New and emerging technologies are impacting clinical trials in many ways, but nowhere is that more apparent than in the area of patient centricity. Janssen is attempting to overcome trial challenges using technology and a three-pronged approach.
When it comes to clinical trials, pharmaceutical companies historically have focused on what the FDA needs to see to support approval. But there can be a gap between what companies demonstrate to the FDA and how that transpires into the real-world setting. Dr. Kerry Cooper believes this is a challenge pharmaceutical companies must overcome by continued evidence generation that can relate to their patient populations.
Digital clinical trials are a popular topic in the life sciences industry. But for all the talk we hear about the use of wearable devices in trials, it’s often hard to gauge exactly how many companies are using these devices.
In July 2019 I had the opportunity to visit the AbbVie campus in North Chicago. My purpose for being there was to tour the company’s Development Design Center (DDC), which provided a detailed look into what AbbVie sees as the future of clinical trials.
Each year, The Avoca Group surveys industry professionals to understand trends in clinical development. For one of its most recent surveys, Avoca examined what sponsors and CROs think about innovation and the use of technology in clinical trials.
Implementing a new technology presents many challenges for companies. There is the implementation itself, the training of users, managing the change, and finally providing support to users. A panel discussion at the 2019 Oracle Health Sciences Connect conference tackled these challenges, providing advice on how to manage all facets of a new technology implementation.
Rebiotix, a Ferring company, hopes to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. The company is developing their proprietary MRT drug platform, which uses a defined manufacturing process and quality control parameters to assess the impact of human-derived microbiota therapies on patient health and disease.
When working groups at AbbVie first began evaluating the use of digital technologies in clinical trials, the discussions were mostly conceptual. Individuals agonized over the right approach, the quality of the data, and whether the efforts would be accepted by regulators. Three years ago, the company decided to stop debating and start executing.
GenSight Biologics believes it is on the cutting edge of ophthalmology, gene therapy, and drug development. The company is focused on finding treatments for patients with neurodegenerative diseases and is developing products that are a combination of gene therapy, its mitochondrial targeting sequence technology, and optogenetics.
Few treatments have been approved for Lupus and the industry has seen many failed clinical trials. Variations in care worldwide, as well as poor overall access to care, has also hampered efforts to bring relief to patients. For those reasons, the international lupus community has come together to conduct a study aimed at identifying clinical and treatment barriers that must be overcome.