Published on BioPharma Dive Author: Malorye A. Branca Creating a breakthrough drug is one of the highest risk ventures in healthcare: Success can mean billions of dollars in revenue for years to come, but failure can mean as much as a $1 billion wasted and a huge gap in a company’s product pipeline. “Clinical trials are very expensive, and the cost is only going up,” says Laurie Halloran, president of the Halloran Consulting Group. So shouldn’t…

Learning from Patient Data to Enhance Clinical Trial Design for Duchenne Muscular Dystrophy Both companies have investigational treatments for Duchenne in late-stage clinical development CAMBRIDGE, Mass., Feb. 7, 2017 (Business Wire) – Marathon Pharmaceuticals LLC and Italfarmaco SpA have joined the Collaborative Trajectory Analysis Project (cTAP), bringing their extensive knowledge and clinical expertise in Duchenne muscular dystrophy to the rapidly growing coalition. Reflecting increased excitement about and participation in cTAP’s unique collaborative structure, the new…

Helping accelerate enriched clinical trial design for the provision of new treatments for Duchenne muscular dystrophy patients Lilly to share data from Phase III trial of tadalafil in Duchenne, increasing knowledge of placebo-arm responses CAMBRIDGE, Mass., December 21 (Business Wire) – Eli Lilly and Company, one of the top 15 global pharmaceutical companies, has joined the Collaborative Trajectory Analysis Project (cTAP), a unique partnership of many stakeholders all committed to accelerating scientific discovery and bringing…

Random errors could have a disproportionate effect on smaller clinical trials. This is because as the sample size becomes larger in any trial, outliers and missed events will have less of an effect and the model will still be accurate, as illustrated by Landray. Susan Ward, founder and executive director, the Collaborative Trajectory Analysis Program (cTAP), pointed out that in smaller trials, however, small variations in data can have an enormous impact on the model….

Two studies categorize and predict disease progression in Duchenne muscular dystrophy Cambridge, Mass (Business Wire) – October 31, 2016 – The Collaborative Trajectory Analysis Project (cTAP), a public-private partnership to accelerate data science solutions to critical problems in drug development for Duchenne muscular dystrophy (DMD), today announced the publication of two research studies with important implications for the design of effective clinical trials. All patients with Duchenne eventually lose the ability to walk, but the…

Advancing Clinical Trial Design for Duchenne Muscular Dystrophy Consortium Working Together to Bring Quality of Treatments to the Duchenne Community NEWPORT BEACH, Calif., October 25, 2016 – The next wave in tackling Duchenne muscular dystrophy is getting a boost from a collaboration of non-profits, biopharmaceutical companies and noted clinicians who have joined together to advance the progress of drug development and bring quality of life treatments to the Duchenne community sooner. Initially funded by CureDuchenne,…