Alexander Schuhmacher
Title
Dr.
Last Name
Schuhmacher
First name
Alexander
Email
alexander.schuhmacher@student.unisg.ch
14 results
Now showing 1 - 10 of 14
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Item type:Publication, A case study assessing the impact of M&A and licensing on FDA drug approvals of leading pharmaceutical companies(Elsevier, 2025); ; - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022)(Elsevier, 2025-02); ; ; Hartl, DominikPrevious 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%.Type:journal articleJournal:Drug Discovery TodayVolume:30Issue:2 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, The R&D productivity challenge: transforming the pharmaceutical ecosystem(2025); ; - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Does pharma R&D need a strategic reset? Adapting to a changing US landscape(Elsevier, 2025); Hartl, DominikR&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.Type:journal articleJournal:Drug Discovery TodayVolume:30Issue:9 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Investigating the origins of recent pharmaceutical innovation(2023-07-05); ; Hartl, DominikLeading pharmaceutical companies have historically been engaged in all stages of the R&D pipeline, from target identification through to drug marketing, and thus have been termed fully integrated pharmaceutical companies (FIPCOs). In the past decade, externally invented assets gained through partnering or mergers and acquisitions (M&As) have become a prominent component of the pipelines of such companies. Given the long development cycles and the increasing level of collaboration between pharma companies and biotech companies, however, the precise origins of innovation are not obvious, in part as regulatory approvals for innovative drugs by agencies such as the FDA are granted to the company filing the applications, which is not necessarily the company that discovered the active pharmaceutical ingredient. Understanding the origins of innovation provides a deeper understanding of the pharma business model and could support strategic improvements. We therefore systematically assessed the origins of innovation for all new molecular entities (NMEs) and new therapeutic biologics (NTBs) approved between 2015 and 2021 by the Center of Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) for the top 20 biopharma companies globally by sales in 2020 (see Supplementary information for details).Type:journal articleJournal:Nature Reviews Drug DiscoveryScopus© Citations 30 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Analysis of pharma R&D productivitya new perspective needed(2023-08-07); Scopus© Citations 80 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Open innovation: A paradigm shift in pharma R&D?(Elsevier Science, 2022-09); ; Scopus© Citations 44 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Systematic risk identification
and assessment using a new risk map
in pharmaceutical R&D(Elsevier Science, 2021); ; Scopus© Citations 17 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Big Techs and startups in pharmaceutical R&D – A 2020 perspective on artificial intelligence(Elsevier Science, 2021); ; Hinder, MarkusType:journal articleJournal:Drug Discovery Today - Some of the metrics are blocked by yourconsent settings
Item type:Publication, The upside of being a digital pharma
player(Elsevier Science, 2020); Scopus© Citations 48