A SUPPLEMENT TO:
INSIDE OutsourcingStrategic OutsourcingTRENDS.SURVEYS.ANALYSIS.
Before you choose a CMO partner, we invite you to put us under the microscope.30+ years of mammalian cell culture experience. 25 years of ll/nish experience. 50+ unique recombinant proteins including IgGs, IgMs, fusion & connective proteins, enzymes & cytokines. Laureate will partner with you from discovery to reality and every step in between. To learn more, visit us online at www.LBioS.com or call 609.919.3300.
Best Contract Manufacturing OrganizationVaccine Industry Excellence Awards (2010-2012) Third Year in a Row
For more information, visit baxterbiopharmasolutions.com Visit us at: email: email@example.com ICSE at Booth #10E25
Baxter and Galaxy are registered trademarks of Baxter International Inc.
* 52 8 3Were more than just a magazine...
INSIDE OutsourcingSALES Russ Pratt, VP of Sales & Group Publisher, Pharma Science Group firstname.lastname@example.org Wayne Blow, Publisher, Applied Clinical Trials email@example.com Michael Tracey, Publisher, Pharmaceutical Technology and BioPharm International firstname.lastname@example.org EDITORIAL Marylyn Donahue, Editor, Inside Outsourcing Special Projects Editor, Pharmaceutical Executive email@example.com William Looney, Editorial Director, Pharmaceutical Executive firstname.lastname@example.org Lisa Henderson, Editor in Chief, Applied Clinical Trials email@example.com Angie Drakulich, Editorial Director, BioPharm International, Pharmaceutical Technology firstname.lastname@example.org Adeline Siew, Editor, Pharmaceutical Technology Europe Peter Houston, Content Director email@example.com CIRCULATION
The ePT weekly e-newsletter delivers critical information on recent contract awards, company mergers & acquisitions, and fresh news of interest to a highly desired community of pharmaceutical manufacturing professionals.
PT Sourcing and Management
The PT Sourcing and Management monthly e-newsletter is the authoritative source on sourcing and management within the pharmaceuticals global supply chain.
Equipment & Processing Report
Equipment & Processing Report focuses on pharmaceutical manufacturing process and technology, providing manufacturing news, related regulatory issues, and current trends.
Mark Rosen, Circulation Director firstname.lastname@example.org
President, Chief Executive Ofcer Joseph Loggia Vice President, Finance & Chief Financial Ofcer Ted Alpert Executive Vice President, Corporate Development Eric I. Lisman Vice President, Electronic Media Group Mike Alic Vice President, Market Development Georgiann DeCenzo Vice President, Media Operations Francis Heid Vice President, Human Resources Nancy Nugent Vice President, General Counsel Ward D. Hewins Executive Vice President, Healthcare & Pharma/Science Ron Wall
Pharmaceutical Technology Europes weekly electronic e-newsletter PTE e-Alert provides news, market developments, industry surveys and information on up and coming trade events.
PharmTech Digital provides readers around the world with authoritative peer-reviewed research and expert analyses in the areas of process development, manufacturing, formulation and drug delivery, API synthesis, analytical technology, packaging, IT, outsourcing, and regulatory compliance.
