Flavia M. Sutera

Acting Head of Preclinical Development at SiSaf Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
UK
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency

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Bio

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Credentials

  • EEA qualified Pharmacist - Abilitazione all’esercizio della professione di Farmacista
    University of Palermo
    Jul, 2010
    - Nov, 2024

Experience

    • United Kingdom
    • Biotechnology Research
    • 1 - 100 Employee
    • Acting Head of Preclinical Development
      • Jan 2023 - Present

      Specialised in design and development of non-viral vectors using mesoporous Silicon particles for gene therapy applications and related Intellectual Property Rights fence. Preclinical development of Gene Therapy products based on administration of siRNA and mRNA associated to SiSaf novel non-viral vector. Providing preclinical reports for Orphan drug designation, CMC and Regulatory support

    • R&D Team Leader
      • Jul 2018 - Present

    • Postdoctoral Research Scientist
      • Jul 2016 - Jul 2018

      Main topics covered:Development of hybrid-silicon based Biocourier systems for drug delivery;Identification of drug lead candidates and optimization of existing formulations;Method development and specification for production, product design and packaging;Preparation of pilot batch formulation materials for in vivo studies.

    • Research Assistant
      • Apr 2015 - Apr 2016

      Main topics covered: Chemical Synthesis of new Dopamine Derivatives and Valproic Acid conjugates; Synthetic strategy; Animal Behaviour Analysis, Addiction, Dopaminergic Neurotransmission, Alcoholism, Depression; Estimation of LADME based on non-compartmental PK, Bioequivalence/Drug-Drug Interaction studies, Drug absorption modelling and simulation, Drug detection. Main topics covered: Chemical Synthesis of new Dopamine Derivatives and Valproic Acid conjugates; Synthetic strategy; Animal Behaviour Analysis, Addiction, Dopaminergic Neurotransmission, Alcoholism, Depression; Estimation of LADME based on non-compartmental PK, Bioequivalence/Drug-Drug Interaction studies, Drug absorption modelling and simulation, Drug detection.

    • PhD in Experimental Medicine and Neuroscience
      • Jan 2012 - Mar 2015

      PhD in Experimental Biomedicine and Clinical Neuroscience, working on a project entitled “New dopaminergic compounds in the treatment of addiction: preclinical studies on murine experimental models” - Dept. BIONEC, Division of NeuroPsychoPharmacology, University of Palermo, Italy PhD Guest at Dept. STEBICEF, University of Palermo, Italy Main topics covered: Chemical Synthesis of new Dopamine Derivatives and Valproic Acid conjugates; Synthetic strategy; Animal Behaviour Analysis, Addiction, Dopaminergic Neurotransmission, Alcoholism, Depression; Estimation of LADME based on non-compartmental PK, Bioequivalence/Drug-Drug Interaction studies, Drug absorption modelling and simulation, Drug detection.

    • Research Assistant
      • Jan 2011 - Jul 2012

      Research Assistant on studies and new applications of the intraoral device "IntelliDrug" in the frame of the project "Home-based Empowered Living for Parkinson's Disease patients" (HELP) granted by the "Ambient Assisted Living" (AAL) European Program. Main topics covered: HPLC, UV, IR instrumentations and related softwares; chromatography applications; Drug absorption simulators and management of related processing experimental data by compartmental analysis. Research Assistant on studies and new applications of the intraoral device "IntelliDrug" in the frame of the project "Home-based Empowered Living for Parkinson's Disease patients" (HELP) granted by the "Ambient Assisted Living" (AAL) European Program. Main topics covered: HPLC, UV, IR instrumentations and related softwares; chromatography applications; Drug absorption simulators and management of related processing experimental data by compartmental analysis.

    • Spain
    • Higher Education
    • 700 & Above Employee
    • PhD Student Guest
      • Jul 2012 - 2012

      Short Research stay at Dept. of Physiological Sciences II (Hospitalet de Llobregat, University), under the supervision of Prof. Jordi Llorens and Dr. Pere Boadas-Vaello. Main topics covered: Fluoro Jade B, a tracer technique generally employed for establishing a neuronal damage with the methodological simplicity and reliability of conventional stains, using a high affinity fluorescent marker for the localization of neuronal degeneration. Short Research stay at Dept. of Physiological Sciences II (Hospitalet de Llobregat, University), under the supervision of Prof. Jordi Llorens and Dr. Pere Boadas-Vaello. Main topics covered: Fluoro Jade B, a tracer technique generally employed for establishing a neuronal damage with the methodological simplicity and reliability of conventional stains, using a high affinity fluorescent marker for the localization of neuronal degeneration.

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Pharmaceutical Analyst
      • May 2011 - Oct 2011

      HPLC, UV, IR instrumentation and related software analysis; chromatography applications; Drug absorption simulators and management of related processing experimental data by compartmental analysis. HPLC, UV, IR instrumentation and related software analysis; chromatography applications; Drug absorption simulators and management of related processing experimental data by compartmental analysis.

    • Clinical Pharmacokinetist / Clinical Research Assistant
      • Sep 2010 - Jan 2011

      Stage at Corporate Clinical Research Directorate - Research & Development - Menarini Ricerche Main topics covered along the stage: - clinical development program, identification of go/no go decision points from first to man until full assessment of risk/benefits ratio; - Estimation of LADME based on non-compartimental PK analysis, Bioequivalence/Drug-Drug Interaction Studies; Basic introduction on Modeling And Simulation with WinNoNLin and NONMEM softwares about clinical pharmacokinetics (Phase I studies) - ICH/EMEA/FDA guidelines applicable to clinical development in general, pharmacokinetics, and to specific therapeutic areas of interest.

Education

  • Università degli Studi di Palermo
    Master's degree, Chemistry and Pharmaceutical Technologies, Faculty of Pharmacy, University of Palermo, Italy
    2004 - 2010

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