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SEPTEMBER 2010 • Contents

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Industry Soundbites



PharmaVOICE Editor's Take Videos enhance some of our popular topics with additional analysis and insights. Recorded on site at some of the industry's hottest events, Editor's Take Videos help keep you on top of the latest trends and challenges facing the industry.
 

Click below to browse our library:

2010 Annual DIA Meeting
BBK, Joan F. Bachenheimer and Matthew Stum
BioClinica, Peter Benton
Cognizant, Nagaraja Srivatsan
Cytel, Irving Dark
i3 Research, Dr. Tracy Tsuetaki
INC Research, Alistair Macdonald
Integrated Clinical Solutions Inc., J. Peter Armerding
Kendle, Ken Hintze, Ph.D.
Kendle, Drew Kilpatrick, Ph.D.
Kforce, Mark Lanfear
MediciGlobal, Elizabeth Moench
Medidata Solutions Worldwide, Glen de Vries
Merge eClinical, Jon DeVries
MMG, Gaynor Anders
Nextrials, Jim Rogers
ParagonRx, Gary Slatko, M.D.
Registrat-MAPI, Ronald Christensen, M.D.
SAFE-BioPharma Association, Mollie Shields-Uehling
Sentrx, Chuck Saldarini

Chatting with the Editor

GSK, Mike Pucci

2009 Annual DIA Meeting
Aureus Research Consultants, Alicia Pouncey
BioClinica, Inc., Mark Weinstein
Criterium, Inc., Lawrence Reiter, Ph.D.
i3 Informatics, Bill Guinn
inVentiv Clinical, Jaye Thompson
Medidata, Graham Bunn

Omnicare Clinical Research, Nancy Meyerson-Hess
United Biosource Corporation, Patrick Lindsay

2008 Annual DIA Meeting

Actelion, Massimo Raineri
Acurian, Scott Connor
Aureus Research Consultants,
 
  Alicia Pouncey  
Beardsworth, Dan Diaz
Clinlogix, JeanMarie Markham
Clinsys, David Williams
CRF, Pamela McNamara
Criterium, Kabelo Pududu
CRN, Gail Adinamis
D. Anderson & Co.,
   Melynda Geurts

DataTrial, Gill Hallet
DSG, Tony Varano
etrials, Michael Mickens
Icon, Dr. Suzanne Gagnon
Imperial, Robert McGrath
INC Research, Alistair Macdonald
Inclinix, Tobin Geatz
inVentiv Clinical Solutions,
   Dr. Scott Treiber

Kendle, Dr. Janet Jones
KForce, Eleanore Doyle
Medidata, Ed Sequine
MedPoint Communications,
   Bill Cooney

Microsoft, Michael Naimoli
Monitorforhire, Scott Freedman
Nextrials, James Rogers
Octagon, Jim Walker
Patient Interaction (Pi), Bob Loll
Patni, Steve Jolley
PHT, Sheila Rocchio
PPD, James Streeter
ProTrials, Jodi Andrews
Rigel Pharmaceuticals,
   Theresa Kane Musser

SAFE-BioPharma Association,
   Mollie Shields Uehling

TechTeam, Joanna Gutkowski
Wyeth, Dr. William Jacobson

From the Show Floor — 2010 DIA Meeting

BBK Worldwide
Thought Leaders: Joan F. Bachenheimer, Founding Principal, and Matthew Stumm, Creative  

Ms. Bachenheimer and Mr. Stumm demonstrate how the Apple iPad is improving patient recruitment and management in global clinical trials. For more information, visit www.bbkworldwide.com
Date Recorded: 6/14/2010 Length: 6:20 Size: 22.3MB
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BioClinica
Thought Leader: Peter Benton, Executive VP, President, eClinical Division  

Mr. Benton provides best practices in analyzing the clinical supply chain that allow sponsors to trim costs before and during a clinical trial. For more information, visit www.bioclinica.com
Date Recorded: 6/15/2010 Length: 4:09 Size: 14.5MB
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Cognizant
Thought Leader: Nagaraja Srivatsan,VP, Head of Life Sciences, North America  

Srivatsan discusses how companies can operate more effectively and efficiently under current cost structures in clinical and commercial operations. For more information, visit www.cognizant.com
Date Recorded: 6/14/2010 Length: 2:31 Size: 8.84MB
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Cytel Inc.
Thought Leader: Irving Dark, VP, Clinical Research Services   

