The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/469666
LIFESCIENCELEADER.COM 46 MARCH 2015 SUPPLY CHAIN biopharma into account, according to Phillips of Xavier Health. They'll need to; adop- tion is not a foregone conclusion. As with any initiative raised to the level of best practices and potentially regula- tory considerations, there will be tough negotiating over nuances in meaning. For example, while Lowndes is looking for a new industry model to facilitate flexibility and customization at suppli- ers, Phillips and others seem inclined to put the onus on the manufacturers for broader industry "harmonization" of parameters and specifications. Maybe a nuance, maybe a mountain. The best practices themselves could prove controversial. An idea flowing from the aforementioned oil and gas industry is one of having a methodology for suppliers to rate manufacturers (not the other way around). Says Phillips: "If industry is really interested in improv- ing product reliability, and know they are part of the problem, then suppliers should rate manufacturers so they can assess how they are doing." She quick- ly adds, by the way, there are ways to ensure the anonymity of the suppliers. Timing is on the side of adoption. The need for change has become apparent to patients, their doctors, and health- care organizations. Big Pharma and med device companies appear ready to face their shortcomings and are looking for solutions. The suppliers, certainly not without issues on their side as well, are caught in the middle of an unten- able situation. The U.S. Congress has responded by passing FDASIA, and the FDA has come to the table to assist. Add the simple fact that outsourced supply chains, despite current issues, are on the rise. Phillips says nobody involved in the Initiative will be satisfied with gener- ating a set of GSPs. "These have to be adopted industrywide," she says. "We'll engage the manufacturers and trade associations to review and endorse the documents, and work with the FDA to have GSPs included in risk assessment of manufacturers and their suppliers. We'll give the industry every reason to adopt these measures." L will fail batches and the drivers for any excessive predictive failure rates," he says. "That helps us and the supplier. When failure happens in the old model, it's just an economic argument about who is accountable." Shire adheres to its stringent supplier selection criteria. (Although Lowndes says the ultimate benchmark is simple: "If the FDA walks in there, will they be happy?") Supplier development is also important. "Issues in the industry creep up as technology and standards evolve," he says. " We work with suppliers to ensure we keep pace." For example, Shire recognized that difficulties in hiring and retaining skilled employees were causing production problems at a supplier. Shire sent its HR team to help the supplier with its HR systems, and instituted programs for attracting, retaining, and training staff. Lowndes says he's most proud of bring- ing together Shire's supply chain partners for its biggest products the same way as if it were an internal supply chain. "We review everything from quality to product strategy and goals. We look at product performance amongst various sites and help each other with challenges." Last year Shire conducted a business continuity exercise assuming a part of the supply chain had gone down. Suppliers strategized on how they would cooperate to address the situation so that patients would not be impacted by a shortage. And for a supply chain, it's the well- being of patients that counts most. "We've actually taken patients to our CMOs to share our motivation with all their employees," says Lowndes. "In the current transactional model, Big Pharma is more apt to take their procurement group to the supplier." LAST CHAPTER NOT WRITTEN The endings in Brothers Grimm folk tales don't always turn out well. The Integrity of Supply Initiative is cur- rently developing GSPs to increase the reliability and quality of drug supplies. GSPs will be tied to return on investment and take real-world business realities and rare-disease products, more flex- ibility and agility are required. "In the current model suppliers can't respond to specific needs driven by our prod- ucts," says Lowndes. "They may have 40 other customers and can't customize for everybody. We've created a model that has CMOs trying to make one-size–fits- all offerings to meet demand and stay profitable." The status quo is supported by "specs wide enough to drive a bus through." Lowndes says manufacturers must pro- vide a better understanding of how higher variability on processes and material impacts products. "As it turned out from the surveys and investigation of the Integrity of Supply Initiative," he says, "we often don't even share what we are using the material for. This is one reason why we get product variability. We own the specs; it's not the supplier's fault." SHIRE'S APPLIED SOLUTIONS Lowndes says the three categories for the GSPs — product and process knowledge and development, supply chain development and management, and driving ideal behaviors — are "pretty logical when you look at them. You want to say, 'It's common sense!'" But com- mon sense, it appears, in large part, is not practiced. At Shire, some of what will come out in the GSPs is already in place. Lowndes believes the foundation for a new model is greater product and process knowledge and development — shared between sponsor and manufacturer. "Shire's batch failure rate [for an out- sourced small molecule supply chain] has gone down from 2 percent to 0.35 percent in a few years. My understand- ing is that for small molecule products 0.5 percent [in a vertically integrated supply chain] is about best practice," he says. Shire shares a knowledge manage- ment system with its biggest partners. There's an overnight exchange of data and trending to proactively address potential issues at the manufacturing site, including such things as operator variability. "We can identify the probability we By L. Garguilo BIOPHARMA LOOKS INTO THE SUPPLY CHAIN MIRROR: WE'RE THE PROBLEM