540 Chemie
Refine
Document Type
- Journal article (90)
- Book chapter (4)
- Doctoral Thesis (4)
- Conference proceeding (3)
- Report (2)
- Book (1)
Is part of the Bibliography
- yes (104)
Institute
- Life Sciences (89)
- Texoversum (11)
- Technik (2)
- ESB Business School (1)
- Informatik (1)
Publisher
- MDPI (19)
- Wiley (17)
- American Chemical Society (14)
- Elsevier (13)
- ACS (7)
- Springer (6)
- Royal Society of Chemistry (4)
- Deutsches Textilforschungszentrum Nord-West (2)
- RSC Publ. (2)
- The Royal Society of Chemistry (2)
The efficiency of pharmaceutical research and development (R&D) reflected by increasing costs of R&D, long timelines, and low probabilities of technical and regulatory success decreased continuously in the past years. Today, the costs for discovering and developing a new drug are enormously high with more than USD 2 billion per new molecular entity (NME), while the average overall success of a research project to provide an NME is in the single-digit percentage rate, and the total timelines of R&D easily exceeds 10 years questioning the return on investment (ROI) of pharmaceutical R&D. As a consequence and also caused by numerous patent expirations of blockbuster drugs that increased the pressure to return to an acceptable ROI, the pharmaceutical industry addressed this challenge and the related causes and identified several actions that need to be taken to increase the output/input ratio of R&D. This book chapter will review the pipeline sizes and the R&D investments of multinational pharmaceutical companies, will describe new processes that have been implemented to increase the reach and to reduce costs of pharmaceutical R&D, and it will illustrate new innovation models that were developed to increase the R&D efficiency.
The reduced research and development (R&D) efficiency, strong competition from generics, increased cost pressure from payers, and an increased biological complexity of new target indications have resulted in a rethinking and a change from a traditional and more closed R&D model in the pharmaceutical industry toward the new paradigm of open innovation. In the past years, pharmaceutical companies have broadened their external networks toward research collaborations with academic institutes, technology providers, or codevelopment partners. To fulfill the demand to reduce timelines and costs, research-based pharmaceutical companies started to outsource R&D activities. In addition, internal R&D processes were adjusted to the more open R&D model and new processes such as alliance management were established. The corporate frontier of pharmaceutical companies became permeable and more open. As a result, the focus of pharmaceutical R&D expanded from a purely internal toward a mixed internal and external model. Today, the U.S. pharmaceutical company Eli Lilly may have established the most open model toward external innovation, as it has integrated its innovation processes with its business model. Other companies are following this more open R&D model with newer concepts such as new frontier sciences, drug discovery alliances, private public partnerships, innovation incubators, virtual R&D, crowdsourcing, open source innovation, and innovation camps.
Clinical development is historically the phase in which a potential new medicine is being tested in phase 2 and phase 3 patient trials to demonstrate the new molecules' efficacy and safety to support the regulatory approval of drugs by health authorities. This relatively focused approach has been considerably expanded by a number of forces from within the pharmaceutical industry and equally important by changes in the healthcare systems. The need to identify the optimal patient population, showstoppers leading to discontinuation of clinical programs, the silent but constant removal of surrogate endpoints for registration, and the increased demand for real-life data which are used to demonstrate the patients' benefit and which have an ever-increasing role for pricing and reimbursement negotiations are today an integral part of this phase.
This chapter will review both the nuts and bolts of clinical development but also recent developments in this area which shape the environment and how the different players have reacted and what options might need to be explored in the future.
It is known that the costs related with drug research and development (R&D) and the timelines to develop a new drug increased over the past years. In parallel, the success rates of drug projects along the pharmaceutical R&D phases are still very low, and the outcome of all R&D efforts is stagnating. In consequence, the R&D efficiency defined as the financial investment per drug has been steadily decreasing. As innovation is the major growth driver of the pharmaceutical industry, reliable data on R&D efficiency and new concepts to overcome these challenges are of great interest for R&D managers and the sustainability of the pharmaceutical industry as a whole. This book chapter reviews publications on R&D performance indicators of the past years, such as the success rates and timelines per phase. Additionally, it illustrates the factors influencing the success rates, timelines, and costs of pharmaceutical R&D most and, thus, the denominators of the R&D efficiency.
This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.
Unter der Zielsetzung der multimodalen, ortsaufgelösten optischen Spektroskopie für die markierungsfreie Charakterisierung biologischer Materialien nach Morphologie und Chemie werden vier Themenschwerpunkte behandelt.
