Preclinical feature articles
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Biologics Clinical Research: The Year’s Best
4/16/2021
Harry Selker, M.D. sits down with BioProcess Online for a candid discussion on the Clinical Research Forum’s work, its awards program that recognizes the year's best advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry.
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Developing Triple-Combination Immunotherapies: Lessons Learned From HIV
7/30/2019
Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.
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PreClinical Video Aims To Attract Patients
12/27/2018
Every company moving into clinical trials on humans will face the challenge of attracting both investors and patients to their study. These challenges can be difficult, but Anthony Hayes, president, CEO, and director of Spherix, believes a 90-second video the company has in its possession will help them overcome both.
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What Would Convince You To Delay Your Trial For 12 Months?
6/19/2018
If you were ready to begin clinical testing on a new molecule but discovered you already had an improved version of the drug in development, would you move forward with the program or delay the Phase 1 trial by more than 12 months? That is a decision Samantha Cobb, CEO of AdAlta, had to make. Her decision centered on the well-being of patients.
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Tissue Modeling May Cut Clinical Trial Time
12/5/2017
In the neuromuscular space, Fulcrum Therapeutics is using tissue donated from patients with facioscapulohumeral (FSH) muscular dystrophy, an incurable form of the disease, to find a treatment. The tissue is used to create research models that look and respond much like natural human tissues
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France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results
3/29/2016
The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.
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Health Experts Weigh In On Zika Risks And Potential For Future Outbreaks
2/10/2016
With the Zika virus spreading in the Americas, the outbreak and potential for future outbreaks in other areas of the world has many health professionals and organizations concerned. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID), which promotes research, risk assessment, knowledge sharing, and best practices in the fight against infectious diseases, is one of those organizations.
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What Went Wrong In France?
1/15/2016
According to news reports, a drug undergoing testing in a French clinic has left one patient dead and four others critically ill, two that may have permanent brain damage. The drug has thus far been unnamed, but it appears to have been produced by the Portuguese company Bial. The French health minister has stated the drug acted on natural receptors found in the body known as endocannibinoids, which regulate mood and appetite.
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Quantitative Systems Pharmacology Brings Value To Drug Development
1/12/2016
Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.
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High Drug Prices: Should We Blame Pharma Or The FDA?
9/29/2015
Last week, the Internet blew up over the greed of pharma companies and the cost of life-improving and life-saving medicines. This time the hatred was focused on Martin Shkreli, CEO of Turing Pharmaceuticals, whose company purchased the generic drug Daraprim and immediately increased the price from $13.60 to $750 per pill. Patients were angry, and politicians were outraged. The uproar even caused one presidential candidate to immediately issue a plan to try and fix the problem. But is the anger being directed at pharma deserved or misplaced?