White Papers

From time to time, Tufts CSDD produces authoritative White Papers to highlight current thinking on critical drug development issues. White Papers present findings and insights from Tufts Center analyses, as well as detailed reviews of roundtable discussions and forums hosted by CSDD. 

 

Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing (October 2017)

This report examines the impact on development costs and net returns for drug developers if clinical development cycle times are reduced, which has implications for development efficiency, innovation incentives, and earlier access by patients to new therapies. The analysis is conducted in the context of estimated differences in development times between single-source and multi-source outsourced contract manufacturing. The full study has been submitted for peer-reviewed publication.

Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development (May 2015)

This report details six primary areas across scientific, operating and manufacturing divisions including new approaches to validating drug targets; integrating real world data into the R&D process; flexible and adaptive clinical trials; and green manufacturing techniques driving efficiency while reducing carbon footprint.

Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years (January 2015)

In the current study (January 2015), Tufts CSDD authors examine a diverse array of evidentiary materials for 19 individual drugs, 6 drug classes and 1 drug combination, identified as the most transformative drugs in health care over the last 25 years, to better understand the respective contributions of the public and private sectors. The results of the analysis show that drug discovery and development is a complex ecosystem with a wide range of novel collaboration archetypes, involving industry-academic partnerships, venture capital, disease foundations, as well as public-private, pre-competitive consortia, so that learning is from many disciplines and the result of multiple feedback loops. 

Industry Usage of Social and Digital Media Communities in Clinical Research (June 2014)

Tufts CSDD convened a working group of 20 pharmaceutical and biotechnology companies, and contract research organizations (CROs) to assess current and anticipated use of social and digital media communities in clinical research; to identify challenges, receptivity and concerns about usage; and to develop a comprehensive set of management principles and policies designed to optimize the value and minimize risk posed by social and digital media use in clinical research.

A New Tool for Predicting Marketing Approval of Oncology Drugs (December 2013)

Tufts CSDD and Janssen Research & Development (JRD) collaborated on a pilot study to develop and test a model capable of predicting the likelihood of marketing approval for oncology NMEs and NBEs. The study assessed the predictive power of select new compound characteristics. 

The Adoption and Impact of Adaptive Trial Designs (May 2013)

Tufts CSDD hosted and facilitated a Senior Leadership roundtable on February 13, 2013 in Boston to discuss the adoption and impact of adaptive design clinical trials. Forty senior executives from a variety of cross-functional areas participated including clinical research and development, biostatistics, project management, and clinical operations. In addition, perspectives from the Food and Drug Administration and European Medicines Agency were represented.

Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S (April 2012)

A new study by the Tufts University Center for the Study of Drug Development explores the breadth and nature of partnerships between biopharmaceutical companies and academic medical centers (AMCs).

Tufts CSDD eBooks

Tufts CSDD eBooks, the newest additions to our publication catalogue, are comprehensive compendia of Tufts CSDD research findings. Offered in long-form digital format for mobile or desktop consumption, Tufts CSDD eBooks provide timely and highly relevant e-reference materials to inform the research-based pharma and biotech industry, as well as other stakeholders involved in new medicines development.

Have an idea for a Tufts CSDD eBook focusing on a particular topic? Contact us to suggest Tufts CSDD eBook topics, or provide feedback on our current offerings.

Current Tufts CSDD eBook offerings:

UPDATED EDITION - FDA Trends: Path to Approval 
Editor: Dr. Christopher-Paul Milne, Director of Research, Tufts Center for the Study of Drug Development
205 pages

The FDA Trends: Path to Approval eBook is a comprehensive compilation of recent Tufts CSDD presentations and publications, government data, and expert perspectives related to FDA approval trends. Offered in long-form digital format for ​mobile or desktop consumption, the eBook covers a broad range of topics, including FDA expedited review programs, the global marketplace, benefit/risk, regulatory science, and differential impact of FDA workload on therapeutic areas.

NEW 2014 - 2015 UPDATE, including: 

  •   New figures for R&D costs, approval time and success rates
  •   Tracking Ebola R&D over the last decade
  •   Biosimilars are “coming to America”
  •   Breakthrough Therapy Designation (BTD) impacts
  •   Trends in personalized medicine investment from 2010 to 2015

TABLE OF CONTENTS:

Here’s what reviewers are saying about Tufts CSDD’s FDA Trends eBook:

  •  "An excellent reference for medical and regulatory affairs teams.
  •  "Offers valuable insights into regulatory processes and trends."
  •  "Great overview of pertinent topics."

