From pilot projects to process changes, the evolution of patient centricity is affecting all aspects of drug development, say industry experts, who share best practices and lessons learned.
After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.
The network for clinical and imaging data launches a new ‘Real World Imaging’ offering to complement existing real world evidence – and help overcome the challenges of bias and homogeneity, says CEO.
The global CRO Cromsource has opened a new office in Research Triangle Park – home to many current and potential clients – after growing more than 150% over the two years, says COO.
Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.
Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.
Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.
The acquisition of Bioclinica’s clinical research site business extends PPD’s trial enrollment business to five continents, 20 countries, and more than 180 research sites.
Arkivum to create an e-archive for Idorsia to store and manage its large amount of data regarding products returned from CROs, after the latter’s separation from Actelion.
908 Devices launches Rebel, a bioprocess analyzer, enabling researchers to conduct their own cell culture media analysis to accelerate process development ‘by weeks’.
Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.
Atelerix to work on the development of gel stabilisation technologies enabling room temperature storage of Rexgenero’s cell therapy candidate, under an Innovate UK grant.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
ARG opens new offices in Warsaw as well as Amsterdam, the new home of the European Medicines Agency, both ‘ideal’ locations among Brexit uncertainty, says CEO.
Enteris enters a licensing agreement with Cara Therapeutics for the ongoing development of the latter’s drug candidate as it continues clinical trials.
Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.
As part of its global network expansion strategy, PCI Pharma Services is investing in a new dedicated clinical facility near Dublin, Ireland, which will provide space for secondary packaging, storage, logistics, and distribution.
Themis obtains an exclusive licence from Merck to develop vaccine candidates with an undisclosed indication, using its measles virus vector-based platform.
Researchers discover scorpion toxin that triggers pain through a previously unknown pathway, potentially opening up new avenues of investigation for treating chronic pain.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.
Researchers show miniature livers can develop steatohepatitis and fibrosis, pointing to potential for personalized hepatic drug discovery and toxicity platforms.
Schrödinger secures further funding, extends collaboration with Morphic Therapeutic on computational discovery platform for oral integrin drugs for the second time.
Veeva Systems launches a software application aiming to reduce the time and effort of manual data entry, which will be integrated to its cloud-based suite.
Engineered cardiac tissues generated using Tara Biosystems' heart-on-a-chip system predict how patients will respond to a range of drugs, as demonstrated in a recent study with GSK.
SGS’ OneVision initiative is working to standardize record-keeping across the global life sciences industry in an aim to accelerate laboratory testing, development, and eliminate paper-based systems.
Iqvia today launches its new patient portal, designed to support clinical trial participants throughout the process with a “direct connection to the clinical research environment,” says company executive.
The increasing number of cell and gene therapies in clinical development is evolving the supply chain into a ‘supply cycle,’ says TrakCel CEO, with service providers being called to maintain control under pressure.
The cell and gene therapy industry cannot grow without a ‘standardized, systematized, industrialized foundation,’ according to experts from Lonza and Vineti, which have teamed up to advance a ‘vein-to-vein’ delivery network.
The multi-stakeholder group is developing a blockchain-powered platform to increase transparency and collaboration in the clinical trial supply chain – and has successfully completed a proof-of-concept project, now looking to next steps.
