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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 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 - 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 -