Patients are Counting on Us: A Little Less Conversation It s Time to Act Martin VanTrieste SVP Quality Amgen, Inc. PDA Missouri Valley Chapter Supply Chain Security in the Pharmaceutical Industry Thousand Oaks, California 12-September-2011
Dr. Woodcock stated at the first PDA - FDA Supply Chain Workshop The heparin situation is Industry s wake up call Industry heard this message and 2
Momentum is building Industry is Conducting more audits which are more thorough Focusing on supply chain security Hearing the message leading to increased supplier transparency Implementing company specific solutions Improving and increasing the level of collaboration Greater achievements are required because the threats are not slowing down 3
Illicit activity is present and threatens the safety of medicines $1000 Counterfeit DVDs $10,000 The criminal element is present, active, and business savvy Benign consumer actions may have tragic consequences Illegal drugs Counterfeit medicine $100,000 $1,000,000 4
To secure the supply chain 1. First use common sense 2. Then embrace best practices 3. Adopt advanced technologies; and 4. Always collaborate You know something is worth the effort if it is easy to say but hard to do 5
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? Every step in the supply chain represents a potential risk 6
Common sense dictates that you do business with a trusted partner Create Win / Win solutions Due diligence Build and maintain a relationship Routine contact Provide routine oversight When a trusted partner is not available 7
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 When there are doubts act quickly 8
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 Rx-360 Draft Points to Consider: Optimizing Pharmaceutical Raw Material Tamper Evidence Most importantly seals should be verified for each shipment and every container 9
Best Practices like Management Review can drive continuous improvement Promotes cross functional focus on events, prioritization and continuous improvement Fosters rapid escalation of significant events Creates awareness of a shared reality Creates tension in the wire Management Review creates data driven action orientated initiatives 10
Best Practices like Photographic Libraries can be embraced to secure raw materials! Increase a sense of awareness and increase the number of eyes looking for problems 11
Best Practices like Right Size Testing can be embraced to secure raw materials! 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? 12
There are best practices that can be embraced to prevent cargo theft! 13
There are best practices that can be embraced to prevent cargo theft! Layers of defenses are required Work cross functionally Apply risk management Selected trusted partners Periodically audit trusted partners Educate truck drivers in hijack awareness and prevention Harden your transportation lanes so criminals go to easier targets 14
There are best practices that can be embraced to prevent cargo theft! Provide a card with emergency contact numbers Approved primary and alternative shipping routes Premises should be fully fenced There should be cameras, alarm systems and guards If thieves do break into a lot, you want to make stealing a load as difficult and time-consuming for them as possible Driver selection is critical 2 Drivers! 1 2 15
There are best practices that can be embraced to prevent cargo theft! Cargo at Rest is Cargo at Risk! Require truckers to drive at least 200 miles (or about 4 hours) until first stop Before truckers stop, they should notify their home base or dispatcher All cargo thefts should be reported to Law Enforcement and the FDA, EMA and / or appropriate regulatory agency 16
There is Good News The incidence of cargo theft in 2010 has flatten and is trending down in 2011 The drop off is likely due to intense efforts by drug makers to harden the supply chain, according to Freight Watch International US Senators are introducing a bill to increase penalties for stealing drugs
New Technologies like Pedigrees can be embraced to secure raw materials! Efpia Pilot 4 months 14 companies 25 pharmacies 95,000 packs scanned Results http://www.efpia.eu Model worked Identified fake and expired packs Did not increase pharmacy s workload High user acceptance What can we do to apply pedigree to raw materials? 18
New technologies are being implemented J&J pioneers validation tool for customs Janssen-Cilag has developed a new web-based tool for customs to check whether a shipment is fake or genuine. www.dvp-eu.com 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. Janssen-Cilag has been trying to encourage other drug makers to join in with the project 19
New technologies are being implemented FedEx SenseAware provides real time monitoring Real time in flight GPS for temperature, humidity, light, barometer, and accelerometer reporting Combines an in-package sensing device with a comprehensive webbased information platform Collaborate by monitoring active ingredients to their manufacturing plant, then monitoring secure and temperature-sensitive transport from plant to wholesalers to clinics 20
New technologies are being implemented Temptime verification via a cell phone Smartphone app captures picture of authentication device and/or temperature monitor. Reading is sent to a central server. Server identifies whether or not: The product is authentic; The temperature has been maintained; The product is within its expiration date; and Other information, such as product recalls, link to product Information, etc. Server captures the data related to product in real-time. Server sends USE / DO NOT USE and other basic information to practitioner/patient.
Collaboration is a game changer Rx-360 provides industry that opportunity 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 1. Educate 2. Share information 3. Standardize 4. Promote best practices 5. Share Audits www.rx-360.org 22
To protect the patients you serve, the product you make and your company I strongly encourage you Apply common sense Embrace best practices Evaluate new technologies Start collaborating Patient safety should never be a competitive advantage 23
History will Be Our Judge Let us Commit to Action Let us not be content to wait and see what will happen, but give us the determination to make the right things happen. 24