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DDT Cover/Back April 2006.Qx June 2007 Vol 7 No 6 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH EURAND’S CHIEF COMMERCIAL OFFICER MR. JOHN FRAHER The eFlow® Nebulizer 30 Shabtai Bauer, PhD Markus Tservistas, PhD Bioadhesive Microspheres 54 Jayvadan Patel, PhD Transdermal Solutions 68 Gary W. Cleary, PhD FEATURING Imaging CROs 72 Richard Taranto Autoimmune The science & business of specialty pharma, biotechnology, and drug delivery Diseases 80 Douglas Kerr, MD Adam Kaplin, MD JuliaJulia Rashba-Rashba- Shaukat Ali, Richard Step,Step, PhDPhD PhD Sitz, MBA EfEfficientficient PulmonaryPulmonary HMW Povidone Beyond Sticky Partnering With DeliveryDelivery ofof BiologicalBiological PolymerPolymer-Based-Based toto Sophisticated:Sophisticated: NovaQuest 84 MoleculesMolecules asas Films for The Many PROMAXXPROMAXX Fast-Dissolving Dimensions Ms. Cindy H. Dubin MicrMicrospheresospheres Drug Delivery of Adhesives June 2007 Vol 7 No 6 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 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.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] International Ralph Vitaro 219 Changebridge Road Montville, NJ 07045 Tel: (973) 299-1200 Fax: (973) 299-7937 6 o E-mail: [email protected] N 7 l Mailing List Rental o V Candy Brecht Tel: (703) 706-0383 7 0 0 Fax: (703) 549-6057 2 E-mail: [email protected] e n u J 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 y responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Delivery Technology g o (ISSN 1537-2898) is published 10 times in 2007, January, February, March, April, May, June, July/August, September, l o October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. n h Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United c e States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug T Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) y r $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. e v i Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send l e address changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under D the U.S., International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may g u be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, r D 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 Technology LLC for libraries and other users registered with the Copywrite Clearance, 222 Rosewood Drive, Danvers, MA 4 01923; phone: (978) 750-8400, fax: (978) 750-4470. 26 Discussing Gastro Retentive Drug Delivery Systems Contributor Cindy H. Dubin interviews some experts on gastro retentive dosage forms, which may be one of the most feasible approaches for achieving a prolonged and predictable drug delivery profile in the GI tract. 44 Beyond Sticky to Sophisticated: The Many Dimensions of Adhesives Richard Sitz, MBA, presents two of his company’s recent innovations in adhesives, which are creating additional opportunities to advance the performance of transdermal drug delivery systems. 48 Efficient Pulmonary Delivery of Biological Molecules as PROMAXX Microspheres Julia Rashba-Step, PhD, explains how multiple biological molecules, including AAT, hGH, and insulin, have been successfully formulated using the PROMAXX microsphere delivery technology as viable products with excellent characteristics for pulmonary drug delivery using a simple dry powder inhaler. 54 Bioadhesive Microspheres & Their Pharmaceutical Applications “In this study, high molecular weight Jayvadan Patel, PhD, provides an introduction to and a comprehensive discussion on the advanced povidone (PVP), for example, Kollidon pharmaceutical applications of bioadhesive 90, was used as a carrier in fast- microspheres. ® 6 dissolving films, demonstrating strong 62 Eurand: Creation of AdvaTab - o N A New Technology for Orally 7 l o hydrophilicity and compatibility with V Disintegrating Tablets 7 Drug Delivery Executive: Mr. John Fraher, Chief 0 0 a wide array of polymers and 2 Commercial Officer of Eurand, discusses his e n u J copolymers.” company’s successful strategy behind AdvaTab and y g how Eurand views its co-development programs in o l o n h light of its specialty pharma growth strategy. c e T y r e v i l e D g u r D p.36 6 68 Corium: New Dimensions in Transdermal Solutions Drug Delivery Executive: Dr. Gary W. Cleary, Co- Founder, President, and Chief Technology Officer of Corium, talks about the exciting opportunities on the forefront of novel drug delivery. 72 Imaging CROs & Their Impact on Clinical Trials Mr. Richard Taranto discusses several critical qualities to consider when choosing a central imaging CRO, including specific operational procedures, access to therapeutic and modality expertise, adherence to rigid quality control processes, use of technology that improves workflow, and the ability to provide regulatory support. 80 Revimmune: Delivering a Knockout Punch to Autoimmune Diseases Douglas Kerr, MD, PhD, and Adam Kaplin, MD, PhD, believe Revimmune, a patent-pending pharmaceutical treatment in late-stage development for a variety of autoimmune diseases, is a potential treatment option for severe, refractory, immune- mediated illnesses. 84 NovaQuest: Strategic Partnering to Optimize Portfolio Value, Growth & Profits Executive Summary: Mr. Ron Wooten, Executive Vice President of NovaQuest, shares his company’s partnership strengths, particularly in regard to product development and commercialization expertise from Quintiles and Innovex, and access to the healthcare industry and investment expertise of TPG-Axon Capital. 3 o 6 N o DEPARTMENTS N 7 l 7 o l V o “An imaging CRO can increase the overall efficiency Market News & Trends . 12 V 7 Attorney Review . .. 21 0 7 0 0 2 of the clinical trial program and decrease the costs 0 Who Needs Motivation? The New Obviousness h 2 c r e Standard in Patents a n associated with the overall development of a u M J Advanced Delivery Devices . .. 30 y y g g o o compound by reducing the length of a clinical l A Novel Electronic Nebulizer for AAT Patients l o o n n h h Excipient Update . .. 36 c c e trial. With the appropriate expertise, an imaging e T T High Molecular Weight Povidone Polymer-Based Films for y y r r e e v v CRO will be able to assist in imaging trial design i Fast-Dissolving Drug Delivery Applications i l l e e D D Technology Showcase . .. 66 g g and acquisition protocols that can potentially u u r r D Facts & Figures . .. 78 D reduce the study’s size and duration.” External Delivery . .. 90 8 p.72 Resumes 101 9 Drug Delivery Technology April 2006 Vol 6 No 4 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Jack Aurora, PhD John A. Bermingham Matthew D. Burke, PhD Senior Director, R&D President & CEO Investigator, Perrigo Company The Lang Companies Pharmaceutical Development GlaxoSmithKline Sarath Chandar, MBA Mahesh Chaubal, Gary W. Cleary, PhD, Vice President, Global PhD, MS PharmD, MBA Marketing & Commercial Associate Director President & CTO Development Baxter Healthcare Corium International SPI Pharma Marc J. Kirchmeier, PhD James N. Czaban, JD John Fraher Associate Director, Partner, FDA Department President, North America Pharmaceutical R&D WilmerHale Eurand Biologicals & Vaccines Merck Research Laboratories Philip Green, PhD Keith Horspool, PhD Ravi Kiron, PhD, MBA COO Director of Business Director, Research Development Formulations LifeTech Innovations, LLC Advanced Drug Delivery Pfizer Global Research & BD Development David Monteith, PhD, MBA Uday B. Kompella, PhD James W. McGinity, PhD Senior Director, Drug Associate Professor of Professor of Pharmaceutics Delivery & Life Cycle Pharmaceutics University of Texas at Austin Development University of Nebraska Schering-Plough Medical Center Nasser Nyamweya, PhD Kinam Park, PhD Philip L. Smith, PhD Technical Service Manager President Investment Manager Degussa Akina, Inc S.R. One, Limited, GlaxoSmithKline 6 o N 7 l o V 7 Ronald L. Smith, PhD Cornell Stamoran Tom Tice, PhD 0 0 Director of Exploratory
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