About Me
Alexandra Günzl, PhD
Independent Non-Clinical Consultant
As non-clinical expert I provide independent, flexible, and practical hands-on support to my clients across the full range of non-clinical activities, tackling different questions and challenges.
With a strong scientific background in cancer research and a postgraduate education in regulatory affairs, I have worked as a non-clinical consultant for more than 15 years.
I have extensive experience supporting non-clinical development and regulatory strategies for a broad range of therapeutic modalities:
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Small molecules
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Biotechnology-derived products (including monoclonal antibodies, recombinant proteins, peptides, antibody-like molecules)
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Advanced therapy medicinal products (ATMPs) / cellular and gene therapies (CGTs), with a particular focus on cell-based therapies
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Radiopharmaceuticals
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Substance-based medical devices.
Work Experience
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Since 2023 Independent Non-Clinical Consultant, Founder and Owner of Karyon Biopharma Consulting e.U.
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2015-2022 Consultant | MC Toxicology Consulting GmbH
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2012-2015 Junior Consultant | MC Toxicology Consulting GmbH
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2009-2013 PhD Student | Medical University Vienna
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2008-2012 Trainee (in parallel to PhD studies) | MC Toxicology Consulting GmbH
Education and Training
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2015-2016 Regulatory Affairs Manager | Postgraduate Program “Regulatory Affairs for Biopharmaceuticals including ATMPs” | European Centre for Regulatory Affairs (EUCRAF)
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2009-2013 PhD Studies “Malignant Diseases” | Medical University Vienna
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2004-2008 Master of Science in Natural Sciences (DI(FH)) | Biotechnology – Biomedicine | University of Applied Sciences Campus Wien