Dear all, The next seminar in our series of statistics talks for people interested in quantitative methods in biology and medicine will take place on Thursday 22 December 2016 at 11h15, in the Salle Delachaux (Biopôle 2, first floor, Route de la Corniche 10, 1010 Lausanne, M2: Vennes). The speaker will be Dr. Dominik Heinzmann (Associate Director Biostatistics, Roche, Basel, Switzerland) Title: Pharmacokinetic challenges and opportunities in drug development Abstract: The talk will first cover basic pharmacokinetic (PK) principles in drug development, including relevant research questions, endpoints to assess the objective, methods of measurement and interpretation. This general framework will then be discussed in the context of real case examples including the development of a different route of administration (subcutaneous versus intravenous) for oncology drugs, the development of an alternative device to administer drugs (handheld syringe versus a device) and the development of biosimilars (analogous to generics for biologics). Finally, feedback to the different approaches from various health authorities will be highlighted to provide the audience with a comprehensive overview on "viability" of those options. Hope to see you there! Valentin (for the organizers: Jérôme Goudet, Valentin Rousson, Frédéric Schütz)