Publication Library & Research Findings

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555 Results
Impact Report
US Offers Patients Faster, Greater Access to Cancer Drugs Than Europe
July/August 2012
Research Article
Resizing the Global Contract R&D Services Market
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
5/30/2012
Impact Report
User Fee Era in US Currently Poses Mixed Regulatory Burden For Sponsors
May/June 2012
Whitepaper
Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S.
April 2012
Impact Report
Pace of CNS Drug Development and FDA Approvals Lag Other Drug Classes
March/April 2012
Research Article
FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
2/15/2012
Research Article
Trends and Novel Approaches to Clinical Supply Outsourcing
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
1/23/2012
Impact Report
Study Monitor Workload High & Varied With Wide Disparity By Global Region
January/February 2012
Commentary
Creating Innovation Nodes to Meet Unmet Medical Needs
PharmTech
Kenneth Kaitin
12/2/2011
Impact Report
New mAbs Entering Clinical Study Rose Steadily From 1997 Through 2010
November/December 2011
Book Chapter
Clinical Research, Patient Care, and Learning That is Real-Time and Continuous: Enhancing the Culture of Patient Contributions to Learning in Health Care
Patients Charting the Course: Citizen Engagement in the Learning Health System
Kenneth Getz
10/21/2011
Commentary
Program Chair Reflects upon DIA 2011
Drug Information Journal
Kenneth Getz
9/1/2011
Impact Report
Nearly 60% of All Protocols Require Amendments; One-Third Are Avoidable
September/October 2011
Commentary
A Dearth of New Meds: Drugs to Treat Neuropsychiatric Disorders Have Become Too Risky for Big Pharma
Scientific American
Kenneth Kaitin
8/1/2011
Research Article
Variability in Protocol Design Complexity by Phase and Therapeutic Area
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz
7/1/2011
Commentary
Transforming R&D Through Open Innovation
Applied Clinical Trials
Kenneth Kaitin, Kenneth Getz
7/1/2011
Research Article
Are Pharmacists a Viable Channel for Education about Clinical Trial Participation?
Drug Information Journal
Kenneth Getz
7/1/2011
Impact Report
Lack of Clinically Useful Diagnostics Hinder Growth in Personalized Medicines
July/August 2011
Commentary
21st Century Innovation
PharmTech
Kenneth Kaitin
6/2/2011
Research Article
Measuring the Incidence, Causes, and Repercussions of Protocol Amendments
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz
5/1/2011
Research Article
Factors Influencing Investigative Site Willingness and Ability to Participate in Clinical Trials
Drug Information Journal
Mary Jo Lamberti, Kenneth Getz
5/1/2011
Impact Report
Biopharmaceutical Product Approvals in the US Rose Dramatically in 2000s
May/June 2011
Research Article
Low Hanging Fruit in the Fight Against Inefficiency
Applied Clinical Trials
Kenneth Getz
3/1/2011
Commentary
The Promise and Progress of DIA 2011
Drug Information Journal
Kenneth Getz
3/1/2011
Impact Report
New or Modified Indications for Existing Drugs Have Steadily Increased in US
March/April 2011
Research Article
A New Mechanism for Tracking Publicly Available Study Volunteer Demographics
Drug Information Journal
Kenneth Kaitin, Kenneth Getz
1/1/2011
Impact Report
US Healthcare Stakeholders Uncertain On Benefits of Risk Evaluation Strategy
January/February 2011
Research Article
Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000–2009
Clinical Pharmacology & Therapeutics
Kenneth Kaitin, Joseph DiMasi
12/29/2010
Research Article
Competitiveness in Follow-On Drug R&D: A Race of Imitation?
Nature Reviews Drug Discovery
Joseph DiMasi
12/10/2010
Impact Report
Personalized Medicine is Playing a Growing Role in Development Pipelines
November/December 2010
Research Article
Deconstructing the Drug Development Process: The New Face of Innovation
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
10/12/2010
Research Article
Anticipating Structural Change in the CRO Market
Contract Pharma
Kenneth Getz
10/8/2010
Research Article
Impact of the New US Health-Care-Reform Legislation on the Pharmaceutical Industry: Who Are the Real Winners?
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
9/22/2010
Commentary
Explaining the Drug Drought
Pharmaceutical Executive
Kenneth Kaitin
9/1/2010
Impact Report
Clinical Approval Success Highest For Smallest Firms Among the Top 50
September/October 2010
Research Article
Drug Development Costs When Financial Risk is Measured Using the Fama-French Three-Factor Model
Health Economics
Joseph DiMasi
7/12/2010
Impact Report
Comparative Effectiveness Research Impacts Patient Access to Cancer Drugs
July/August 2010
Commentary
The Landscape for Pharmaceutical Innovation: Drivers of Cost-Effective Clinical Research
Pharm Outsourcing
Kenneth Kaitin
5/1/2010
Impact Report
Rising Protocol Complexity, Execution Burden Varies Widely By Phase and TA
May/June 2010
Impact Report
Rising Demand is Expanding Scope and Workload of Regulatory Affairs Function
March/April 2010
Research Article
Deconstructing the Drug Development Process: The New Face of Innovation
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
2/3/2010
Research Article
Trends in Risks Associated with New Drug Development: Success Rates for Investigational Drugs
Clinical Pharmacology & Therapeutics
Joseph DiMasi
2/3/2010
Commentary
Private Sector Contributions to Pharmaceutical Science: Thirty-Five Summary Case Histories
American Journal of Therapeutics
Joseph DiMasi
1/1/2010
Impact Report
US Orphan Product Designations More Than Doubled From 2000-02 to 2006-08
January/February 2010
Research Article
Factors Associated with Multiple FDA Review Cycles and Approval Phase Times
Drug Information Journal
Joseph DiMasi
12/30/2009
Commentary
Drug Development Shifts to Small-Scale, Focused Targets
Mass High Tech (MHT)
Kenneth Kaitin
12/16/2009
Commentary
Translational Medicine: An Engine of Change for Bringing New Technology to Community Health
Science Translational Medicine
Kenneth Kaitin
11/9/2009
Impact Report
Drug Approvals For Neglected Diseases Increase Along With More R&D Funding
November/December 2009
Impact Report
Marketing Exclusivity For First-In-Class Drugs Has Shortened to 2.5 Years
September/October 2009
Research Article
Drug Development Portfolio and Spending Practices after Mergers and Acquisitions
Therapeutic Innovation & Regulatory Science
Joseph DiMasi, Kenneth Kaitin, Kenneth Getz
7/1/2009