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LSL LIFESCIENCELEADER.COM JUNE 2014 8 A TRADITIONAL RAW MATERIAL SPECIFICATION AND PARAMETERS TO DEFINE QUALITY might include variables such as particle size, water content, density, and composition. It is increasingly recognized that additional information such as particle shape and surface properties, powder cohesion, bulk permeability, and shear properties are critical to product function and manufacturing eff ciency. The sharing of this additional information could help minimize capital equipment spend, reduce product development times, mitigate batch variability, and optimize QA/QC. The most eff cient way to share this information is through a centralized database, which, until recently, did not exist. The National Institute for Pharmaceutical Technology and Education (NIPTE) created pharmaHUB — an FDA excipients knowledge base offering public visitors access to a range of material properties. However, for the database to achieve its full potential, we need to ensure material properties are well def ned and reliably collated. TIM FREEMAN Tim Freeman is managing director for powder characterization company Freeman Technology. He has 10+ years of experience in understanding and characterizing powder behavior and works closely with the pharmaceutical and powder processing industries. 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 G. STEVEN BURRILL CEO & Founder, Burrill & Company 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 is your best practice for preparing to present at investor conferences? A EVERY INVESTOR CONFERENCE IS UNIQUE BECAUSE THE PSYCHOLOGY OF THE FINANCIAL MARKETS IS CONSTANTLY CHANGING. Presenting at JP Morgan is no different from any other investor presentation. What is different is the size of the attendee universe. From my experience as former CEO of Chimerix, the focus was on assuring our message was consistent: We completed a successful IPO in April 2013, initiated enrollment of phase 3 SUPPRESS trial of brincidofovir, and anticipated data in mid-2015. Our focus was on the competitive advantages of the candidate, as well as the recent hire of a chief commercial off cer to facilitate brincidofovir's commercial positioning. Strive to provide complete and accurate information, so investors, sell-side analysts, and bankers know your goal is to communicate openly and effectively. KENNETH MOCH Kenneth Moch, former CEO of Chimerix, has 30 years of experience creating, managing, and f nancing biomedical companies. In addition to Chimerix, Moch has been CEO of several other companies, including Alteon and Biocyte, and he cofounded The Liposome Company (acquired by Elan). A THE BEST ADVICE I RECEIVED EARLY IN MY CAREER CAME FROM VICTOR BAUER, PH.D. At the time, he was president of the U.S. division for Hoechst-Roussel Pharmaceuticals, and I was running the cardiovascular laboratory in Bridgewater, NJ. I had been with the company for only about three years when he called to tell me there was an opportunity in clinical pharmacology in the clinical research department that I should consider. When I asked why he thought this to be a good move, he replied, "Be open to new opportunities to better understand all aspects of the business." This led to many opportunities to expand my experience in both the pharmaceutical and CRO industries. He opened the door for me, but I needed to step through and be open to learning new things. JOHN HUBBARD Dr. John Hubbard is senior VP and worldwide head of development operations for Pf zer. In this position, he is responsible for global clinical trial management from Phase 1 to 4, which includes more than 700 clinical projects. What is the best leadership advice you ever received? What do you see as an exciting development toward improving pharma manufacturing effi ciency? 0 6 1 4 _ E A B . i n d d 1 0614_EAB.indd 1 5 / 2 1 / 2 0 1 4 1 1 : 5 1 : 2 4 A M 5/21/2014 11:51:24 AM