April 2008 Vol 8 No 4 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH PHARMAFORM’S VP, BUSINESS DEVELOPMENT MICHAEL CROWLEY, PhD MBO Financing 28 Derek G. Hennecke, MBA Injectable Packaging 40 Frances L. DeGrazio Partnering With dermaCM 56 Robert L. Dowdell FEATURING CRO Strategies 60 Cindy H. Dubin Late-Stage The science & business of specialty pharma, biotechnology, and drug delivery Development 68 Robert Zerbe, MD Bhupendra Christine M. Stuart Madden, Prajapati, Ford, MBA Challenges in MPharm Investment Trends PhD Driving Combination Which Way to 78 The Upcoming Era China Product Drug Approval? Ames Gross of Nanomedicine: A Development Briefing April 2008 Vol 8 No 4 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie Malcolm A. Teasdale TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. 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Every precaution is taken to ensure accuracy, but publishers cannot accept o l [email protected] responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Delivery Technology o n (ISSN 1537-2898) is published 10 times in 2008, January, February, March, April, May, June, July/August, September, h c October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. e T Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United y States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug r International - Ralph Vitaro • Tel: (973) 263-5476 e Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) v i l $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. e [email protected] D Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send address g changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under the US u r International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may be D 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 Delivery 4 Technology LLC for libraries and other users registered with the Copywrite Clearance, 222 Rosewood Drive, Danvers, MA 01923; phone: (978) 750-8400, fax: (978) 750-4470. 28 Financing the Purchase: Where Will it Come From? Derrek G. Hennecke, MBA, continues with part 3 of his 7- part series chronicling the challenges, issues, and more importantly, the opportunities he faced throughout his Management Buy-Out. 40 A Historical Look at Injectable Pharmaceutical Packaging Frances L. DeGrazio reviews the drivers behind the advancement of material science and manufacturing technologies and what can be expected moving forward regarding industry requirements, regulatory guidances, advanced manufacturing technologies, and the shift in healthcare delivery to the increasing use of self- administered drugs. 46 The Upcoming Era of Nanomedicine: A Briefing Bhupendra G. Prajapati, MPharm; Jayvadan K. Patel, PhD; Vishnu M. Patel, PhD; and Krunal V. Prajapati provide a short brief on the current state and applications of nanomedicine. 50 PharmaForm, LLC: Drug Delivery & Product Development Expertise Drug Delivery Executive: Michael Crowley, PhD, VP of Business Development for PharmaForm, talks about his perspectives on providing services to the pharmaceutical and biotechnology industries. “Depending on a final tally for the 56 dermaCM: A Contract Manufacturer With year, total investments in medical Advanced Nanotechnology Drug Delivery Executive: Robert L. Dowdell, Executive Director devices in 2007 may have reached of Sales for dermaCM, shares his thoughts on how dermaCM is making significant inroads in the development of drug $3.75 billion, a more than 40% delivery technologies, while providing a full suite of contract 4 manufacturing, R&D, and technologies licensing services. o N increase from 2006. Combination 8 l o 60 Specialty Pharma Makes CROs Part of its V products, which integrate a drug, a Pipeline Strategy 8 0 0 Contributor Cindy H. Dubin asked some of the leading CROs 2 l i biologic, and/or a medical device r how they are addressing the important issues of today and p A what they are doing to distinguish themselves from the rest y g o into a single product, have emerged l of the crowd. o n h c e T as an important segment of the well- y r e 66 Quality, Solution, Leading & Experience: v i l e funded medical device market.” It’s all too Predictable D g u Malcolm A. Teasdale explains how you cannot expect results r D p.36 just because you purchased media space or advanced some 6 publicity initiative; you have to stick out! 68 QuatRx: Focusing on Late-Stage Development Programs in Major Therapeutic Areas “Gone are the days of slow and Executive Summary: Robert Zerbe, MD, CEO, and Co-founder of QuatRx, discusses the key strategic decisions that have expensive drug development cycles and contributed to the company’s rapid growth and success. large pharma’s deep pockets for drug 72 Lucrative Therapeutic Markets: development. For many Specialty Opportunities, Challenges & Future Outlook Frost & Sullivan Analyst Barath S. Shankar believes the Pharma companies, success may hinge realignment of growth strategies by most Big Pharma and on a single compound and all of the Specialty Pharmaceutical companies is toward areas within specialty and niche markets that have been significantly company’s resources are focused on under-penetrated and represent a lucrative market pushing that compound through the opportunity. development process as efficiently as 74 Which Way to Drug Approval? Stuart Madden, PhD, outlines a Product Development Plan possible.” and the influencing factors that can change throughout the product’s development lifetime, sometimes as a result of the program itself and/or from external factors. 78 Changing Business Practices in the Chinese Pharmaceutical Market Ames Gross and John Minot indicate the pharmaceutical market in China is currently growing at about 15% per year, but warn that the times will be just as challenging as they are exciting. DEPARTMENTS Market News & Trends . .. 12 Excipient Update . 22 Influence of Drug-to-Lipid Ratio & Release Modifier on Dipyridamole Release From Floating Lipid Granules 3 4 o N o Attorney Review . .. 32 N 7 l 8 o Obviousness - The Subject That Just Won’t l V o V 7 Go Away 0 8 0 0 2 0 2 h Combination Update . 36 c l r i r a p M Investment Trends Driving Combination A y y g g Product Development o o l l o o n n h h c c e e Technology Showcase . 54 T T y y r r e e v v i i l Facts & Figures . .. 77 l e e D D g g u u r r External Delivery . 82 D D p.60 Greedy-Nomics 8 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Shaukat Ali, PhD, MSc John A. Bermingham Der-Yang Lee, PhD Technical Service Manager President & CEO Research Fellow, R&D BASF Pharma Solutions The Lang Companies Technology, R&D Labs McNeil Consumer Healthcare, Johnson & Johnson Sarath Chandar, MBA Derek G. Hennecke, MBA Gary W. Cleary, PhD, Vice President, Global President & CEO PharmD, MBA Marketing & Commercial Xcelience President & CTO Development Corium International SPI Pharma Ms. Debra Bingham James N. Czaban, JD John Fraher Partner Partner, FDA Department President, North America Valeo Partners WilmerHale Eurand Philip Green, PhD Keith Horspool, PhD Ali Rajabi-Siahboomi, Director of Business Director, Research PhD Development Formulations Global Technical Director, Modified Release Advanced Drug Delivery Pfizer Global Research & Technologies Development BD Colorcon David Monteith, PhD, MBA Uday B. Kompella, PhD James W. McGinity, PhD Senior Director, Drug Professor, Department of Professor of Pharmaceutics Delivery & Life Cycle Pharmaceutical Sciences University of Texas at Austin Development University of Colorado Schering-Plough Denver Nasser Nyamweya, PhD James S.