ePedigree & Serialization Adoption Support Initiative

BSMA Launches ePedigree & Serialization Adoption Support Initiative for Biotech Companies

Calabasas, California, July 9, 2013. The Bio Supply Management Alliance (BSMA) has appointed Amy Penticoff as the Chairman of the “ePedigree and Serialization Initiative for Biotech” in order to support the preparedness for the ePedigree Law of the State of California which goes into effect by January 2015. The subject of preparing for the adoption of the Law will be a major area of focus at the upcoming Annual Conference of BSMA on October 8 in Foster City, where Ms. Virginia Herold, the Executive Officer of the CA State Board of Pharmacy, will deliver the Keynote address. Devendra Mishra, Executive Director of BSMA stated, “We are committed to getting our members prepared for the ePedigree Law of the State of California while being mindful of the similar initiatives in other major regions of USA and the world.

penticoff_optMs. Amy Penticoff brings 20 years of industry leadership and experience in clinical and commercial supply chain, project management, and product development to the organization. She will leverage the collective efforts of three Steering Committees of BSMA, namely Risk Management, Strategic Sourcing and Information Technology. ePedigree and Serialization is a business imperative for it provides visibility and accountability in the supply chain to maximize patient care which has significant economic benefit.” Ms. Penticoff observed, “We will… – educate and communicate the value proposition of ePedigree and Serialization in terms of the technologies, processes and benefits, and – develop the base of stakeholders, consisting of biotech drug manufacturers, distributors, packaging machine suppliers, Information Systems service networks and Transportation and Logistics. The opportunity to be adequately and efficiently prepared is timely and significant, particularly for the numerous small and mid-sized companies who have limited resources but can benfit from collaboration.”

Q&A WITH Ms. AMY PENTICOFF

Why should we implement serialization now? There are good business reasons, outside of the forthcoming legislation, to begin implementing serialization into the supply chain. Companies lose as much as $75 billion in business each year to counterfeit drug makers, according to the World Health Organization. The ability to detect counterfeits before injury to patients or damage to the brand is imperative to a company’s bottom line. Serialization will protect assets as well as your brand by minimizing theft, counterfeiting and diversion of product. And, importantly, consumer trust will be built when the supply chain is transparent. Serialization will allow for better inventory control by improving visibility of exactly which items were delivered and when by providing immediate proof of delivery, and will optimize and increase productivity in the ordering process by catching errors earlier in the process. Serialization will also help in reverse logistics as well – recalls, returns, rebates, chargebacks etc.

What’s going on with the regulation anyway? California SB 1307, or the ePedigree Law, is the first US requirement to require electronic unit-level chain of custody tracking, beginning in 2015. It will be fully phased in by the end of 2017. In early June, the US House of Representatives passed H.R. 1919, the Safeguarding America’s Pharmaceuticals Act, which would preempt the California law. But instead of immediately requiring unit-level, electronic tracing, H.R. 1919 requires a lot-level, paper based pedigree. The US Senate has also introduced their own bill, S. 957, The Drug Supply Chain Security Act, in May, 2013, which is more in line with the California law but sets a 10 year deadline for unit-level serialization. Whether the Senate will act on either bill, or will merge both into a single bill, remains to be seen. But while federal legislation is under development, California is not backing down. Indeed, the CA state board of pharmacy went on record opposing H.R. 1919, stating that it does not go far enough to protect patients and that it limits their ability to regulate wholesalers. The state has not revised its timelines, and is unlikely to do so unless and until a federal bill is signed into law. In addition, there is emerging legislation for serialization around the globe – China, India, South Korea, Argentina & Brazil are implementing legislation, and the European Falsified Medicines Directive begins its first phase this year.

Can a small company just let its CMO/CPO deal with this? First of all, regulations state that the brand owner is ultimately responsible for their products, including the labeling, serialization and the supply chain. Even if the serialization happens on a vendor’s packaging line, companies will still need to incorporate serialization into their overall business processes for procurement, inventory, shipping, receiving & billing. If much of the business process and exchange of information between you and your packagers is still manual – i.e. email, spreadsheets, fax, then a lot of work needs to be done between now and serialization to communicate data electronically. Your packager likely does not have the resources or IT systems ready to handle the integration for serialization data exchange.

How long will serialization take to implement? It will likely take longer and be more complicated than you expect. It took Pfizer about a year from planning to shipment for their first pilot study. Depending on your organization, there may be long lead-times for securing the financing, implementing the capital equipment required, and testing and piloting the program. Piloting will be critical to test the implementation across every trading partner across the entire supply chain. It is critical to pilot early in order to ensure the interoperability of the system and to uncover bugs or issues well in advance of the deadlines. It is also critical to ensure that the solution is scalable across all the partners. But the clock is ticking. As California’s deadline gets closer, there will be a surge in demand for serialization partners and vendors, and they will start to book up.

How does an enterprise get started? First, involve your senior management. This is not just a supply chain & logistics project – serialization will require cross-functional dedication from Packaging, Manufacturing and Operations to IT, Quality and Regulatory/Legal and a project of this magnitude must have support from the top down. Look at where you are today with your business processes and systems to determine the best cross-enterprise solutions. Start looking at potential implementation partners – before they are booked up. And learn from those who have already begun.

REQUEST: Please contact Amy Penticoff to get involved with this biotech industry initiative and if you wish to receive information.

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