Ismail Savas, MD

Princeton, NJ

435-***-****

ad15r7@r.postjobfree.com

I have 20 years of experience in clinical care and research areas. I specialized in clinical trial management of studies conducted in patients with lung cancer, asthma, chronic obstructive pulmonary diseases, venous thromboembolism, and pulmonary infections. I managed approximately 15 clinical trials in last years as a Clinical Trial Coordinator and Manager. I have lots of experience in patient selection, enrollment and tracking for the clinical trial, training of research coordinator and other staff, in collaborating with sponsors regarding on Serious Adverse Events, Adverse Events and potential SUSAR, close out of the study. I performed and monitored the patients’ records, data cleaning and query resolution throughout the trials on Electronic Data Capture Systems.

Clinical Trial Coordinator and Manager, Regional Cancer Care Associates, Teaneck, NJ

(2021-2023)

Managed oncology phase 1-4 clinical trials in lung, breast, colorectal, multiple myeloma, non- Hodgkin’s lymphoma (diffuse large B-cell and follicular lymphoma) Managed clients (Pfizer, BMS, Eli Lilly, Astra Zeneca, Daiichi Sankyo, Jazz, Regeneron) Collected and Reviewed Serious Adverse Events and potential SUSAR, informed sponsors/IRB, collaborates with the other staff to process Serious Adverse Events (SAEs). Evaluated the inclusion and exclusion criteria in the protocol and make decisions for patient selection based on these criteria.

Proposed the patients to sub-investigators based on medical judgment and selection criteria Led communications with LabCorp, IQVIA, Parexel, Ipsen, Medpace, and PPD Collated data for assessments such as feasibility and site Monitored and updated investigator/site status for the trial, and supported with clinical trial registry postings

Managed site initiation visits and follow-up meetings with sponsor or CRO Supported and collaborated with medical monitor for Phase I and potentially Phase II studies, ensuring the safety and efficacy of drug compounds Collaborated with the clinical team to design and implement the strategies for studies Conducted medical literature

Contributed to the design of study protocols by offering medical input and to review of study documents such as informed consent forms, case report forms and facilitated study document reviews per company standard operating procedures

Worked with the team to analyze and interpreted clinical data and make recommendations Contributed to the growth and success of the clinical programs Developed medical training material and medical support for clinical research coordinators Initiated and participated daily meetings on Standard Operating Procedures (SOP) update, revisions, protocol review, slide preparation, data reconciliation or departmental initiatives Reactivated the patient screening and enrollment logs Supervised site coordinators for recruitment and enrollment processes Reviewed and Prescreened eligible patients in EMR databases Identified, enrolled, and randomized patients to respective studies Followed up the site activation, enrollment, and monitoring visits to projected plans and the laboratory, radiologic parameters of the patients

Oversaw clinical data entry into the eCRFs such as Medidata RAVE, Zelta, and Medrio Spearheaded data cleaning and query resolution throughout the trials and prior to close-out Answered medical questions from sites or project team. Attended, participated, and/or presented in investigator meetings Provided therapeutic and protocol training to the clinical site staff involved in the trial Gave a medical review and assistance in the preparation of final study reports Maintained working knowledge of good clinical practice and regulatory requirements related to clinical development and safety to ensure compliance with ethical, legal, and regulatory standards selection

Mentors other medical staff as needed and consistently shows exemplary work ethics, compassion and integrity as a medical professional and clinical researcher Attending Physician, Ankara Guven Hospital, Ankara, Turkey (2017- 2020) Evaluated and treated 1000+ inpatient patients with lung cancer, heart diseases, asthma, COPD, pulmonary thromboembolism, pulmonary infections, pulmonary and systemic hypertension Managed outpatient and inpatient cardiopulmonary clinics, bronchoscopy, and pulmonary function test laboratory

Established the interventional bronchoscopy department Performed 300+ endobronchial ultrasonography (EBUS) interventions Provided care to 300+ patients with COVID-19 in 2020 Attending Physician,

Ankara University School of Medicine

Managed patients with lung diseases, heart diseases, VTE, pulmonary and systemic hypertension Provided medical consulting to Bristol Myers Squibb, Astra Zeneca, and Eli Lilly Founded the first unit performing EBUS-TBNA in Ankara, Turkey, in 2011 Performed 6000+ diagnostic and 1500+ interventional bronchoscopy procedures, including EBUS-TBNA (Endobronchial ultrasonographic transbronchial needle aspiration) Lecturer and attending physician at the Department of Internal Medicine Mentored and trained 15 residents and fellows in internal medicine and pulmonary medicine Principal Investigator, Ankara University School of Medicine, Ankara, Turkey (2000-2017)

