European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)’s Post

Inviting medical providers, engineers, pharmaceutical scientists, as well as designers to explore topics on biomedical monitoring, medication storage, extreme clothing design, as well as a discussion of the science around the management of hypothermia and cold injury. Frozen feet, cold medications, inability to provide consistent monitoring, patchy communications and navigation — these are just some of the many issues faced by people in extreme cold. This interdisciplinary symposium seeks to tackle the topic of medicine at the extremes and how we might address the challenges of providing medical care in these conditions. Learn more at: https://lnkd.in/eFSp39ED

https://lnkd.in/gDieBSJa DRAGEN v4.3 is launching, with notable accuracy gains AND built-in mosaic calling. Quoting from some of the release material: Broad Clinical Labs has been systematically researching the accuracy of variant calls made by DRAGEN v4.3. Marina DiStefano, PhD, FACMG, associate lab director at Broad Clinical Labs, said: "We generated whole-genome sequence data from samples with confirmed calls in genes covered by DRAGEN v4.3 specialized callers, such as PMS2, NEB, and HBA, and from samples with orthogonally confirmed CNV calls. We also analyzed very-high-coverage WGS samples for mosaic evaluation. We are happy with the accuracy and speed and believe that DRAGEN v4.3 is a powerful tool for our clinical whole-genome research."

An important publication recognizing the importance of EQA/proficiency testing in standardization 👏👏👏. Click on the link below for the full article.

According to the United Nations, the proportion of people aged over 65 now outnumber children younger than 5. The enormous #growth in the #elderly population is posing a #socioeconomic #challenge to societies worldwide, and necessitates new sweeping interventions for age-associated diseases. This year we have an incredibly exciting program with global thought-leaders sharing their latest insights into aging and how we target aging process ensuring everyone lives a healthier and longer life.

Catch up with latest Phase 3 clinical trial results with the novel #PCSK9 inhibitor, #lerodalcibep, being developed to treat high #cholesterol, in Professor Derick Raal’s new video from the 20th Closed Scientific Expert Meeting of PCSK9 Education and Research Forum >> https://lnkd.in/eWZJ93cy #PCSK9i #heartdisease #atherosclerosis

#FactOfTheDay Contrary to what has been documented in previous studies of academic publications across a number of disciplines, an analysis of the clinical trials registered in the largest repository in the world, http://ClinicalTrials.gov, does not detect evidence for widespread manipulation of results to clear the 5% threshold for statistical significance. Trial results just above the threshold are slighlty more frequent than expected and only patterns at smaller pharma companies raise some concerns. These discrepancies are minor compared to those recorded in fields without registration. Find more in "P-hacking in clinical trials and how incentives shape the distribution of results across phases", by Project Leader Jérôme Adda, Christian Decker, PhD and Marco Ottaviani in PNAS: https://lnkd.in/dATwQVMZ

The Use of Real-World Evidence for Regulatory Decisions in China Jiayue Xu, Wenkai Wu, Xia Zhang, Yan Ren, Minghong Yao, Mei Liu, Kang Zou, Wen Wang, Xin Sun Clinical Pharmacology & Therapeutics

Effective solutions begin with clean and compelling data. If you *Know* you know. 😁

Listening in to the first show by the Center for Excellence for Quantitative Medicine at the FDA. The first show at the FDA can sometimes look like the last organizational meeting for a new regulatory organization. That's not the case here. Once the show got over a discussion about the concept of quantitative medicine, and who the CDER stakeholders will be, some really exciting information was shared about bridging the gap between generic modeling and simulation and real quantitative medicine clinical applications. The introduction of "fit for purpose" approvals underpinned by early acceptance by the FDA of modeling and simulation approaches redefines the regulatory approval pathway for novel therapies. Now, all we need to do is to confirm the impact of these regulatory strategy ideas on therapeutic product approvals.

Learn more about SciLifeLab's call for Clinical Development Projects in Precision Medicine and Pandemic Laboratory Preparedness. Register now for the information seminar to be held on March 7th on the link below! #precisionmedicine #pandemicpreparedness #scilifelab #translationalresearch #clinicalresearch #research #lifesciences