There may be as many as 7,000 rare diseases. Support from FDA, EMA and other regulatory agencies, combined with technological and scientific advances, have made it more feasible for pharmaceutical companies to give dedicated attention to orphan drug development. In doing so, they're developing medications for rare diseases that often have no cure and no available treatment. To ensure novel therapies advance from the lab to regulatory approval, a blockbuster-drug approach won't work. Managing rare disease studies to completion requires innovative thinking in nearly every phase of program development.
Biorasi’s Oncology Center of Excellence remains at the forefront of this exciting field. Our team of clinicians, program managers and other experts stay up to date on the latest developments, from Tumor Infiltrating Lymphocyte (TIL) therapy to gene therapy advances. This experience, combined with Biorasi’s worldwide site network and data-driven approach, allows us to guide oncology programs to success—on time and on budget.
Why Do So Many Clinical Trials Fall Behind? Clinical trials are not immune to missed deadlines and cost overruns. However, with proper advance planning, you can up the odds of success and avoid major glitches. Our studies show that about 33% of all clinical trials are behind schedule at any given moment. These trials under-perform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval.
Movement disorders such as Parkinson’s disease, ataxias, tremor, dystonia, tics, Tourette’s, and dozens of rare diseases, […]
In our rescue white paper, 3 Measures to Overcome Operational Failures, we explain our ROI concept. Early in a trial, intervention provides dramatic benefits for minimal cost. An assessment or review may be all that’s needed to get a study back on track.
Each year, doctors diagnose about 1,000 Americans with cystic fibrosis, a rare hereditary disease that affects […]
Business as usual is not an option for conducting #clinicaltrials in the wake of the #COVID19 pandemic. Customized solutions and #patientcentricity are more optimal approaches in this environment. Jimmy El Hokayem, Ph.D., Associate Director of Program Development and Head of the Neurology and Regenerative Medicine Center of Excellence at Biorasi, shares his insights into #directtopatienttrials
Achieving optimization in CE trials means engaging in careful analysis and decision-making throughout the entire process. CE studies represent a significant expense for sponsors in both time and money. The process of designing and running CE studies is wrought with choices, decisions, tradeoffs and challenge. Explore Biorasi's vision to achieving successful CE ANDA clinical programs in ophthalmology.
Clinical Endpoint ANDA Program Optimization White Paper Series: Optimizing the Amount of Investigational Materials in ANDA Studies – Part One
This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry.