ABSTRACT
The article reports that Twelfth International Society for Applied Biological Sciences Conference on Forensic and Anthropologic Genetics and Mayo Clinic Lectures in Individualized Medicine. Topics include application of ancient DNA methodology in degraded forensic samples, forensic training in crime scene investigation, and aquatic death;and anthropological aspects of global health in the time of crisis covering dietary adherence, the role of sex and geography in COVID-19 variation.
ABSTRACT
The declared aim of "personalized", "stratified" or "precision" approaches is to place individual variation, as ascertained through genomic and various other biomarkers, at the heart of Scientific Medicine using it to predict risk of disease or response to therapy and to tailor interventions and target therapies so as to maximize benefit and minimize risk for individual patients and efficiency for the health care system overall. It is often contrasted to current practices for which the scientific base is rooted in concepts of a "universal biology" and a "typical" or "average patient" and in which variation is ignored. Yet both approaches equally overlook the hierarchical nature of human variation and the critical importance of differences between populations. Impact of genetic heterogeneity has to be seen within that context to be meaningful and subsequently useful. In Africa such complexity is compounded by the high effective size of its populations, their diverse histories and the diversity of the environmental terrains they occupy, rendering analysis of gene environment interactions including the establishment of phenotype genotype correlations even more cumbersome. Henceforth "Individualized" methods and approaches can only magnify the shortcomings of universal approaches if adopted without due regard to these complexities. In the current perspective we review examples of potential hurdles that may confront biomedical scientists and analysts in genomic medicine in clinical and public health genomics in Africa citing specific examples from the current SARS-COV2 pandemic and the challenges of establishing reference biobanks and pharmacogenomics reference values.
ABSTRACT
Natalizumab effectively prevents disease activity in relapsing-remitting multiple sclerosis, but many treated patients report subjective wearing-off symptoms at the end of the 4-week interval between infusions. Extended interval dosing (EID) is a promising strategy to mitigate the risk of natalizumab-associated progressive multifocal leukoencephalopathy, but it is unknown whether EID affects wearing-off symptoms. In this observational study, we evaluated if prevalence or intensity of wearing-off symptoms changed when natalizumab dosing intervals were extended from 4 to 6 weeks in 30 treated patients during the outbreak of COVID-19 in Norway. New or increased wearing-off symptoms during EID were reported by 50%. Symptom increase was more frequent among patients with pre-existing wearing-off symptoms during standard dosing compared to patients without such pre-existing symptoms [p = 0.0005]. Our observations support the need to study the effect of EID on wearing-off symptoms in randomized controlled trials.
Subject(s)
COVID-19 , Leukoencephalopathy, Progressive Multifocal , Multiple Sclerosis, Relapsing-Remitting , Humans , Immunologic Factors/adverse effects , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/epidemiology , Natalizumab/adverse effects , Pandemics , SARS-CoV-2ABSTRACT
This year's annual conference of the Food and Drug Law Institute (FDLI) drew more than 700 attendees, including over 200 from the U.S. Food and Drug Administration (FDA), and featured 93 speakers. Despite being held virtually for the first time, the event offered a full agenda comprising breakout sessions, award presentations, and opportunities for networking that included postsession roundtable discussions and a sponsor virtual exhibit hall. Not surprisingly, the reality of the COVID-19 public health emergency was a recurrent and emphasized theme throughout the 3 days of the conference. This report summarizes several of the 29 breakout sessions from the event.