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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