1. Clinical Development and Initial Approval of Novel Immune Checkpoint Inhibitors in Oncology: Insights From a Global Regulatory Perspective. Issue 3 (12th September 2018) Authors: Serrano, Philippe; Hartmann, Markus; Schmitt, Elmar; Franco, Pedro; Amexis, Georgios; Gross, Jan; Mayer‐Nicolai, Christine Journal: Clinical pharmacology & therapeutics Issue: Volume 105:Issue 3(2019) Page Start: 582 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Real-world data in drug development strategies for orphan drugs: Tafasitamab in B-cell lymphoma, a case study for an approval based on a single-arm combination trial. Issue 6 (June 2022) Authors: Serrano, Philippe; Yuen, Hiu Wah; Akdemir, Julia; Hartmann, Markus; Reinholz, Tatjana; Peltier, Sylvie; Ligensa, Tanja; Seiller, Claudia; Paraiso Le Bourhis, Achta Journal: Drug discovery today Issue: Volume 27:Issue 6(2022) Page Start: 1706 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