Maria Fardis, CEO of Iovance Biotherapeutics, has spent 18 years working in the pharma industry. Although most of her experience has been in small molecules and proteins, she now works in the cell therapy space and notes these treatments are a new and exciting space with meaningful differences in how clinical trials are conducted.
On the eve of World AIDS Day 2017, the Bill & Melinda Gates Foundation and the National Institutes of Health (NIH) have joined forces with Johnson & Johnson (J&J) to advance a potential “global vaccine” that could prevent a wide range of viral strains responsible for the world’s HIV pandemic.
In the neuromuscular space, Fulcrum Therapeutics is using tissue donated from patients with facioscapulohumeral (FSH) muscular dystrophy, an incurable form of the disease, to find a treatment. The tissue is used to create research models that look and respond much like natural human tissues
Large pharma companies have a variety of outsourcing models they can use, from strategic partnerships to functional service provider models. But if you are a small biotech company, does the size of your firm limit your outsourcing options? And how big a role should cost and therapeutic expertise play in that decision?
Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.
For a small biotech company, making the transition from discovery to clinical is where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time, no position will be more important than your director of clinical development.
According to research performed on recruitment, 85 percent of trials are delayed due to enrollment issues and more than 30 percent of total trial time is spent simply recruiting patients. Those issues are present in all therapeutic areas, including Alzheimer’s disease. To mitigate these problems, cut the time of trials, and get needed medicines to patients faster, the Global Alzheimer’s Platform (GAP) Foundation is implementing a new model that promises to increase patient participation in Alzheimer’s research.
Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.
Janssen is seeking to replace paper-based conventional processes of managing clinical supplies and tracking patient health data with a new suite of cohesive digital technologies. The new iSTEP (Integrated Smart Trial & Engagement Platform) is a technology toolset developed to automate investigative product supply and data management in clinical studies.
A survey of top corporate data protection challenges has found only 6 percent of companies are prepared to be compliant with the EU’s General Data Protection Regulation (GDPR), which goes into effect on May 25, 2018. The regulation will have a significant impact on the industry, so why are so few companies prepared for it and discussing it?