By Deb Borfitz
As of this year, Eli Lilly and Company is converting to a new operating model designed to streamline drug development and better “capture the value” of a record-setting number of new medicines in its pipeline…read more
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 [...]
Yili Pritchett of Abbott was able to show real data from a trial we ran for them between 2007-2009. Read more.
Long known for its scientific software delivery expertise and technical staffing capability, Tessella now dedicates 100 consultants (30% of its business) to life sciences…read more
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 [...]
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
Tessella are proudly sponsoring SMi’s 4th annual conference in Adaptive Designs in Clinical Drug Development. The conference and workshop are being held on February 3rd – 4th 2010, at the Crowne Plaza Hotel, St James, London, UK.
Tessella’s Tom Parke, head of clinical trial solutions, will be presenting Adaptive Trial Design for Oncology Trials on Wednesday [...]
Long known for its scientific software delivery expertise and technical staffing capability, Tessella is mounting a push to climb higher up the consultancy ladder…read more
By Tom Parke
The US Food and Drug Administration (FDA) end-of-Phase 2a (EOP2A) meeting guidance issued on the September 2009 emphasises the value of the greater use of trial simulation and alternative design strategies in the clinical trials design process. The FDA’s primary purpose of an EOP2A meeting is to select the dosing regime and design [...]
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