The FDA Trends eBook is also available in a multi-user license, giving everyone in your organization immediate access.  Email us for pricing information.

 

PLEASE NOTE: Orders are processed as quickly as possible during Tufts CSDD business hours of 9AM – 5PM. Orders placed outside of business hours or on weekends will be processed and delivered at the on the following business day.

Tufts CSDD Impact Reports

Analysis and insight into critical drug development issues. Cutting edge information. Original research. Your most reliable guide to drug development.

Tufts CSDD Impact Reports present original research, data, and insights on a broad variety of topics, ranging from Tufts CSDD’s most current drug development metrics analyses, to global pharmaceutical reimbursement policies. Tufts CSDD Impact Reports findings have been quoted in the Wall Street Journal, Forbes, Time magazine, and the New England Journal of Medicine, among others.

Thumbnail of Impact Report covers

Tufts CSDD Impact Reports make critical information readily accessible.

  • Charts and tables present key points, letting you focus on major findings
  • Clear, concise—and brief—bulleted items highlight key findings, saving you time deciphering extensive text
  • Explanatory sidebars and definitions ensure a shared understanding of key concepts and terms.

Corporate Multi-Reader Subscriptions

The Tufts CSDD Impact Report is also available as a corporate subscription, giving everyone in your organization immediate access to these timely reports. Priced to be cost effective, a corporate subscription provides a significant volume discount off the annual individual subscription fee. If you are interested in a multi-reader subscription, please contact us by phone at 617-636-0840 or by .(JavaScript must be enabled to view this email address).

Academic/Government/Non-Profit subscription rate also available

This special rate is subject to verifaction, please contact us by phone at 617-636-0840 or by .(JavaScript must be enabled to view this email address) for more details.

Single Issues

All Tufts CSDD Impact Reports are available for single issue ordering. Single issues can be purchased at $125 per issue. If you would like to request more than two issues, please contact Tufts CSDD at 617-636-2170 or email .(JavaScript must be enabled to view this email address).


PLEASE NOTE: Orders are processed manually within 24 hours of receipt, during the regular business hours of Monday-Friday, 9AM – 5PM (excluding university holidays). Orders placed outside of business hours will be processed on the following business day.

Tufts CSDD Outlook

Tufts CSDD’s Outlook highlights near-term pharmaceutical and biopharmaceutical development trends. Data and analyses contained in Tufts CSDD’s Outlook are based on proprietary research conducted by the Tufts CSDD staff, and include insights into current industry, regulatory, and policy trends.

Here are the highlights of Tufts CSDD's Outlook 2016

  • Continued scientific achievements that increase understanding of the pathophysiology of oncological diseases will result in approvals of new cancer therapies, which will outpace new drug approvals in other therapeutic areas, as they have over the last 15 years.
  • Sponsors and CROs will make greater use of electronic medical information and drug development management metrics to perform more robust, predictive analytics to drive operating efficiency, improve feasibility, inform portfolio strategy, and support more effective patient recruitment.
  • Major regulatory agencies will emphasize harmonization of global activities to coordinate and facilitate pediatric studies, prompted by recent changes in policy that will increase the demand for pediatric patients to participate in clinical trials.
  • U.S. payers and providers will quantify clinical benefits of new cancer and orphan products to align price with value by measuring safety, effectiveness, convenience of use, and other attributes in relation to cost.

Archive

Press Releases

 

Tufts CSDD R&D Management Reports

Tufts CSDD R&D Management Reports highlight speaker presentations and main discussion points from each Tufts CSDD Executive Forum roundtable.  Roundtables typically include a presentation on current research by Tufts CSDD staff, followed by industry speakers, who present case studies on their companies’ experiences. Open discussion by all attendees generates a lively exchange on the pros and cons of different approaches to solving specific R&D challenges, and identifies best practices.

 

Single Issues

All Tufts CSDD R&D Management Reports are available for single issue ordering. Single issues can be purchased at $250 per issue. If you would like to request more than two issues, please contact Tufts CSDD at 617-636-2170 or email .(JavaScript must be enabled to view this email address).


PLEASE NOTE: Orders are processed manually within 24 hours of receipt, during the regular business hours of Monday-Friday, 9AM – 5PM (excluding university holidays). Orders placed outside of business hours will be processed on the following business day.

