@inproceedings{BaderGassmann2012, author = {Bader, Martin and Gassmann, Oliver}, title = {Management von Technologietransfer}, booktitle = {Technologietransfer: M{\"o}glichkeiten und Grenzen rechtlicher Gestaltung, Referate der Tagung vom 30. November 2011 in St.Gallen}, editor = {Thouvenin, Florent and Wildhaber, Isabelle}, publisher = {Institut f{\"u}r Rechtswissenschaft und Rechtspraxis}, address = {St. Gallen}, isbn = {978-3-906049-02-1}, pages = {9 -- 29}, year = {2012}, language = {de} } @book{GassmannBader2006, author = {Gassmann, Oliver and Bader, Martin}, title = {Patentmanagement}, subtitle = {Innovationen erfolgreich nutzen und sch{\"u}tzen}, publisher = {Springer}, address = {Berlin}, isbn = {978-3-540-30039-7}, doi = {https://doi.org/10.1007/3-540-30039-2}, pages = {X, 367}, year = {2006}, language = {de} } @book{GassmannBader2017, author = {Gassmann, Oliver and Bader, Martin}, title = {Patentmanagement}, subtitle = {Innovationen erfolgreich nutzen und sch{\"u}tzen}, edition = {4., vollst{\"a}ndig {\"u}berarbeitete und erweiterte Auflage}, publisher = {Springer Gabler}, address = {Berlin}, isbn = {978-3-662-49527-8}, doi = {https://doi.org/10.1007/978-3-662-49527-8}, pages = {XI, 306}, year = {2017}, language = {de} } @book{GassmannBader2011, author = {Gassmann, Oliver and Bader, Martin}, title = {Patentmanagement}, subtitle = {Innovationen erfolgreich nutzen und sch{\"u}tzen}, edition = {Dritte, vollst{\"a}ndig {\"u}berarbeitete und erweiterte Auflage}, publisher = {Springer}, address = {Berlin}, isbn = {978-3-642-16605-1}, doi = {https://doi.org/10.1007/978-3-642-16605-1}, pages = {IX, 385}, year = {2011}, language = {de} } @book{GassmannBader2007, author = {Gassmann, Oliver and Bader, Martin}, title = {Patentmanagement}, subtitle = {Innovationen erfolgreich nutzen und sch{\"u}tzen}, edition = {Zweite, aktualisierte Auflage}, publisher = {Springer}, address = {Berlin}, isbn = {978-3-540-68973-7}, doi = {https://doi.org/10.1007/978-3-540-68973-7}, pages = {X, 368}, year = {2007}, language = {de} } @article{BonakdarFrankenbergerBaderetal.2017, author = {Bonakdar, Amir and Frankenberger, Karolin and Bader, Martin and Gassmann, Oliver}, title = {Capturing value from business models: the role of formal and informal protection strategies}, volume = {73}, journal = {International Journal of Technology Management}, number = {4}, publisher = {Inderscience}, address = {Cointrin}, issn = {1741-5276}, doi = {https://doi.org/10.1504/IJTM.2017.083073}, pages = {151 -- 175}, year = {2017}, language = {en} } @book{GassmannBaderThompson2021, author = {Gassmann, Oliver and Bader, Martin and Thompson, Mark James}, title = {Patent Management}, series = {Management for Professionals}, subtitle = {Protecting Intellectual Property and Innovation}, publisher = {Springer}, address = {Cham}, isbn = {978-3-030-59009-3}, doi = {https://doi.org/10.1007/978-3-030-59009-3}, pages = {XX, 264}, year = {2021}, language = {en} } @book{GassmannBader2024, author = {Gassmann, Oliver and Bader, Martin}, title = {Patentmanagement}, subtitle = {Innovationen erfolgreich nutzen und sch{\"u}tzen}, edition = {5., vollst{\"a}ndig {\"u}berarbeitete und erweiterte Auflage}, publisher = {Springer}, address = {Berlin}, isbn = {978-3-662-68488-7}, doi = {https://doi.org/10.1007/978-3-662-68488-7}, pages = {XXI, 386}, year = {2024}, language = {de} } @inbook{BaderGassmann2021, author = {Bader, Martin and Gassmann, Oliver}, title = {Patent Strategies in the Networked Economy}, booktitle = {Connected Business: Create Value in a Networked Economy}, editor = {Gassmann, Oliver and Ferrandina, Fabrizio}, publisher = {Springer}, address = {Cham}, isbn = {978-3-030-76897-3}, doi = {https://doi.org/10.1007/978-3-030-76897-3_14}, pages = {247 -- 264}, year = {2021}, language = {en} } @book{GassmannSchuhmachervonZedtwitzetal.2024, author = {Gassmann, Oliver and Schuhmacher, Alexander and von Zedtwitz, Max and