From The Editor
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My Opinion: CRCs, CRAs, and CTMs Have It Tough
11/27/2023
With 20+ years as a CRC, CRA, clinical trial manager, and project manager, Tiffany Ashton, MAS, CCRA talks about how difficult it can be working in some of these roles in today’s clinical trials industry.
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Bayer Launches Investigator-Sponsored Collaborative Studies
11/10/2023
Bayer added three Phase 3 trials to its MOONRAKER clinical development program for the study of Kerendia (finerenone) as a potential treatment for heart failure. Overall, the goal for the program is to enroll 15,000 participants.
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Legal And IP Protection For New Biotechs
10/31/2023
Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs.
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AI's Potential To Improve Clinical Operations, Trial Matching
8/11/2023
Microsoft's Dr. Hoifung Poon explains how AI (specifically, large language models) can be used to improve patient care and clinical workflows by making it easier to match patients to trials.
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How Blockchain Can Empower Patients And Improve Clinical Trials
8/4/2023
Blockchain is far bigger than cryptocurrency. It's a data encryption technology that can not only strengthen existing clinical systems, but also (and most importantly) empower patients by giving them more control and ownership of their clinical data.
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Improving Recruitment Through Community Engagement
8/1/2023
UPMC's Dr. Ken Ho shares personal insights about effective community engagement, which allowed him to increase recruitment in the Pitt Men's Study by 35% in just six months.
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Adapting To The Recruiting Challenges Of Rare Diseases
7/31/2023
Senior VP and head of R&D for Takeda's Plasma-Derived Therapies Business Unit, Dr. Kristina Allikmets, describes the challenges recruiting in the rare (and ultra-rare) disease space.
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3 Questions On Precigen’s Cell Therapy Studies
6/13/2023
Clinical Leader recently touched base with Helen Sabzevari, Ph.D., CEO of Precigen, about the biopharma’s clinical-stage research in the CAR-T therapeutics space. The company currently has six products in its clinical pipeline, including three that use its UltraCAR-T platform.
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FDA Submission Automation: Coming To A Cloud Near You
2/15/2023
The FDA is laying the groundwork for standardized, cloud-based electronic submission standards via an initiative that leverages data automation and artificial intelligence. What will it mean to biopharma filers?
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Astellas Pharma: Moving On from Clinical Hold
1/26/2023
Ha Tran, Executive Medical Director at Astellas Pharma, explains the cause of the clinical hold and the future of the program now that the hold has been lifted.