TY - JOUR A1 - Schuhmacher, Alexander A1 - Gatto, Alexander A1 - Hinder, Markus A1 - Kuss, Michael A1 - Gassmann, Oliver T1 - The upside of being a digital pharma player JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2020.06.002 Y1 - 2020 UR - https://doi.org/10.1016/j.drudis.2020.06.002 SN - 1878-5832 VL - 25 IS - 9 SP - 1569 EP - 1574 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Dodel, Alexander A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Investigating the origins of recent pharmaceutical innovation JF - Nature Reviews Drug Discovery UR - https://doi.org/10.1038/d41573-023-00102-z Y1 - 2023 UR - https://doi.org/10.1038/d41573-023-00102-z SN - 1474-1784 SN - 1474-1776 VL - 22 IS - 10 SP - 781 EP - 782 PB - Springer CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - von Stegmann und Stein, Alexander A1 - Hartl, Dominik A1 - Gassmann, Oliver T1 - Analysis of pharma R&D productivity – a new perspective needed JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2023.103726 Y1 - 2023 UR - https://doi.org/10.1016/j.drudis.2023.103726 SN - 1878-5832 VL - 28 IS - 10 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gatto, Alexander A1 - Kuss, Michael A1 - Gassmann, Oliver A1 - Hinder, Markus T1 - Big Techs and startups in pharmaceutical R&D – A 2020 perspective on artificial intelligence JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.04.028 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.04.028 SN - 1878-5832 VL - 26 IS - 10 SP - 2226 EP - 2231 PB - Elsevier CY - Amsterdam ER - TY - BOOK A1 - Gassmann, Oliver A1 - Schuhmacher, Alexander A1 - von Zedtwitz, Max A1 - Reepmeyer, Gerrit T1 - Führung und Organisation pharmazeutischer Innovation BT - Wie man den Wettlauf der Life Sciences gewinnt UR - https://doi.org/10.1007/978-3-031-43818-9 Y1 - 2024 UR - https://doi.org/10.1007/978-3-031-43818-9 SN - 978-3-031-43818-9 SN - 978-3-031-43817-2 PB - Springer Gabler CY - Cham ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus T1 - Changing R&D models in research-based pharmaceutical companies JF - Journal of Translational Medicine N2 - New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2–32.3 billion (2006–2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. UR - https://doi.org/10.1186/s12967-016-0838-4 Y1 - 2016 UR - https://doi.org/10.1186/s12967-016-0838-4 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-53816 SN - 1479-5876 VL - 14 PB - BioMed Central CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - McCracken, Nigel A1 - Hinder, Markus T1 - Open innovation and external sources of innovation. An opportunity to fuel the R&D pipeline and enhance decision making? JF - Journal of Translational Medicine N2 - Historically, research and development (R&D) in the pharmaceutical sector has predominantly been an in-house activity. To enable investments for game changing late-stage assets and to enable better and less costly go/no-go decisions, most companies have employed a fail early paradigm through the implementation of clinical proof-of-concept organizations. To fuel their pipelines, some pioneers started to complement their internal R&D efforts through collaborations as early as the 1990s. In recent years, multiple extrinsic and intrinsic factors induced an opening for external sources of innovation and resulted in new models for open innovation, such as open sourcing, crowdsourcing, public–private partnerships, innovations centres, and the virtualization of R&D. Three factors seem to determine the breadth and depth regarding how companies approach external innovation: (1) the company’s legacy, (2) the company’s willingness and ability to take risks and (3) the company’s need to control IP and competitors. In addition, these factors often constitute the major hurdles to effectively leveraging external opportunities and assets. Conscious and differential choices of the R&D and business models for different companies and different divisions in the same company seem to best allow a company to fully exploit the potential of both internal and external innovations. UR - https://doi.org/10.1186/s12967-018-1499-2 