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EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Barry Eisenstein, M.D. Senior VP, Scientific Affairs Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Heather Erickson President and CEO Life Sciences Foundation Mary Rose Keller Former VP Clinical Operations Sangart Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) G. Steven Burrill CEO & Founder, Burrill & Company Jeffrey Evans, Ph.D. Life Science Entrepreneur Norman Klein Principal, Core Results Kenneth I. Moch President & CEO Chimerix, Inc. Tim Freeman Timothy Krupa Director of Operations at Freeman President, TSK Clinical Development Technology and Past Chair of the Process Analytical Technology Focus Group of AAPS John LaMattina, Ph.D. Senior Partner, PureTech Ventures Ron Cohen, M.D. Laura Hales, Ph.D. President and CEO Lynn Johnson Langer, Ph.D. Founder, The Isis Group Acorda Therapeutics , Inc. Director, Enterprise and Regulatory Affairs Program Fred Hassan Laurie Cooke Center for Biotechnology Education Chairman of the Board CEO Johns Hopkins University Healthcare Businesswomen's Association (HBA) Bausch + Lomb William F. Ciambrone EVP, Technical Operations Shire John Hubbard, Ph.D. Alan Eisenberg Senior VP & Worldwide Head Executive VP, Emerging of Development Operations, Pfizer Companies and Bus. Dev. Biotechnology Industry Organization (BIO) Maik Jornitz Founder, BioProcess Resources, LLC Immediate Past Chair, PDA Craig Lipset Head of Clinical Innovation, Worldwide Research & Development Pfizer Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation Mike Myatt Leadership Advisor, N2growth Carol Nacy, Ph.D. CEO, Sequella, Inc. Sesha Neervannan, Ph.D. VP Pharmaceutical Development Allergan Kevin O'Donnell Senior Partner, Exelsius Cold Chain Mgt. Consultancy U.S., Chair Int. Air Transport Assoc. Time & Temp. Task Force John Orloff, M.D. Former Senior VP, CMO, Global Development Novartis Pharma AG Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics James Robinson VP, Vaccine & Biologics Technical Operations, Merck Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Leslie Williams Founder, President, and CEO ImmusanT Save The Date | 03.12.14 The CMO Leadership Awards Reception & Ceremony Join us at the W Hotel, New York City, to celebrate award recipients, network with industry leaders, and make new business contacts. For more information, email cmoawards@lifescienceleader.com. PRESENTED BY : RESEARCH CONDUCTED BY : SPONSORED BY : A LIFE SCIENCE CONNEC T BRAND ASK THE BOARD Have a response to our experts' answers or a question of your own? Send us an email to atb@lifescienceconnect.com. Q: Which life sciences industry shipping guidance should executives be familiar with? PDA Technical Report No. 58 "Risk Management for TemperatureControlled Distribution" was published in 2012 by a team of global authors and contributors from pharmaceutical and biopharmaceutical manufacturers, their supply chain partners, and service providers. It is meant to assist stakeholders in the supply chain to preserve the quality, safety, and efficacy of these medicinal products during distribution. This guidance document complements the information provided in ICH Q9 "Quality Risk Management" by assessing, controlling, and reviewing risks with equipment, processes, people, and external factors, such as weather and natural disasters, during distribution. As the pharm industry continues its global expansion, temperaturecontrolled distribution risk management becomes a dynamic and interactive process. Supply chain members are responsible for assessing, analyzing, and evaluating the risks associated with the transportation of these medicinals. Rafik Bishara, Ph.D. Bishara is the chair of the Pharmaceutical Cold Chain Interest Group (PCCIG) within the Parenteral Drug Association (PDA). He had a distinguished 35-year career with Eli Lilly & Co. as director, quality knowledge management and technical support. 8 LifeScienceLeader.com Q: What global trend do you think will have the biggest positive impact on clinical trials and why? Get your head in the cloud. We are in the midst of a mind-boggling transformation brought about by unprecedented access to variables that will take hypothesis testing supersonic. Big Data requires a new level of collaboration and engagement across industry and around the globe to realize our dream of precision medicine. The cloud will provide realworld information to combine with traditional trial data to navigate the complex disease pathways and more efficiently and effectively identify new treatments. During a recent talk, Thomas Kolopolus, president and founder of Delphi Group, shared his opinion that the next generations will be so used to collaboration that they will shun the assumption of knowledge ownership, or that anything can be learned without constant sharing and transparency. In this scenario, the concept of owned IP (an innovation inhibitor) is likely to become the next dinosaur. Mary Rose Keller Keller, a former VP of clinical operations, has proven success in planning, management, and delivery of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products. February 2014 Q: How can manufacturers proactively avoid metal contamination? On avoiding specific contamination risks, I like to come back to knowing your process intimately. What are the risks of various contaminants – equipment (shedding, wear), raw materials (vendor controls, incoming testing), and people (shedding, handling, open systems) from an end-to-end walk-down of your process, and create what mitigations are necessary to drive these risks to zero – equipment preventative maintenance and replacement, vendor audits and corrective actions, closing systems, and automation, respectively. Active monitoring of complaints and signals of extraneous matter in your process, cataloging extraneous matter found, and comparing to a library of potential sources (from your end-to-end process walk-down) helps to develop corrective actions when issues emerge. Jim Robinson Robinson is the vice president for vaccine and biologics technical operations for Merck & Co. In this role, he supports the manufacturing strategy, process development, technical transfer, approval, and production of Merck's vaccines and biologicals at eight internal sites in the U.S. and Europe, and several partner sites globally.