@article{HartldeLucaKostikovaetal.2021, author = {Hartl, Dominik and de Luca, Valeria and Kostikova, Anna and Laramie, Jason and Kennedy, Scott and Ferrero, Enrico and Siegel, Richard and Fink, Martin and Ahmed, Sohail and Millholland, John and Schuhmacher, Alexander and Hinder, Markus and Piali, Luca and Roth, Adrian}, title = {Translational precision medicine: an industry perspective}, volume = {19}, pages = {245}, journal = {Journal of Translational Medicine}, publisher = {BioMed Central}, address = {London}, issn = {1479-5876}, doi = {https://doi.org/10.1186/s12967-021-02910-6}, year = {2021}, abstract = {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.}, 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} } @inbook{HinderHartlSchuhmacher2022, author = {Hinder, Markus and Hartl, Dominik and Schuhmacher, Alexander}, title = {Biopharmaceutical Innovation at a Glance}, 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.ch1}, pages = {1 -- 6}, 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{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{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{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} }