Reepmeyer, Gerrit}, title = {F{\"u}hrung und Organisation pharmazeutischer Innovation}, subtitle = {Wie man den Wettlauf der Life Sciences gewinnt}, publisher = {Springer Gabler}, address = {Cham}, isbn = {978-3-031-43818-9}, doi = {https://doi.org/10.1007/978-3-031-43818-9}, pages = {XV, 205}, year = {2024}, language = {de} } @article{SchuhmacherGassmannHinder2016, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus}, title = {Changing R\&D models in research-based pharmaceutical companies}, volume = {14}, pages = {105}, journal = {Journal of Translational Medicine}, publisher = {BioMed Central}, address = {London}, issn = {1479-5876}, doi = {https://doi.org/10.1186/s12967-016-0838-4}, year = {2016}, abstract = {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.}, language = {en} } @article{SchuhmacherGassmannMcCrackenetal.2018, author = {Schuhmacher, Alexander and Gassmann, Oliver and McCracken, Nigel and Hinder, Markus}, title = {Open innovation and external sources of innovation. An opportunity to fuel the R\&D pipeline and enhance decision making?}, volume = {16}, pages = {119}, journal = {Journal of Translational Medicine}, number = {1}, publisher = {BioMed Central}, address = {London}, issn = {1479-5876}, doi = {https://doi.org/10.1186/s12967-018-1499-2}, year = {2018}, abstract = {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.}, language = {en} } @book{GassmannSchuhmachervonZedtwitzetal.2018, author = {Gassmann, Oliver and Schuhmacher, Alexander and von Zedtwitz, Max and Reepmeyer, Gerrit}, title = {Leading Pharmaceutical Innovation}, subtitle = {How to Win the Life Science Race}, edition = {Third Edition}, publisher = {Springer}, address = {Cham}, isbn = {978-3-319-66833-8}, doi = {https://doi.org/10.1007/978-3-319-66833-8}, pages = {XV, 179}, year = {2018}, language = {en} } @inbook{SchuhmacherGassmannHinder2016, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus}, title = {A Review of the Pharmaceutical R\&D Efficiency: Costs, Timelines, and Probabilities}, booktitle = {Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation}, editor = {Schuhmacher, Alexander and Hinder, Markus and Gassmann, Oliver}, publisher = {Wiley}, address = {Weinheim}, isbn = {978-3-527-69343-6}, doi = {https://doi.org/10.1002/9783527693405.ch4}, pages = {61 -- 79}, year = {2016}, language = {en} } @inbook{BaderGassmann2022, author = {Bader, Martin and Gassmann, Oliver}, title = {Patents in the Biomedical Sciences and Industry - The Case of the Swiss Life Science Company Prionics}, booktitle = {Principles of Biomedical Sciences and Industry: Translating Ideas into Treatments}, editor = {Hinder, Markus and Schuhmacher, Alexander and Goldhahn, J{\"o}rg and Hartl, Dominik}, publisher = {Wiley-VCH}, address = {Weinheim}, isbn = {978-3-527-34571-7}, doi = {https://doi.org/10.1002/9783527824014.ch16}, pages = {305 -- 315}, year = {2022}, language = {en} } @article{SchuhmacherHinderBogeretal.2022, author = {Schuhmacher, Alexander and Hinder, Markus and Boger, Nikolaj and Hartl, Dominik and Gassmann, Oliver}, title = {The significance of blockbusters in the pharmaceutical industry}, volume = {22}, journal = {Nature Reviews Drug Discovery}, number = {3}, publisher = {Springer Nature}, address = {London}, issn = {1474-1784}, doi = {https://doi.org/10.1038/d41573-022-00213-z}, pages = {177 -- 178}, year = {2022}, language = {en} } @article{SchuhmacherBriekeGassmannetal.2021, author = {Schuhmacher, Alexander and Brieke, Clara and Gassmann, Oliver and Hinder, Markus and Hartl, Dominik}, title = {Systematic risk identification and assessment using a new risk map in pharmaceutical R\&D}, volume = {26}, journal = {Drug Discovery Today}, number = {12}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2021.06.015}, pages = {2786 -- 2793}, year = {2021}, language = {en} } @article{SchuhmacherHinderBriefetal.2025, author = {Schuhmacher, Alexander and Hinder, Markus and Brief, Elazar and Gassmann, Oliver and Hartl, Dominik}, title = {Benchmarking R\&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022)}, volume = {30}, pages = {104291}, journal = {Drug Discovery Today}, number = {2}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104291}, year = {2025}, abstract = {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\%.