Maximizing the return on investment in quality innovation was the topic of a BIO International Convention Super Session on Tuesday which explored challenges and opportunities for pharmaceutical companies in improving efficiencies and ensuring patient safety. Panelist Martin VanTrieste, Senior Vice President, Quality, Amgen described a global initiative formed by industry and regulators to share knowledge and best practices that will help secure the pharmaceutical supply chain and quality of materials. Rx-360, a consortium of pharmaceutical companies, suppliers and regulatory agencies, is tasked with developing voluntary standards for the quality and authenticity of supplies and suppliers, and developing audit standards, training and certification programs. The goal is to prevent counterfeited, adulterated and contaminated materials from entering the supply chain, and jeopardizing patient safety. One tragic example was the introduction of contaminated heparin, a blood thinner, linked to 80 deaths in U.S. patients and allergic reactions in 2008. VanTrieste said the consortium “has been highly effective in bringing industry leaders in the quality and supply chain security space together to come up with common solutions” in addressing the very difficult problems associated with globalization. “By working together we get to the answer faster and it’s more efficient.”
The FDA has been very supportive of the consortium, he said, even though initially there was some concern that it would lobby the agency. “We’re not asking the FDA to water down their standards,” VanTrieste noted. “We’re creating a standard that we think is the best practice and we ask the agency to comment.” Since its founding in 2009, the consortium has “uncovered things of an unethical nature and turned those over to the regulatory authorities so they can deal with it in an appropriate manner.” Bottom line “it’s all about patient safety and serving patients,” he added. For more information visit www.rx-360.org. #BIO2014.