We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” the...
Among common degenerative disorders, Parkinson’s disease strikes more frequently than all but one: Alzheimer’s. Parkinson’s affects about 1 percent of the population over age 60 and claims 60,000 new diagnoses in the United States each year.[1] The cause of Parkinson’s remains a mystery, and the dopamine promoter levodopa — notwithstanding its limitations — has been...
Over the last two decades, biologics have improved the management of patients with psoriasis and advanced melanoma, many of whom either did not respond to traditional treatments or experienced severe side effects from them. With their success in deadly forms of melanoma and more common chronic inflammatory conditions such as psoriasis, drug developers are now targeting rarer...
Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts with...
In 1976, pop culture icon John Travolta starred in the made-for-television movie The Boy in the Plastic Bubble about a young man with a compromised immune system. The premise of the film is that Travolta’s character has to decide between living in isolation behind a protective bubble or dying engaged with the physical world. Hollywood...
It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technological...
The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies.
Recently, researchers at King’s College London published a study in Translational Psychiatry on a feedback loop underlying brain degeneration in Alzheimer’s disease (AD) that, they suggest, may be the reason so many clinical trials targeting this disease have failed. In this new study, the researchers found that when amyloid beta (Abeta) destroys a synapse, the...
Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...
Global clinical trials are projected to exhibit a compound annual growth rate of 12.4 percent and reach revenues of $57 billion by 2020, according to a recent report by Frost & Sullivan.[1] As the cost and complexity of drug development continue to increase, the Asia Pacific (APAC) region is a key destination for the conduct...