The Official Magazine of ISPE September-October 2016 | Volume 36, Number 5 Lou Schmukler of BMS on Creating Supply Chain Excellence How to Fight a Bully: An Interview with Nicole Pierson Meet Your 2016-2017 Board of Directors Quarterly Report: BIOTECHNOLOGY www.PharmaceuticalEngineering.org Pharmaceutical Engineering | September-October 2016 | 1 WHY WE DO IT CLEAN AIR MATTERS camfilapc.com/cleanairmatters Farr Gold Series® Camtain Dust Collector Quad Pulse Package Dust Collector Dust, Mist and Fume Collectors AIR POLLUTION CONTROL www.camfilapc.com • e-mail: [email protected] • 855-405-2271 CHANGE IS OPPORTUNITY Some see change as a problem; we see change as an opportunity. Adapting to the evolving trends and ever- changing regulations in the life sciences industry is what we’re known for. We’re driven to find the right solution to the most technically challenging problems. And we’re satisfied only when we’ve produced results that make you successful. crbusa.com THE RELENTLESS PURSUIT OF SUCCESS. YOURS .™ Biological Animal Health OSD Blood Fractionation Fill/Finish Oligonucleo/Peptides Vaccines Medical Devices API’s Nutraceuticals Engineering | Architecture | Construction | Consulting Editor’s Voice A First Time for Everything My introduction to the world of biopharma occurred in June 2015 as I listened to Andy Skibo, then Chair of ISPE’s Board, deliver his “Biologics Supply Chain Risks” keynote address at the ISPE/FDA/PQRI Editorial Board Quality Manufacturing Conference in Washington, DC. He emphasized the potential effect of supply Editor in chief: Anna Maria di Giorgio chain risk on biologics, which are projected to account for 80% of the pipeline and 70% of sales revenue Managing editor: Amy Loerch by 2020—just three short years away. The unsettling possibilities may have given many in the audience Pharmaceutical Engineering Committee reason for pause. Chair: Roger Nosal, Pfizer Inc. That presentation is the introduction to our first Quarterly Report on Biotechnology, which offers a Peter Werner Christensen, Novo Nordisk Nissan Cohen, Rohrback Cosasco Systems variety of viewpoints on what it takes to succeed in biotech and biopharma. Other highlights include Robert Del Ciello, Northshire Associates the role of sustainability and Ireland’s impressive bio footprint. Our cover story features Lou Schmukler, Robert Dream, HDR Company LLC president of Bristol-Myers Squibb’s Global Manufacturing and Supply organization, who shares his in- Michelle Gonzalez Nuha al-Hafez, Merck KGaA sight into leadership, supply chain excellence, and achieving superior performance. Wendy Haines, Mangan, Inc. Willem Kools, EMD Millipore This issue has a few other firsts, as well: Our first patient interview tells Nicole Pierson’s story of a Louis Milano, Project Planning & Development LLC parent’s struggle to keep her son alive and healthy; it also presents a patient’s perspective on access to George Millili, Genentech the knowledge required to do that. If you heard her keynote address at ISPE’s 2016 Annual Meeting you James M. O’Brien, NAMA Industries Pietro Perrone, EMD Millipore Corporation know that she’s a passionate and engaging advocate. Sundermurti “Tony” Rao, Stantec Consulting Services Inc. Inside you’ll also find two new columns: “Message from the Chair” gives 2016–2017 Board Chair Mike Brian E. Severson, Sage Products, LLC Chris Smalley, Merck & Co, Inc. Arnold a forum for discussion; “Career Q&A,” penned by Biogen’s David Smith, answers questions that Pravin Todkar, Siemens Ltd. are front of mind for our YP members. We also take a look at the ISPE Training Institute as it celebrates Jonathan C. Walker, Tetraphase Pharmaceuticals Steven Wisniewski, Commissioning Agents, Inc. its first anniversary. Lastly, we introduce you to your 2016–2017 Board officers, ISPE’s new CFO and VP Anders Vidstrup, NNIT A/S of Administration, and, we hope, to new concepts with the technical articles published this issue. Christian Woelbeling, Werum IT Solutions Joerg Zimmerman, Vetter Pharma-Fertigung GmbH This issue truly reflects the diversity of thought, experience and knowledge of our members and I hope you enjoy it. ¢ Continued on page 6 Anna Maria di Giorgio, Editor in chief PURAD HIGH PURITY PIPING SYSTEM HIGH PURITY PIPING SYSTEM • Available in PVDF and PP • USP Class VI and BSE/TSE free BEST SURFACE QUALITY • Smooth finish reduces biofilm • No roughing and corrosion ONE STOP SHOPPING • 100 % cleanroom manufacturing • Automated IR and beadless welding AGRU Kunststofftechnik GmbH T. +43 7258 7900 Ing.