(List of trials provided in references section below) Trained site staff to complete records in CRFs and eCRFs in Electronic Data Capture Personally managed and followed randomized patients with thoracic pathologies Reported Adverse Events (AE)/Serious AEs, ensured source document and data integrity Completed follow-up letters

Ensured robust clinical trial documents and drug accountability Shared ideas on optimizing trial objectives, designs, and protocols Worked closely with Covance, Quintiles, and other Contract Research Organizations, actively involved in site initiation visits, site management procedure Education:

Research Fellow, New York University, Department of Pulmonary Medicine, New York Participated in the research “Gene therapy of Non-Small Cell Lung Cancer” at Bellevue Hospital Performed PCR, western blotting technique, lung cancer cell culture, adenovirus transmission into lung adenocancer cells

Fellowship and Residency Program, Cardiopulmonary Department, Ankara University School of Medicine Ankara, Turkey

Managed patients with Lung Cancer, Asthma, Chronic Obstructive Pulmonary Disease, Venous thromboembolism

Performed numerous diagnostic and interventional bronchoscopy procedures Managed patients under supervision; Performed bronchoscopy and pulmonary function tests Completed rotations of Cardiology for six months; of Infectious Diseases for three months; of Radiodiagnostics for one month; of Internal Medicine for three months; of Emergency Room for one month

Doctor of Medicine (MD) Ankara University, School of Medicine, Ankara, Turkey Memberships:

European Respiratory Society

American Thoracic Society

International Association Lung Cancer Study Group

Principal Investigator of the International Clinical Trials below 1) Gefitinib (ZD1839, Iressa®) in non-small-cell lung cancer 2003: To determine the contribution of molecular alterations in EGFR to response and survival of gefitinib in refractory non-small cell lung cancer. Compound: Gefitinib (Iressa ZD 1839) is an anilinoquinazoline compound, often referred to as a

"specific" or "selective" inhibitor of epidermal growth factor receptor. 2) A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA) Versus Intravenous Docetaxel (TAXOTERE) in Patients with Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy 2005:

Compounds: Gefitinib and Docetaxel

Compared gefitinib and docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer treated with platinum-based chemotherapy. 3) ADOPT Trial, 2011 (NCT 00457002) Randomized Controlled Trial: Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. Compound: Apixaban

In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than enoxaparin.

(N Engl J Med. 2011 Dec 8;365(23):2167-77).

4) CASSOPEA Trial, 2011 (NCT 00345618) Randomized Controlled Trial: Enoxaparin followed by once weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: A randomized, double-blind, doubledummy, non-inferiority trial.

Compound: EnoxaparinIdrabiotaparinux could provide an attractive alternative to warfarin for the long-term treatment of VTE and is associated with reduced bleeding.

(Lancet. 2012 Jan 14;379(9811):123-9).

5) Hokusai-VTE Investigators; 2013 (NCT02073682)) Randomized Controlled Trial Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism: Compound: Edoxaban

Oral edoxaban was non-inferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower, but major bleeding was higher with edoxaban than with dalteparin.

(N Engl J Med 2013 Oct 10;369(15):1406-15).

6) GARFIELD-VTE Study by Thrombosis Research Institute in the UK based 2014-2017, Observational Study 36-month clinical outcomes of patients with venous thromboembolism. Cancer-associated thrombosis. This observational study an about venous thromboembolism in patients with lung cancer and their treatment protocol and prognosis. There was no intervention 7) M14-359 study, 2014: (NCT02264990) A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers:

Compound: Veliparib ABT-888 (poly ADP ribose polymerase - PARP inhibitor) Compared Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC).

8) AVANA study 2016 (NCT02810457) Evaluation of FKB238 and Avastin in Patients with Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer by Centus Biotherapeutics Limited, Phase III study:

Compound: FKB238

Randomized, Parallel, Double-Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin In 1st Line Treatment for Patients with Advanced/Recurrent Non-Squamous NSCLC in Combination of Paclitaxel and Carboplatin.

9) R2810-ONC-1624 STUDY by REGENERON 2017 (NCT03088540), Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Phase III study:

Compound: REGN2810 -Anti -PD-1 ANTIBODY

A randomized study of REGN2810 versus platinum-based chemotherapy in the first-line treatment of patients with advanced or metastatic PD-L1+ non-small cell lung cancer

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