Medical Device

Focused Industry Initiatives 27

Supplier Led Working Group Supplier-Led forum to collaborate with manufacturers on developing standardized solutions

Activity Contacts: Gary Perkins, Sigma-Aldrich, [email protected] Rick Calabrese, Sartorius, [email protected]

Afternoon Presentation by: Luísa Paulo, Hovione [email protected]

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Medical Device Working Group • The recently launched Medical Device Working Group

seeks to identify and address the supply chain quality and security needs of medical device companies • Working with the leadership of Rx-360, the Device Working Group is pro-actively integrating the goals and priorities of the Medical Device industry with the ongoing programs of Rx-360 Activity Contact: Matt Anderson, Merz, [email protected]

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Where Rx-360 is Currently Engaged • • • • •

Joint Audits Audit Licensing BSI Integration auditsPLUS Medical Device/GDP Audit Development

Audit Operations

• • • • •

Serialization Cargo Theft Data Information Sharing Upstream Supply Chain Africa

Supply Chain Security

• China • Audits • Supply chain • membership • India

New Regions

• Supplier Working Group • Medical Device

Focused Industry Initiatives 30

Monitoring & Reporting Working Group Objectives: Monitor and report on key regulatory, legislative, and policy developments relevant to supply chain integrity • Global in scope • Summaries of regulatory guidance, proposed legislation, and other

important developments are posted on Rx-360’s public website (132 summaries published to date; to view the Flash Reports, visit http://www.rx-360.org/News/Rx360FlashReports/tabid/137/Default.aspx) Activity Contacts: Barbara Unger, Amgen [email protected]

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Monitoring and Reporting Working Group Accomplishments

Regulators from all over the world routinely download the reports; Rick Friedman at the FDA has commented that this is a great service offered by Rx-360.

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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, [email protected] • Vivian Berni, LifeConEx, [email protected]

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Current Rx-360 Membership Observers

Members Manufacturers (27) • • • • • • • • • • • • • • • • • • • • • • • • • • •

Suppliers (29)

• 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.

AMPAC Fine Chemicals LLC Ash Stevens Aurisco Avantor Performance Materials, Inc. BASF Cambridge Major Laboratories, Inc. Cardinal Health DSM Nutritional Products Ltd. FUJIFILM Diosynth Biotechnologies U.S.A., Inc. GE Healthcare Hikal Hovione Imperial Health Sciences Labochim LifeConEx Ligand Merck KGaA Neuland Laboratories Limited Novozymes OSO BioPharmaceuticals Manufacturing LLC Resilinc Sartorius AG Sigma Aldrich Spectrum Chemical Mfg. Corp. TempTime Thermo Fisher VWR West York Container

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 (20) • • • • • • • • • • • • • • • • • • • •

Alliance for Safe Online Pharmacies 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 USDM Life Sciences, LLC

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Information Exchange and Database External – The Rx-360 Website - www.rx-360.org

The Rx-360 website provides a platform for sharing information with the greater community through: • News reports • Flash Alerts • Rx-360 audit guidelines • White papers • Newsletters • Presentations 35

How We Communicate Externally

Social Media

• Rx-360 is social, click on the labels below to follow us on:

Mobile

• Smart phone APP for iPads / iPhones and Android Phones • Click on the labels below to download the APP:

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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!

We know how our patients will benefit! 37

Questions?

The Value of Rx-360 is in the Engagement

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Summary Privilege & Responsibilities

Serving patients is a privilege that comes with responsibilities...

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