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CONTENTS


In this Issue 10 | INSIDER INSIGHT


What’s The Real Answer to Rising Costs of Blockbuster Drugs? Competition


Ed Price, President PCI Synthesis


12 | CONTRACT MANUFACTURING Parenteral Preparations, Challenges in Formulations


Dr. Elham Blouet, Global Market Manager Injectable and Dialysis Global Business Unit Pharma & Health ROQUETTE


28 | CMO


Future Manufacturing Constraints Innovative Technologies the Solution: Single-Use Devices, Higher Titer, Continuous


Eric S. Langer, President and Managing Partner BioPlan Associates, Inc.


32 | CLINICAL TRIALS


Barriers to Increased Participation of Minorities in Clinical Trials


Sujay Jadhav, CEO goBalto


36 | COLD CHAIN Biostorage: Closing the Loop in Biopharmaceutical Supply Chain Management


Mark W. Sawicki, PhD, Chief Commercial Officer Cryoport


REGULAR FEATURES 2 EDITOR'S MESSAGE


7 EDITORIAL ADVISORY BOARD 8 CN PERSPECTIVES 9 SOCIAL MEDIA CONNECTIONS 23 AN INTERVIEW WITH SUI XENOTECH, LLC 26 AN INTERVIEW WITH LSNE CONTRACT MANUFACTURING 39 INFORMEX EVENT PREVIEW 46 INDUSTRY NEWS 48 STATEMENT OF OWNERSHIP 48 ADVERTISER’S INDEX


40 | RESEARCH


Environmental Monitoring: An Evolving Process for Today’s Evolving Production


John Bray, Scientific Content Contributor That’s Nice LLC/Nice Insight


44 | HORIZON LINES Horizon Lines: A Quarterly Review of NDAs – 2Q16


Sonal Pathak, MS, Harshada Sant, MS and Hemant N. Joshi, PhD, MBA Tara Innovations LLC


Pharmaceutical Outsourcing | 6 | November/December 2016


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