+ access to
Get all this and more. Subscribe now at
Copyright 2012 Advanstar Communications Inc. All rights reserved. Return all undeliverable Canadian addresses to: Circulation Department or DPGM, 7496 Bath Road #2, Mississauga ON L4T 112. Printed in the USA. INSIDE OUTSOURCING does not verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damages incurred by readers relying on such content. Advanstar Communications Inc. provides certain customer data to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to our readers. If you do not want Advanstar Communications Inc. to make your contact information available to third parties for marketing purposes, call toll-free (888) 527-7008 between the hours of 7:30 a.m. and 5:00 p.m., EST, and follow the instructions to remove your name from Advanstar Communications Inc. lists. Outside the United States, please phone (218) 723-9477.COVER IMAGE: GETTY IMAGES
Parenteral Contract Manufacturing Service of Hospira
Our comfort zone is global parenteral manufacturing Biologics Highly Potent Drugs Cytotoxics Betalactams Controlled Substances Sterile Compounding Single-Use Technology Lyophilization Global Regulatory Services QP Release
Discover your comfort zone at one2onecmo.comGet your custom report online or contact One 2 One. Call +1-224-212-2267 or +44 (0) 1926 835 554 or e-mail email@example.com
Your Parenteral Comfort ZoneParenteral Contract Manufacturing Service of HospiraP11-3517A-Jan., 12
TABLE OF CONTENTS
Contents8 10 18 20 27IntroductionLetter from the Publisher
28 32 32 40
ROU NDTA BLE
5 Key Leaders on The New InnovationThought leaders weigh on whats new
L E A D S T O RY
Risk: The Peril and PromiseOperating risk and resource risk from sponsors to CROs being facilitated By Kenneth GetzM A N UFA CT UR IN G
Lillys New HybridA look at a very different insourcing relationship between Eli Lilly and its partner, AMRI By Patricia Van Arnum
Taking MeasureInside Outsourcings annual report on the state of the biopharmaceutical industry By Eric LangerC L I NI CA L T R IA LS
SU RVE Y
Does the Size of Your Outsourcing Organization Really Matter?It may not be rational but when picking an outsourcing partner tends to go with sIze By Janice Hutt
Making it Succeed: OptimizationSolving the common hurdles and challenges for conducting Phase II and Phase III studies. By Lisa HendersonO U TL O O K COMMENTA RY
Strategic Partnership: The Emperors New ClothesWith all the talk, are strategic partnerships really partnerships, and are they strategic? By Andrew Parrett
Boom TimeBetter-than-expected business performance for contract services industry into 2013 By Jim Miller
Full Service Contract Manufacturing Clinical to Commercial Multiple Dosage Forms Regulatory Excellence
Ask us about our
LAB SERVICES:Interphex, NYC Bio, Chicago
I almost lost herFifty years of marriage, three children, six grandchildren, and two great-grandchildren. We were nally getting to sit back and enjoy our golden years. It all ashed before me with a single, chilling image on a screen my wife had a brain tumor. Thanks to her strong will and quality medical treatments, Mieko and I are back to doing what we love best enjoying our family. We didnt think about how the quality of Miekos medications helped speed her recovery, but Jubilant HollisterStier does.Mieko is the mother of a JHS employee
Scan the barcode or visit jublHS.com to review a video about our organization
Now offering Laboratory Services as part of our extended outsourcing capabilities.jublHS.com info@jublHS.com 800.655.5329 locations in U.S.A., Canada and India
Solid Dosage Non-Sterile Topicals & Liquids Sterile Ophthalmics & Otics Sterile Injectable Fill/Finish
FROM THE PUBLISHERNew Models for a New Worldn the six years since Advanstars Pharma Science Group began publishing Inside Outsourcing, weve witness a meteoric rise in outsourcing and a dramatic evolution in the dierent forms it takes from tactical to strategic relationships between sponsors and their service providers CROs and CMOs. Today, nearly all of the large sponsor companies (e.g., major and some mid-sized pharmaceutical and biotechnology companies) have adopted and are actively using single- and multi-functional partnerships under long-term alliance arrangements. Sponsors are seeking not only more ecient access to dedicated global capacity and talent, but also cost savings through partnerships with a select and reduced number of contract service providers. Tis has been a boom to the outsourcing industry. As Ken Getz points out in his fascinating story Te Peril and Promise of Risk Imbalance on page 10, the total global market for all contract services supporting prescription drug R&D is $90 billon to $105 billon, nearly ve times larger than commonly cited. Te pressure for the pharmaceutical industry to achieve higher levels of clinical development has never been greater and more intense. Problem is with this shift towards strategic integrated alliances and the transfer of operating and resource risk, CROs are in new territory. Tey are being asked to
take on more responsibility to create and implement solutions far more innovative than have been traditionally generated and to weigh aggressive growth strategies that may redene the scope of contract services traditionally oered. Whether or not outsourcers are ready to assume this responsibility and whether the sponsors will let them remains to be seen. One thing is for surewhen it comes to pharmaceutical and biopharmaceutical outsourcing were not in Kansas anymore. Inside Outsourcing, an annual publication, is delivered digitally in a Nextbook edition to be found on all of Advanstars Pharma Science websites. Id like to thank the combined marketing, sales, and productions stas for their eort