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Christina brings a more than 15 years experience in International Regulatory Affairs with special focus on the development of novel, innovative biotechnological products.

Particularly, the Regulatory planning and execution of the early development of Advanced Therapy Medicinal Products (ATMPs), Genetically Modified Organisms (GMOs) and Gene Therapy Products are key elements of Christina's operating area.
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Nicolodi Regulatory Affairs Consulting Services

In March 2020 Nicolodi Regulatory Affairs Consulting Services was founded by Christina Nicolodi who previously worked at global pharmaceutical players such as Takeda Pharmaceutical Company Limited/Shire Pharmaceuticals and Baxter/ Baxalta Innovations as European Regulatory Affairs Lead focusing on the clinical development and centralized procedure for advanced biotechnological products. 

Current projects are
  • Viral vector expressing a SARS Cov-2 antigen
  • Treatment for mild and moderate symptoms of Covid-19
  • Viral vector expressing tumour antigens
  • Viral vector expressing IFN
  • Life-attenuated influenza vaccine
  • Nasal spray against common cold

References

Takeda Pharm. Company/ Shire Pharmaceuticals
EU RA Lead for
  • AAV-8 Vector expressing FVIII (Phase 1)
  • AAV-8 Vector expressing FIX (Phase 1)
Baxter Innovations / Baxalta Innovations
EU RA Lead for
  • Obizur® (Phase 3 and CP)
  • Lyme vaccine (Phase 2)
  • Inactivated influenza vaccines (LCM)
AVIR Green Hills Biotechnology AG
Global RA Lead for
  • Seasonal Life-attenuated influenza vaccine (Phase 2)
  • Pandemic Life-attenuated influenza vaccine (Phase 1)
Gruenenthal GesmbH Austria
Regional RA Manager for
  • Contraceptives (MRP, LCM)
  • Pain killers (LCM)
  • NSARs (LCM)
  • Antibiotics (LCM)

Education

Medical University of Vienna, Dept. Clinical Pharmacology and Dept. Immunology, Austria, 2010-2014
Doctoral thesis: "Evaluation of immunological correlates of protection for delNS1-live-attenuated influenza vaccines"; Moessler et al, 2013

Medical University of Vienna, Dept. Medical Biology, Austria, 2003-2004
Diploma thesis: "Phage-host systems in the aerobic water column and sediment ot the Kuehwoerther Wasser, a mesotrophic, macrophyte-dominated oxbow lake."

Karl Franzens University Graz, Dept. Molecularbiology, Biochemistry and Microbiology, Austria, 1999-2004

Publications

Mössler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T.
Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1.
Vaccine. 2013; 31: 6194-6200

Nicolodi C, Groiss F, Kiselev O, Wolschek M, Seipelt J, Muster T. 
Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1. 
Vaccine. 2019; 37(28): 3722-3729

Nicolodi C
Orphan drug designation in Europe - Procedural guidance and challenges. 
IJDRA. 2019; 7(3): 1-7

Nicolodi C
ORF Gastbeitrag and Interview: Der lange Weg zur CoV-Impfung. ORF. 07May2020; https://science.orf.at/stories/3200704/ 
(Publication and Interview in the Austrian broadcast ORF: The long way to a CoV-vaccine. Article in German)

Interview for the ORF article: Vogler C. CoV-2 Impfstoff. Forschungsstand nur schwer zu beurteilen. ORF. 2020; https://orf.at/stories/3168737/ 
(Publication and Interview in the Austrian broadcast ORF: CoV-2 Vaccine. State of research. Article in German)

Interview for "Der Standard": Taschwer K. Der rasante Wettlauf um einen Covid-19-Impfstoff. Der Standard. 27/28Jun2020; https://www.derstandard.at/story/2000118196260/der-rasante-wettlauf-um-einen-covid-19-impfstoff 
(Publication and Interview in the Austrian newspaper "Der Standard": Race for a Covid-19-vaccine. Article in German)

Interview for "Kurier": E. Mauritz, C. Schimper. Die Nagelprobe steht noch aus oder Coronavirus-Impfstoff: Wie weit die Forschung bereits gekommen ist.
 Kurier 23Jul2020; 
https://kurier.at/wissen/gesundheit/coronavirus-impfstoff-wie-weit-die-forschung-bereits-gekommen-ist/400979210 
(Publication and Interview in the Austrian newspaper "Kurier": Coronavirus-Vaccine: State of research. Article in German)

Interview in "Kurier" Podcast 23Jul2020: https://kurier.at/podcasts/daily/podcast-corona-impfstoff-noch-2020-realistisch/400979006 

Interview for "Der Standard": Rennert D, Gaigg V. Die Corona-Impfung scheint greifbar, aber wird sie auch akzeptiert. Der Standard. 10Aug2020
https://www.derstandard.at/story/2000119174918/die-corona-impfung-scheint-greifbar-aber-wird-sie-auch-akzeptiert
(Publication and Interview in the Austrian newspaper "Der Standard": State of research and acceptance of a Coronavirus-Vaccine, Article in German)

Interview in the Austrian broadcast ORF, Studio 2. SARS-Cov-2 Vaccines. 10Aug2020

Panel discussion "Impfen, streiten, demonstrieren: Spaltet Corona unser Land" Servus TV, Talk im Hangar-7. 03Sept2020
https://www.youtube.com/watch?v=yVnoksZYEss 
(Is Corona splitting the society?, Panel discussion in German)

Interview in the Austrian broadcast ORF, Guten Morgen Österreich. SARS-Cov-2 Vaccines. 10Sept2020
https://tv.orf.at/gutenmorgen/stories/3006737/  

Panel discussion "Fact or Fake". Bank Austria Future Talk. 09Nov2020
https://www.bankaustria.at/future-talk-fakt-oder-fake.jsp with Andre Wolf (Mimikama) and Michael Litschka (Ethicist for Media), Panel discussion in German

Interview for "Der Standard": Tascher K. Wie geht es mit den Corona-Impfungen weiter? Der Standard. 10Nov2020 
https://www.derstandard.at/story/2000121588003/wie-geht-es-nach-dem-durchbruchmit-den-corona-impfungen-nun 
(Interview for the Austrian newspaper "Der Standard": SARS-Cov-2 vaccines: What's next?, Article in German)

Interview for "Der Standard": Taschwer K. Die logistische Herausforderung des Corona-Impfstoffs von BioNTECH. Der Standard. 19Nov20;
https://www.derstandard.at/story/2000121847750/die-logistische-herausforderung-des-corona-impfstoffs-von-biontech 
(Publication and Interview in the Austrian newspaper "Der Standard": Logistical barriers for the distribution of BioNTECH's SARS-Cov-2 vaccine, Article in German)

Interview for the ORF article: Hutsteiner R. Wie Impfstoffzulassung in EU funktioniert. ORF 23Nov2020; https://science.orf.at/stories/3203082/ 
(Publication and Interview in the Austrian broadcast ORF: License procedure for vaccines in the European Union. Article and interview in German)