Tufts CSDD R&D Management Reports Single Issue

Pediatric Oncology Drug Development: Maximizing Ef ciency While Complying with FDA & EMA Regulations
October 2016; Vol. 11 No. 2

To better understand current and emerging trends in pediatric oncology drug development, Tufts CSDD recently convened a roundtable discussion of senior leaders from drug compa­nies, government agencies, and academia. Key points from that meeting are highlighted in this report.

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Patient Recruitment and Retention 2.0
January 2016; Vol. 11 No. 1

Responding to strong and growing pressures to accelerate the pace at which new medicines are launched, drug developers are innovating clinical study volunteer recruitment and retention to significantly improve clinical trial performance and efficiency, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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Novel Approaches to Overhauling the Clinical Development Process

October 2015; Vol. 10 No. 4

Although pharmaceutical companies have long aspired to improve drug development efficiency, the drug development process remains highly inefficient and fraught with delays and rising costs, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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Diagnostic-Therapeutic Co-Development Strategies

August 2015; Vol. 10 No. 3

With interest in personalized medicines growing, drug and diagnostics companies are investing in the development of companion diagnostics that can show that their use in conjunction with personalized therapeutics will lead to positive health outcomes, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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Assessing the FDA’s Breakthrough Therapy Designation

April 2015; Vol. 10 No. 2

Flexibility and a willingness to learn from each other are key factors that enable drug companies and regulators to engage successfully in development projects that have been accorded breakthrough therapy designation, or BTD, according to R&D executives participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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Anticipating and Managing a Changing Site Landscape

January 2015; Vol. 10 No. 1

Improved investigative site relationship use and effectiveness are top objectives in 2015 for pharmaceutical companies and contract research organizations, according to drug industry R&D executives participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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New Directions in Clinical Study Outsourcing Practices

October 2014; Vol. 9 No. 4

Strategic relationships between drug developers and contract research organizations(CROs) are generating innovative approaches to clinical trial design and execution, but creating lasting value for both parties requires them to act in new ways, R&D executives from the pharmaceutical and biotech industry said at a gathering recently hosted by the Tufts Center for the Study of Drug Development.

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Risk-Sharing Partnerships and Alliances: Strategic and Operational Challenges

August 2014; Vol. 9 No. 3

As pharmaceutical and biotech companies look to speed development, lower cost, and reduce technical risks associated with new drug development, they are increasing the number and types of collaborative relationships they are forming with other developers, as well as with service providers and other stakeholders, according to the Tufts Center for the Study of Drug Development.

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Predictors of Clinical Success to Boost Success Rates

April 2014; Vol. 9 No. 2

Drug companies and their development partners who are seeking to increase clinical success rates of new drug candidates are developing tools to help them predict the likelihood of marketing approval and incorporating business planning earlier in clinical development, according to R&D leaders who recently participated in a roundtable discussion convened by the Tufts Center for the Study of Drug Development.

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Enhancing Product Value through Comparator and Co-Therapy Clinical Trials

January 2014; Vol. 9 No. 1

Drug developers are aggressively implementing new strategies to improve their access to and use of comparator drugs, which are used in clinical trials to determine how development candidates compare to existing therapies, according to leaders from the research-based drug industry who recently participated in a roundtable discussion convened by the Tufts Center for the Study of Drug Development.

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Outsourcing to Maximize Clinical Trial Operating Efficiency

October 2013; Vol. 8 No. 4

While drug sponsor use of strategic relationships with contract service providers has increased dramatically during the past five years, improvements in clinical trial efficiency has fallen short, suggesting that both parties need to better align practices, processes, and systems, according to leaders from the research-based drug industry, recently convened by the Tufts Center for the Study of Drug Development to discuss the issue.

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New Approaches to Risk-Sharing Collaborations

August 2013; Vol. 8 No. 3

Responding to a widely shared need to improve the probability of R&D success, leaders from the research-based drug industry, recently convened by the Tufts Center for the Study of Drug Development, agreed that collaboration holds strong promise for improving the rate at which much needed medicines can be developed and brought to market.

