Gabriel Kaufman Email & Phone Number

-Develop and execute pharmacokinetic analyses supporting clinical dug development programs-Responsible for GCP regulatory compliance-Process improvement initiatives

Tel Aviv, Israel

-Developed and executed drug metabolism and pharmacokinetics (DMPK) analyses supporting preclinical and clinical programs: more than 30 Phase 1, Phase 2, and Phase 3 studies, including single ascending dose (SAD), multiple ascending dose (MAD), bioequivalence (BE), and dose proportionality. Disease areas included oncology, neurology, and metabolic disorders.-Performed noncompartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD) and exposure-response (E R) modelling using Phoenix WinNonlin.-Authored analysis plans, reports, regulatory filings, and slide decks for submission to clients and regulatory authorities: 20 studies, including clinical study report sections, pharmacokinetic (PK) reports, and common technical document sections 2.7.1 and 2.7.2.-Contributed to clinical pharmacology strategy for drug development programs under senior scientific leadership: 3 programs, including dose escalation, biomarker selection and analysis, and PK/PD correlations. Disease areas included oncology and neurology.-Functioned as a subject matter expert to generate new business in collaboration with business development office: 2 project wins, including data formatting and biostatistics.

Montreal, Quebec, Canada

-Developed and executed DMPK analyses supporting preclinical and clinical programs: 80 studies across preclinical, Phase 1, Phase 2, and Phase 3 including SAD, MAD, and dose proportionality. Disease areas included oncology, rare diseases, and metabolic disorders. Responsible for Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulatory compliance.-Performed noncompartmental analysis (NCA), statistical analyses, and nonlinear mixed-effects modelling (NLME) using Phoenix WinNonlin, Phoenix NLME, and R.-Performed in vitro/in vivo correlations (IVIVC) using Phoenix WinNonlin for submission of bioequivalence waivers to US FDA: 2 ophthalmology projects.-Compiled population PK (PopPK) meta-analysis report for 5 studies in a neurology program.-Organized and cleaned data for regulatory submissions: 15 studies, including CDISC submission package preparation, Define-XML, data definition files, and legacy study data conversions.-Developed business with new and existing clients: 10 project wins, including pharmacokinetics (PK) and data management.

Senneville

-Managed bioanalysis (BA) projects supporting preclinical and clinical studies: 30 studies, mainly for metabolic disorders and oncology indications. Methods included ELISA, hybridization assay, and multiplex bead assays. Instrumentation included spectrophotometry, fluorophotometry, and Meso Scale Discovery.-Developed, validated, and analyzed trial samples for large-molecule drugs, including biologics, nucleic acids, and antibodies.-Mentored 5 technical staff in method development, method validation, and sample analysis as per FDA and EMA bioanalytical method regulatory guidance and GLP/CGP compliance.-Led internal process-improvement initiatives: investigated electronic laboratory notebook (ELN) systems and redesigned data form documents for smoother data capture.

Montreal, Canada

PhD student in laboratory of Bruce Mazer at RI-MUHC.-Tested new treatments for allergic asthma using animal models and cell-culture approaches.-Developed and optimized experimental protocols for flow cytometry, respiratory physiology, and other immunological techniques.-Point person for rederivation of laboratory animal colony in new animal facility.-Obtained salary/research support grant (105K) from Canadian Institutes of Health Research-Mentored junior lab members (2 project students, 1 intern) in study planning, lab techniques, writing and presentation skills.

Complex Traits Group

Research assistant for new academic research lab directed by Jörg Fritz.-Managed operational start-up of new research lab: 250K Canada Foundation for Innovation and 200K McGill seed funding. Responsible for budgeting and procurement process for infrastructure equipment.-Lab coordinator, purchasing and inventory manager, and technical resource-person.-Trained project students (2) in laboratory skills.

MSc student in laboratory of Florina Moldovan MD PhD.-Developed animal model of osteoarthritis to test novel drug combination.-Reverse-engineered apparatus for small-animal orthopaedics research.-Coordinated patent application and technology transfer process for novel drug combination. Drafted specification with patent agent.-Obtained Canadian Institutes of Health Research operating grant funding (94K). Managed all aspects of project from study planning through to reporting.

Project research student (part-time) in laboratory of Janet E Henderson PhD.-Optimized cell culture methods using orthopaedic implant materials.

Doctor Of Philosophy (Ph.D.), Experimental Medicine

Experimental Medicine, immunology concentration. Dissertation entitled "Immune modulation by intravenous immune globulin: cross-talk.

Graduate Diploma In Business Administration, Business Administration, Management And Operations

Graduate diploma coursework in in management, strategy and operations, accounting and finance, marketing

Master’S Degree, Biomedical Sciences

Master's of Biomedical Science, musculoskeletal concentration. Dissertation entitled: "Therapeutic potential of endothelin receptor type.

Bachelor’S Degree, Cell Biology And Anatomy

Major in Anatomy & Cell Biology. Research project in third year.