1 Rx-360 An International Pharmaceutical Supply Chain Consortium Working Together for Success Martin VanTrieste, R.Ph. Amgen, Senior Vice President Quality June, 2010 FDA-PIA 8th Regulatory Conference

2 Rx-360 An International Pharmaceutical Supply Chain Consortium Working Together for Success Martin VanTrieste, R.Ph. Amgen, Senior Vice President Quality June, 2010 FDA-PIA 8th Regulatory Conference for Patients Patient safety must never be compromised as a competitive advantage

3 Illicit Activity is Present and Threatens the Safety of Medicines The criminal element is present, active, and business savvy ‘Benign’ consumer actions may have tragic consequences $1000 $10,000 Counterfeit DVDs $100,000 Illegal drugs $1,000,000 Counterfeit medicine

5 May 7, children die in Haiti due to contaminated glycerin in acetaminophen syrup Tragic Consequences Not If… But When and Where

6 Rx-360 Mission Create and monitor a global quality system that meets the expectations of industry and regulators, that assures patient safety by enhancing product quality and authenticity throughout the supply chain

7 Rx-360 Operating Model Designed to meet competition law requirements Not intended to replace regulatory systems or oversight International not-for-profit organization Volunteer based Broad and inclusive membership –Small and large companies –Branded and generic –Suppliers, distributors, brokers and manufacturers Companies are members not individuals

Rx-360 is Having an Impact Information Sharing Technology Sharing Standard Setting Audit Sharing 8

9 Since April 2009 Rx-360 Has Distributed Information to Registered Users

10 Rx-360.org Shares Information That Can Benefit Us All: Swine Flu Impact Analysis

11 Rx-360.org Shares Technology That Can Benefit Us All: Acetonitrile Method Determination of Adulteration of Acetonitrile using Gas Chromatography with Thermal Conductivity Detection

12 Standards Are Required to Create a Level Playing Field Identify existing best practices Endorse best practices Implement quickly Continuously refine after successful implementation “Perfection is the enemy of good.”

Rx-360 Working Groups Are Building Infrastructure Standards Approved –API auditing (ICHQ7/APIC standard) –Rx-360 Security Standard Standards Close to Approval –Excipients (will endorse the IPEC standard) –Basic Chemicals (based upon ISO 9001:2008) Auditor registration site launched Audit D-base developed and approved Audit Pilots are almost ready to start 13 Rx-360 will be effectively piloting the standards and will be able to feedback to IPEC any proposed changes following the Rx- 360 pilots. The intention is to work closely with those organizations which develop standards and adopt those standards, where appropriate. As the basic chemicals standards are not an existing standard, these, together with the supply chain security standards will be put out for public comment in parallel with the operation of the pilot audits.

14 Sharing Supplier Audits Will Increase Compliance, Quality and Efficiency 1.Sharing existing audit information from one member with many members 2.Sponsor audits are initiated by a single pharmaceutical firm 3.Audits led by Rx-360 are initiated by the consortium based on input from all members 4.Subscription audits are existing audits that are redacted and placed into a secure database for member access Numerous 1 or 2 day audits will be replaced with fewer & more thorough audits thus eliminating “Audit Fatigue”

15 Value Proposition Rx-360 Is Pursuing a Win-Win for All Parties Confidence for our Patients Safety, Security, and Quality for Regulators Efficiency for Suppliers Safety, Security, Quality, Knowledge, and Efficiency for Biotech & Pharma Companies Delighted Members for Professional Organizations

16 Rx-360 Has Momentum Mar ’09 Launched web-sitewww.Rx-360.org Apr ’09 Initiated news distribution to registered users June ’09 Incorporated Rx-360 as a 501(c)(6) non-profit June ’09US launch event in Washington D.C. July ’09 Appoint interim Board of Directors Nov ‘09 Europe launch event in UK  Ongoing Survey member companies on audit schedules  Ongoing Bring on member companies, target is 50  Q2 ’10 Conduct audit pilot

Pharmaceuticals: Abbott, Alcon, Amgen, Amylin, AstraZeneca, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Cephalon, Eli Lilly, GlaxoSmithKline, Hospira, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi Aventis, Takeda, Watson Suppliers: Archimica, BASF, Fagron, Freight Watch, GE Healthcare, Hovione, LifeConEx, Mallinckrodt Baker, Merck KGaA, Reliable Biopharmaceuticals, Sigma Aldrich, Temptime, VWR, West Observers: APIC, EFGC, EGA, ISPE, IPEC, PDA, Pharmaceutical Service Group, RMC, SOCMA, SQA Services 17 Over 40 Organizations Have Signed On Thus Far

