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MARCH 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:

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 — 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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From the Show Floor — 2008 DIA Meeting

Actelion
Date Recorded: 6/22/08 Length: 01:48 Size: 2.8MB
Thought Leader: Massimo Raineri, Head of Systems Development - Biometry, Actelion

Massimo talks about the complexity of global drug development.
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Acurian
Date Recorded: 6/22/08 Length: 01:56 Size: 6.6MB
Thought Leader: Scott Connor, VP, Marketing, Acurian

Scott discusses why patient recruitment remains a major industry challenge.                   
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Aureus Research Consultants
Date Recorded: 6/22/08 Length: 02:02 Size: 6.9MB
Thought Leader: Alicia Pouncey, Med., Managing Dir., Aureus Research Consultants   

Alicia identifies clinical staffing and education as two major challenges.
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Beardsworth
Date Recorded: 6/22/08 Length: 01:06 Size: 3.7MB
Thought Leader: Dan Diaz, VP, Business Development, Beardsworth

Dan says the industry needs to overcome the challenge of enrolling quality subjects into complex trials.
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Clinlogix
Date Recorded: 6/22/08 Length: 01:54 Size: 6.1MB
Thought Leader: JeanMarie Markham, President/CEO, Clinlogix

JeanMarie discusses why the loss of experienced people due to mergers will impact trials. 
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Clinsys
Date Recorded: 6/22/08 Length: 01:22 Size: 2.1MB
Thought Leader: David Williams, CEO, Clinsys

David addresses the need to deliver quality services to industry sponsors.                         
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CRF
Date Recorded: 6/22/08 Length: 02:35 Size: 9.5MB
Thought Leader: Pamela McNamara, CEO, CRF

Pam outlines five major issues that are impacting the clinical trial space.                            
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Criterium
Date Recorded: 6/22/08 Length: 01:09 Size: 1.8MB
Thought Leader: Kabelo Pududu, CRA, Criterium

Kabelo says finding investigators for clinical trials is a major challenge.                             
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CRN
Date Recorded: 6/22/08 Length: 01:40 Size: 5.7MB
Thought Leader: Gail Adinamis, President/CEO, CRN

Gail confirms patient recruitment and retention are still impacting clinical trial efficiency.   
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D. Anderson & Co.
Date Recorded: 6/22/08 Length: 01:34 Size: 5.3MB
Thought Leader: Melynda Geurts, COO, D. Anderson & Company

Meylnda talks about the challenges involved with the ongoing delays with trials.                
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DataTrial
Date Recorded: 6/22/08 Length: 01:20 Size: 4.2MB
Thought Leader: Gill Hallet, M.Sc., Dir., European Operations, DataTrial

Gill talks about the need for speed in clinical trials.                                                               
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DSG
Date Recorded: 6/22/08 Length: 01:57 Size: 6.9MB
Thought Leader: Tony Varano, President/CEO, DSG

Tony discusses the need for re-tooling the clinical process.                                               
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etrials
Date Recorded: 6/22/08 Length: 01:58 Size: 6.6MB
Thought Leader: Michael Mickens, VP, Sales and Client Services, etrials

Michael discusses the need for technology integration.                                                       
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Icon
Date Recorded: 6/22/08 Length: 01:49 Size: 2.8MB
Thought Leader: Suzanne Gagnon, M.D., Senior VP, Icon  

Dr. Gagnon talks about the public perception regarding drug safety.                                  
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Imperial
Date Recorded: 6/22/08 Length: 01:32 Size: 5.1MB
Thought Leader: Robert McGrath, Sales & Marketing Mgr., Imperial

Bob talks about risk mitigation and why this is a major challenge.                                       
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INC Research
Date Recorded: 6/22/08 Length: 02:54 Size: 10.8MB
Thought Leader: Alistair Macdonald, Sr. VP, Data Services, INC Research

Alistair discusses the changing role of CROs.                                                                     
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Inclinix
Date Recorded: 6/22/08 Length: 02:25 Size: 8.2MB
Thought Leader: Tobin Geatz, CEO and Chairman, Inclinix

Tobin says the drug development process needs to change.                                             
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inVentiv Clinical Solutions
Date Recorded: 6/22/08 Length: 01:49 Size: 6.1MB
Thought Leader: Dr. Scott Treiber, Sr. VP, Clinical Operations, inVentiv Clinical Solutions

