Pharmaceutical-Drug Testing, Development, Toxicology and Validation Expert

Expertise

Summary

Over 17 years of drug testing experience on the development, validation, and application of analytical methods. 

Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures. 

SOPs, preparation, forensic toxicology expert witness, and the preparation of clinical and non-clinical overview, (Module 2) expert reports for submission of CTD dossiers in regulatory authorities.Design-Operations-Maintenance of: Toxicological Testing Lab (Forensic/Clinical):  Cannabis Testing Lab:  Drug Testing Lab, and d) Bioequivalence, Pharmaceutical testing lab for start-ups.

• Bioanalytical methods development and validation for small molecules (LC-MS/MS, HPLC, GCMS).
• Regulatory requirements for cannabis testing.
• Guidance on purchasing necessary equipment.
• Preparation of SOPs for toxicological including cannabis and bioequivalence testing laboratories.
• Quality Assurance (QA) of forensic toxicology testing lab (ISO 17025) and bioequivalence and pharmaceutical testing lab (GLP).
• Pharmaceutical Analysis (Drug testing) – Quality Control (Drug stability).
• Preparation of  Forensic Toxicology Expert reports in more than 3000 cases.
• Design and execution of bioequivalence studies of generic drugs (Phase I).
• Preparation of Clinical and Non-Clinical overview expert reports for submission of CTD dossiers in regulatory authorities.
• Preparation of bio-waiver and deficiency expert reports to regulatory authorities.
• Migration studies of liquid pharmaceutical formulations.

Expert Witness 

• Numerous forensic cases (related to car accidents involving use of alcohol and cannabis).

Experience

Undisclosed University, Associate Professor of Toxicology, 2015 - Present

• Member of Alternative Sampling Strategies Committee (International Association of Therapeutic Drug Monitoring and Clinical Toxicology.

University of Athens, School of Medicine, Athens, Greece, 2006 – 2015

Assistant Professor of Forensic Toxicology, 2012 - 2015

Lecturer of Forensic Toxicology, 2006 - 2012

• Served as forensic toxicologist expert and witness on behalf of the Greek police and the Greek

Ministry of Justice.

• Quality Assurance Manager of ISO 17025 Forensic Toxicology lab
• Consultant to Greek Pharmaceutical generic companies (e.g. Vianex, Famar, Genepharm) and
• pharmaceutical CRO (Institute for Clinical Investigation, Lamda Pharmaceuticals).
• Advisory board for prescribed Drugs, National Organization for Medicines (EOF).
• Auditor for Forensic Toxicology and Doping laboratories, Greek Accreditation System (E.SY.D.)
• Technical Committee for Laboratories No.1, Greek Accreditation System (E.SY.D.)
• Team Leader for the accreditation of the forensic toxicology lab according to the ISO 17025 standard.
• Project Manager for the development and validation of analytical methods for the determination of drugs of abuse and prescribed drugs in biospecimens (Immunoassays, LC-MS, GC-MS, HSGC-FID, GC-NPD).
• Evaluated more than 3000 forensic toxicological cases.
• Managed the re-certification of the lab with ISO17025 standard.
• Research including the development of new bioanalytical methods in LC-MS for the determination of drugs and drugs of abuse in biospecimen.
• Expert consultant for a) the design of bioequivalence and drug testing studies (Quality control tests, migration studies of leachables and extractables), b) the preparation of Clinical and Non Clinical Overview expert reports (Module 2 of CTD for EMEA submission) for latanoprost, amlodipine, citalopram, ondansetron, ranitidine, mometasone, and oxaliplatin generic drugs and c) the preparation of biowaiver justification expert reports for amisulpride, ondansetron, trazodone, citalopram, and ranitidine generic drugs.
• All products were indented for submission and approval by the Greek and the EU pharmaceutical authorities.

ILS SA, Athens, Greece (CRO Pharmaceutical company), 2002 - 2006

• Laboratory Director and Project Manager of GLP bioanalytical laboratory for pharmacokinetic/bioequivalence studies of generic pharmaceutical products (Clinical studies Phase I) in healthy volunteers.

• Responsibilities included the coordination and the supervision of teams as well as the involvement on the development and validation of bioanalytical methods for the determination of drugs in human plasma and urine and their application in bioequivalence and pharmacokinetic studies (HPLC-UV/Vis, HPLC-Fl, LC-QQQ-MS/MS, LC-ion trap-MS/MS).
• Evaluated bioequivalence and pharmacokinetic studies.
• Principal Analytical Investigator at Phase I Clinical Trials for generic formulations.
• Laboratory Director and Project Manager for the development, validation and application of bioanalytical instrumental methods for the bioequivalence assessment but not limited of a) cefuroxime axetil 250 mg b) mirtazapine 30 mg c) alendronate 80 mg d) enalapril 20 mg e) risperidone 4 mg , f) glimepiride 4 mg, g) ondansetron 8mg, h) venlafaxine IR 75 mg, i) finasteride 5 mg, j) fosinopril 10 mg, k) hydrochlorothiazide 12.5 mg l) omeprazole 20mg m) fluconazole 100mg, n) losartan 25mg, o) indapamide 1.5mg, fluvastatin 20mg, p) citalopram 20mg, generic formulations.

• Principal Analytical Investigator at Phase I Clinical Trials for the generic formulations of venlafaxine XR 150 mg steady state, venlafaxine IR 150 mg, lisinopril 20 mg, fosinopril 10mg, glimepiride 4mg and mirtazapine 30mg tablets.

• Responsibilities included the supervision of the proper implementation of analytical protocol of the study, according to the GLP guidelines.
• Prepared the laboratory for system and Clinical Trials Phase I audit according to the GLP and GCP guidelines by ADAMAS (UK).
• Prepared the laboratory for system and Clinical Trials Phase I audit according to the GLP and GCP guidelines by the Greek National Organization for Medicines (EOF).

The University of Georgia Athens, College of Pharmacy, GA, 2001 – 2002

• Post-doctoral fellow

Honors & Publications

Languages

• Greek, Mother Tongue (Fluent in conversation, writing, reading)

Academic and Professional Affiliations

• Alternative Sampling Strategies Committee (International Association of Therapeutic DrugMonitoring and Clinical Toxicology, IATDMCT)

  Advisory Board for prescribed Drugs, National Organization for Medicines (EOF), Greece
• Auditor for Forensic Toxicology and Doping laboratories, Greek Accreditation System (E.SY.D.)
• Technical Committee for Laboratories No.1, Greek Accreditation System (E.SY.D.)
• Northeastern Association of Forensic Scientist (NEAFS)
• The International Association of Forensic Toxicologists (TIAFT)
• International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT)

Awards

• University Honors College Outstanding Faculty Award

Publications and Patents

• Author and Co-Author of 54 peer reviewed articles, 35 presentations in local and international meetings, 4 chapters in books with subjects in the pharmaceutical analysis, bioequivalence, pharmacokinetics, toxicology, and forensic toxicology.

Education

• Ph.D. Pharmaceuticals, University of Athens, Greece
• M.Sc. Pharmaceutical Analysis-Quality Control, University of Athens, Greece
• B.S.   Pharmacy, Aristotle University of Thessaloniki, Thessaloniki, Greece