18 Register as a User on and Receive Valuable Industry News

Myths vs Truths 19 For profit scheme US Centric Select companies’ initiative Restrictive Auditors 505(C)(6) nonprofit European participation One member, one vote Open application process

Myths vs Truths 20 Big Pharma Secretive Prevent Regulation Biotech, pharma, generic, suppliers & audit firms Open & Transparent Not intended to replace eliminate regulatory oversight

To secure the supply chain 1.First use common sense 2.Then embrace new ideas 3.Adopt advanced technologies; and 4.Always collaborate 21 Numerous 1 or 2 day audits will be replaced with fewer & more thorough audits thus eliminating “Audit Fatigue”

Common sense dictates that you understand your supply chain Who is the manufacturer? Where is it manufactured? How many links are in your supply chain? Is your supplier transparent? How is the material transported and stored? 22 Every step in the supply chain represents a potential risk

Common sense dictates that you do business with a trusted partner Due diligence Build and maintain a relationship Routine contact Provide routine oversight 23 When a trusted partner is not available…

Common sense dictates that you have a robust risk management process Apply resources based on risk When there is an unacceptable risk -Move them up -Move them out -Install risk mitigation 24 When there are doubts act quickly

Common sense dictates the use of tamper evident seals Tamper evident seals –Not a K-mart zip tie –Not Ace Hardware duct tape –Not a piece of string –Not a rubber band –Not a knotted plastic bag Seals should have a unique number 25 Most importantly seals should be verified for each shipment and every container

There are many new ideas that can be embraced to secure raw materials! Photographic Libraries 26 Increase a sense of awareness and increase the number of eyes looking for problems

There are many new ideas that can be embraced to secure raw materials! Right Size Testing –Need to change the paradigm to drive more robust screening Skip lot, abbreviated, reduced testing, etc. –Compendia testing may not be sufficient –What about NIR, Raman, Mass Spec GC, NMR, etc. 27

There are many new ideas that can be embraced to secure the supply chain! Pedigree Efpia Pilot –4 months –14 companies –25 pharmacies –95,000 packs scanned Results – –Model worked –Identified fake and expired packs –Did no increase pharmacy’s workload –High user acceptance 28 What can we do to apply pedigree to raw materials?

There are many new ideas that can be embraced to prevent cargo theft! Two drivers Chase cars Can’t stop for at least 4 hours or 200 miles Inform the driver they are being tracked Use covert tacking devices and services 29 Harden your transportation so criminals go to easier targets

There are many new ideas that can be embraced to prevent cargo theft! Janssen-Cilag has developed a new web-based tool for customs to check whether a shipment is fake or genuine. Collaboration with customs officials and was road- tested last year by 17 customs officials in 10 EU countries Janssen-Cilag will sometimes change product packaging every year, as this is in itself a protection against counterfeiting, but this makes it even more hard to ensure that all 27 EU customs authorities have up-to-date information. 30 Janssen-Cilag has been trying to encourage other drug makers to join in with the project

New technologies are being implemented FedEx SenseAware provides real time monitoring Sensing: In flight GPS real time communications, and sensors for temperature, humidity, light, barometer, and accelerometer New-to-world information service and interface SA Alliance Certification: Programs and processes to certify 3rd party’s hardware, software, and accessories, along with management of IP-licensing Multiple SA Solutions: Integrated and configurable sensors and accessories available for purchase, such as packaging, pallet, and container systems that address different environmental, energy, security, and communication management scenarios 31

New technologies are being implemented FreightWatch offers product tracking Tracks shipments vs a pre-defined route called a geofence Provides alarms if the geofence is violated Emergency Response Center are on-call 24x7 to coordinate recovery of stolen cargo with a nationwide network of law enforcement agencies and cargo theft investigators 32

To protect the patients you serve, the product you make and your company I strongly encourage you –Apply common sense –Embrace new ideas –Evaluate new technologies –Start collaborating by convincing you company to join Rx-360! 33 Patient safety should never be a competitive advantage and can never be achieved by….

We Must Act Now 34  There is a significant un-met need  Minimal costs are required to start-up and operate  The consortium allows us to collaborate to serve patients  The consortium has generated enthusiasm and excitement

35 Thank you Jim Jamieson Drinker, Biddle & Reath +1 (202) For More Information