Clinical Trials
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Lilly Uses Patient Awareness & Access To Cut Clinical Trial Timelines
5/2/2018
According to Anne White, Lilly’s VP of next generation development and project management, for the past three years the company has steadily worked toward finding a way to get its medicines to patients faster.
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Study Proves Importance Of Patient Diversity In Clinical Trials
3/7/2018
“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.”
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Deal Building From Testing The Water To Hitting The Market
2/7/2018
The story of how Oxford BioMedica won a key contract from Novartis to provide the commercial and clinical supply of lentiviral vectors used to produce the Big Pharma's CAR-T cell therapy Kymriah.
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Why All The Talk About Real-World Evidence?
12/7/2017
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?
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More Gender-Based Analysis Needed In Medical Device Studies
11/8/2017
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.
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Why South Korea Is The Hottest Growth Spot For Clinical Trials
10/10/2017
“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.
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How The FDA Views Natural Language Processing
8/9/2017
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.
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Alternatives To Funding Lower-Priority Trials
8/9/2017
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.
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Patient-Centricity — Answering Industry's Key Questions
7/7/2017
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.
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Genentech Masters Breakthrough Therapy Designation
6/7/2017
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.