Katarina Ilic Md Msc Phd Mph Email & Phone Number

United States

Hampton, Nj, Us

•Experienced drug safety and clinical pharmacology leader managing all aspects of drug safety and pharmacovigilance in biologics clinical development, with a focus on inflammatory, allergic, and autoimmune diseases, within a fast-paced biotech environment.•Responsible for establishing and managing PV system, ensuring regulatory compliance, and leading risk-benefit assessment and risk management strategies. •Collaborates cross-functionally with clinical, regulatory, and research teams to monitor, analyze, and report safety data. Leads safety reviews, signal detection, and benefit-risk assessments for investigational products. •Key contributor in creating drug safety policies and enhancing patient safety measures. •Manages safety team and represents the company in regulatory interactions.

Philadelphia, Us

Tokyo, Jp

• Supported maribavir (LIVTENCITY) clinical development program and NDA approval, Medical monitor for more than 10 Ph1 studies for maribavir program.• Clinical Development Lead for monoclonal antibody for immune thrombocytopenic purpura (ITP) program. • Clinical representative for Wilson’s Gene therapy program. • With a startup company 149 Medical Inc worked on development and deployment a Near Infrared Doppler Spectroscope for monitoring cerebral blood flow in premature infants in clinical trials. • Permanent member of Takeda Global Coding Commitee (MeDRA and WHODrug). • Seven years the only physician – member of Clinical Standards Governance Board (CSGB) at Legacy Shire and Takeda.

Brussels, Be

Evaluated, graded and recommended for funding project proposals three times during 2016-2023 period.

Tokyo, Jp, Jp

• Developed protocols for 4Ph1 and 2 Ph1/2 studies. Responsible for protocol development, and medical monitoring, data analysis and data interpretation, signing CSR for Ph1/Ph2 studies in healthy volunteers and patients. • Performed due-diligence reviews of potential in-license projects and transfer of programs to another company.• Clinical Pharm. subject matter expert (SME) for Ph1-4 phases of clinical programs and preclinical drug development.• Clinical lead for the studies in multiple therapeutic areas:Rare and Genetic diseases (Gaucher disease: both gene therapy and enzyme replacement therapy), Infectious Diseases/ Organ Transplants (CMV), Neurology (Huntington Disease Gene Therapy, ADHD, Duchene Muscular Dystrophy); Ophthalmology (open angle glaucoma); Immunology: Systemic Lupus Erythematosus; Hematology (Sickle Cell Diseases). • Oncology: 2 BLA submissions (FDA, EMA, Health Canada) and marketing approvals of Oncaspar® (pegaspargase) and Asparlas® (calaspargase-pegol) for Acute Lymphoblastic Leukemia (ALL), and divestment to Servier. Coauthored RMP and USPIs & SmPCs / CCDSs for Oncaspar. Coauthored USPI for Asparlas. Participated in an FDA inspection /FDA interactions during the BLA review of Asparlas. • Coauthored PWR, and PIP for Mydayis (mixed salts of single entity amphetamine product).• Member of Safety Review Teams (SRTs), and Drug Induced Liver Injury (DILI) Charter. • Invited by Drug Safety as a SME to DMC meetings, SRT, ESC meetings to solve complex cases and to provide expertise for benefit-risk assessment for drugs in development, and on the market.

• Managed 6 pharmacovigilance (PV) professionals, including EU-QPPV and a Deputy QPPV. • Founding member of the cross-functional inspection readiness team.• Voting member of the Safety Review Team (SRT), the Labeling Team and Project Proposal Review Team. • Responsible for strategic, scientific, and organizational leadership for global PV for marketed and investigational products and implemented new processes and systems. • Successfully demonstrated strategic and multi-project planning, resource allocation and budgeting.• Participated in due diligence activities and EU inspection. • Responsible for closing CAPA actions on time in collaboration with the Compliance Representative. • Initiated safety surveillance and performed signal detection. • Senior reviewer / signatory of the aggregate reports (PADERs, PSURs, DSURs, PBRER), the Pharmacovigilance System Master file (PSMF), RMP and 20 standardized operating procedures (SOPs).• Authored the SOP Safety Signal Management, Core Company Safety Information and Label for Procysbi, safety sections of study protocols, CSRs, safety reviews, signal detection reports and regulatory filing documents.• Medical assessment of individual case safety reports (ICSR).