-Pesendorfer-Straße 31 F. +43 7258 790 - 2850 4540 Bad Hall, Austria [email protected] www.agru.at 2 | Pharmaceutical Engineering | September-October 2016 INTEGRATED SOLUTIONS CONS IRE TR H U T C C T I E O R N I D & MODU PPLY CHA N LA U IN IO R S T I A Z A C I T R I O B N A F ERING NE D E I TIO TE XEC ICA N, BU U G IF AN I T D D R I N O T O A S E M I N P , S S D E E R C T N O I N A T N E C E C G T R N I U I T A Y O CLIENT M N R E S M T E ION NT AN R N CAT S E D T O TR M O U T L A IP O L T C E U L A G Q S TI B O I E N E O L S G ATER ACT STA W TR FF N IN O G C www.fluor.com © 2016 Fluor Corporation. ADGV136516 1516_FKL_PE_ad.pdf 1 6/23/15 8:01 PM Contents “Fristams are the best pumps going.” - Plant Maintenance Manager, Midwest Production Facility New Column ISPE News Message from the Chair 11 Transparency, Diversity, Collaboration, Volume 36, Number 5 and Strengthening Our Core Published since 1980 New 2016 Board Executive Editorial Policy 12 ISPE Announces Board of Directors Pharmaceutical Engineering inspires engineers and Election Results regulators around the world with engaging and useful articles. From technical articles that provide practical 25 ISPE Training Institute Marks First how-to advice to thought-provoking features on Anniversary current issues, Pharmaceutical Engineering offers Cover readers a global picture of the profession and the industry. Opinions expressed herein do not necessarily 28 Japan Affiliate Annual Meeting Focused reflect the views of ISPE. on New Manufacturing Trends Pharmaceutical Engineering is published six times ISPE Ireland YPs Host Summer Seminar a year by ISPE. 33 and BBQ ISPE Headquarters 35 Hot Off the Presses 7200 Wisconsin Ave., Suite 305 Bethesda, MD 20817 USA Appointments Tel: +1-301-364-9201 C Fax: +1-240-204-6024 14 Lou Schmukler, President of Global M Positive Manufacturing and Supply at Displacement ISPE Operations and Training Center Profile Y FKL Pump 600 N. Westshore Blvd., Suite 900 Bristol-Myers Squibb: Tampa, Florida 33609 USA Creating Supply Chain Excellence, CM Telephone +1-813-960-2105 Achieving Superior Performance MY Fax +1-813-264-2816 CY ISSN 0273-8139 Features CMY US Postmaster Send change of address to: K Pharmaceutical Engineering Magazine 20 How to Fight a Bully: 600 N. Westshore Blvd, Suite 900 Compassionate Use Policy Offers Options Tampa, Florida 33609 When None Exist Periodicals postage paid at Tampa, Florida, US, and 37 ISPE India Affiliate: additional post offices Supporting One of the World’s Leading Pharma Markets PD Pumps From the Experts You Trust Canada Postmaster Send change of address and undeliverable copies to: For decades, Fristam WFI and CIP-return pumps integrity of your product and keep your critical Pharmaceutical Engineering Magazine PO Box 122 A YP State of Mind have set the industry standard for clean, reliable, path up and running. and efficient processing. Niagara Falls, ON L2E 6S8 Canada Like all Fristam pharmaceutical pumps and parts, 40 New Opportunities for a Young Our FKL positive displacement pumps are built the FKL is available with comprehensive Canada Post mail agreement #40012899 Professional All rights reserved. The contents of this publication with that same traditional Fristam quality and documentation and comes with the best service may not be reproduced in any form without written manufactured of 316L stainless steel, for high and delivery time in the industry. performance and long-lasting reliability. Fristam permission from ISPE. 22 The new world of patient engagement Contact Fristam, your trusted resource for Career Q&A FKL PD pumps are designed to safeguard the © 2016 International Society for Pharmaceutical pharmaceutical pumps, to learn more. Engineering 42 Consulting: A Young Professional 44 What Makes a Qualified Candidate? Perspective 82 Shire plc: Expanded Facility in Italy Responding to Increased Market Demand 1.877.841.5001 | fristam.com/pharma 4 | Pharmaceutical Engineering | September-October 2016 1516_FKL_PE_ad.pdf 1 6/23/15 8:01 PM “Fristams are the best pumps going.” - Plant Maintenance Manager, Midwest Production Facility C M Positive Displacement Y FKL Pump CM MY CY CMY K PD Pumps From the Experts You Trust For decades, Fristam WFI and CIP-return pumps integrity of your product and keep your critical have set the industry standard for clean, reliable, path up and running. and efficient processing. Like all Fristam pharmaceutical pumps and parts, Our FKL positive displacement pumps are built the FKL is available with comprehensive with that same traditional Fristam quality and documentation and comes with the best service manufactured of 316L stainless steel, for high and delivery time in the industry. performance and long-lasting reliability. Fristam Contact Fristam, your trusted resource for FKL PD pumps are designed to safeguard the pharmaceutical pumps, to learn more. 1.877.841.5001 | fristam.com/pharma Contents Quarterly Report: Technical Articles BIOTECHNOLOGY 47-81 87 Characterization of Silicone Tubing: Continued from page 2 Effect of Pressure and Irradiation on Pharmaceutical Engineering Reviewers Tubing Diameter Marc Abromovitz, Novartis Pharmaceuticals Pietro Perrone, Csilla Kollar, Andrew Diehl, Joanne Barrick, Eli Lilly & Co Purusottom Bhattacharjee, Fresenius kabi Oncology Limited and Ernie Jenness Jose Caraballo, Bayer Healthcare Chris Clark, TenTenTen Consulting 94 Balancing Pre- and Post-Market Control of John Connor, IMA-Telstar Health Supplements Mel Crichton Steven Davy, NNE Pharmaplan Chan Lai Wah, Benjamin Tan Zhi Yang, Thomas Dine, Dine Consultancy Ltd Vimal Sachdeva, and Sia Chong Hock Martin Dueblin, 11 Eleven GmbH Paul Egee, IMA North America Massimo Eli, MSD Italy SrL / Merck Corp.