Mr. Dark discusses why CROs need to incorporate automation tools and simulation-based decision-making technologies to meet evolving demands. For more information, visit www.cytel.com
Date Recorded: 6/15/2010 Length: 2:10 Size: 7.67MB
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i3 Research
Thought Leader: Dr. Tracy Tseutaki, President, i3 Research   

Dr. Tsuetaki discusses product development and regulatory considerations when entering the Chinese market, the state of the life sciences market in China, and adapting U.S. clinical development practices in China. For more information, visit www.i3research.com
Date Recorded: 6/15/2010 Length: 3:12 Size: 11.2MB
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INC Research
Thought Leader: Alistair Macdonald, Executive VP, Strategic Development

Mr. Macdonald outlines the largest challenges in drug development and how clinical delivery alliances can help overcome these hurdles. For more information, visit www.incresearch.com
Date Recorded: 6/14/2010 Length: 2:56 Size: 10.3MB
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Integrated Clinical Solutions Inc.
Thought Leader: J. Peter Armerding, Founder and President, Integrated Clinical Solutions Inc.

Mr. Amerding describes how process automation tools can improve clinical operations in the field. For more information, visit www.inclinical.com
Date Recorded: 6/15/2010 Length: 3:05 Size: 10.8MB
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Kendle
Thought Leader: Ken Hintze, Ph.D., VP, Scientific and Medical Affairs   

Dr. Hintze talks about the functional service provider (FSP) model, including its benefits, safety issues, and impact on cost. For more information, visit www.kendle.com
Date Recorded: 6/15/2010 Length: 2:36 Size: 9.22MB
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Kendle
Thought Leader: Drew Kilpatrick, Ph.D., Director, Global Safety & Pharmacovigilance   

Dr. Kilpatrick explores electronic adjudication as a patient eligibility tool and its primary benefits for customers. For more information, visit www.kendle.com
Date Recorded: 6/15/2010 Length: 2:33 Size: 9.01MB
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Kforce
Thought Leader: Mark Lanfear, VP, Strategic Alliances  

Mr. Lanfear shares the latest trends impacting personnel placement for biopharmaceutical companies, including lean manufacturing and career expectations and opportunities in this new economy. For more information, visit www.kforce.com
Date Recorded: 6/14/2010 Length: 2.51 Size: 10.1MB
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MediciGlobal
Thought Leader: Elizabeth Moench, President and Founder   

Ms. Moench outlines the benefits of connecting patient recruitment companies with patient advocacy organizations and contrasts supply-driven with demand-driven patient recruitment. For more information, visit www.mediciglobal.com
Date Recorded: 6/15/2010 Length: 3:23 Size: 12.0MB
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Medidata Solutions Worldwide
Thought Leader: Glen de Vries, President  

Mr. de Vries explains how Software as a Service (SaaS) can improve the clinical development process as well as optimize sponsors' R & D investments. For more information, visit www.mdsol.com
Date Recorded: 6/14/2010 Length: 3:51 Size: 13.5MB
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Merge eClinical
Thought Leader: Jon DeVries, General Manager  

Mr. DeVries discusses how integrated solutions can be used to develop image-enabled EHR and other health IT applications, while improving patient care and reducing costs. For more information, visit www.merge.com
Date Recorded: 6/15/2010 Length: 2:58 Size: 10.3MB
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MMG
Thought Leader: Gaynor Anders, VP, Global Operations  

Ms. Anders discusses patient recruitment issues for smaller trial sizes, and whether social media is a boon or a bust for patient recruitment. For more information, visit www.mmgct.com
Date Recorded: 6/15/2010 Length: 2:05 Size: 7.36MB
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Nextrials
Thought Leader: Jim Rogers, Founder, President, and CEO

Mr. Rogers outlines the real-world benefits of EHR integration in clinical research, including integrating prepopulated data with real-time data. For more information, visit www.nextrials.com
Date Recorded: 6/15/2010 Length: 2:32 Size: 8.87MB
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ParagonRx
Thought Leader: Gary Slatko, M.D., Chief Medical Officer, ParagonRx, an inVentiv Clinical company