}, language = {en} } @article{SchuhmacherGassmannHinderetal.2021, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus and Kuss, Michael}, title = {The present and future of project management in pharmaceutical R\&D}, volume = {26}, journal = {Drug Discovery Today}, number = {1}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2020.07.020}, pages = {1 -- 4}, year = {2021}, language = {en} } @article{SchuhmacherGrinchenkoGassmannetal.2025, author = {Schuhmacher, Alexander and Grinchenko, Kyrylo and Gassmann, Oliver and Hartl, Dominik and Hinder, Markus}, title = {A case study assessing the impact of M\&A and licensing on FDA drug approvals of leading pharmaceutical companies}, volume = {30}, pages = {104306}, journal = {Drug Discovery Today}, number = {3}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104306}, year = {2025}, abstract = {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.}, language = {en} } @article{SchuhmacherWilischKussetal.2021, author = {Schuhmacher, Alexander and Wilisch, Lucas and Kuss, Michael and Kandelbauer, Andreas and Hinder, Markus and Gassmann, Oliver}, title = {R\&D efficiency of leading pharmaceutical companies - A 20-year analysis}, volume = {26}, journal = {Drug Discovery Today}, number = {8}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2021.05.005}, pages = {1784 -- 1789}, year = {2021}, language = {en} } @article{SchuhmacherGattoHinderetal.2020, author = {Schuhmacher, Alexander and Gatto, Alexander and Hinder, Markus and Kuss, Michael and Gassmann, Oliver}, title = {The upside of being a digital pharma player}, volume = {25}, journal = {Drug Discovery Today}, number = {9}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2020.06.002}, pages = {1569 -- 1574}, year = {2020}, language = {en} } @article{SchuhmacherGermannTrilletal.2013, author = {Schuhmacher, Alexander and Germann, Paul-Georg and Trill, Henning and Gassmann, Oliver}, title = {Models for open innovation in the pharmaceutical industry}, volume = {18}, journal = {Drug Discovery Today}, number = {23-24}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2013.07.013}, pages = {1133 -- 1137}, year = {2013}, language = {en} } @article{SchuhmacherHinderBogeretal.2023, author = {Schuhmacher, Alexander and Hinder, Markus and Boger, Nikolaj and Gassmann, Oliver and Hartl, Dominik}, title = {Is the blockbuster imperative broken?}, volume = {28}, pages = {103789}, journal = {Drug Discovery Today}, number = {11}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2023.103789}, year = {2023}, language = {en} } @article{SchuhmacherGassmannKussetal.2019, author = {Schuhmacher, Alexander and Gassmann, Oliver and Kuss, Michael and Hinder, Markus}, title = {The Art of Virtualizing Pharma R\&D}, volume = {24}, journal = {Drug Discovery Today}, number = {11}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2019.07.004}, pages = {2105 -- 2107}, year = {2019}, language = {en} } @article{SchuhmacherHinderDodeletal.2023, author = {Schuhmacher, Alexander and Hinder, Markus and Dodel, Alexander and Gassmann, Oliver and Hartl, Dominik}, title = {Investigating the origins of recent pharmaceutical innovation}, volume = {22}, journal = {Nature Reviews Drug Discovery}, number = {10}, publisher = {Springer}, address = {London}, issn = {1474-1784}, doi = {https://doi.org/10.1038/d41573-023-00102-z}, pages = {781 -- 782}, year = {2023}, language = {en} } @article{SchuhmacherGassmannBienioketal.2022, author = {Schuhmacher, Alexander and Gassmann, Oliver and Bieniok, Doria and Hinder, Markus and Hartl, Dominik}, title = {Open innovation: A paradigm shift in pharma R\&D?