Articles By Ed Miseta
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Kazia Tries Adaptive Approach For Brain Cancer Trial
5/14/2018
Getting drugs to cross the blood-brain barrier can be a challenge for sponsor companies. Kazia Therapeutics is working on a treatment for glioblastoma, the most common and aggressive form of brain cancer. Kazia will use an adaptive approach in a Phase 2 trial using a product which was designed by Genentech to cross the blood-brain barrier.
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A Six-Year Approach To Improving Clinical Trial Efficiencies
5/2/2018
According to Victoria DiBiaso, global head of clinical operations strategy and collaboration at Sanofi, “When it comes to improving trials, you have to look at protocol optimization. For us, that is where it all begins.
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Fixing Trials Requires A True Commitment To Patient-Centricity
5/2/2018
Less than 12 percent of the drugs entering clinical testing will ultimately receive FDA approval. Even representatives of the FDA now admit our process for performing trials is “broken.”
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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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Patient Recounts Reimbursement Challenges
4/23/2018
One area of patient centricity that might be getting overlooked is patient reimbursement. When patients travel to clinical sites for treatment, how much of their own money are they required to shell out? Are they being promised reimbursement for those expenses? And, if so, how long is it generally taking for them to receive the funds?
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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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Doctors And Researchers Attempt To Stop Right-To-Try Legislation
2/7/2018
A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.
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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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Pet Medicines: Smaller Market, Lower Costs, Greater Margins
11/8/2017
“We have not seen the price escalation that has occurred in clinical trials for human drugs,” says Richard Chin, CEO of KindredBio.
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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.