Publication Library & Research Findings

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569 Results
Research Article
Benchmarking the Study Initiation Process
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
1/1/2013
Research Article
The Scoop on Drug Shortages
Pharmaceutical Executive
Mary Jo Lamberti, Kenneth Getz
1/1/2013
Research Article
Oncology Drug Development and Approval of Systemic Anticancer Therapy by the US Food and Drug Administration
Oncologist
Kenneth Kaitin, Kenneth Getz
1/1/2013
Impact Report
89% of Trials Meet Enrollment, But Times Slip, Half of Sites Under-Enroll
January/February 2013
Research Article
Mapping and Characterizing the Development Pathway from Non-Clinical through Early Clinical Drug Development
Pharmaceutical Medicine
Kenneth Getz
12/23/2012
Research Article
Research and Development Costs for New Drugs by Therapeutic Category
PharmacoEconomics
Joseph DiMasi
11/15/2012
Commentary
Weighing Access and Affordability
PharmTech
Kenneth Kaitin
11/2/2012
Impact Report
One in Five Procedures Generates Extraneous Clinical Trials Data
November/December 2012
Research Article
Translational Research and the Evolving Landscape for Biomedical Innovation
Journal of Investigative Medicine
Kenneth Kaitin
10/1/2012
Book Chapter
R&D Costs and Returns to New Drug Development: A Review of the Evidence
The Oxford Handbook of the Economics of the Biopharmaceutical Industry
Joseph DiMasi
9/18/2012
Research Article
The Economics of Follow-On Drug Research and Development
PharmacoEconomics
Joseph DiMasi
9/3/2012
Impact Report
Oncology Drugs Get Faster Approvals Than Non-Oncology Drugs in US
September/October 2012
Research Article
Microaggressions, Interrupted: The Experience and Effects of Gender Microaggressions for Women in STEM
Journal of Business Ethics
Jennifer Kim
8/5/2012
Research Article
Evaluating the Impact of Patient Recruitment and Retention Practices
Drug Information Journal
Mary Jo Lamberti, Kenneth Getz
7/13/2012
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