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Downloads/Advisorycommit Analgesics * DD&D Jan 2014 Covers.qxp_DDT Cover/Back April 2006.qx 1/3/14 4:59 PM Page 2 January 2014 Vol 14 No 1 www.drug-dev.com IN THIS ISSUE INTERVIEW WITH EMD MILLIPORE’S HEAD OF PORTFOLIO DEVELOPMENT STEFFEN DENZINGER Second Quadrant 22 Marshall Crew, PhD Device Engineering 26 Chris Hurlstone Deterring Opiod Abuse 34 Cindy H. Dubin Lyophilization Packaging 42 Thomas Otto The science & business of drug development in specialty pharma, biotechnology, and drug delivery Drug Delivery Innovation 66 Amy Heintz, PhD Derek Geoff Carr, PhD Justin M. Hennecke Developing & Validating an Efficient Wright, PhD Six Reasons Why Data Method to Determine Delivering the Next the Affordable Residuals of Generation in Glass Management 68 Care Act May Be Hormone Products Prefillable Syringes a Bad-Tasting by LC-MS After Martin Magazzolo Medicine That Cleaning Equipment Could Heal Our Industry 2-4 DDD January 2014 front pages.qxp_DDT Frntmttr apr06 06.2-4.qx 1/3/14 5:00 PM Page 2 2-4 DDD January 2014 front pages.qxp_DDT Frntmttr apr06 06.2-4.qx 1/3/14 5:00 PM Page 3 2-4 DDD January 2014 front pages.qxp_DDT Frntmttr apr06 06.2-4.qx 1/3/14 5:00 PM Page 4 January 2014 Vol 14 No 1 PUBLISHER/PRESIDENT Ralph Vitaro [email protected] EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin John A. Bermingham Josef Bossart, PhD Katheryn Symank TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drug-dev.com Advertising Sales Offices International Global Sales & Marketing Director Ralph Vitaro John Kiesewetter 219 Changebridge Road P.O. Box 8548 Montville, NJ 07045 Eugene, OR 97408 Tel: (973) 299-1200 Tel: (541) 338-0022 Fax: (541) 338-0044 Fax: (973) 299-7937 [email protected] E-mail: [email protected] East & Midwest Patricia Loyas 977 Wall St. Diamond Point, NY 12824 Tel: (518) 668-4144 Fax: (518) 668-9794 E-mail: [email protected] All editorial submissions are handled with reasonable care, but the publishers assume no responsibility for the safety of artwork, photographs, or manuscripts. Every precaution is taken to ensure accuracy, but publishers cannot accept responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Development & Delivery (ISSN) 1537-2898 is published 9 times in 2014, January/February, March, April, May, June, July/August, September, October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. Subscription rates: $120.00 for 1 year in the United States, Canada, and Mexico. $188.00 for 1 year outside the United States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug Development & Delivery LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) $20.00, US, Canada, and Mexico; $25.00 in all other countries. Add $5.00 per order for shipping and handling. Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send address changes to Drug Development & Delivery, 219 Changebridge Road, Montville NJ 07045. All rights reserved under the US International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without written permission from the publisher. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Drug Development & Delivery for libraries and other users registered with the Copywrite Clearance, 222 Rosewood Drive, Danvers, MA 01923; phone: (978) 750-8400, fax: (978) 750-4470. Proud member of 5-9 DD&D January 2014 TOC pages.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:01 PM Page 5 5-9 DD&D January 2014 TOC pages.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:01 PM Page 6 Abuse-Deterrent 18 Six Reasons Why the Affordable Care Act May Be a Bad-Tasting Medicine That Opiods Could Heal Our Industry Derek Hennecke says that whether you love the ACA or abhor it, the fact is, there are billions of dollars of government money in play, and some industries are going to benefit tremendously. 22 A New Year for Solubility Enhancement Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility. 34 Reformulating Opioids to Deter Abuse Roundtable Discussion - Contributor Cindy H. Dubin talks with some leading Specialty Pharma companies to find out how they are formulating technologies to deter the growing problem of opioid abuse. 