@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} }