Y1 - 2018 UR - https://doi.org/10.1186/s12967-018-1499-2 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-53862 SN - 1479-5876 VL - 16 IS - 1 PB - BioMed Central CY - London ER - TY - JOUR A1 - Herrmann, Michael A1 - Schuhmacher, Alexander A1 - Mühldorfer, Inge A1 - Melchers, Klaus A1 - Prothmann, Christian A1 - Dammeier, Sascha T1 - Identification and characterization of secreted effector proteins of Chlamydophila pneumoniae TW183 JF - Research in Microbiology UR - https://doi.org/10.1016/j.resmic.2005.12.005 Y1 - 2006 UR - https://doi.org/10.1016/j.resmic.2005.12.005 SN - 0923-2508 VL - 157 IS - 6 SP - 513 EP - 524 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Melchers, Klaus A1 - Schuhmacher, Alexander A1 - Buhmann, Anita A1 - Weitzenegger, Thomas A1 - Belin, Dominique A1 - Grau, Sandra A1 - Ehrmann, Michael T1 - Membrane topology of CadA homologous P-type ATPase of Helicobacter pylori as determined by expression of phoA fusions in Escherichia coli and the positive inside rule JF - Research in Microbiology UR - https://doi.org/10.1016/s0923-2508(99)00106-0 Y1 - 1999 UR - https://doi.org/10.1016/s0923-2508(99)00106-0 SN - 0923-2508 VL - 150 IS - 8 SP - 507 EP - 520 PB - Elsevier CY - Amsterdam ER - TY - BOOK A1 - Gassmann, Oliver A1 - Schuhmacher, Alexander A1 - von Zedtwitz, Max A1 - Reepmeyer, Gerrit T1 - Leading Pharmaceutical Innovation BT - How to Win the Life Science Race UR - https://doi.org/10.1007/978-3-319-66833-8 Y1 - 2018 UR - https://doi.org/10.1007/978-3-319-66833-8 SN - 978-3-319-66833-8 SN - 978-3-319-66832-1 PB - Springer CY - Cham ET - Third Edition ER - TY - JOUR A1 - Schuhmacher, Alexander T1 - Exploring open source as a strategy to enhance R&D productivity JF - Expert Opinion on Drug Discovery UR - https://doi.org/10.1080/17460441.2024.2417352 Y1 - 2024 UR - https://doi.org/10.1080/17460441.2024.2417352 SN - 1746-0441 SN - 1746-045X VL - 19 IS - 12 SP - 1399 EP - 1402 PB - Taylor & Francis CY - London ER - TY - CHAP A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus ED - Schuhmacher, Alexander ED - Hinder, Markus ED - Gassmann, Oliver T1 - A Review of the Pharmaceutical R&D Efficiency: Costs, Timelines, and Probabilities T2 - Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation UR - https://doi.org/10.1002/9783527693405.ch4 Y1 - 2016 UR - https://doi.org/10.1002/9783527693405.ch4 SN - 978-3-527-69343-6 SN - 978-3-527-33913-6 SP - 61 EP - 79 PB - Wiley CY - Weinheim ER - TY - CHAP A1 - Hinder, Markus A1 - Schuhmacher, Alexander ED - Schuhmacher, Alexander ED - Hinder, Markus ED - Gassmann, Oliver T1 - The Evolution of Clinical Development: From Technical Success to Clinical Value Creation T2 - Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation UR - https://doi.org/10.1002/9783527693405.ch10 Y1 - 2016 UR - https://doi.org/10.1002/9783527693405.ch10 SN - 978-3-527-69343-6 SN - 978-3-527-33913-6 SP - 203 EP - 223 PB - Wiley CY - Weinheim ER - TY - CHAP A1 - Schuhmacher, Alexander A1 - Betz, Ulrich A. K. ED - Schuhmacher, Alexander ED - Hinder, Markus ED - Gassmann, Oliver T1 - The Pharmaceutical Industry is Opening Its R&D Boundaries T2 - Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation UR - https://doi.org/10.1002/9783527693405.ch15 Y1 - 2016 UR - https://doi.org/10.1002/9783527693405.ch15 SN - 978-3-527-69343-6 SN - 978-3-527-33913-6 SP - 335 EP - 361 PB - Wiley CY - Weinheim ER - TY - JOUR A1 - Hartl, Dominik A1 - de Luca, Valeria A1 - Kostikova, Anna A1 - Laramie, Jason A1 - Kennedy, Scott A1 - Ferrero, Enrico A1 - Siegel, Richard A1 - Fink, Martin A1 - Ahmed, Sohail A1 - Millholland, John A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Piali, Luca A1 - Roth, Adrian T1 - Translational precision medicine: an industry perspective JF - Journal of Translational Medicine N2 - In the era of precision medicine, digital technologies and artificial intelligence, drug discovery and development face unprecedented opportunities for product and business model innovation, fundamentally changing the traditional approach of how drugs are discovered, developed and