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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 […]

Gaining insight with artificial intelligence

In part three of this blog series about best practices in toxicology, we continue the discussion from previous articles that outlined elements in the discovery stage that could impact safety, and considering a drug’s effects on toxicity of specific organs and specific patients via toxicogenomics, pharmacogenomics and pharmacoepigenomics. To help reach a deeper understanding of […]

Organ-specific Toxicity and Personalized Approaches

In part two of this blog series about best practices in toxicology, we continue the discussion from the previous post, which described the aspects of drug discovery that could impact safety. Because safety can vary by person and organ, we also need to identify how we can determine a drug’s potential toxic effects on specific […]

Identifying risks in drug discovery

It is estimated that for every eight active substances entering Phase I clinical trials, only one product is approved and marketed.[1] The low success rate for clinical trials is largely driven by poor efficacy in humans and adverse events leading to the discontinuation of a drug development program.[2] Findings related to the inherent properties of the […]

Celebrating 30 years of BioWorld

BioWorld™ has built an enduring relationship with everyone in the drug development and medical technology sectors. As we celebrate our 30th anniversary, we reflect on how the publication has changed over the years to accommodate shifts in media consumption and industry needs.   BioWorld has built an enduring relationship with everyone in the drug development […]

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]