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New Protocol Design Approaches Will Improve Clinical Trial Performance and Efficiency

April 2013; Vol. 8 No. 2

Growing protocol complexity-responsible for longer clinical study times, greater difficulty in recruiting volunteers, and rising drug development costs-is spurring new approaches to optimizing protocol design, according to leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Development Strategies for Companion Diagnostics

January 2013; Vol. 8 No. 1

Companion diagnostics, which are central to the creation of personalized medicines, have captured the interest of many drug companies, but face a number of hurdles that could impede development, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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The Technical and Support Services Outsourcing Landscape

October 2012; Vol. 7 No. 4

Drug sponsors and their contract service providers are using more sophisticated, integrated, and coordinated relationship structures to deliver greater speed and efficiency, a trend that is expected to accelerate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Making Academic-Industry Partnerships Work for Both Parties

August 2012; Vol. 7 No. 3

Drug developers are forging new ways to work with academic medical centers to create the next generation of breakthrough medicines, which is changing the way drug companies do science, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Managing the Transition from Nonclinical to Early Clinical Development

April 2012; Vol. 7 No. 2

Drug companies looking to increase the efficiency and productivity of their R&D pipelines are turning to a host of techniques and approaches aimed at shortening the time from nonclinical to early clinical development—with promising results—according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Resource Management Strategies to Optimize R&D Performance

January 2012; Vol. 7 No. 1

Pharmaceutical and biopharmaceutical companies, under pressure to increase R&D productivity, are expanding their use of strategic partnerships to bring new drugs to market more quickly and at lower cost, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Designing and Maintaining Successful Innovation Partnerships

October 2011; Vol. 6 No. 4

Responding to strong and growing pressure to reduce development times and increase the output of new medicines, drug companies are engaging in innovative partnerships that are leading to, among other things, more molecular entities entering Phase I trials and shorter study times, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Management Implications of the Global Regulatory Environment

August 2011; Vol. 6 No. 3

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Managing Global Investigative Sites for Peak Operational Efficiency

April 2011; Vol. 6 No. 2

Looking to improve the operational efficiency of clinical trials, drug developers are actively pursuing new strategies that include collaborating with investigative sites in developing protocols and educating patients about trials before they agree to participate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.

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Using Translational Science to Improve Drug Development

January 2011; Vol. 6 No. 1

To produce drug candidates at the pace needed to remain competitive, pharmaceutical and biotech companies increasingly are using translational science to make decisions about what targets to pursue and how to allocate resources, according to a panel of pharmaceutical and biotech industry leaders and academics recently convened by the Tufts Center for the Study of Drug Development.

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Outsourcing Strategies Across the Value Chain

October 2010; Vol. 5 No. 4

The current business climate is challenging pharmaceutical and biotech companies to rethink their approach to outsourcing and how best to build alliances with external service providers as part of a long term drug development strategy, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

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Maintaining Portfolio Diversity to Drug Development Risk

August 2010; Vol. 5 No. 3

Drug developers need to change the way they allocate resources for new product development, lifecycle management, and business development and licensing—collectively known as portfolio management—if they are to improve drug development productivity, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

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Improving ROI and Late Stage Clinical Success Rates

April 2010; Vol. 5 No. 2

Innovative approaches to drug development, including alliances and partnerships, may prove the best way to increase the rate at which the research-based drug industry brings new products to market, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

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Comparative Approaches to Capacity Forecasting

January 2010; Vol. 5 No. 1
Growing pressure within the research-based drug industry to bring new products to market faster and more efficiently is transforming clinical trial capacity planning and forecasting from an important area of concern to a critical success factor, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.
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Best R&D Practices of Top Pharma/Biotech Performers

October 2009; Vol. 4 No. 4
Drug companies racing to develop new products to replace drugs coming off patent are finding that success is increasingly tied to the company’s ability to align operational goals with strategic objectives, according to a panel of pharmaceutical and biotech industry leaders.
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Moving Drug Development Outsourcing to a Higher Level

June 2009; Vol. 4 No. 3
If drug developers are to remain competitive, they must rely less on traditional outsourcing, in which external service providers offer a way to quickly staff up for specific tasks, and seek to become development partners with those same service providers, according to a panel of drug industry leaders.
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In-licensing/Out-Licensing Strategies and Practices

April 2009; Vol. 4 No. 2
Pharmaceutical firms looking to license new drug candidates from other firms will improve their chances of achieving a successful alliance if they focus on building a relationship, not just acquiring an asset.
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Change and Opportunity in the Phase I Landscape

January 2009; Vol. 4 No. 1
Under pressure to develop new medicines more quickly and at lower cost, drug sponsors are looking to answer as many questions as possible in Phase I. Developers are increasing their reliance on patient volunteers—now accounting for 38% of all human subjects in Phase I studies—who typically cost more to recruit and retain than healthy volunteers.
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Optimizing Protocol Design Strategies to Improve Clinical Research Performance

