Featured Clinical Leader Editorial
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6 Tips For Collaboration In Rare Disease Clinical Research
7/28/2023
What does it mean to truly collaborate within industry in clinical research, particularly as it relates to advancing cures for rare disease? Baylor University Medical Center Program Director for the Department of Internal Medicine Ankit Mehta, MD, shares six ways clinical research professionals can better work alongside each other.
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Study Participant Consenting — Can We Do A Better Job?
7/24/2023
Informed consent documents (ICDs) can be long and complicated, for consenting patients, for auditors, and, sometimes, for regulators. So what can be done to make them better? Guest expert Kamila Novak shares real-life examples of ICDs gone wrong and a few ways to make things right.
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Why Do So Many Alzheimer’s Clinical Trials Fail?
7/19/2023
Over the past 20 years, 98% of Alzheimer’s disease treatment clinical trials have failed. But why? INmune Bio CEO and Chief Medical Officer RJ Tesi, MD explores what he says are the three main reasons why so few AD clinical trials succeed.
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Better Biomarkers Increase The Probability Of Success In Alzheimer’s Drug Development
7/10/2023
The efficacy of an Alzheimer's disease therapeutic is measured by the change in a patient's cognitive ability and can takes month, if not years, to observe. Cognition Therapeutics CEO Lisa Ricciardi advocates that, to improve better assess a drug's impact, drug developers must focus on and leverage better biomarkers for quicker assessment.
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Advancing Alzheimer’s Disease Treatment With An OLE, Expanded Access, & A Better Patient Experience
6/21/2023
TrueBinding CEO Dongxu Sun, Ph.D. discusses the journey toward an Alzheimer’s disease drug that reduces (and reverses) symptoms — supported by an open label extension (OLE), compassionate use designation, and careful attention to patient experience.
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BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity
6/15/2023
On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.
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What’s Next In Smoking Cessation Therapies: A Q&A With Qnovia CEO Brian Quigley And Advisor Mitch Zeller
6/15/2023
More than two-thirds of smokers intend to quit, but less than one in 10 is successful. For its part, Qnovia is developing the first-ever inhaled prescription nicotine replacement therapy. To discuss the immediate public health need and the future of NRTs, we held a Q&A with Qnovia CEO Brian Quigley and Qnovia advisor Mitch Zeller.
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How PROs Enhance Patient Care Decisions And Future Clinical Research
6/12/2023
Patient-reported outcomes (PROs) offer unique insights that complement traditional treatment efficacy endpoints, such as survival or disease relapse, and can facilitate better discussions between clinicians and patients. When PROs are incorporated into clinical trial protocols, sponsors can gain a better understanding of the treatment’s impact from the patient’s perspective.
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Leveraging Genetics To Inform Clinical Trials And Drug Development In Alzheimer’s Disease
5/30/2023
At the Eisai Center for Genetics Guided Dementia Discovery (G2D2), the discovery process starts with human genetics as it aims to better understand the genesis of dementia, including Alzheimer’s disease (AD). Because genetics lend greater insight into what causes disease versus how the body changes in response to a disease, Eisai has more confidence in selecting targets for therapeutic modulation based on genetic evidence.
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What If We Could Do Clinical Trials Before We Do Clinical Trials?
5/26/2023
New techniques are not only proving to be more effective than animal testing but will herald a completely new way of investigating novel treatments. Using these techniques, like human chip models, medical researchers will be able to actually run “clinical trials” before testing a drug in live humans.