42 Packaging Freeze-Dried Substances - There Are Options Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise. “Our patented abuse-deterrent drug delivery technology is 49 Developing & Validating an Efficient called SMART/Script (SMART/Simple, Method to Determine Residuals of controllable, resistant, insoluble, physical Hormone Products by LC-MS After Cleaning of Equipment trap). The Atlantic technology is unique Geoff Carr, PhD, describes the benefits of LC-MS and presents an Vol 14 Vol No 1 amongst physical technologies in that when a effective method using this technology to determine the moderate amount of physical force, such as potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in January 2014 that incurred by chewing or grinding with a their manufacture. coffee mill, is applied to the product, the drug contained is sequestered and reduced from dose dumping. This decrease in release may be permanent depending on the circumstances.” Drug Development Drug & Development Delivery 6 p.34 5-9 DD&D January 2014 TOC pages.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:01 PM Page 7 5-9 DD&D January 2014 TOC pages.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:01 PM Page 8 Residual Impurities “Effective determination of residual drug substance 53 EMD Millipore: Enhancing the after cleaning equipment used in the manufacture of Bioavailability of Active Pharmaceutical pharmaceutical products is a GMP requirement and Ingredients Drug Development Executive: Steffen Denzinger, Head of Portfolio regulatory expectation. Pharmaceutical companies need Development at EMD Millipore, talks about bioavailability a fast, reliable analytical procedure to verify that the challenges and how EMD Millipore’s formulation portfolio and equipment is free of residuals, but method development expertise are helping the pharmaceutical industry achieve and validation followed by testing of swabs after the maximum efficacy with APIs. manufacture of each drug product can be time- consuming and challenging. High-performance liquid 55 BD Neopak - Delivering the Next Generation in Glass Prefillable Syringes chromatography used with mass spectrometry detection Justin M. Wright, PhD, and Herve Soukiassian highlight (LC-MS) is an efficient, sensitive, and accurate significant development and commercial manufacturing technology with high specificity that can analyze investments in glass PFS container technology for the biotech multiple drug substances simultaneously, saving industry with three key areas of focus: reducing overall variability, considerable time.” reducing SbVPs, and increasing glass strength and durability performance. 66 Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering Drug Development Executive: Amy Heintz, PhD, Senior Research Scientist at Battelle, speaks about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions. 68 Taking Regulated Content to the Cloud Martin Magazzolo believes the cloud presents a strong alternative to costly internal solutions when managing content for R&D, allowing companies to shift their focus to innovation. DEPARTMENTS Market News & Trends . 12 Advanced Delivery Devices . 26 Engineering the Perfect Click for Drug Delivery Devices Technology & Services Showcase . 62 External Delivery . 82 Product Versus Service Businesses 8 p.49 5-9 DD&D January 2014 TOC pages.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:01 PM Page 9 10-17 DD&D Jan 2014 Market News.qxp_DDT April 06 TOC 5-9.qx 1/3/14 5:02 PM Page 10 The Dan Marino, MSc Executive Director Drug Development & Delivery EDITORIAL Advisory Board Shaukat Ali, PhD, John A. Der-Yang Lee, PhD MSc Bermingham Senior Research Fellow Technical Service Manager Chief Operating Officer Global Technology, R&D, BASF Pharma Solutions 1st Light Energy & McNeil Consumer Healthcare, Conservation Lighting Johnson & Johnson Cornell Stamoran Derek G. Hennecke James Smith, PhD Vice President of Strategy President & CEO President & Corporate Development NanoSmart Pharmaceuticals Xcelience Catalent Pharma Solutions Executive Board Member Catalent Applied Drug Delivery Institute Ms. Debra Bingham Clifford M. John Fraher Partner Davidson, Esq. President Founding Partner Valeo Partners Aptalis Pharmaceutical Davidson, Davidson & Technologies Kappel, LLC Marshall Crew,
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