Publication Library & Research Findings

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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
Impact Report
New Breakthrough Therapy Designation Program Aims to Cut Clinical Trial Time
January/February 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
Whitepaper
A New Tool for Predicting Marketing Approval of Oncology Drugs
December 2013
Editorial
Drug Development Study Designs Have Reached the Danger Zone
Expert Review of Clinical Pharmacology
Kenneth Getz
11/14/2013
Impact Report
Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically
November/December 2013
Impact Report
Causes of Clinical Failures Vary Widely by Therapeutic Class, Phase of Study
September/October 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
Impact Report
Annual Approvals For Neglected Diseases Rose From 2.6 in 2000-08 to 5 in 2009-12
July/August 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
Impact Report
Clinical Success Rates for New Cancer Drugs Double While More Enter Testing
May/June 2013
Whitepaper
The Adoption and Impact of Adaptive Trial Designs
May 2013
Impact Report
Global Site Landscape Remains Highly Fragmented With Variable Performance
March/April 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
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