}, volume = {27}, journal = {Drug Discovery Today}, number = {9}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2022.05.018}, pages = {2395 -- 2405}, year = {2022}, language = {en} } @article{SchuhmacherGassmannHinderetal.2024, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus and Hartl, Dominik}, title = {Comparative analysis of FDA approvals by top 20 pharma companies (2014-2023)}, volume = {29}, pages = {104128}, journal = {Drug Discovery Today}, number = {9}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2024.104128}, year = {2024}, abstract = {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.}, language = {en} } @article{SchuhmacherHaefnerHonsbergetal.2022, author = {Schuhmacher, Alexander and Haefner, Naomi and Honsberg, Katharina and Goldhahn, J{\"o}rg and Gassmann, Oliver}, title = {The dominant logic of Big Tech in healthcare and pharma}, volume = {28}, pages = {103457}, journal = {Drug Discovery Today}, number = {2}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2022.103457}, year = {2022}, language = {en} } @article{SchuhmacherHindervonStegmannundSteinetal.2023, author = {Schuhmacher, Alexander and Hinder, Markus and von Stegmann und Stein, Alexander and Hartl, Dominik and Gassmann, Oliver}, title = {Analysis of pharma R\&D productivity - a new perspective needed}, volume = {28}, pages = {103726}, journal = {Drug Discovery Today}, number = {10}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2023.103726}, year = {2023}, language = {en} } @article{SchuhmacherGattoKussetal.2021, author = {Schuhmacher, Alexander and Gatto, Alexander and Kuss, Michael and Gassmann, Oliver and Hinder, Markus}, title = {Big Techs and startups in pharmaceutical R\&D - A 2020 perspective on artificial intelligence}, volume = {26}, journal = {Drug Discovery Today}, number = {10}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2021.04.028}, pages = {2226 -- 2231}, year = {2021}, language = {en} } @article{KwisdaKremerSievertsenetal.2025, author = {Kwisda, Sebastian and Kremer, Malte and Sievertsen, Niels and Gassmann, Oliver and Hartl, Dominik and Schuhmacher, Alexander}, title = {Does pharma R\&D need a strategic reset? Adapting to a changing US landscape}, volume = {30}, pages = {104442}, journal = {Drug Discovery Today}, number = {9}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104442}, year = {2025}, abstract = {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.}, language = {en} } @article{SchuhmacherGassmannKwisdaetal.2025, author = {Schuhmacher, Alexander and Gassmann, Oliver and Kwisda, Sebastian and Kremer, Malte and Hinder, Markus and Hartl, Dominik}, title = {The R\&D productivity challenge: transforming the pharmaceutical ecosystem}, volume = {30}, pages = {104494}, journal = {Drug Discovery Today}, number = {11}, publisher = {Elsevier}, address = {Amsterdam}, issn = {1878-5832}, doi = {https://doi.org/10.1016/j.drudis.2025.104494}, year = {2025}, abstract = {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.}, language = {en} } @inbook{SchuhmacherGassmannHinder2016, author = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus}, title = {New Innovation Models in Pharmaceutical R\&D}, booktitle = {Value Creation in the Pharmaceutical Industry: The Critical Path to Innovation}, editor = {Schuhmacher, Alexander and Gassmann, Oliver and Hinder, Markus}, publisher = {Wiley}, address = {Weinheim}, isbn = {978-3-527-69343-6}, doi = {https://doi.org/10.1002/9783527693405.ch18}, pages = {401 -- 415}, year = {2016}, language = {en} } @unpublished{BoemelburgSchuhmacherGassmann2025, author = {Boemelburg, Raphael and Schuhmacher, Alexander and Gassmann, Oliver}, title = {Open Innovation Strategies and Product Performance in Pharma R\&D: Insights into Exploration and Exploitation}, titleParent = {SSRN}, publisher = {Elsevier}, address = {Amsterdam}, doi = {https://dx.doi.org/10.2139/ssrn.5562088}, year = {2025}, language = {en} }