October 2008; Vol. 3 No. 4
Improved protocol design, perhaps more than any other drug development stratagem, holds the key to faster and more efficient development and improved protocol designs provide step-by-step guidance for the conduct of clinical trials, have been shown to have a pronounced effect on reducing performance burdens and costs and accelerating development cycle time.
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Leveraging Metrics and Market Factors for Portfolio Decision Making

June 2008; Vol. 3 No. 3
While the trend to outsource key elements of drug development to service providers could slow down due in part to rising operating costs worldwide, drug developers need to adopt an outsourcing strategy that optimizes their skill sets.
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Strategic Outsourcing and Global Drug Development

March 2008; Vol. 3 No. 2
The trend to outsource key elements of drug development to service providers could slow down in the future, due in part to rising operating costs worldwide. As sponsors seek higher levels of development performance and efficiency, they are poised to move from transactional outsourcing to more strategic partnerships. This report summarizes a recently convened executive roundtable on the issue.
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Operating Models for R&D Excellence

February 2008; Vol. 3 No. 1
How drug developers organize their companies affects operational and financial performance: The results of the study concluded that in order to speed the pace of new drug development, pharmaceutical and biopharmaceutical companies will not only partner with each other, but will also form strong alliances with organizations outside the drug development industry.
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Tufts CSDD Impact Reports Single Issue

PLEASE NOTE: Orders are processed as quickly as possible during Tufts CSDD business hours of 9AM – 5PM. Orders placed outside of business hours or on weekends will be processed and delivered at the on the following business day.

2017
 

Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose
Sep/Oct, Vol. 19 No.5

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Abuse-Deterrent Opioid Development and Uptake Are Tied to Efficacy and Regulatory/Payer Policies
Jul/Aug, Vol. 19 No. 4

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Biotech products accounted for 35% of all new FDA approvals in 2000-16
May/Jun, Vol. 19 No. 3

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Approval time for 505(b)(2) drugs is nearly five months longer than for NMEs
Mar/Apr, Vol. 19 No. 2

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Poor physician and nurse engagement driving low patient recruitment
Jan/Feb, Vol. 19 No. 1

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2016

Pediatric regulatory science, clinical trial networks hold promise for studies
Nov/Dec, Vol. 18 No. 6

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Diabetes drug development is riskier compared to all drug development
Sep/Oct, Vol. 18 No. 5

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Global regenerative medicine market is poised for strong growth
Jul/Aug, Vol. 18 No. 4

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Expected Growth in PBM Exclusion Lists Poses a Challenge to Drug Developers
May/June, Vol. 18 No. 3

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Promise of immuno-oncology therapies is boosting R&D funding, alliances
March/April, Vol. 18 No. 2

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Amendments reduce number of patients, but at high cost, longer study times
January/February, Vol. 18 No. 1

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2015

First-in-class drugs in competitive development races with later entrants
November/December, Vol. 17 No. 6

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Adverse Drug Event Reporting in U.S. Beset by Incompleteness and Inaccuracy
September/October, Vol. 17 No.5

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Vaccine products in the R&D pipeline have more than tripled since 2005
July/August 2015, Vol. 17 No. 4

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Personalized medicine gains traction but still faces multiple challenges
May/June 2015, Vol. 17 No. 3

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Biosimilars entering the U.S. market are likely to face multiple challenges
March/April 2015, Vol. 17 No. 2

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High turnover, protocol noncompliance plague the global site landscape
January/February 2015, Vol. 17 No. 1

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2014

CNS drugs take longer to develop, have lower success rates, than other drugs
November/December 2014, Vol. 16 No. 6

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Protocol design optimization starting to improve study performance
September/October 2014, Vol. 16 No. 5

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Patients face new challenges accessing a growing number of orphan drugs
July/August 2014, Vol. 16 No. 4

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Collaboration & risk-sharing programs experience longer development times
May/June 2014, Vol. 16 No. 3

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Drug sponsors tread cautiously using social media to aid clinical research
March/April 2014, Vol. 16 No. 2

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New Breakthrough Therapy Designation program aims to cut clinical trial time
January/February 2014, Vol. 16 No. 1

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2013

Biotech products in Big Pharma clinical pipelines have grown dramatically
November/December 2013, Vol. 15 No. 6

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Causes of clinical failures vary widely by therapeutic, phase of study
September/October 2013, Vol. 15 No. 5

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Annual approvals for neglected diseases rose from 2.6 in 2000-08 to 5 in 2009-12
July/August 2013, Vol. 15 No. 4

