125742 S1 M5 5351 bnt162 01 interim3 sponsor personnel list
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BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162 -01 Page 1 of 1 Version: 2.0 Date: 26 Nov 2020 16.1. 13 List of sponsor personnel who materially affected the trial conduct The following table presents a list of sponsor personnel who materially affected the trial conduct. The full list of all involved sponsor personnel is maintained in the trial master file ( TMF). Name Role Özlem Türeci , MD Chief Medical Officer ( Spons or’s medically qualified person ) b Svetlana Shpyro , MD Medical Expert Dr. Stefan Liebscher Biostatistician (External BioNTech Consultant) Sean Murphy Biostatistician (External BioNTech Consultant) Dr. Christopher Marshallsay Head Scientific -Medical Writing a Dr. Frans van Huizen Senior Scientific / Medical Writer Dr. David Langer Clinical Study Manager Dr. Stefanie Bolte Clinical Study Manager Martin Bexon , MD Medical Monitor (External BioNTech Consultant) Amélie Caneparo Pharmacovigilance Manager Claudia Müller Clinical Data Manager (External BioNTech Consultant) Dr. Tania Palanche Senior Clinical Data Manager a) Document owner fulfills the requirements of the author according to ICH E3. b) Corresponds to the medical officer defined in ICH E3. 090177e195a37562\Approved\Approved On: 28-Nov-2020 02:43 (GMT) Page 1 FDA-CBER-2021-5683-0049413