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Posts Tagged ‘drug-development’

Bio-IT Best Practice Awards 2010, April 21, World Trade Centre, Boston, MA, USA

Once again, Tessella is proudly sponsoring this years’ Bio-IT Best Practice Awards 2010, being held at the World Trade Centre, Boston, MA, USA on April 21, 2010 in conjunction with Bio-IT’s World Conference and Expo 2010.
Established in 2003, the award programme recognizes teams in industry and academia for their outstanding innovations and excellence in the enabling [...]

Tessella and Berry Consultants team to deliver smarter clinical trials

Tuesday, February 9th, 2010

Faced with the challenge of falling success rates in drug development, clinical development teams must find new ways forward. Tessella and Berry Consultants believe that designing smarter clinical trials is part of the solution. We believe that better trial design can help:
• Maximize the impact of your clinical trials on your drug development process.
• Ensure your trial [...]

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Friday, January 8th, 2010

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue [...]

Podcast – Translational Medicine: Evaluating its Promise, Pitfalls and Profitable Use

Wednesday, January 6th, 2010

Kevin Davies, Editor-in-Chief, Bio-IT and Tessella’s Dr Andrew Chadwick, Principle Consultant, Life Sciences and Health Care discuss Translational Medicine. Listen to this podcast and learn about:

Effective, ethical approaches to trial design that harness incompletely validated predictive and prognostic biomarkers
Ways to improve the value of image information and other rich data
The tradeoffs to expect in using [...]

Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group

Tuesday, December 22nd, 2009

A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is in preparation; this article is an Executive Summary for that full White Paper, and summarizes the findings [...]

Drug Information Journal articles cite significant benefits when using response adaptive clinical trials

Two Drug Information Journal articles on planning and executing response adaptive clinical trials state savings of 2 to 5 months and $1 million to $14 million when using adaptive trials versus using more traditional designs. The Journal’s articles are available on-line: article one - The Process page 710 and article two - Case Studies page 725

Lorus Therapeutics Announces Positive Result in its Phase II Clinical Study of LOR-2040 in Acute Myeloid Leukemia (AML)

Tuesday, December 1st, 2009

- Efficacy and safety data supports advancement to a comparative trial as a strategy to support registration -
Read more pdf

Researchers mobilizing global resources to test new treatments for severe H1N1 infection

Friday, November 13th, 2009

Quick ‘bench-to-bedside’ clinical trial would enroll 1,400 influenza patients to test corticosteroids and statins as potential treatments
TORONTO, Ont., November 10, 2009 — An important, ground-breaking initiative is unfolding in the global critical care community in response to the H1N1 pandemic. Read more ….

BENZINGA: AG Mednet Announces Milestones in Electronic Image Submission Compliance and Broad Worldwide Adoption of Its Network Platform

Tuesday, November 3rd, 2009

BOSTON, Nov. 2, 2009 (GLOBE NEWSWIRE) — AG Mednet, the world’s largest diagnostic imaging network, announced today that more than 2000 users around the world have been credentialed to access and use its electronic diagnostic image submission platform…read more

MDS Follows The Critical Path — And Sees Benefits

Monday, November 2nd, 2009

Life Science Leader Magazine – Erie,PA,USA
In 2004, the FDA unveiled a project called the Critical Path Initiative. As then Commissioner of Food and Drugs Andrew C. Von Eschenbach, M.D., later explained to Congress, “This project has the potential to transform the way medical products in the United States are designed, developed, tested, and used.” more

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