Proper preparation of an Investigational New Drug (IND) application is a carefully orchestrated process that requires many disciplines to collaborate in delivering a consistent message regarding the safety of an investigative compound. Proactively identifying and avoiding common IND submission pitfalls can help ensure that your application is clear, concise, and error-free. Preparation of an Investigational...
Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial. Since the first drugs for neurodegenerative diseases (NDDs) were approved in the 1990s, an increasing number of disease- modifying therapies have been approved for...
In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis on...
Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of...
No matter your role in the industry, you may have heard about the significant upcoming changes to European medical device regulations. But just what are they? What’s the proposed implementation timeline? Here’s an overview of the proposed legislation, as well as a tentative schedule of important dates. Getting Up to Speed In June 2016, the...
With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny on...
As our understanding of the genetic and molecular basis of cancer advances, rare oncology research is accelerating at an unprecedented pace. In fact, in 2014, more than 40 percent of U.S. Food and Drug Administration’s orphan drug designations were for rare cancers. Moreover, the trend toward increasing international cooperation among big pharma, biotech, and academia...
Pain is a significant health problem that impacts quality of life and imparts high costs to society. Despite intense research effort and progress in our understanding of the mechanistic and molecular basis of pain, there have been few real breakthroughs in novel analgesic drug development over the past 50 years. One major obstacle to the...
Breakthrough therapy designation in the U.S. and PRIority MEdicines (PRIME) in the EU are two programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs. By successfully engaging with regulatory authorities early in the clinical development process, sponsors of eligible investigational drugs can help ensure that their development...
Central nervous system (CNS) disorders are a diverse group of conditions that include psychiatric, neurological and substance abuse disorders. Unfortunately for patients, treatment options for CNS disorders are often limited (or non-existent). To make matters worse, comparatively few CNS drugs are in the development pipeline. What aspects of CNS disorders contribute to lagging drug development? Read on to...