Clinical Trials

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]

Delays in clinical trials present opportunities for pharma companies to evolve

COVID-19 has upended clinical trial timelines – putting billions of forecasted sales at risk and delaying getting life-saving treatments to patients. This analysis from Garima Kaul, Senior Director, Research and Insights, Decision Resources Group, part of Clarivate, and Jamie Munro, Executive Director, CIRS explores the opportunities that delays in clinical trials present for pharma companies. […]

Biomarkers have several key roles in clinical trials and precision medicine

Biomarker use in clinicals trials has expanded over the last few decades. Designing a protocol that incorporates biomarkers can reduce trial timelines and increase the chance of success. However, biomarkers remain underutilized for a variety of reasons. Evaluating the trends in biomarker use allows us to monitor the effectiveness of new strategies and identify areas […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

Fatty liver disease, NASH surge amid global obesity epidemic

Non-alcoholic fatty liver disease and the more severe form of this disease called non-alcoholic steatohepatitis, or NASH, are two increasingly prevalent diseases characterized by the progressive accumulation of fat or triglycerides within the liver. This accumulation occurs in the absence of excessive alcohol consumption. It can lead to inflammation, oxidative damage and the development of […]

Neuroscience lures dealmakers despite drug development challenges

While no other therapeutic area matches oncology in dealmaking volume, neurology is “among the nearest contenders.” That’s the main theme of recent analysis developed by Jamie Munro and Helen Dowden, of Clarivate Analytics. Their article, “Trends in Neuroscience Dealmaking,” was featured in the Biopharma Dealmakers supplement to Nature Biotechnology and Nature Reviews: Drug Discovery. Munro, […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]