* DDT March 2009 Covers:DDT Cover/Back April 2006.qx 2/26/09 11:31 AM Page 2 March 2009 Vol 9 No 3 www.drugdeliverytech.com INTHIS ISSUE INTERVIEW WITH DEPOMED’S PRESIDENT & CEO CARL A. PELZEL Combination Devices 18 Abhijit Gokhale, PhD Excipient Sourcing 22 Alen Guy, PhD Solid Dose Injection 24 Charles Potter, PhD Nanomedicine Market 32 Bill Martineau, MBA FEATURING Analytical The science & business of drug development in specialty pharma, biotechnology, and drug delivery Testing Labs 62 Xiaochun Yu, Ms. Cindy H. Mr. Mike PhD Dubin Mesa Cardiology & From Battlefield to A New Approach to Proteins & Peptides: Oncology 68 Dependent On Backpack: Evolution Threshold Evaluation & of the Auto-Injector Stuart L. Cantor, PhD Quantitation of Advances in Drug Unknown Extractables Delivery? & Leachables Using HPLC/CAD 2-4 DDT March 09 front pages :DDT Frntmttr apr06 06.2-4.qx 2/26/09 11:33 AM Page 2 2-4 DDT March 09 front pages :DDT Frntmttr apr06 06.2-4.qx 2/26/09 11:33 AM Page 3 2-4 DDT March 09 front pages :DDT Frntmttr apr06 06.2-4.qx 2/26/09 11:33 AM Page 4 March 2009 Vol 9 No 3 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 Keep abreast of the marketplace with the E-mail: [email protected] International industry’s only publication entirely devoted Ralph Vitaro 219 Changebridge Road to drug delivery and development. Montville, NJ 07045 Tel: (973) 299-1200 Fax: (973) 299-7937 Go to www.drugdeliverytech.com E-mail: [email protected] Mailing List Rental Vol 9 No 3 and click on Subscription Services Candy Brecht Tel: (703) 706-0383 Fax: (703) 549-6057 Once on the website you can also subscribe E-mail: [email protected] March 2009 to our eNewsletter! 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 Delivery Technology (ISSN 1944-818X) is published 10 times in 2009, 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: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 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 For more information contact Ralph Vitaro at 973-299-1200 Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. 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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. 5-9 DDT March 2009 TOC pages:DDT April 06 TOC 5-9.qx 2/26/09 11:34 AM Page 5 5-9 DDT March 2009 TOC pages:DDT April 06 TOC 5-9.qx 2/26/09 11:34 AM Page 6 32 Nanomedicine in a Nanominute: A Market Brief Bill Martineau, MBA, predicts that all five groups of nanomedicines, spurred by expanding indications and a continuing flow of new products into the marketplace, will record strong growth in demand throughout the next decade and beyond. 36 Proteins & Peptides: Dependent on Advances in Drug Delivery? Contributor Cindy H. Dubin talks with some of the industry's leading protein and peptide manufacturers about how new drug delivery systems will improve next-generation drugs. 42 From Battlefield to Backpack: Evolution of the Auto-Injector Mike Mesa, using his company’s historical perspective, indicates that as auto-injectors continue to evolve, their safety, reliability, durability, and ease of use will remain critical considerations for researchers, physicians, and end-users. 50 A New Approach to Threshold Evaluation & Quantitation of “The increased use, development, and Unknown Extractables & Vol 9 No 3 discovery of protein therapeutics will lead to Leachables Using HPLC/CAD increasing opportunities for drug delivery Xiaochun Yu, PhD, Steve Zdravkovic, Derek companies. Pharma companies need to use Wood, Chunyu Li, Yufei Cheng, PhD, and Xiaoya March 2009 these technologies to gain a competitive edge Ding, PhD, provide a case study involving the in an increasingly crowded therapeutic protein evaluation of the extractables of an elastomeric market. The protein therapeutic market is packaging component to demonstrate one of the largely immediate release, but there is a many applications of this new technique. trend moving toward increased sustained- Drug Delivery Technology release formulations.” 6 p.36 5-9 DDT March 2009 TOC pages:DDT April 06 TOC 5-9.qx 2/26/09 11:34 AM Page 7 5-9 DDT March 2009 TOC pages:DDT April 06 TOC 5-9.qx 2/27/09 9:17 AM Page 8 Analytical Outlook 56 Depomed: Leader in Gastric Retention Technology “Overall, the ability to remain flexible to Drug Delivery Executive: Carl A. Pelzel, President different client needs is critical as we work and CEO of Depomed, discusses his company’s with contracting companies to create tailored innovative technology, its business model, and strategic goals. solutions that enable them to accelerate development, meet critical milestones, or manage capacity. For contracting pharma 62 Analytical Testing Labs in the companies with defined project goals and Pharma Industry: Where Do They Stand? core areas of expertise, the ideal outsourcing Contributor Cindy H. Dubin leads a roundtable relationship may require a mode of discussion with executives from the industry's interaction that optimizes their ability to top contractors to learn how Specialty Pharma companies can get the most from their manage capacity overflow.” analytical lab partnership. 68 Cardiology & Oncology Drug Development & Regulation Stuart L. Cantor, PhD, and Kadriye Ciftci, PhD, discuss the road to development and regulatory approval associated with two of the leading therapeutic focus markets: cardiology and oncology. DEPARTMENTS Market News & Trends .............. 12 Combination Update ............... 18 Combination Devices to Protect Women From Sexual Transmission of HIV Vol 7 No 3 Vol 9 No 3 Excipient Update .................. 22 21st Century Pharmaceutical Quality: Are We There Yet? March 2007 March 2009 Advanced Delivery Devices .......... 24 A Solid Alternative to Needle & Syringe Technology Technology Showcase ............... 59 Drug Delivery Technology Drug Delivery Technology External Delivery .................. 74 8 p.62 Fear Factor of Phailure 5-9 DDT March 2009 TOC pages:DDT April 06 TOC 5-9.qx 2/26/09 11:34 AM Page 9 10-17 DDT March 09 Market News:Layout 1 2/26/09 11:35 AM Page 10 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Shaukat Ali, PhD, John A. Der-Yang Lee, PhD MSc Bermingham Research Fellow, R&D Technical Service Manager President & CEO Technology, R&D Labs BASF Pharma Solutions The Lang Companies McNeil Consumer Healthcare, Johnson & Johnson Sarath Chandar, MBA Derek G. Hennecke, Gary W. Cleary, PhD, Vice President, Global MBA PharmD, MBA Marketing & Commercial President & CEO President & CTO Development Xcelience Corium International SPI Pharma Ms. Debra Bingham Clifford M. John Fraher Partner Davidson, Esq. President, North America Valeo Partners Founding Partner Eurand Davidson, Davidson & Kappel, LLC 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, Uday B. Kompella, James W. McGinity, MBA PhD PhD Senior Director, Drug Professor, Department of Professor of Pharmaceutics Delivery & Life Cycle Pharmaceutical Sciences University of Texas at Austin Development University