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...
Use of long-acting injectable antipsychotics is often reserved for patients with chronic or treatment-refractory schizophrenia or repeated non-compliance issues. However, recent studies have consistently found a role for these treatments both soon after diagnosis and in the treatment of chronic disease. A severe and often debilitating neurodevelopmental disorder, schizophrenia affects a person’s ability to think...
Data monitoring committees and clinical endpoint committees can provide independent, expert review of study data and opinions to standardize outcomes and optimize data quality to help sponsors meet complex trial monitoring requirements. As global, multi-center medical device studies become increasingly common, trial monitoring is growing more complex. Regulators require that sponsors perform site monitoring to...
Dementia is a global epidemic, affecting nearly 50 million people worldwide. By 2050, it’s estimated that 115 million people will suffer from some form of dementia. Alzheimer’s disease (AD) is the most common type of dementia occurring late in life. AD is also the only condition among the leading causes of death that cannot currently be...
Advances in medical technology have opened the door for dermatology mobile health (mHealth) programs, and these same technologies have the potential to radically change dermatology trial designs. Here are four ways digital disruption in the dermatology field is benefiting both patients and providers: 1. Reduced wait times: Digital health assessments make time spent scheduling, traveling,...
Finding patients for trials in very rare conditions is difficult under any circumstances, and in this case the odds were really stacked high against success. The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The...
Small- to mid-sized biotech and pharma companies face many challenges when planning and executing an early-phase oncology trial, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints. Sponsors of first-in-human trials of novel oncology compounds face significant challenges. Beyond the typical circumstances of limited budget,...
Medical science is making significant advances in treating schizophrenia, but for all the progress we’ve seen, patients don’t benefit much unless they regularly take their medications. Second-generation (or atypical) long-acting injectable antipsychotic treatments (LATs) that ensure consistent administration of medication have become widely available over the past 15 years, but they remain a tough sell...
CAR-T cells are complex products, and translating them from basic and preclinical research to clinical trials and commercialization can be challenging. Understanding the regulations and developing a protocol that puts safety first—at every stage of development—are important first steps in bringing promising CAR-T cell therapies to the patients who need them most. CAR-T Cell Therapies:...
Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning process...