1. Theorie der elastischen / inelastischen Lichtstreuung und laterale Auflösung in der Mikroskopie
2. Erweiterung eines Raman Mikroskops zu einem multimodalen spektralen Imaging System (MSIS) mit Photonenmigrations-Technologie
3. Erweiterung des MSIS zu Super-Resolution Raman Mikroskopie mit einer Festkörper-Immersionslinse
4. Anwendung des entwickelten MSIS auf biologische Materialien
Block-copolyesters of polyethylene terephthalate (PET) and polyethylene naphthalate (PEN) were synthesized via reactive extrusion. The influence of processing parameters on the material properties on a molecular scale like degree of trans-esterification, block length, and degree of randomness were investigated. The varied process factors were extrusion temperature and rotational speed. The effects of process parameter variation were investigated by 1H-NMR-spectroscopy. The experimental results show a clear dependence of the molecular properties on the processing conditions. By using statistical experimental design (DoE), it was possible to prepare defined copolyesters from PET and PEN without addition of further chemicals. With a degree of randomness between 0.05 and 0.5, the presence of an actual copolyester was confirmed when appropriate extrusion conditions were applied. The reactive extrusion process was confirmed to be suitable to produce defined block-copolyesters in a predictable and reproducible way. It was possible to produce designed sequence lengths, which could be adjusted within a range of 11–136 repeating units in the case of PET and, in the case of PEN, of 2.5–26. The produced materials can be used as barrier materials or barrier coatings to protect substrates against molecular oxygen and water vapour, e.g., in organic photovoltaic applications or food packaging. The described method is a one-pot alternative method to the previously described chemical recycling pathway.
The interfacial compatibility between polymers and nanoclay fillers as well as the thermostability of both components are important characteristics for processing them into polymer composites. While the polymer component is often grafted using common polymerization reactions, the nanoclay component is usually surface modified by surfactant treatment to improve compatibility. In the present study, the polymer ethylene vinyl alcohol and a nanoclay filler based on natural bentonite are both surface modified by different silanes, 3-glycidoxypropyltrimethoxysilane and methacryloxymethyltrimethoxysilane and their interfacial properties are investigated by inverse gas chromatography. The silane-modified samples had improved interfacial properties as reflected by a significant increase in dispersive and specific surface energies. Lewis acidities were determined using chloroform and 1,4-dioxane as polar probes and showed a good match between polymer and nanofiller interfaces. Lewis acidity was generally lower after silane-modification. Silanization yielded increased thermal stability of the treated samples. Thus, silanization led to improved compatibility and enhanced thermal stability which facilitates further processing.
Ion Mobility Spectrometry (IMS) is a widely used and `well-known’ technique of ion separation in the gaseous phase based on the differences in ion mobilities under an electric field. All IMS instruments operate with an electric field that provides space separation, but some IMS instruments also operate with a drift gas flow that provides also a temporal separation. In this review we will summarize the current IMS instrumentation. IMS techniques have received an increased interest as new instrumentation and have become available to be coupled with mass spectrometry (MS). For each of the eight types of IMS instruments reviewed it is mentioned whether they can be hyphenated with MS and whether they are commercially available. Finally, out of the described devices, the six most-consolidated ones are compared. The current review article is followed by a companion review article which details the IMS hyphenated techniques (mainly gas chromatography and mass spectrometry) and the factors that make the data from an IMS device change as a function of device parameters and sampling conditions. These reviews will provide the reader with an insightful view of the main characteristics and aspects of the IMS technique.
Ion Mobility Spectrometry (IMS) is a widely used and ‘well-known’ technique of ion separation in the gaseous phase based on the differences of ion mobilities under an electric field. This technique has received increased interest over the last several decades as evidenced by the pace and advances of new IMS devices available. In this review we explore the hyphenated techniques that are used with IMS, specifically mass spectrometry as an identification approach and a multi-capillary column as a pre-separation approach. Also, we will pay special attention to the key figures of merit of the ion mobility spectrum and how data sets are treated, and the influences of the experimental parameters on both conventional drift time IMS (DTIMS) and miniaturized IMS also known as high Field Asymmetric IMS (FAIMS) in the planar configuration. The present review article is preceded by a companion review article which details the current instrumentation and contains the sections that configure both conventional DTIMS and FAIMS devices. These reviews will give the reader an insightful view of the main characteristics and aspects of the IMS technique.