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This book investigates and highlights the most critical challenges the pharmaceutical industry faces in an increasingly competitive environment of inflationary R&D investments and tightening cost control pressures. The authors present three sources of pharmaceutical innovation: new management methods in the drug development pipeline; new technologies as enablers for cutting-edge R&D; and new forms of cooperation and internationalization, such as open innovation in the early phases of R&D. New models and methods are illustrated with cases from Europe, the US, and Asia. This third fully revised edition was expanded to reflect the latest updates in open and collaborative innovation, the greater strategic importance of venture capital and early stage investments, and the new range of emerging technologies now being put to use in pharmaceutical innovation.
Pre-clinical evaluation of advanced nerve guide conduits using a novel 3D in vitro testing model
(2018)
Autografts are the current gold standard for large peripheral nerve defects in clinics despite the frequently occurring side effects like donor site morbidity. Hollow nerve guidance conduits (NGC) are proposed alternatives to autografts, but failed to bridge gaps exceeding 3 cm in humans. Internal NGC guidance cues like microfibres are believed to enhance hollow NGCs by giving additional physical support for directed regeneration of Schwann cells and axons. In this study, we report a new 3D in vitro model that allows the evaluation of different intraluminal fibre scaffolds inside a complete NGC. The performance of electrospun polycaprolactone (PCL) microfibres inside 5 mm long polyethylene glycol (PEG) conduits were investigated in neuronal cell and dorsal root ganglion (DRG) cultures in vitro. Z-stack confocal microscopy revealed the aligned orientation of neuronal cells along the fibres throughout the whole NGC length and depth. The number of living cells in the centre of the scaffold was not significantly different to the tissue culture plastic (TCP) control. For ex vivo analysis, DRGs were placed on top of fibre-filled NGCs to simulate the proximal nerve stump. In 21 days of culture, Schwann cells and axons infiltrated the conduits along the microfibres with 2.2 ± 0.37 mm and 2.1 ± 0.33 mm, respectively. We conclude that this in vitro model can help define internal NGC scaffolds in the future by comparing different fibre materials, composites and dimensions in one setup prior to animal testing.
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.
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.
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.
Der Begriff Value-Based-Selling kam erstmals in Europa zur Jahrtausendwende in Mode. Doch so neu ist das wertorientierte Verkaufen nun auch wieder nicht. So wird doch jeder gute Verkäufer dem Kunden stets die Kundenvorteile ausreichend transparent machen. Das war doch schon immer so, auch wenn das früher niemand mit Value Based-Selling bezeichnet hatte. Doch eine kundennutzenorientierte Formulierung im Verkaufsgespräch ist nur eine Seite der Medaille. Der Ansatz des Value-Based Selling geht weit darüber hinaus. Er hat mehr Substanz, als weitläufig bekannt ist.
Development of an IoT-based inventory management solution and training module using smart bins
(2023)
Flexibility, transparency and changeability of warehouse environments are playing an increasingly important role to achieve a cost-efficient production of small batch sizes. This results in increasing requirements for warehouses in terms of flexibility, scalability, reconfigurability and transparency of material and information flows to deal with large number of different components and variable material and information flows due to small batch sizes. Therefore, an IoT-based inventory management solution and training module has been developed, implemented and validated at Werk150 – the Factory on campus of the ESB Business School. Key elements of the developed solution are smart bins using weight mats to track the bin’s content and additional sensors and buttons which are connected to an IoT – Hub to collect data of material consumption and manual handling operations. The use of weight mats for the smart bins offers the possibility to measure the container content independent of the specific component geometry and thus for a variety of components based on the specific component weights. The developed solution enables focusing on key for success elements of the system to provide synchronization of the flow of materials and information resulting an increase of flexibility and significantly higher transparency of the material flow. AIbased algorithms are applied to analyse the gathered data and to initiate process optimizations by providing the logistics decision makers a profound and transparent basis for decision making. In order to provide students and industry visitors of the learning factory with the necessary competences and to support the transfer into practice, a training module on IoT-based inventory management was developed and implemented.