Dr. Slatko provides a number of best practices for developing a REMS program and discusses how these programs differ based on therapeutic class or type of risk. For more information, visit www.paragonrx.com

Date Recorded: 6/15/2010 Length: 4:14 Size: 14.9MB
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Registrat-MAPI
Thought Leader: Ronald Christensen, M.D., Co-CEO   

Dr. Christensen explains why having a direct patient management program is so important, and how it can be designed to effectively track long-term data. For more information, visit www.registratmapi.com
Date Recorded: 6/14/2010 Length: 4:35 Size: 16.1MB
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SAFE-BioPharma Association
Thought Leader: Mollie Shields-Uehling, President and CEO  

Ms. Shields-Uehling provides an overview of the SAFE-BioPharma digital signature standard and how it is being adopted in the industry. For more information, visit www.safe-biopharma.org
Date Recorded: 6/15/2010 Length: 3:13 Size: 11.4MB
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Sentrx
Thought Leader: Chuck Saldarini, CEO

Mr. Saldarini describes how integrating pharmacovigilance with global clinical development provides new opportunities for CROs and what CROs should look for in a pharmacovigilance partner. For more information, visit www.sentrx.com
Date Recorded: 6/15/2010 Length: 3:09 Size: 11.0MB
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PV100 videos

Cognizant
Thought Leaders: Nagaraja Srivatsan, VP, Head of Life Sciences, North America  
Date Recorded: 6/14/2010 Length: 1:52 Size: 2.39MB
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Medidata Solutions Worldwide
Thought Leaders: Graham Bunn, Ph.D., Vice President, Partnerships & Alliances  
Date Recorded: 6/14/2010 Length: 1:43 Size: 2.69MB
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Pfizer
Thought Leaders: Craig Lipset, Director, Molecular Medicine, Clinical Research  
Date Recorded: 6/14/2010 Length: 1:32 Size: 2.4MB
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From the Show Floor — 2009 DIA Meeting

Aureus Research Consultants
Date Recorded: 6/24/09 Length: 03:13 Size: 11.1MB
Thought Leader: Alicia Pouncey, M.Ed., Managing Director, Aureus Research Consultants   

Alicia discusses using medical simulation for CRA training, how technology-based training benefits younger CRAs, and offers some best practices for maintaining protocol compliance.
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BioClinica
Date Recorded: 6/24/09 Length: 02:34 Size: 6.9MB
Thought Leader: Mark Weinstein, President & CEO, BioClinica, Inc.

Mark talks about combining Medical Imaging with EDC and offers advice to sponsors regarding this integration.
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Criterium, Inc.
Date Recorded: 6/24/09 Length: 02:38 Size: 10.1MB
Thought Leader: Lawrence Reiter, Ph.D., Director of Global Affairs, Criterium, Inc.

Lawrence discusses how CROs can differentiate themselves, full-service vs. a la carte services, and integrating multiple CROs within a project.                         
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i3 Informatics
Date Recorded: 6/24/09 Length: 03:31 Size: 12.3MB
Thought Leader: Bill Guinn, VP of Clinical Informatics, i3 Informatics

Bill offers insights on data mining for patients for clinical trials.                            
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inVentiv Clinical
Date Recorded: 6/24/09 Length: 02:32 Size: 10.1MB
Thought Leader: Jaye Thompson, Ph.D., Senior VP, inVentiv Clinical

Jaye discusses the adaptive outsourcing model, regulatory challenges, and communicating risks to the public.                   
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Medidata
Date Recorded: 6/24/09 Length: 05:22 Size: 18.9MB
Thought Leader: Graham Bunn, VP, Global CRO Partnerships, Medidata

Graham talks about EDC's impact on clinical monitoring and how numerous new technologies are affecting clinical roles.
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Omnicare Clinical Research
Date Recorded: 6/24/09 Length: 03:25 Size: 11.6MB
Thought Leader: Nancy Meyerson-Hess, MSc, Senior VP, Project Management International, Omnicare Clinical Research

Nancy talks about strategic project management and the skill set needed by today's project managers. 
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United BioSource Corporation
Date Recorded: 6/24/09 Length: 06:35 Size: 23.1MB
Thought Leader: Patrick Lindsay, EVP, United Biosource Corporation

Patrick discuss risk management and navigating the regulatory environment.                   
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