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LSL LIFESCIENCELEADER.COM JULY 2014 8 A ELECTRONIC MEDICAL RECORDS (EMRs). I recently attended the MAGI Clinical Research Conference in Philadelphia. I was stunned to learn the issues with implementing EMR systems and equally shocked at the number of systems in use. When I Googled EMR (according to one website www.capterra.com), I found there are 329 EMR systems on the market. Sites indicated that they struggle to get study-specif c information into the EMR systems and have issues about output of information from the systems regarding management of protected health information (PHI). A requirement to train clinical research associates (CRAs) on systems is rarely factored into study setup. On the sponsor and CRO sides, I am concerned that we are woefully unprepared to achieve potential eff ciencies of data capture through EMR and question if we are doing enough to ensure alignment with the various EMR system procedures. MARY ROSE KELLER As a former VP of Clinical, Mary Rose Keller has proven success in planning, management, and delivery of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products. EDITORIAL ADVISORY BOARD EAB ASK THE BOARD Have a response to our experts' answers? Send us an email to atb@lifescienceconnect.com . JOHN BALDONI Chair, Leadership Development Practice, N2growth RAFIK BISHARA, PH.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA WILLIAM CIAMBRONE EVP, Technical Operations, Shire RON COHEN, M.D. President and CEO Acorda Therapeutics , Inc. LAURIE COOKE CEO, Healthcare Businesswomen's Association (HBA) ALAN EISENBERG Executive VP, Emerging Companies and Bus. Dev., Biotechnology Industry Organization (BIO) BARRY EISENSTEIN, M.D. Senior VP, Scientif c Affairs Cubist Pharmaceuticals HEATHER ERICKSON President and CEO Life Sciences Foundation JEFFREY EVANS, PH.D. Life Science Entrepreneur TIM FREEMAN Director of Operations at Freeman Technology and Past Chair of the Process Analytical Technology Focus Group of AAPS RON GUIDO President, Lifecare Services, LLC LAURA HALES, PH.D. Founder, The Isis Group FRED HASSAN Chairman of the Board Bausch + Lomb JOHN HUBBARD, PH.D. Senior VP & Worldwide Head of Development Operations, Pf zer MAIK JORNITZ Founder, BioProcess Resources, LLC Immediate Past Chair, PDA MITCHELL KATZ, PH.D. Exec. Dir. of Medical Research Operations, Purdue Pharma, L.P. MARY ROSE KELLER Former VP Clinical Operations, Sangart NORMAN KLEIN Principal, Core Results TIMOTHY KRUPA President, TSK Clinical Development JOHN LAMATTINA, PH.D. Senior Partner, PureTech Ventures LYNN JOHNSON LANGER, PH.D. Director, Enterprise and Regulatory Affairs Program Center for Biotechnology Education, Johns Hopkins University CRAIG LIPSET Head of Clinical Innovation, Worldwide Research & Development, Pf zer GREG MACMICHAEL, PH.D. Global Head of Biologics Process R&D; Novartis JEROLD MARTIN Chairman Bio-Process Systems Alliance (BPSA) KENNETH MOCH Former CEO, Chimerix 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. Head of Global Clinical Development Merck Serono MARK PYKETT, PH.D. President and CEO Navidea Biopharmaceuticals JOHN REYNDERS, PH.D. Chief Information Off cer Moderna Therapeutics JAMES ROBINSON VP, Vaccine & Biologics Technical Operations, Merck MARK SNYDER, PH.D. Former Associate Director, Purif cation Process Development Bayer HealthCare LESLIE WILLIAMS Founder, President, and CEO ImmusanT Q Q Q What book has had the greatest impact on you personally/professionally and why? A THREE CENTURIES OF MICROBIOLOGY by Hubert Lechevalier and Morris Solotorovsky. Both authors were professors at Rutgers University. They taught a class called The History of Microbiology. You had to read the book and take an oral exam at the end of the course. They told me that if I got an "A" in the class they would accept me in their lab as a Ph.D. student. They also told me that no one ever got an "A" in their class. That "A" changed my life! The f rst change involves attitude. I learned to accept, even embrace, challenges with a realistic but consistently positive attitude. The second change conf rmed the importance of persistence. Keeping the goal in mind, it is important to persevere and stay the course. Sometimes, the only difference between you and your colleagues is your perseverance and commitment to achieving the goal. MITCH KATZ In his position at Purdue Pharma L.P., Dr. Mitchell Katz is the executive director of medical research operations responsible for leading activities across all clinical programs. He has 26 years' experience in the pharmaceutical and biotech industries. A THE BEST LEADERSHIP ADVICE I EVER RECEIVED WAS GIVEN TO ME BY MORT COLLINS, CHAIRMAN OF THE VENTAIRA PHARMACEUTICS BOARD. I rapidly rose through the ranks at Ventaira and became president & CEO. During this time Mort advised me to "trust my gut." He was an incredible mentor who empowered me at a pivotal point in my career. His belief in my capabilities, even when I was unsure, allowed me to grow. I began to rely on my intuition to gauge the appropriate timing of decisions and the course of action for the company. Of course, when and how to act is driven by the collection and interpretation of hard and soft data. As I look back, I do share this advice with others, but I also add the importance of having a good mentor. LESLIE WILLIAMS Leslie Williams is president, CEO, and founder of ImmusanT, Inc., an early-stage company focused on peptide treatments for autoimmune diseases. She has more than 20 years of industry experience. What is the best leadership advice you ever received? What would you describe as being the biggest game-changing technology in clinical trials and why? 0 7 1 4 _ E A B . i n d d 1 0714_EAB.indd 1 6 / 2 3 / 2 0 1 4 2 : 5 3 : 5 6 P M 6/23/2014 2:53:56 PM