Publications by authors named "Jessica J Mistilis"
Article Synopsis
- * An international group is collaborating to tackle regulatory challenges related to microneedles combined with pharmaceuticals for skin application, guided by Quality by Design principles.
- * The resulting 'White Paper' highlights key dosage form classifications, potential critical quality attributes, and aims to create a foundation for regulatory guidance that will help bring safe and effective microneedle products to market faster.
: The Measles-Rubella Microarray Patch (MR-MAP) is an important technology that is expected to reduce coverage and equity gaps for measles-containing vaccines (MCVs), reach zero-dose children, and contribute to elimination of measles and rubella. MR-MAPs are anticipated to be easier to deploy programmatically and could be delivered by lesser-trained health workers, thereby increasing immunization coverage. The most advanced MR-MAP has reached clinical proof-of-concept through a Phase I/II trial in the target population of infants and young children.
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- Measles and rubella micro-array patches (MR-MAPs) are innovative alternatives to traditional needle and syringe vaccines, offering single-dose convenience, easier handling, and better temperature stability.
- An initial full value vaccine assessment (iFVVA) evaluated their potential impact, finding that widespread use of MR-MAPs could prevent millions of measles cases, deaths, and years lost to disability by reaching an additional 80 million children over the next decade.
- The assessment also emphasized the need for financial investment in manufacturing and clinical studies, while showing that MR-MAPs have the potential to be cost-effective for routine immunization in many low- and middle-income countries, depending on pricing and coverage uncertainties.*
Microneedle Array Patches (MAPs) are an emerging dosage form that creates transient micron-sized disruptions in the outermost physical skin barrier, the stratum corneum, to facilitate delivery of active pharmaceutical ingredients to the underlying tissue. Numerous MAP products are proposed and there is significant clinical potential in priority areas such as vaccination. However, since their inception scientists have hypothesized about the risk of a clinically significant MAP-induced infection.
View Article and Find Full Text PDFMeasles and rubella microarray patches (MR-MAPs) are critical in achieving measles and rubella eradication, a goal highly unlikely to meet with current vaccines presentations. With low commercial incentive to MAP developers, limited and uncertain funding, the need for investment in a novel manufacturing facility, and remaining questions about the source of antigen, product demand, and regulatory pathway, MR-MAPs are unlikely to be prequalified by WHO and ready for use before 2033. This article describes the current progress of MR-MAPs, highlights challenges and opportunities pertinent to MR-MAPs manufacturing, regulatory approval, creating demand, and timelines to licensure.
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