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EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Heather Erickson, President and CEO Life Sciences Foundation Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Norman Klein Principal, Core Results Jeffrey Evans, Ph.D. Life Science Entrepreneur Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) Tina Morris, Ph.D. VP, Biologics and Biotechnology USP Division of Documentary Standards 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 Barry Eisenstein, M.D. Immediate Past Chair PDA Senior VP, Scientific Affairs Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Sesha Neervannan, Ph.D. VP Pharmaceutical Development Allergan Kenneth Newman, M.D. CMO, Exec. VP, Clinical Dev. and Medical Affairs, Acton Pharmaceuticals Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis Kevin O'Donnell Senior Partner, Exelsius Cold Chain Mgt. Consultancy US, Chair Int. Air Transport Assoc. Time & Temp. Task Force Leslie Williams Founder, President, and CEO ImmusanT Ann Willmoth General Manager Blue Standard Consulting MORE ONLINE CONTENT Want to find out what's on the mind of our Chief Editor, Rob Wright? Check out his blog on our website where he writes about a variety of topics such as recent shows attended, conversations with industry experts, and irritating business buzzwords. And don't forget about your opportunity to pick the brains of our editorial board. Send your questions for our monthly "Ask the Board" section to atb@lifescienceconnect.com. ASK THE BOARD James Robinson VP, Vaccine & Biologics Technical Operations, Merck Carol Nacy, Ph.D. CEO, Sequella, Inc. Craig Lipset Head of Clinical Innovation, Worldwide Research & Development Pfizer CHIEF EDITOR'S BLOG John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics Mike Myatt Leadership Adviser, N2growth John LaMattina, Ph.D. Tim Freeman Senior Partner, PureTech Ventures Director of Operations at Freeman G. Steven Burrill Technology and Past Chair of the Process Eric Langer CEO & Founder, Burrill & Company Analytical Technology Focus Group of AAPS President and Managing Partner BioPlan Associates Ron Cohen, M.D. Laura Hales, Ph.D. President and CEO Founder, The Isis Group Lynn Johnson Langer, Ph.D. Acorda Therapeutics , Inc. Director, Enterprise and Fred Hassan Regulatory Affairs Program Laurie Cooke Chairman of the Board Center for Biotechnology Education CEO Johns Hopkins University Healthcare Businesswomen's Association (HBA) Bausch + Lomb Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation Timothy Krupa President, TSK Clinical Development John Orloff, M.D. Senior VP, CMO, Global Development Novartis Pharma AG Find more original content in (or submit your own to) any of the other Life Science Connect websites, such as BioresearchOnline.com, ClinicalLeader.com, and PharmaceuticalOnline.com. Have a response to our experts' answers? Send us an email to atb@lifescienceconnect.com. Q: What was your most interesting experience as a CEO, and why? Q: What are the challenges and opportunities around Big Data? I was in Uppsala, Sweden, in 1997 talking to front-line executives as the new CEO of Pharmacia and Upjohn. I was surprised to learn that a new product launch opportunity, Detrol, had been compromised to Forest Labs by a relatively junior person in the previously "decentralized" Pharmacia. This resulted in arbitration hearings. Our strategy required unfettered rights to Detrol. I had known Forest CEO, Howard Solomon, for a long time. We had developed mutual respect and trust. I played my trust card with Howard, enabling us to strike a $25 million deal for the unfettered rights to Detrol prior to the arbitration decision. What I learned, first, was to not delegate strategic asset decisions to managers who are beyond your line of sight. Second, always be respectful and kind to people. You never know when someone may be across the table from you. Nearly all states have one or more industry-driven organizations focused on supporting life sciences companies. These groups can be excellent resources for advice, mentorship, and introductions, as well as cost-saving purchasing groups, educational resources, and information about government programs and regulations. BIO's page for the Council of State Bioscience Associations provides a listing of most state biotech associations. Another effective avenue for connecting with state assistance is speaking with your elected officials. Few things excite legislators as much as helping companies grow and create well-paying jobs in their districts. Legislators have direct connections with their capitals, state agencies, and economic development programs, and often know where the best assistance is hiding. Government resources may seem unintelligible but can be worth the effort. Some include managing data at massive scale, integrating very diverse data sets, accessing distributed data across the globe, machine learning and mining techniques to identify patterns, and decision support environments which translate data into effective and timely decisions. These challenges have found their way into the umbrella term "Big Data" and are real challenges that appear in multiple phases of the pipeline — the complexity of phenotypic screening, the volume of next-gen sequencing data, the diverse data brought together in composite biomarkers, or classes of real-world evidence for on-market products. Big Data is not a silver bullet. Avoid the temptation to assemble Big Data platforms in the hope of self-emergent insight. In my experience, Big Data yields the most value when the system's design and development are driven by well-constructed scientific hypotheses. Fred Hassan Hassan is the chairman of Bausch + Lomb and senior advisor with the private equity firm Warburg Pincus. In addition, he serves on the boards of Avon and Time-Warner. 8 Q: How can a small start-up biotech get help? Heather Erickson Erickson is president & CEO of the Life Sciences Foundation, the independent steward of biotech heritage. Previously, she was founding president of MedTech Association, serving New York's bioscience community. John Reynders Dr. Reynders is the CIO for Moderna Therapeutics. He has held senior R&D; and technology leadership positions at AZ, J&J;, Lilly, Celera Genomics, and Los Alamos National Laboratory. LifeScienceLeader.com August 2013