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--- biontech [2022/05/03 23:06]
pamela [Development of mRNA Vaccine Technology]
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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.((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))
-==== 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 ((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf))
-== 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. ((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf))
-{{ ::biontech_trial_officials.png?600 |}}