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Pharma Business And how often are existing — especially long-term employees — monitored without prejudice because of longevity or internal political alliances? History is littered with turncoats who have been denied promotion or whose pet projects have been defunded. We recommend that HR executives re-examine background-checking protocols, especially in the terrorist-vulnerable areas of laboratories, manufacturing, and distribution. The access to technology, materials, and equipment should make careful screening of personnel staffing in these areas a priority. Routine reference checks and in-person interviews should be supplemented with psychological screening for personality disorders such as paranoia, narcissism, and anger management issues. There should be deep online searches, including checks for public records of instability and/or arrest. And CV-enhancing claims of publications, patents, speaking engagements, and other professional accomplishments should be carefully reviewed for plausibility and credibility. Also recommended is a policy of ongoing personnel investigation and monitoring, especially of staff scientists and engineers with specialized pharmaceutical skills and purchasing responsibilities. They occupy roles that, given the right circumstances, can be turned against their employers. Common scenarios include retribution for cancellation of a favored program, a reprimand, refusal of a patent or paper, or losing a promotion. Issues less visible to management, but potentially exploitable by a terrorist organization, are alcohol or substance abuse, financial and other personal problems, sexual orientation, or family members living in high-threat nations. The determined terrorist will use blackmail to leverage these situations for access to equipment and expertise or to divert materials or to force the unauthorized purchase of critical substances. of ingredients — has resulted in widespread misery and loss of life. While deaths have generally been in the hundreds, sophisticated terrorists infiltrating a production facility and introducing assay-resistant toxic ingredients could alter that calculus dramatically. This is no idle concern. In 2007 and 2008, dozens of U.S. patients experienced adverse events from heparin that had been adulterated while being manufactured in China. In 2009 a shipment of more than 125,000 vials of insulin was stolen and stored in unknown conditions before being sold to pharmacies and patients. And 115 Panamanians died from ingesting cough syrup in which cheap diethylene glycol had been substituted for more expensive glycerin. Manufacturers need to adopt electronic pedigree techniques to track and trace drug ingredients. They also need to advocate more direct action by the FDA and other regulatory bodies. The counterfeit problem is more severe. According to the Center for Medicine in the Public Interest, sales of counterfeit drugs are around $75 billion and growing rapidly. Sales from counterfeit drugs are around $75 billion and growing rapidly. SECURITY Traditional brick-and-mortar security is needed in every industry. But new challenges require biopharmaceutical industry security executives to embrace a fully integrated approach, combining physical protection, access controls, and materials accountability. Combined with the information security and personnel screening described earlier, these will strengthen the company's physical and cyber perimeters. We strongly advise biometric devices as part of the protection of laboratory and other facilities housing materials and equipment, and servers. We also recommend ongoing inventorying and proper chain-of-custody protocols for all terror-prone biologicals, chemicals, and equipment outside of access-controlled areas. PROTECTING THE SUPPLY CHAIN FROM ADULTERATION AND COUNTERFEITS Economically motivated adulteration (EMA) — the adulteration 40 LifeScienceLeader.com January 2014 SECURING THE FUTURE It's said that awareness is the first step toward change. Growing numbers of pharmaceutical decision makers are becoming aware of the problems discussed in this article. More attention needs to be directed to hiring and personnel monitoring practices. Scrutinizing online identities needs to be standardized with sophisticated cryptographic technologies. Terrorist groups already are counterfeiting drugs and distributing them through criminal cartels. The industry needs more initiatives to identify bogus drugs and to inform pharmacy professionals and consumers of ways to avoid and/or detect them. Of greatest concern is the potential for terrorist groups to expropriate criminal cartel resources and turn them from a source of income to a form of targeted destruction. The technologies to prevent that doomsday scenario will evolve. For now, companies need to be aware of the problem, take practical action, and remain vigilant. It is a matter of corporate — and public — health. About the Authors Dr. Miri Halperin Wernli is VP, deputy head of global clinical development, and head of global business and science affairs at Actelion Pharmaceuticals. Dr. Boaz Ganor is deputy dean and Ronald Lauder chair for counterterrorism at the Lauder School of Government, Diplomacy, and Strategy. He is also founder and executive director of the International Institute for Counter-Terrorism (ICT) and the head of the counterterrorism and homeland security studies programs at the Interdisciplinary Center (IDC) in Herzliya, Israel.