Igor K. Email & Phone Number

Valemetostat development.

Newton, Massachusetts, United States

DLBCL, MDS/AML, myelofibrosis, melanoma, and COVID-19 trials

Danvers, Ma

Clinical development of immunohistochemistry (IHC) and in situ hybridization (ISH) companion diagnostic assays for the next generation of oncology therapeutic agents. Represent Clinical Affairs CDx in Pharma teams and at FDA.Study design – protocol writing, tissue procurement, statistical analysis planStudy conduct – management of external vendors & contract research organizations (CROs), oversight of database/biostatistical analysis of assay data, ensuring accuracy of data, clinical study operations/logisticsStudy reporting – data analysis & presentation to internal and external stakeholders, contribution to clinical reports

Cambridge, Ma

Responsible for directing the design, conduct, and interpretation of clinical studies supporting development and approval of companion diagnostic assays supporting the oncology pipeline. Regulatory submissions including: bridging studies to demonstrate diagnostic utility in the context of pivotal clinical trials; method comparison studies of the novel companion diagnostic in comparison to gold standard approaches; multi-laboratory reproducibility studies of the diagnostic test kit; sample acquisitions studies of rare tumor types, conducted under GCP. Manage clinical studies including detailed oversight of TMFs and laboratory data. Support regulatory activities for companion diagnostics including briefing books, IDE preparation, risk assessment, CSRs, etc. Manage IVD laboratory site monitoring in the capacity of study sponsor, to ensure regulatory compliance. Project management of external vendors and CROs for laboratory testing and clinical studies. Daily engagement with multi-disciplinary CDx subteams and external partners on multiple diagnostic projects.

Billerica, Ma

Clinical study design for novel Glucose Binding Protein (GBP) Continuous Glucose Monitoring (CGM) system.-Write and finalize protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for numerous clinical trials in support of CGM-Develop and oversee external medical affairs engagement plan and KOL strategy across the platform; primary focus on glucose sensing.-Deliver summary/presentations from Medical Advisory Boards (MAB) to the entire Business UnitDrive projects that ensure successful execution of pre-clinical trials to support product development:-Lead preclinical study design of novel GBP based CGM system.-Write, finalize and execute protocols for preclinical perfusion, temperature and reinsertion studies-Support preclinical team in conducting canine animal model hyper- and hypo- glucose excursions (preclinical clamp studies) -Analyze preclinical data and support in developing an algorithm by leveraging Matlab and Calibrator softwareProvide Medical Affairs services / representation to Diabetes Care Business Unit for advanced technology projects with primary focus on glucose sensing:-Deliver medical expertise, direction, and leadership in analysis of new diabetes care opportunities.-Provide input to device development; ensure alignment with medical needs and subject safety.-Manage delivery of clinical study path to engender regulatory approval of new devices; facilitate and design clinical studies to obtain product development input, demonstrate safety / effectiveness, and manage reimbursement for health claims.-Develop study and analysis plans and support regulatory submission preparation for feasibility studies; also support data analysis planning and execution for clinical studies.

Billerica, Ma

Introductory experiential rotation, with aim to foster professional development, provide intensive, hands-on training, and expose PharmD interns to a variety of industry and academia-based opportunities. Some of the experience includes:-Worked with marketing, regulatory and clinical research teams on project and product development-Worked with clinical operation team to draft the protocol for Class 3 medical device-Worked on the development of national and global KOL/external engagement strategy-Managed regional advisory boards/educational round table-Worked with managed markets and HEOR group on product value propositions in diabetes-Presentation on Glucose Sensing Technology to Vice President and World Wide Director of BD

Boston, Ma

Pharmacy Intern (Oncology)MGH/North Shore Center for Outpatient CareFeb 2013-Mar2013-Developing patient specific chemotherapy regimens based on most current guidelines -Attending physician rounds focusing on patient treatment and medication management -Patient Counseling-Educating the nursing staff on new chemotherapy agent Trisenox and other novel therapies upcoming in the futurePharmacy Intern (Internal Medicine)Melrose-Wakefield HospitalMay 2012 – Jun 2012Tasked with performing histories and physical examinations, building differential diagnoses, working productively with outpatient preceptors, and exemplifying professionalism. -Performing duties of pharmacist in internal medicine setting-Counseling of patients on admission and discharge-Medication Reconciliation -Grand rounds with physicians/nurses-Psychiatric unit rounds with physicians and nursesPharmacy Intern (Ambulatory Care)Beverly HospitalJan 2013 – Feb 2013-Patient education on anticoagulant, antibiotic and pain management therapy upon discharge-Presentation to P&T Committee on cheaper version of Intravenous Immunoglobulin (IVIG) Octagam versus Flebogamma-Educating pharmacy staff on anticoagulant medications-Drug order verification under supervision of licensed pharmacist-Daily ICU rounds with physicians and nursesPharmacy Intern (Behavioral Health Solutions)Beacon Health Strategies-Assisting with design and implementation of drug interaction algorithms to be used as screening tool to assist insurance companies with cost saving measures-Assisted with software implementation of drug interaction algorithms -Daily clinical consults with nurses who would use the software to screen large data files from insurance companies to identify potential problems to be addressed with physicians.Pharmacy Intern (Community Pharmacy Setting)Consultation and new prescription intake under the pharmacist in charge.

Master Of Business Administration - Mba, Healthcare

Doctor Of Pharmacy (Pharmd)