Alameda, California, Us

• Directly supervised two safety scientists. • Chair /presenter at the Safety Management Team (SMT) • Surveillance of Cometriq (cabozantinib), tyrosine kinase inhibitor, Signal Detection, Risk Management (risk identification, pre-marketing and post-marketing risk assessment and prioritization). • Authored safety reports for independent drug safety monitoring boards and regulatory agencies. • Assessed ICSRs, authored/ reviewed aggregate safety reports, and literature reports. • Researched safety profiles of competitor tyrosine kinase inhibitors. • Provided medical safety expertise for clinical protocols, amendments, IBs, coauthored safety documents (PSUR, DSUR, PBRER), SOPs and work instructions. • In collaboration with biostatisticians improved the tables and listings of adverse events and interfaced with a drug safety system engineer to improve quality of aggregate reports. • Used Argus DataBase, Pharmapendium, Spotfire

Fairfax, Va, Us

Budapest, Hu

Consulted pharmaceutical companies regarding drug approvals in the Serbian market. Wrote preapproval documents and summary of product characteristics (SPCs) for > 15 medicinal products

Belgrade, Rs

PHARMACOLOGY/CLINICAL PHARMACOLOGY/PHARMACOTHERAPY/PHARMACOEPIDEMIOLOGY• Lectured undergraduate and graduate level courses in pharmacology and pharmacotherapy.• Taught graduate level pharmacovigilance course. • Participated in the submission and/or development of 13 research projects: (3) cardiovascular pharmacology, (1) neuroscience, (2) public health, (4) pharmacoepidemiology, (3) data mining. • Mentored five PhD candidates and developed protocol proposals for their thesis. Two candidates defended their thesis with the following titles: “Pharmacoepidemiological study of spontaneously reported hepatotoxic reactions of drugs and herbal dietary supplements” and "A prospective study of the use of antibiotics and the condition of bacterial resistance in hospitalized children".• Supervised two pharmacist specialist for their final written and 18 graduate students for their final written work.

Silver Spring, Md, Us

• Worked on enhancing Liver Toxicity Knowledge Base (LTKB) created by the NCTR.• Participated in writing three project proposals, one was funded by the FDA. • Coauthored two manuscripts

Brentford, Middlesex, Gb

CLINICAL PHARMACOLOGY• Sitamaquine Project -participated in writing the protocols for 2 Phase 1 studies: - Sitamaquine cocktail interaction study. - A phase one, multi-center, open label, single dose study to evaluate the effects of a CYP3A4 inducer and a CYP3A4 inhibitor on the pharmacokinetics of sitamaquine in patients with visceral leishmaniasis who are also co-infected with tuberculosis.• Troponin Project: Enumerated the rationale for inclusion of troponin in clinical studies, the assay employed and its performance characteristics, actions due to troponin values and authored written report.DRUG SAFETY• Participated in introduction of Molecular Clinical Safety program. • Performed research regarding Drug Induced Liver Injury and coauthored three poster presentations and two manuscripts. REGULATORY AFFAIRS Project for Cancer immunotherapeutics: Proleukin, DTIC-Dacarbazine, Temodar and Interleukin E • Reviewed Summary Bases of Approval (SBAs), labels, product websites, FDA websites, and other websites and summarized information from clinical studies (design, indications, patient populations, endpoints), label (indications, contraindications, AEs, concomitant medications).

Chapel Hill, Nc, Us

Pharmacokinetics-PharmacogeneticsCYP2B6 Genotype-Phenotype and Influence of Race/ Ethnicity. Sponsor: FDAPrincipal Investigator (PI) / Investigator/ Safety Physician/ Medical Monitor • Wrote protocol amendments & annual progress reports for FDA IRB & UNC IRB. • Determined eligibility of the participants in the study, monitored adverse events and wrote safety reports.• Interacted weekly with the FDA and participated in the FDA site inspection and maintained study regulatory data.• The first author of the manuscript. • Performed statistical analysis, data interpretation and wrote manuscript• Responsible for budget and purchasing supplies. • Recruited 85/100 study participants (male and female Caucasians, female African American and female Latinas) and shortened the planned recruitment period from one year to 6 months. PharmacokineticsLCCC 0509: A two arm phase one escalation trial of vinflunine with erlotinib or pemetrexed in refractory solid tumors. Sponsors: Bristol-Myers Squibb Oncology, Eli Lilly and Company, Genentech • Developed and executed pharmacokinetic plan.Cytochrome P450 metabolic activity in patients receiving a 96-hour continuous infusion of fluorouracil (5-FU). Sponsor: The UNC Lineberger Comprehensive Cancer Center• Assessed WebCis, reviewed patients’ study files, lab results and data on co-medications and comorbidity.• Created data base and performed statistical analysis.

New Orleans, La, Us

• Investigator funded by U.S. Louisiana Health Excellence Fund for the project which investigated cardiovascular AEs of statins related to the role of P-glycoprotein. • Developed assay for cholesterol extraction from tissue culture cells. • Used Molecular biology techniques: RNA and DNA extraction, protein extraction, PCR.• Used Win Non Lin for non-compartmental PK analysis, and PK/PD modeling.

London, Greater London, Gb

Advisor Sir Salvador Moncada, Nobel prize nominee• Investigated the role of nitric oxide (NO) in cancer cells.

Master Of Public Health (Mph), Epidemiology And Clinical Research-Joint Degree

Phd Pharmacology

Master Of Science (M.Sc.), Pharmacology

Internal Medicine (Endocrinology) And Clinical Pharmacology

Doctor Of Medicine - Md