Publication Library & Research Findings

Filter By Core Concepts
555 Results
Research Article
Hard Truths about Executing Outsourcing Relationships
Pharmaceutical Outsourcing
Mary Jo Lamberti, Kenneth Getz
7/21/2016
Impact Report
Global Regenerative Medicine Market is Poised For Strong Growth
July/August 2016
Research Article
Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy
Therapeutic Innovation & Regulatory Science
Joseph DiMasi
5/20/2016
Research Article
Bridging the Academia/Industry Chasm: Proposed Solutions
The Journal of Clinical Pharmacology
Paul Beninger, Kenneth Getz
5/6/2016
Research Article
Identifying And Valuing Patient Group Engagement Methods
Value in Health
Kenneth Getz
5/1/2016
Impact Report
Rapid Growth in PBM Exclusion Lists Poses Challenges to Drug Developers
May/June 2016
Research Article
Is Earlier Signal Detection Always Better?
Drug Safety
4/11/2016
Research Article
Acknowledging Cycle Time Impact from Protocol Amendments
Applied Clinical Trials
Kenneth Getz
4/1/2016
Impact Report
Promise of Immuno-Oncology Therapies is Boosting R&D Funding, Alliances
March/April 2016
Research Article
The Impact of Protocol Amendments on Clinical Trial Performance and Cost
Therapeutic Innovation & Regulatory Science
Kenneth Getz
2/22/2016
Research Article
Assessing The Discovery Outsourced Services Market
Life Science Leader
Kenneth Getz
2/1/2016
Research Article
Clinical Trial Knowledge Missed, Gained, and Shared
Applied Clinical Trials
Kenneth Getz
2/1/2016
Research Article
Optimizing Collaboration Effectiveness in Alliance Partnerships
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
1/28/2016
Research Article
Mobile Nurse Services in Clinical Trials: Usage and Industry Perceptions
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/27/2016
Impact Report
Amendments Reduce Number of Patients, But at High Cost, Longer Study Times
January/February 2016
Research Article
Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations
Therapeutic Innovation & Regulatory Science
12/30/2015
Research Article
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2015
Research Article
Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2015
Research Article
An Examination of eClinical Technology Usage and CDISC Standards Adoption
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
11/1/2015
Impact Report
First-In-Class Drugs in Competitive Development Races With Later Entrants
November/December 2015
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