610 Medizin, Gesundheit
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The present work proposes the use of modern ICT technologies such as smartphones, NFCs, internet, and web technologies, to help patients in carrying out their therapies. The implemented system provides a calendar with a reminder of the assumptions, ensures the drug identification through NFC, allows remote assistance from healthcare staff and family members to check and manage the therapy in real-time. The system also provides centralized information on the patient's therapeutic situation, helpful in choosing new compatible therapies.
We investigated the state of artificial intelligence (AI) in pharmaceutical research and development (R&D) and outline here a risk and reward perspective regarding digital R&D. Given the novelty of the research area, a combined qualitative and quantitative research method was chosen, including the analysis of annual company reports, investor relations information, patent applications, and scientific publications of 21 pharmaceutical companies for the years 2014 to 2019. As a result, we can confirm that the industry is in an ‘early mature’ phase of using AI in R&D. Furthermore, we can demonstrate that, despite the efforts that need to be managed, recent developments in the industry indicate that it is worthwhile to invest to become a ‘digital pharma player’.
It has been widely shown that biomaterial surface topography can modulate host immune response, but a fundamental understanding of how different topographies contribute to pro-inflammatory or anti-inflammatory responses is still lacking. To investigate the impact of surface topography on immune response, we undertook a systematic approach by analyzing immune response to eight grades of medical grade polyurethane of increasing surface roughness in three in vitro models of the human immune system. Polyurethane specimens were produced with defined roughness values by injection molding according to the VDI 3400 industrial standard. Specimens ranged from 0.1 μm to 18 μm in average roughness (Ra), which was confirmed by confocal scanning microscopy. Immunological responses were assessed with THP-1-derived macrophages, human peripheral blood mononuclear cells (PBMCs), and whole blood following culture on polyurethane specimens. As shown by the release of pro-inflammatory and anti-inflammatory cytokines in all three models, a mild immune response to polyurethane was observed, however, this was not associated with the degree of surface roughness. Likewise, the cell morphology (cell spreading, circularity, and elongation) in THP-1-derived macrophages and the expression of CD molecules in the PBMC model on T cells (HLA-DR and CD16), NK cells (HLA-DR), and monocytes (HLA-DR, CD16, CD86, and CD163) showed no influence of surface roughness. In summary, this study shows that modifying surface roughness in the micrometer range on polyurethane has no impact on the pro-inflammatory immune response. Therefore, we propose that such modifications do not affect the immunocompatibility of polyurethane, thereby supporting the notion of polyurethane as a biocompatible material.
The recovery of our body and brain from fatigue directly depends on the quality of sleep, which can be determined from the results of a sleep study. The classification of sleep stages is the first step of this study and includes the measurement of vital data and their further processing. The non-invasive sleep analysis system is based on a hardware sensor network of 24 pressure sensors providing sleep phase detection. The pressure sensors are connected to an energy-efficient microcontroller via a system-wide bus. A significant difference between this system and other approaches is the innovative way in which the sensors are placed under the mattress. This feature facilitates the continuous use of the system without any noticeable influence on the sleeping person. The system was tested by conducting experiments that recorded the sleep of various healthy young people. Results indicate the potential to capture respiratory rate and body movement.
Methods based exclusively on heart rate hardly allow to differentiate between physical activity, stress, relaxation, and rest, that is why an additional sensor like activity/movement sensor added for detection and classification. The response of the heart to physical activity, stress, relaxation, and no activity can be very similar. In this study, we can observe the influence of induced stress and analyze which metrics could be considered for its detection. The changes in the Root Mean Square of the Successive Differences provide us with information about physiological changes. A set of measurements collecting the RR intervals was taken. The intervals are used as a parameter to distinguish four different stages. Parameters like skin conductivity or skin temperature were not used because the main aim is to maintain a minimum number of sensors and devices and thereby to increase the wearability in the future.
The ballistocardiography is a technique that measures the heart rate from the mechanical vibrations of the body due to the heart movement. In this work a novel noninvasive device placed under the mattress of a bed estimates the heart rate using the ballistocardiography. Different algorithms for heart rate estimation have been developed.
Artificial intelligence (AI) technologies, such as machine learning or deep learning, have been predicted to highly impact future organizations and radically change the way how projects are managed. The Project Management Institute (PMI), the network of around 1.1 million certified project managers, ranked AI as one of the top three disruptors of their profession. In an own study on the effect of AI, 37% of the project management processes can be executed by machine learning and other AI technologies. In addition, Gartner recently postulated that 80% of the work of today's project managers may be eliminated by AI in 2030.
This editorial aims to outline today's project and portfolio management in context of pharmaceutical research and development (R&D), followed by an AI-vision and a more tangible mission, and illustrate what the consequences of an AI-enabled project and portfolio management could be for pharmaceutical R&D.
Die rasante Entwicklung der Sensortechnik im Endverbraucherbereich lässt einen klinischen Nutzen der verfügbaren dezentral erhobenen Daten aus dem Patientenalltag zur Überwachung des individuellen Gesundheitszustands vermuten. Zur Überprüfung dieser Vermutung ist die Bereitstellung einer entsprechenden Plattform in den klinischen Alltag erforderlich. Hierzu wird die bwHealthApp entwickelt, mit der sowohl die aktuelle Bandbreite als auch die Evolution der Sensortechnik auf die klinische Anwendung abbildbar ist. Mit dem flexiblen Entwurf lässt sich der klinische Nutzen für die personalisierte Medizin evaluieren. Außerdem bietet die bwHealthApp einen an Machbarkeit orientierten Diskussionsbeitrag zu offenen rechtlichen, regulatorischen und ethischen Fragestellungen der Digitalisierung in der Medizin in Deutschland.
The aim of this work was to investigate the mean fill weight control of a continuous capsule-filling process, whether it is possible to derive controller settings from an appendant process model. To that end, a system composed out of fully automated capsule filler and an online gravimetric scale was used to control the filled weight. This setup allows to examine challenges associated with continuous manufacturing processes, such as variations in the amount of active pharmaceutical ingredient (API) in the mixture due to fluctuations of the feeders or due to altered excipient batch qualities. Two types of controllers were investigated: a feedback control and a combination of feedback and feedforward control. Although both of those are common in the industry, determining the optimal parameter settings remains an issue. In this study, we developed a method to derive the control parameters based on process models in order to obtain optimal control for each filled product. Determined via rapid automated process development (RAPD), this method is an effective and fast way of determining control parameters. The method allowed us to optimize the weight control for three pharmaceutical excipients. By conducting experiments, we verified the feasibility of the proposed method and studied the dynamics of the controlled system. Our work provides important basic data on how capsule filler can be implemented into continuous manufacturing systems.
In networked operating room environments, there is an emerging trend towards standardized non-proprietary communication protocols which allow to build new integration solutions and flexible human-machine interaction concepts. The most prominent endeavor is the IEEE 11073 SDC protocol. For some uses cases, it would be helpful if not just medical devices could be controlled based on SDC, but also building automation systems like light, shutters, air condition, etc. For those systems, the KNX protocol is widely used. We build an SDC-to-KNX gateway which allows to use the SDC protocol for sending commands to connected KNX devices. The first prototype system was successfully implemented at the demonstration operating room at Reutlingen University. This is a first step toward the integration of a broader variety of KNX devices.