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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 […]

Resilient supply chain requires geographic diversity

Manufacturing location is vital to securing the biopharma supply chain – for the finished product, APIs and the raw materials. How vulnerable are we?   “There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this […]

The future of continuous manufacturing in pharma

Batch processing has been the standard manufacturing method used by the pharma industry for the last 50 years. But recent advances in manufacturing technology have resulted in a faster, more efficient process known as continuous manufacturing. How do the two processes compare? And what are regulators saying?   The Food and Drug Administration (FDA) describes […]

Patient enrollment continues to be a limiting factor for trial durations

To prepare for our recent webinar “Trends in Clinical Trial Planning,” we dug into proprietary data from The Centre for Medicines Research (CMR) International, a wholly owned subsidiary of Clarivate working with leading global pharmaceutical companies to provide insights into industry trends — to strengthen R&D planning and effectiveness.   The length of clinical trials […]

Understanding disruptions to the antibiotic supply resulting from COVID-19

The COVID-19 pandemic has highlighted vulnerabilities within the generic drug supply chain. To minimize the effects of antibiotic API supply disruptions, it is important to understand the underlying reasons for shortages to then identify the best-fit manufacturing partners.   The COVID-19 pandemic has disrupted the global drug supply, as manufacturing companies contend with government-mandated or […]