Publication Library & Research Findings

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Research Article
A New Look at the Arsenal of Tech Solutions
Applied Clinical Trials
Kenneth Getz
10/1/2015
Impact Report
Adverse Drug Event Reporting in US Beset By Incompleteness and Inaccuracy
September/October 2015
Research Article
A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds
Clinical Pharmacology & Therapeutics
Joseph DiMasi, Kenneth Getz
8/3/2015
Research Article
ROI for Patient-Centric Drug Development
Applied Clinical Trials
Kenneth Getz
8/1/2015
Research Article
The Unintended Inefficiencies of Outsourcing Practice
Pharmaceutical Outsourcing
Mary Jo Lamberti, Kenneth Getz
7/31/2015
Impact Report
Vaccine Products in the R&D Pipeline Have More Than Tripled Since 2005
July/August 2015
Research Article
Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices
Drug Safety
Kenneth Getz
6/25/2015
Research Article
Compliance with Results Reporting at ClinicalTrials.gov
The New England Journal of Medicine
Kenneth Getz
6/11/2015
Research Article
Characterizing the Real Cost of Site Regulatory Compliance
Applied Clinical Trials
Kenneth Getz
6/1/2015
Correspondence
The Cost of Drug Development
New England Journal of Medicine
Joseph DiMasi
5/14/2015
Research Article
The Transformative Promise of Patient-Centric R&D
Pharmaceutical Business Review
Kenneth Getz
5/7/2015
Impact Report
Personalized Medicine Gains Traction But Still Faces Multiple Challenges
May/June 2015
Whitepaper
Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development
May 2015
Research Article
Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins
Therapeutic Innovation & Regulatory Science
Kenneth Getz
4/15/2015
Research Article
Establishing Return-on-Investment Expectations for Patient-Centric Initiatives
Therapeutic Innovation & Regulatory Science
Kenneth Getz
4/15/2015
Research Article
Giving Pharma Credit for Medical Innovation
Applied Clinical Trials
Kenneth Getz
4/1/2015
Research Article
Quantifying the Magnitude and Cost of Collecting Extraneous Protocol Data
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
3/1/2015
Impact Report
Biosimilars Entering the US Market Are Likely to Face Multiple Challenges
March/April 2015
Research Article
The Evolution Of Biotechnology And Its Impact On Health Care
Health Affairs
Kenneth Kaitin
2/1/2015
Commentary
Meeting Unmet Medical Needs: The Disparity Dilemma
Pharmaceutical Executive
Kenneth Kaitin
2/1/2015
Research Article
The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation
Health Affairs
Joseph DiMasi
2/1/2015
Research Article
Closing in on Opportunities to Simplify Protocol Design
Applied Clinical Trials
Kenneth Getz
2/1/2015
Book Chapter
Chapter 1 - Why Is the Pharmaceutical and Biotechnology Industry Struggling?
Re-Engineering Clinical Trials
Kenneth Kaitin, Kenneth Getz
1/1/2015
Book Chapter
Chapter 10 - The Impact of Bad Protocols
Re-Engineering Clinical Trials
Kenneth Kaitin, Kenneth Getz
1/1/2015
Impact Report
High Turnover, Protocol Noncompliance Plague the Global Site Landscape
January/February 2015
Whitepaper
Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years
January 2015
Research Article
Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2014
Research Article
Evaluating the Completeness and Accuracy of MedWatch Data
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
11/1/2014
Impact Report
CNS Drugs Take Longer to Develop, Have Lower Success Rates, Than Other Drug
November/December 2014
Research Article
Taking the Pulse of Strategic Outsourcing Relationships
Clinical Therapeutics
Mary Jo Lamberti, Kenneth Kaitin, Kenneth Getz
10/1/2014
Research Article
Is 'Open Integration' Beyond Our Reach?
Applied Clinical Trials
Kenneth Getz
10/1/2014
Impact Report
Protocol Design Optimization Starting to Improve Study Performance
September/October 2014
Impact Report
Patients Face New Challenges Accessing a Growing Number of Orphan Drugs
July/August 2014
Research Article
Adaptive Trial Design: Prepping for Adoption
Pharmaceutical Executive
Kenneth Getz
6/19/2014
Whitepaper
Industry Usage of Social and Digital Media Communities in Clinical Research
June 2014
Research Article
Q&A With Jean Burns: Insights from a Study Volunteer
Applied Clinical Trials
Kenneth Getz
5/28/2014
Research Article
Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance
International Journal of Environmental Research and Public Health
Kenneth Getz
5/12/2014
Research Article
Clinical Supply Capabilities, Practices, and Perceptions Among Investigative Sites
Applied Clinical Trials
Mary Jo Lamberti
5/12/2014
Impact Report
Collaboration & Risk-Sharing Programs Experience Longer Development Times
May/June 2014
Report
An FDA Report Card: Wide Variance in Performance Found Among Agency's Drug Review
Manhattan Institute for Policy Research
Joseph DiMasi
4/23/2014
Commentary
Regional Trends in Bioinnovation Investment
Pharmaceutical Executive
Kenneth Kaitin
4/16/2014
Research Article
Coming to Terms with Interrupted Drug Development Programs
Applied Clinical Trials
Kenneth Getz
4/1/2014
Impact Report
Drug Sponsors Tread Cautiously Using Social Media to Aid Clinical Research
March/April 2014
Research Article
The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times
Therapeutic Innovation & Regulatory Science
Joseph DiMasi, Jennifer Kim, Kenneth Getz
2/5/2014
Research Article
A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
2/1/2014
Research Article
The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology's Success
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
1/21/2014
Editorial
Open Innovation: the New Face of Pharmaceutical Research and Development
Expert Review of Clinical Pharmacology
Kenneth Kaitin, Kenneth Getz
1/10/2014
Research Article
Pharmaceutical R&D Performance by Firm Size: Approval Success Rates and Economic Returns
American Journal of Therapeutics
Joseph DiMasi
1/1/2014
Research Article
. Non-Clinical Drug Development in Asia: A Literature Review and Landscape Assessment.
Pharma Focus Asia
1/1/2014
Research Article
Therapeutic Area Variability in the Collection of Data Supporting Protocol End Points and Objectives
Clinical Investigation
Kenneth Getz
1/1/2014