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EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Heather Erickson President and CEO Life Sciences Foundation Mary Rose Keller Former VP Clinical Operations Sangart Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Jeffrey Evans, Ph.D. Life Science Entrepreneur Norman Klein Principal, Core Results Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) Timothy Krupa Tim Freeman President, TSK Clinical Development Director of Operations at Freeman 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 Eric Langer Founder, The Isis Group Acorda Therapeutics , Inc. President and Managing Partner BioPlan Associates Fred Hassan Laurie Cooke Chairman of the Board CEO Lynn Johnson Langer, Ph.D. Healthcare Businesswomen's Association (HBA) Bausch + Lomb Director, Enterprise and Regulatory Affairs Program John Hubbard, Ph.D. Alan Eisenberg Center for Biotechnology Education Senior VP & Worldwide Head Executive VP, Emerging Johns Hopkins University of Development Operations, Pfizer Companies and Bus. Dev. Biotechnology Industry Organization (BIO) Craig Lipset Maik Jornitz Head of Clinical Innovation, Founder, BioProcess Resources, LLC Barry Eisenstein, M.D. Worldwide Research & Development Immediate Past Chair, PDA Senior VP, Scientific Affairs Pfizer Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. G. Steven Burrill CEO & Founder, Burrill & Company John Orloff, M.D. Former Senior VP, CMO, Global Development Novartis Pharma AG Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals Tina Morris, Ph.D. VP, Biologics and Biotechnology USP Division of Documentary Standards Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics James Robinson VP, Vaccine & Biologics Technical Operations, Merck Mike Myatt Leadership Adviser, N2growth Carol Nacy, Ph.D. CEO, Sequella, Inc. Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Sesha Neervannan, Ph.D. VP Pharmaceutical Development Allergan Leslie Williams Founder, President, and CEO ImmusanT Kevin O'Donnell Senior Partner, Exelsius Cold Chain Mgt. Consultancy U.S., Chair Int. Air Transport Assoc. Time & Temp. Task Force Ann Willmoth General Manager Blue Standard Consulting WIN A COPY OF THIS BOOK! Ask the Board wants to hear from you. Have a question that you would like to pose to our editorial advisory board of experts? Send it to atb@lifescienceconnect.com. If we select your question for publication, we will provide you with a complimentary copy of a business book or CD, such as Too Good To Fail by Clifford M. Gross. 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: When you first became a CEO, what is the one thing you wish you had done differently and why? Q: What is a common pitfall you have witnessed biotech entrepreneurs encountering, and what should they do to avoid it? When I first became a CEO, the biggest shift was not the change in my duties, but the way in which I was perceived as I carried them out. I had to quickly formulate a blend of the legacy culture with my own leadership style and vision. Initially, I did not appreciate how uncomfortable the stylistic change of a new executive would be for many employees — it took several months before everyone was completely integrated and up to speed. If I were to do it again, I would have made more time very early on for one-on-one interactions to build rapport with my senior staff. While doing this would have required more investment at the beginning, it would have created a much more decisive and immediately effective start to my tenure. Clinical collaboration generally breaks down when team relationships fray, and unless there is a personality conflict, the general cause of this deterioration is a misalignment of performance and expectations. Increase the likelihood of a successful collaboration by augmenting ongoing open and frank discussions among teammates and their leaders with a lessons-learned process. Make a product of the kickoff meeting a well-designed lessons-learned document. For a Phase 2/3 study, perform the first lessons learned early — at the end of study start. The timing of other lessons-learned meetings is dependent on the length of the study and could be quarterly or milestone driven. I prefer face-to-face quarterly meetings to build the team with lessons learned as part of the agenda. New biotech entrepreneurs often fall back on their scientific training and strive to tweak their work until they are 100 percent satisfied. It can be difficult for them to move quickly in a commercial setting and either "let go" of a project and allow the idea to move through the commercialization process or to decide to "kill" the project. Entrepreneurs need to rely on their network of colleagues and experts whose opinions they trust to help them know what to move forward. Holding on too long to a project that may not be commercially viable can be the death knell of a company. New entrepreneurs need the passion to champion their project but also the wisdom to know when to change course or direction. 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. 8 Q: What is one of the mistakes you have seen destroy a clinical collaboration, and what should have been done to avoid it? Tim Krupa Krupa is president of TSK Clinical Development, LLC, a consulting firm providing leadership and solutions in clinical planning, project management, clinical operations, and outsourcing. He began his career with Eli Lilly, and he most recently served as executive director, project management with Quintiles. Lynn Johnson Langer, Ph.D., MBA Langer is president emeritus of Women In Bio (WIB) and the director of enterprise and regulatory affairs programs in the Center for Biotechnology Education at Johns Hopkins University where she teaches graduate courses in biotechnology leadership and management. LifeScienceLeader.com December 2013