Articles

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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
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
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
Research Article
New Governance Mechanisms to Optimize Protocol Design
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Kenneth Getz, Jennifer Kim
12/30/2013
Research Article
Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes About Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2013
Editorial
Drug Development Study Designs Have Reached the Danger Zone
Expert Review of Clinical Pharmacology
Kenneth Getz
11/14/2013
Research Article
Characterizing the Global Market for Contract R&D Services
Monographic supplement series CROs/CMOs: Chimica Oggi - Chemistry Today
Mary Jo Lamberti, Jennifer Kim, Kenneth Getz
7/1/2013
Research Article
Characterizing the Cost of Non-Clinical Development Activity
Contract Pharma
Jennifer Kim, Kenneth Getz
6/5/2013
Research Article
Clinical Approval Success Rates for Investigational Cancer Drugs
Clinical Pharmacology & Therapeutics
Joseph DiMasi
6/5/2013
Research Article
Tracking Trial Cost Drivers: The Impact of Comparator Drugs and Co-Therapies
Pharmaceutical Executive
Mary Jo Lamberti, Kenneth Getz
5/1/2013
Research Article
Unfulfilled Translation Opportunities in Industry Sponsored Clinical Trials
Contemporary Clinical Trials
Kenneth Getz
5/1/2013
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
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
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
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
Research Article
Resizing the Global Contract R&D Services Market
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
5/30/2012
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
Commentary
Creating Innovation Nodes to Meet Unmet Medical Needs
PharmTech
Kenneth Kaitin
12/2/2011
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
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
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
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
Research Article
A New Mechanism for Tracking Publicly Available Study Volunteer Demographics
Drug Information Journal
Kenneth Kaitin, Kenneth Getz
1/1/2011
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