marketed. Critical to this transformation is the adoption of new technologies in the drug development process, catalyzing the transition from serendipity-driven to data-driven medicine. This paradigm shift comes with a need for both translation and precision, leading to a modern Translational Precision Medicine approach to drug discovery and development. Key components of Translational Precision Medicine are multi-omics profiling, digital biomarkers, model-based data integration, artificial intelligence, biomarker-guided trial designs and patient-centric companion diagnostics. In this review, we summarize and critically discuss the potential and challenges of Translational Precision Medicine from a cross-industry perspective. UR - https://doi.org/10.1186/s12967-021-02910-6 KW - Translational medicine KW - Precision medicine KW - Drug development KW - Biomarkers KW - Multi-omics KW - Modeling KW - Artificial intelligence KW - Pharmaceutical industry KW - Digital biomarkers KW - Companion diagnostics Y1 - 2021 UR - https://doi.org/10.1186/s12967-021-02910-6 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-39873 SN - 1479-5876 VL - 19 PB - BioMed Central CY - London ER - TY - CHAP A1 - Schuhmacher, Alexander A1 - Hinder, Markus ED - Hinder, Markus ED - Schuhmacher, Alexander ED - Goldhahn, Jörg ED - Hartl, Dominik T1 - Project, Risk, and Portfolio Management – Managing R & D Projects Today* T2 - Principles of Biomedical Sciences and Industry: Translating Ideas into Treatments UR - https://doi.org/10.1002/9783527824014.ch14 Y1 - 2022 UR - https://doi.org/10.1002/9783527824014.ch14 SN - 978-3-527-34571-7 SN - 978-3-527-82401-4 SP - 257 EP - 279 PB - Wiley-VCH CY - Weinheim ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Boger, Nikolaj A1 - Hartl, Dominik A1 - Gassmann, Oliver T1 - The significance of blockbusters in the pharmaceutical industry JF - Nature Reviews Drug Discovery UR - https://doi.org/10.1038/d41573-022-00213-z Y1 - 2022 UR - https://doi.org/10.1038/d41573-022-00213-z SN - 1474-1784 VL - 22 IS - 3 SP - 177 EP - 178 PB - Springer Nature CY - London ER - TY - CHAP A1 - Hinder, Markus A1 - Hartl, Dominik A1 - Schuhmacher, Alexander ED - Hinder, Markus ED - Schuhmacher, Alexander ED - Goldhahn, Jörg ED - Hartl, Dominik T1 - Biopharmaceutical Innovation at a Glance T2 - Principles of Biomedical Sciences and Industry: Translating Ideas into Treatments UR - https://doi.org/10.1002/9783527824014.ch1 Y1 - 2022 UR - https://doi.org/10.1002/9783527824014.ch1 SN - 978-3-527-34571-7 SN - 978-3-527-82401-4 SP - 1 EP - 6 PB - Wiley-VCH CY - Weinheim ER - TY - JOUR A1 - Behbehani, Mehri A1 - Glen, Adam A1 - S. Taylor, Caroline A1 - Schuhmacher, Alexander A1 - Claeyssens, Frederik A1 - W. Haycock, John T1 - Pre-clinical evaluation of advanced nerve guideconduits using a novel 3D in vitro testing model JF - International Journal of Bioprinting N2 - Autografts are the current gold standard for large peripheral nerve defects in clinics despite the frequentlyoccurring side effects like donor site morbidity. Hollow nerve guidance conduits (NGC) are proposed alternatives toautografts, but failed to bridge gaps exceeding 3 cm in humans. Internal NGC guidance cues like microfibresare believed to enhance hollow NGCs by giving additional physical support for directed regeneration of Schwann cellsand axons. In this study, we report a new 3D in vitro model that allows the evaluation of different intraluminal fibrescaffolds inside a complete NGC. The performance of electrospun polycaprolactone (PCL) microfibres inside 5 mmlong polyethylene glycol (PEG) conduits were investigated in neuronal cell and dorsal root ganglion (DRG) culturesinvitro. Z-stack confocal microscopy revealed the aligned orientation of neuronal cells along the fibres throughout thewhole NGC length and depth. The number of living cells in the centre of the scaffold was not significantly different tothe tissue culture plastic (TCP) control. For ex vivo analysis, DRGs were placed on top of fibre-filled NGCs to simulatethe proximal nerve stump. In 21 days of culture, Schwann cells and axons