Dr. Treiber says speed, global development, and staffing are three major issues.
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Kendle
Date Recorded: 6/22/08 Length: 01:23 Size: 4.6MB
Thought Leader: Dr. Janet Jones, Director, Feasibility & Patient Recruitment, Kendle

Dr. Jones says shrinking patient pools are affecting recruitment.
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KForce
Date Recorded: 6/22/08 Length: 01:33 Size: 2.4MB
Thought Leader: Eleanore Doyle, VP, Business Development, KForce

Eleanor says the rising costs of drug development are impacting cycle times.               
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Medidata
Date Recorded: 6/22/08 Length: 02:12 Size: 7.5MB
Thought Leader: Ed Sequine, General Mgr., Medidata

Ed believes managing the ever-increasing complexity of the entire pharmaceutical industry is a major challenge.
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MedPoint Communications
Date Recorded: 6/22/08 Length: 02:08 Size: 7.4MB
Thought Leader: Bill Cooney, President/CEO, MedPoint Communications

Bill talks about the need to improve research productivity to offset the expense of developing new drugs.
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Microsoft
Date Recorded: 6/22/08 Length: 03:01 Size: 10.3MB
Thought Leader: Michael Naimoli, Director, Life Sciences Industry Solutions, Microsoft

Michael says continuing to innovate in a risk-averse environment is a major challenge.
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Monitorforhire
Date Recorded: 6/22/08 Length: 01:12 Size: 4.2MB
Thought Leader: Scott Freedman, President, Monitorforhire

Scott discusses the need for quality individuals and for training.                                        
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Nextrials
Date Recorded: 6/22/08 Length: 01:27 Size: 4.9MB
Thought Leader: James Rogers, President/CEO, Nextrials

James talks about how the increasing costs of drug development are impacting companies.
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Octagon
Date Recorded: 6/22/08 Length: 01:21 Size: 4.5MB
Thought Leader: Jim Walker, CEO, Octagon

Jim discusses the need for processes as a way to increase efficiencies.                          
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Patient Interaction (Pi)
Date Recorded: 6/22/08 Length: 01:07 Size: 3.7MB
Thought Leader: Bob Loll, VP, Business Development, Patient Interaction (Pi)

Bob talks about the misperceptions surrounding clinical trials and the need to increase the value of the trial process.
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Patni
Date Recorded: 6/22/08 Length: 02:28 Size: 8.6MB
Thought Leader: Steve Jolley, VP, Pharmacovigilance, Patni

Steve identifies increasing pressure from regulators to address safety concerns as a major challenge.
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PHT
Date Recorded: 6/22/08 Length: 01:40 Size: 5.5MB
Thought Leader: Sheila Rocchio, VP Marketing, PHT

Sheila says clients are forced to do more with fewer resources.                                         
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PPD
Date Recorded: 6/22/08 Length: 01:32 Size: 5.0MB
Thought Leader: James Streeter, Executive Dir., EDC, PPD

James discusses how regulatory controls, rising costs, and patient recruitment are impacting large and small companies.
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ProTrials
Date Recorded: 6/22/08 Length: 01:30 Size: 5.0MB
Thought Leader: Jodi Andrews, President/CEO, ProTrials

Jodi identifies the global factors that are impacting clinical research.                                  
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Rigel Pharmaceuticals
Date Recorded: 6/22/08 Length: 01:21 Size: 4.4MB
Thought Leader: Theresa Kane Musser, Exec. Dir., Development Operations, Rigel Pharmaceuticals

Theresa talks about the need for excellent science.
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SAFE-BioPharma Association
Date Recorded: 6/22/08 Length: 01:44 Size: 5.7MB
Thought Leader: Mollie Shields Uehling, President/CEO, SAFE-BioPharma Association

Mollie says the biggest challenge today is getting innovative products to patients faster.
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TechTeam
Date Recorded: 6/22/08 Length: 01:11 Size: 3.8MB
Thought Leader: Joanna Gutkowski, Acct. Mgr., TechTeam                                      

Joanna says in light of acquisitions there is a need for cost-effective solutions.     
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Wyeth
Date Recorded: 6/22/08 Length: 01:38 Size: 5.4MB
Thought Leader: Dr. William Jacobson, Dir. Project Mgmt., Wyeth

Dr. Jacobson identifies the enormous changes in the regulatory environment as having a major impact.
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