ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature

Since 2007, a new class of biologic products for human use called “advanced therapy medicinal products (ATMP)” have been legally integrated in the European Medical Agency. They consist of recombinant nucleic acid, engineered cells, cells, or tissues. In the United States, ATMP fall under the regulatory framework of biological products and the term “cell and gene therapy product” is used in the legislative and regulatory documents. Potential clinical applications are broad, particularly, in the field of cancer, inherited genetic disease, and regenerative medicine. Indeed, the benefit conferred by CD19 chimeric antigen receptor T cells led to the first engineered cell therapy products to be approved by the Food and Drug Administration (FDA) in 2017. Gene therapy products to treat orphan diseases are also extensively developed with many clinical trials ongoing in the world. Nevertheless, the use of these therapeutic products is complex and requires careful considerations in the terms of regulatory and hospital setting requirements, such as storage, handling, administration, and disposal which justify the implementation of a secured medication circuit. Through this systematic review of the literature, the authors wanted to compile data on the assessment of environmental exposure related to the use of ATMP in healthcare setting to secure their medication circuit. A literature search was conducted on PubMed and Web of Science, and 32 publications dealing with environmental exposure assessment and ATMP were selected. In addition, marketed ATMPs were identified and data regarding the environmental concerns were extracted from product information sections from European Public Assessment Reports (EPAR). The environmental contamination assessments were mainly addressed in the reviews rather than in original articles related to the use of ATMP. Most of the product information sections from EPAR suggested precautions rather than requirements when dealing with environmental consideration following ATMP handling. Nevertheless, these precautions usually remain elusive especially concerning waste disposal and the detection of biological material on the work surfaces, and mainly relate to the genetically modified organisms (GMO) over non-GMO cellular products. Pharmaceutical oversight and adherence to the good preparation practices and good clinical practices are essential to ensure the safe use in term of environmental concern of these new therapeutic products in healthcare setting.

An Integrated Individual Environmental Exposure Assessment System for Real-Time Mobile Sensing in Environmental Health Studies

The effects of environmental exposure on human health have been widely explored by scholars in health geography for decades. However, recent advances in geospatial technologies, especially the development of mobile approaches to collecting real-time and high-resolution individual data, have enabled sophisticated methods for assessing people’s environmental exposure. This study proposes an individual environmental exposure assessment system (IEEAS) that integrates objective real-time monitoring devices and subjective sensing tools to provide a composite way for individual-based environmental exposure data collection. With field test data collected in Chicago and Beijing, we illustrate and discuss the advantages of the proposed IEEAS and the composite analysis that could be applied. Data collected with the proposed IEEAS yield relatively accurate measurements of individual exposure in a composite way, and offer new opportunities for developing more sophisticated ways to measure individual environmental exposure. With the capability to consider both the variations in environmental risks and human mobility in high spatial and temporal resolutions, the IEEAS also helps mitigate some uncertainties in environmental exposure assessment and thus enables a better understanding of the relationship between individual environmental exposure and health outcomes.

Using Open Street Map Data in Environmental Exposure Assessment Studies: Eastern Massachusetts, Bern Region, and South Israel as a Case Study

There is an increase in the awareness of the importance of spatial data in epidemiology and exposure assessment (EA) studies. Most studies use governmental and ordnance surveys, which are often expensive and sparsely updated, while in most developing countries, there are often no official geo-spatial data sources. OpenStreetMap (OSM) is an open source Volunteered Geographic Information (VGI) mapping project. Yet very few environmental epidemiological and EA studies have used OSM as a source for road data. Since VGI data is either noncommercial or governmental, the validity of OSM is often questioned. We investigate the robustness and validity of OSM data for use in epidemiological and EA studies. We compared OSM and Governmental Major Road Data (GRD) in three different regions: Massachusetts, USA; Bern, Switzerland; and Beer-Sheva, South Israel. The comparison was done by calculating data completeness, positional accuracy, and EA using traditional exposure methods. We found that OSM data is fairly complete and accurate in all regions. The results in all regions were robust, with Massachusetts showing the best fits (R2 0.93). Results in Bern (R2 0.78) and Beer-Sheva (R2 0.77) were only slightly lower. We conclude by suggesting that OSM data can be used reliably in environmental assessment studies.