infiltrated the conduits along the microfibreswith 2.2 ± 0.37 mm and 2.1 ± 0.33 mm, respectively. We conclude that this in vitro model can help define internal NGCscaffolds in the future by comparing different fibre materials, composites and dimensions in one setup prior to animal testing. UR - https://doi.org/10.18063/IJB.v4i1.123 Y1 - 2017 UR - https://doi.org/10.18063/IJB.v4i1.123 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-54035 SN - 2424-8002 SN - 2424-7723 VL - 4 IS - 1 PB - AccScience Publishing CY - Singapur ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Brieke, Clara A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Systematic risk identification and assessment using a new risk map in pharmaceutical R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.06.015 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.06.015 SN - 1878-5832 SN - 1359-6446 VL - 26 IS - 12 SP - 2786 EP - 2793 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Kuss, Michael T1 - The impact of crowdsourcing in modern drug discovery JF - Expert Opinion on Drug Discovery UR - https://doi.org/10.1080/17460441.2020.1751116 Y1 - 2020 UR - https://doi.org/10.1080/17460441.2020.1751116 SN - 1746-045X SN - 1746-0441 VL - 15 IS - 8 SP - 865 EP - 867 PB - Taylor & Francis CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Brief, Elazar A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022) JF - Drug Discovery Today N2 - Previous analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006–2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%. UR - https://doi.org/10.1016/j.drudis.2025.104291 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104291 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-56382 SN - 1878-5832 N1 - Corrigendum verfügbar unter https://doi.org/10.1016/j.drudis.2025.104326 VL - 30 IS - 2 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Germann, Paul-Georg A1 - Schuhmacher, Alexander A1 - Harrison, Juan A1 - Law, Ronald A1 - Haug, Kevin A1 - Wong, Gordon T1 - How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective JF - Human Genomics UR - https://doi.org/10.1186/1479-7364-7-5 Y1 - 2013 UR - https://doi.org/10.1186/1479-7364-7-5 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-54053 SN - 1479-7364 VL - 7 IS - 1 PB - BioMedCentral CY - London ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Kuss, Michael T1 - The present and future of project management in pharmaceutical R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2020.07.020 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2020.07.020 SN - 1878-5832 VL - 26 IS - 1 SP - 1 EP - 4 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Grinchenko, Kyrylo A1 - Gassmann, Oliver A1 - Hartl, Dominik A1 - Hinder, Markus T1 - A case study assessing the impact of M&A and licensing on FDA drug approvals of leading pharmaceutical companies JF - Drug Discovery Today N2 - Despite a recent increase in FDA new drug approvals, leading pharmaceutical companies continue to face R&D productivity challenges. This highlights the need to better understand the context of their R&D concepts and related R&D outputs. Consequently, we conducted a systematic assessment of the impact of R&D expenditures, R&D intensities, mergers & acquisitions (M&A) deals and licensing agreements on new drug approvals of leading pharmaceutical companies between 2012 and 2021. Our analysis provides key insights into differentiating R&D factors: whereas R&D expenditures and the number of M&A deals correlate with the number of new drug approvals, our analysis shows no correlation with R&D intensity or the number of licensing agreements. UR - https://doi.org/10.1016/j.drudis.2025.104306 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104306 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-57756 SN - 1878-5832 VL - 30 IS - 3 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Wilisch, Lucas A1 - Kuss, Michael A1 - Kandelbauer, Andreas A1 - Hinder, Markus A1 - Gassmann, Oliver T1 - R&D efficiency of leading pharmaceutical companies – A 20-year analysis JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2021.05.005 Y1 - 2021 UR - https://doi.org/10.1016/j.drudis.2021.05.005 SN - 1878-5832 VL - 26 IS - 8 SP - 1784 EP - 1789 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Germann, Paul-Georg A1 - Trill, Henning A1 - Gassmann, Oliver T1 - Models for open innovation in the pharmaceutical industry JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2013.07.013 Y1 - 2013 UR - https://doi.org/10.1016/j.drudis.2013.07.013 SN - 1878-5832 VL - 18 IS - 23-24 SP - 1133 EP - 1137 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Boger, Nikolaj A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Is the blockbuster imperative broken? JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2023.103789 Y1 - 2023 UR - https://doi.org/10.1016/j.drudis.2023.103789 SN - 1878-5832 VL - 28 IS - 11 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Kuss, Michael A1 - Hinder, Markus T1 - The Art of Virtualizing Pharma R&D JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2019.07.004 Y1 - 2019 UR - https://doi.org/10.1016/j.drudis.2019.07.004 SN - 1878-5832 VL - 24 IS - 11 SP - 2105 EP - 2107 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Bieniok, Doria A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Open innovation: A paradigm shift in pharma R&D? JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2022.05.018 Y1 - 2022 UR - https://doi.org/10.1016/j.drudis.2022.05.018 SN - 1878-5832 VL - 27 IS - 9 SP - 2395 EP - 2405 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander T1 - Pharma innovation: how evolutionary economics is shaping the future of pharma R&D JF - Drug Discovery Today N2 - This paper describes the theory of evolutionary economics in the context of pharmaceutical R&D. In this context, the R&D productivity crisis acts as a key selection mechanism, and R&D, technology and industry trends provide mechanisms of variation. Drawing on today’s prevailing business model among leading pharmaceutical companies, the biotech-leveraged pharma company (BIPCO), I propose two new value creation logics: the technology-investigating pharma company (TIPCO) and the asset-integrating pharma company (AIPCO). Although some companies already share aspects of these business models, it is not yet clear, in terms of evolutionary economics, what the ultimate outcome of the evolutionary process in pharma R&D will be. UR - https://doi.org/10.1016/j.drudis.2024.104222 Y1 - 2024 UR - https://doi.org/10.1016/j.drudis.2024.104222 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-53311 SN - 1878-5832 VL - 29 IS - 12 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus A1 - Hartl, Dominik T1 - Comparative analysis of FDA approvals by top 20 pharma companies (2014–2023) JF - Drug Discovery Today N2 - This article addresses the research and development (R&D) productivity challenge of the pharmaceutical industry, focusing on United States Food and Drug Administration (FDA)-related new drug approvals of the top 20 pharmaceutical companies (2014–2023). We evaluated the degree of innovation in new drugs to determine the innovativeness of these leading companies. A key finding of our analysis is the decline in the number of new drugs approved by the FDA for these leading companies over the investigated time period. This trend suggests that some of the leading companies are losing ground in R&D innovation, raising concerns about their ability to sustain competitive advantage, ensure long-term market success, and maintain viable business models. UR - https://doi.org/10.1016/j.drudis.2024.104128 Y1 - 2024 UR - https://doi.org/10.1016/j.drudis.2024.104128 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-50058 SN - 1878-5832 VL - 29 IS - 9 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Haefner, Naomi A1 - Honsberg, Katharina A1 - Goldhahn, Jörg A1 - Gassmann, Oliver T1 - The dominant logic of Big Tech in healthcare and pharma JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2022.103457 Y1 - 2022 UR - https://doi.org/10.1016/j.drudis.2022.103457 SN - 1878-5832 VL - 28 IS - 2 