ARTICLES BY ED MISETA
Appili’s CRO Selection Reflects Realities of Clinical Studies in a Pandemic
When Appili Therapeutics was ready to enter a Phase 3 trial for a COVID-19 treatment, the CRO selection process was tightly linked to the fact that the company would be conducting the study on infected patients during a global pandemic.
10 Years Of Progress In 10 Months: 2020 Was A Reset Year For Pharma
A new report from McKinsey & Company highlights why 2020, despite the COVID-19 pandemic, was a banner year for innovation in drug development, and why we should be optimistic for the future of the industry.
UCB Uses Decentralized Trials To Manage Studies
UCB has a long history of conducting trials in immunology and neurology, with an emphasis in epilepsy. According to Tero Laulajainen, VP and head of global clinical science and operations for UCB, the company has a broad range of therapeutic expertise and numerous global trials, including studies in China. Therefore, the company expected to be impacted when news of the COVID-19 virus first began to make headlines.
Why Did Veeva Become A Public Benefit Corporation?
On February 1, 2021 Veeva Systems officially became a Public Benefit Corporation (PBC). With this move, it becomes the first technology company supporting life sciences to transition to a PBC and is also the first publicly traded corporation in any industry to make that move. How will the designation benefit he company?
How Ionis Pharmaceuticals Is Advancing Multiple Late-Stage Trials During COVID
Ionis Pharmaceuticals has experienced substantial growth since its founding in 1990. The company used to boast that it had one drug for every 10 employees, from the cleaning staff up to the CEO. With the acquisition of Akcea Therapeutics in the fall of 2020, Ionis now has a pipeline of 47 products based on its antisense technology platform, which allows for the rapid discovery of new drugs.
AI And Machine Learning Prepare Pharma For The Data Onslaught
When I reached out to several clinical executives in my network for their thoughts on trends that will impact trials in the coming year, the two mentioned most frequently were AI and decentralized trials.
Janssen’s Best Practices For Patient Diversity Success
The public's understanding of clinical research has increased as a result of the pandemic. However, that will not necessarily lead to improved patient recruitment in trials, especially among the much-needed minority populations. Cassandra Smith, director, diversity and inclusion in clinical trials at Janssen, believes future recruitment efforts will require heart and will need to lead with humility and empathy.
Zogenix Puts Focus On Safety In Seizure Patients
When Zogenix was planning its clinical trials for Fintepla, the safety of patients was a major concern. COO Ashish Sagrolikar discusses the precautions put in place, and adjustments that had to be made when conducting trials during a pandemic.
Is AI Improving Outcomes In Clinical Trials?
In October 2020, I hosted a webinar on the topic of AI and how it will improve outcomes in clinical trials. This article highlights some of the comments from that discussion.
The Decentralized Trials & Research Alliance Hopes To Advance Studies
Amir Kalali and Craig Lipset spent a good portion of 2020 reaching out to pioneers in the clinical space who were working on decentralized trials. Conversations centered on what more could be done to scale their use. They worked together to create the Decentralized Trials & Research Alliance (DTRA) to accelerate the adoption of decentralized methodologies in research.