プロフィール詳細

プロジェクトを作成

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Dr. Nikolaos D.に依頼

United Kingdom

Analytical Development & CMC Consultant | PhD Biochemist | Method Validation, Potency Assay & Regulatory Compliance Expe

プロフィール概要

I am an Analytical Development Scientist and Biochemist (PhD in Drug Delivery & Microbiology) with over a decade of experience in biologics, cell & gene therapy and advanced therapy medicinal products (ATMPs). My expertise spans analytical method development, validation, comparability studies and CMC documentation in alignment with EMA/FDA and ICH regulatory standards. I have served as Molecular Biology Subject Matter Expert at Quell Therapeutics (London, UK) and were the Lead Scientist / Study Manager (Research Associate) of the Antigen Presentation Research Group at Imperial College London. Previously, at MSD Animal Health and Bristol Laboratories, I gained extensive experience in QC method transfer, stability studies, and lifecycle management of analytical assays. I have led the development and optimisation of a wide variety of methods, spanning label-free bioassays (biosensing), potency assays, ELISAs, PCR (quantitative and digital) and HPLC. My consultancy focuses on bridging science and regulatory expectations - from assay qualification and specification setting to analytical control strategy and data integrity. I bring a pragmatic, solution-driven approach to every project and ensure scientifically robust, inspection-ready deliverables. I collaborate with biotech startups, CROs and pharma companies worldwide to streamline analytical workflows and achieve compliance across the product lifecycle.

専門分野

• ★ Biochemical Assays
• ★ PCR
• ★ Bioanalytical Testing
• ☆ Natural Product Chemistry
• ☆ Physical Chemistry
• ☆ Biopolymers
• ☆ Polymer Chemistry
• ☆ Electrochemistry
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Oxidative Stress & Mitochondrial Function
• ☆ Antioxidants
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Epigenetics
• ☆ Gene Expression Analysis
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytogenetics
• ☆ Gene Regulation
• ☆ Biotechnology & Bioengineering
• ☆ Microscopy
• ☆ Light Microscopy
• ☆ Fluorescence Microscopy
• ☆ Data Analysis
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Data Visualization
• ☆ Data Collection
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Text Mining & Analytics
• ☆ Biomarker Discovery
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Industrial Biotechnology
• ☆ Biosensors
• ☆ Population Genetics
• ☆ Cytometry
• ☆ Cell Aging
• ☆ Drug Development
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ Feasibility Studies
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Technical Writing

Research Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Quality Assurance & Control (QA/QC)

職務経験

Scientist II, Analytical Development (R&D)

Quell Therapeutics Ltd

7月 2023 - 6月 2025

Research Associate

Imperial College London

1月 2022 - 7月 2023

QC specialist

MSD Animal Health UK

11月 2020 - 1月 2022

Analytical Development Scientist

Bristol laboratories

10月 2019 - 11月 2020

PhD candidate

Cardiff University

4月 2016 - 7月 2020

National and Kapodistrian University of Athens

Research Associate / R&D Officer

5月 2015 - 3月 2016

QC / AD / R&D Analyst

Greek Military Pharmaceutical Laboratories

11月 2014 - 8月 2015

学歴

PhD (Pharmacy and Pharmaceutical Sciences)

Cardiff University

4月 2016 - 7月 2020

MSc (Pharmaceutical Technology)

National and Kapodistrian University of Athens

10月 2012 - 10月 2014

BSc (Biochemistry and Biotechnology)

University of Thessaly

9月 2008 - 10月 2012

認定資格

• n/a

  n/a

  1月 2025 - 1月 2025

出版物

JOURNAL ARTICLE

Bostan, H.B., Taghdisi, S.M., Bowen, J.L., Demertzis, N., Rezaee, R., Panahi, Y., Tsatsakis, A.M., Karimi, G.(2018). Determination of microcystin-LR, employing aptasensors . Biosensors and Bioelectronics. 119. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 110-118.

Katsarou, M.-S., Giakoumaki, M., Papadimitriou, A., Demertzis, N., Androutsopoulos, V., Drakoulis, N.(2018). Genetically driven antioxidant capacity in a Caucasian Southeastern European population . Mechanisms of Ageing and Development. 172. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1-5.

(2017). Effect of Olive Oil Phenolics on Lipidemic Profile and Oxidative Stress in Mice . Journal of Food Nutrition and Dietetics.

A Lymberopoulos and C Demopoulou and M Kyriazi and MS Katsarou and N Demertzis and S Hatziandoniou and H Maswadeh and G Papaioanou and C Demetzos and H Maibach and M Rallis(2017). Liposome percutaneous penetration in vivo . Toxicology Research and Application. 1. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 239784731772319. {SAGE} Publications

Katsarou, M.-S., Karakonstantis, K., Demertzis, N., Vourakis, E., Skarpathioti, A., Nosyrev, A.E., Tsatsakis, A., Kalogridis, T., Drakoulis, N.(2017). Effect of single-nucleotide polymorphisms in ADH1B, ADH4, ADH1C, OPRM1, DRD2, BDNF, and ALDH2 genes on alcohol dependence in a Caucasian population . Pharmacology Research and Perspectives. 5. (4).

Katsarou, M.-S., Latsi, R., Papasavva, M., Demertzis, N., Kalogridis, T., Tsatsakis, A.M., Spandidos, D.A., Drakoulis, N.(2016). Population-based analysis of the frequency of HFE gene polymorphisms: Correlation with the susceptibility to develop hereditary hemochromatosis . Molecular Medicine Reports. 14. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 630-636.

Goutzourelas, N., Stagos, D., Demertzis, N., Mavridou, P., Karterolioti, H., Georgadakis, S., Kerasioti, E., Aligiannis, N., Skaltsounis, L., Statiri, A., et al.(2014). Effects of polyphenolic grape extract on the oxidative status of muscle and endothelial cells . Human and Experimental Toxicology. 33. (11). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1099-1112.