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BioNTech
Development of mRNA Vaccine Technology
On October 16, 2019, Nature published an article describing BioNTech's successes in testing experimental immunotherapy vaccines for cancer, and suggested the progress could be applied to solve problems like rabies and pandemic influenza.1)
Clinical Trials Pfizer FOIA
BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162-01 Page 1 of 1 Version: 2.0 Date: 26 Nov 2020 2)
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 (looking for it)
- Name Role
- Özlem Türeci, MD Chief Medical Officer (Sponsor’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. 3)
1)
Dolgin, E. (2019). Unlocking the potential of vaccines built on messenger RNA. Nature, 574(7778), S10–S12. https://doi.org/10.1038/d41586-019-03072-8