Life Science Leader Magazine

JAN 2014

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

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Pharma Business Botulinum toxin, ricin, tetradotoxinm, conotoxin, and other deadly toxins already are present in many private-research laboratories. Is the security keeping them from us any more than a key to the front door and knowledge of what might be found in the fridge? And, perhaps most significant, there is an ample supply of personnel trained to understand bioengineering processes. A 2009 WHO survey identified 466 biomedical and clinical engineering teaching units in 90 of its member states. That comprises a global educational infrastructure that has produced engineers, technologists, technicians, and assistants in the tens of thousands, if not more. There is no lack of talent that, with the right incentive or intimidation, could be redirected to harm. The industry will never have total control of these risk factors, but it can take measures to minimize them. Toward this end, we have grouped security risks into "identity" and "security." Cyber-Terrorism Use of the Internet for global collaboration opens the possibility that those we rely on are not who they present themselves to be. This possibility of cyber-terrorism masked as false representation can compromise drug discovery, development, manufacturing, and distribution by allowing the wrong people access to valuable intellectual property and other information assets. Mitigating this risk is possible through the use of standardized digital identities. The global SAFE-BioPharma digital identity standard was developed by the industry and regulators, such as the FDA and EMA (European Medicines Agency), to provide highassurance trust between parties engaged in secure Internet transactions. Many companies already are members of the nonprofit that manages the standard, and its IT, HR, and security groups can utilize its sophisticated cryptographic technology to guard against unauthorized access to protected information. IDENTITY UPGRADING HR PROCEDURES Establishing a trustworthy framework for information and human resources is an essential first step in minimizing, if not preventing, the effects of insidious forms of terrorism. As vulnerable as IT may be, human resources is even more exposed. Conventional screening techniques are inadequate to reveal bad actors intent on infiltrating an organization for the wrong reasons. Training that's EVERYTHING you need it to be! Training. You need it and regulators require it. Travel costs, busy schedules, and diferent requirements make selecting and attending courses difcult. The Life Science Training Institute (LSTI) has your solution: • Customized client-site courses, tailored online training, or blended courses • Practical, actionable course design built for adult learners with case studies, testing, training documentation and value-added tools • The best subject matter experts delivering a wide range of content – from product discovery to commercialization For more information, contact LSTI at info@lifesciencetraininginstitute.com or 215-675-1800, ext. 123 Actionable, Practical Instruction for Life Science Professionals www.lifesciencetraininginstitute.com 5340 Fryling Road, Suite 300 | Erie, PA 16510 PH: (215) 675-1800 ext. 123 January 2014 LifeScienceLeader.com 39

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