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Clinical success rates for new cancer drugs double while more enter testing
May/June 2013, Vol. 15 No. 3

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Global site landscape remains highly fragmented with variable performance
March/April 2013, Vol. 15 No. 2

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89% of trials meet enrollment, but timelines slip, half of sites under-enroll
January/February 2013, Vol. 15 No. 1

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2012

One in five procedures generates extraneous clinical trials data
November/December 2012, Vol. 14 No. 6

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Oncology drugs get faster approvals than non-oncology drugs in U.S.
September/October 2012, Vol. 14 No. 5

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U.S. offers patients faster, greater access to cancer drugs than Europe
July/August 2012, Vol. 14 No. 4

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User fee era in U.S. currently poses mixed regulatory burden for sponsors
May/June 2012, Vol. 14 No. 3

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Pace of CNS drug development and FDA approvals lags other drug classes
March/April 2012, Vol. 14 No. 2

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Study monitor workload high & varied with wide disparity by global region
January/February 2012, Vol. 14 No. 1

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2011

New mAbs entering clinical study rose steadily from 1997 through 2010
November/December 2011, Vol. 13 No. 6

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Nearly 60% of all protocols require amendments; one-third are avoidable
September/October 2011, Vol. 13 No. 5

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Lack of clinically useful diagnostics hinder growth in personalized medicines
July/August 2011, Vol. 13 No. 4

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Biopharmaceutical product approvals in the U.S. rose dramatically in 2000s 
May/June 2011, Vol. 13 No. 3

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New or modified indications for existing drugs have steadily increased in U.S.
March/April 2011, Vol. 13 No. 2

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U.S. healthcare stakeholders uncertain on benefits of risk evaluation strategy
January/February 2011, Vol. 13 No. 1

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2010

Personalized medicine is playing a growing role in development pipelines
November/December 2010, Vol. 12 No. 6

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Clinical approval success highest for smallest firms among the top 50
September/October 2010, Vol. 12 No. 5

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Comparative effectiveness research impacts patient access to cancer drugs
July/August 2010, Vol. 12 No. 4

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Rising protocol complexity, execution burden varies widely by phase and TA   
May/June 2010, Vol. 12 No. 3  
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Rising demand is expanding scope and workload of regulatory affairs function
March/April 2010, Vol. 12 No. 2
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U.S. orphan product designations more than doubled from 2000-02 to 2006-08
January/February 2010, Vol. 12 No. 1
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2009
 

Drug approvals for neglected diseases increase along with more R&D funding
November/December 2009, Vol. 11 No. 6
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Marketing exclusivity for first–in–class drugs has shortened to 2.5 years
September/October 2009, Vol. 11, No. 5
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Large pharma success rate for drugs entering clinical trials in 1993–04: 16%
July/August 2009 Vol. 11, No. 4
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Therapeutic peptides in clinical study in 2000–07 nearly doubled 1990s rate
May/June 2009, Vol. 11, No. 3
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75% of U.S. health plans reimburse off–label uses of prescription drugs
March/April 2009, Vol. 11, No. 2
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Current investigator landscape poses a growing challenge for sponsors
January/February 2009, Vol.11, No.1
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2008


While total approvals decline, U.S. is preferred market for first launch
November/December 2008, Vol.10, No.6
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Fast track designations more than doubled during the last five years
September/October 2008, Vol.10, No.5
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Postmarketing studies are becoming the norm in U.S., Europe, and Japan
July/August 2008 Vol.10 No.4
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Drug plans non–compliant with Medicare
May/June 2008, Vol.10, No.3
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Number of mAbs entering clinical study nearly tripled in last decade
March/April 2008, Vol.10, No.2
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Growing protocol design complexity stresses investigators, volunteers
January/February 2008, Vol.10, No.1
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2007
 

Notable gender & racial disparities exist among clinical investigators
November/December 2007, Vol.9, No.6
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Despite more cancer drugs in R&D, overall U.S. approval rate is 8%
September/October 2007, Vol.9, No.5 
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Follow-on drugs and indications play key role for World Health Organization
July/August 2007, Vol. 9, No. 4
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Challenges loom for postmarketing study commitments; benefits unclear
May/June 2007, Vol. 9, No. 3
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Pediatric Study Costs Rose Substantially from 2000 as Complexity Grew
March/April 2007 Vol. 9, No. 2
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EMEA meets performance goals, but lags U.S. FDA in drug approvals
January/February 2007 Vol.9 No.1
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