“The key to fully understanding the safety and efficacy of new medical and device therapies is developing clinical trial databases that adequately reflect the diversity of the U.S. population.”
“A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.
In 2017, real-world evidence (RWE) became the topic everyone wanted to discuss. Several executives I have spoken to recently believe it will continue to grow in importance as we move into 2018 and beyond. But why the sudden interest in RWE?
It is widely known that women, as well as elderly and minority populations, have long been underrepresented in clinical trials for drugs and biologics. A new study found a similar pattern when it comes to evaluating medical devices.
“The Korean pharmaceutical industry has been accelerating investments in open innovation and focusing on R&D for entry into overseas markets,” says Deborah Chee, president, Korean National Enterprise for Clinical Trials.
According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.
While some pharma companies struggle to backfill their pipelines, others find the opposite, that they have more development opportunities than they can pursue. While this may seem to be a nice problem to have, it also means that otherwise good drug candidates may be pushed down the list of priorities.
The adoption of patient-centric processes is still so new that no standards or best practices exist yet. Here we present research from the Study of Patient-Centric Initiatives in Drug Development.
Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.
Regulatory agencies today are looking for Phase 3 trials to demonstrate a reduction in mortality as well as greater patient mobility. Unfortunately, Phase 3 trials also cost a lot of money to run, making them a challenge for small biotech firms.