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Kwisda, Sebastian A1 - Kremer, Malte A1 - Sievertsen, Niels A1 - Gassmann, Oliver A1 - Hartl, Dominik A1 - Schuhmacher, Alexander T1 - Does pharma R&D need a strategic reset? Adapting to a changing US landscape JF - Drug Discovery Today N2 - R&D productivity has long challenged research-based pharmaceutical companies, raising concerns about the sustainability of their research-driven business models. These firms have traditionally relied on the U.S. as a stable hub for biomedical innovation, skilled talent, and high-price markets—supporting the biotech-leveraged pharma company (BIPCO) model However, recent geopolitical shifts—especially under the new Trump administration, including FDA budget cuts, reduced U.S. research funding, and pharmaceutical tariffs—are destabilizing this foundation. The once-reliable “safe harbor” is no longer secure. As a result, pharma R&D now faces strategic risks beyond its prior scope. With the weakening of the U.S.-centered innovation model, companies must rethink R&D pipelines, secure key technologies, maintain global clinical networks, and adjust supply chain and tax strategies. The viability of the current R&D model—rooted in U.S. leadership and premium markets—is now uncertain, requiring urgent strategic realignment. UR - https://doi.org/10.1016/j.drudis.2025.104442 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104442 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-61966 SN - 1878-5832 VL - 30 IS - 9 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Hinder, Markus A1 - Madesh, Nandhini A1 - Hartl, Dominik A1 - Schuhmacher, Alexander T1 - The Role of Data Monitoring Committees in drug research JF - Drug Discovery Today UR - https://doi.org/10.1016/j.drudis.2025.104474 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104474 SN - 1878-5832 VL - 30 IS - 10 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Kwisda, Sebastian A1 - Kremer, Malte A1 - Hinder, Markus A1 - Hartl, Dominik T1 - The R&D productivity challenge: transforming the pharmaceutical ecosystem JF - Drug Discovery Today N2 - The persistent decline in pharmaceutical R&D productivity has been extensively analyzed and debated for over two decades, with profound implications for the structure and strategy of the pharmaceutical industry. This systemic challenge forced many leading companies to adapt their R&D models, influencing internal capabilities and external innovation strategies. In response, the industry has evolved into a complex, interdependent biopharmaceutical ecosystem encompassing large pharmaceutical corporations, biotech innovators and specialized service providers. Although R&D productivity affects all research-driven companies, its consequences are particularly pronounced for large pharmaceutical firms, because the scale and capital intensity of their R&D activities make productivity a crucial determinant of long-term competitiveness and sustainability. By contrast, other stakeholders are only partially adversely affected, whereas some can even obtain value from it. UR - https://doi.org/10.1016/j.drudis.2025.104494 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104494 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-64218 SN - 1878-5832 VL - 30 IS - 11 PB - Elsevier CY - Amsterdam ER - TY - CHAP A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver A1 - Hinder, Markus ED - Schuhmacher, Alexander ED - Gassmann, Oliver ED - Hinder, Markus T1 - New Innovation Models in Pharmaceutical R&D T2 - Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation UR - https://doi.org/10.1002/9783527693405.ch18 Y1 - 2016 UR - https://doi.org/10.1002/9783527693405.ch18 SN - 978-3-527-69343-6 SN - 978-3-527-33913-6 SP - 401 EP - 415 PB - Wiley CY - Weinheim ER - TY - INPR A1 - Boemelburg, Raphael A1 - Schuhmacher, Alexander A1 - Gassmann, Oliver T1 - Open Innovation Strategies and Product Performance in Pharma R&D: Insights into Exploration and Exploitation T2 - SSRN UR - https://dx.doi.org/10.2139/ssrn.5562088 Y1 - 2025 UR - https://dx.doi.org/10.2139/ssrn.5562088 PB - Elsevier CY - Amsterdam ER -