Samir A. Farghaly

PROFESSIONAL SUMMARY

Over the past 15 years, lead Oncology Biomarkers research, validation and implementation activities for oncology drug candidates.

Worked closely with internal team members and external resources/collaborators (e.g. major academic/medical research centers) establishing strategy, research plans/activities, executed research, testing, validation which was used for clinical development plans.

Also, have strong expertise in immuno-oncology, experience with both cell-based assays and in vivo models, experience with antibody and protein therapeutics, have excellent track record in discovery and development projects, acted as research programs leader.

Have acted as senior investigator in several projects, and program leader for research initiative in immuno-oncology.

Have strong publication record.

Tested leader on projects with successful outcomes.

Have had leadership roles in complex team environment.

Had designed research strategies within a team and conveyed and implemented those strategies, including initiation of new targets.

Able to work effectively with partners and multiple stakeholders - both internal and external.

Have considerable institutional experience with small molecule antagonists for immuno-oncology and precision oncology targets.

Have supervised ongoing research projects on small molecule antagonists of programmed death ligand -1 (PD-L1) and Interleukin 1 receptor associated kinase 4 (IRAK4).

Moreover, have promoted and will continue to promote innovation, responsibility, and high productivity in the field of immuno-oncology.

Have also, provided input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database) related to clinical trials.

Partnered with SMT team on the evaluation & management of signals emerging from any data source.

Authored the Safety Topic Review/ Signal Report and tracks signals for other means of communication.

In addition, have had several clinical trials experience as principal investigator Phase I- Phase IV related to OB& GYN and Oncology.

Headed the drug safety committee in our academic medical center and affiliated hospitals (3500 inpatient beds, with satellite outpatient’s clinics and emergency rooms).

The responsibility of this committee is to oversee drugs utilization and safety in our facilities.

Have been a member of our institutional review board (IRB), which approve, require modifications in planned research prior to approval, or disapprove research.

In addition, is responsible for critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

Clinical Trials Experience:

Provided medical expertise on drug development and, benefit/risk evaluations throughout life-cycle of several compounds.

Supported study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.

Provided continuous medical monitoring during study conduct, answering questions on inclusion/exclusion criteria or other protocol questions, evaluation of SAEs and AEs, review of laboratory and other patient’s data, review of codes for medical history, concomitant diseases and medications, adverse events, and provides medical expertise to project team during life-cycle of study.

Assumed responsibility for ethical, e.g. medical, aspects of several studies in OB& GYN and Oncology.

Lead and contributed to discussions with regulators and/ other investigators.

Supported the feasibility group in developing feasibility plan and questionnaire, and reviewed feasibility results and report.

Provided drug safety expertise for drugs, diagnostics, and devices.

Reviewed Safety Management Plans, evaluated adverse events and assessed regulatory reporting requirements, generated and/or reviewed notification letters to regulators, other investigators, IRBs, and Ethic Committees, reviewed, analyzed and summarized data for Data Monitoring Committees, generated and reviewed Annual Safety Reports, protocol deviations and correspondence to health authorities, investigators, clients, and/or third parties.

Evaluated benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options, developed Safety Development Plans, Pharmacovigilance Plans, Risk Management Programs including design and conduct of safety studies.

Established safety systems including SOPs, Safety Database, tracking system, metrics, and served as qualified PV person.

Supported generation of publications.

Reviewed and interpreted several studies results and reports.

Consulting Experience:

Over the past 10 years, had consulted as Key opinion leader (KOL) regarding Cancer therapeutics strategy, oncology drug development (early and late phases), targeted cancer therapy, and immune-oncology therapy with JP Morgan Bank, Citigroup Bank, Bank of America, Wells Fargo Bank, UBS Bank, Jeffries Investment Bank, Cowen investment Bank, ROTH Investment Bank, Boston Consulting, Bain Consulting, Mackenzie and Co., Guidepoint global, Third Bridge Consulting and Primary Insight Consulting.

Special Positions:

Chairman, Gynecological Cancer Vaccines Session, The International Conference of Vaccines, Dubai, UAE (April 2015).

Medical and Scientific Adviser/Expert to The National Fund for Scientific Research (F.R.S-FNRS)- Belgium (current)

Several visiting professorships: University of Sydney- Australia, University of Melbourne- Australia, University College London- UK, University of University of Paris- France, University of Tokyo-Japan, University of British Columbia- Canada, Charles University- The Czech Republic, University of Rome- Italy, The Catholic University- Belgium, Albert Einstein College of Medicine- New York, USA, Albany Medical college- NY, USA, Brown University- RI, USA, Free university of Berlin- Germany, University of Maryland- USA, University of Alabama- USA, University of Oklahoma- USA, University of Pennsylvania- USA, University of Pittsburgh- USA, University of Athens- Greece, and University of Alabama- USA

TECHNICAL EXPERIENCE

Software/Databases: SPSS/PC+, Lotus 1-2-3, MS PowerPoint, Endnote

Operating Systems: Microsoft Window 10

Methodologies: Risk Management

Others: Implementation, Research, Leadership, Statistical Analysis, Physician

PROFESSIONAL EXPERIENCE

THE MEDICAL COLLEGE OF CORNELL UNIVERSITY AND THE NEW YORK HOSPITAL – WEILL CORNELL UNIVERSITY MEDICAL CENTER, New York, NY Jan 2016 – PRESENT

Physician / Scientist – Professor

Provided medical expertise on drug development and, benefit/risk evaluations throughout life-cycle of several compounds.

Brochure, Statistical Analysis Plan, and other study material.

Provided continuous medical monitoring during study conduct, answering questions on inclusion/exclusion criteria or other protocol questions, evaluation of SAEs and AEs, review of laboratory and other patient’s data, review of codes for medical history, concomitant diseases and medications, adverse events, and provides medical expertise to project team during life-cycle of study.

Reviewed Safety Management Plans, evaluated adverse events and assessed regulatory reporting requirements, generated and/or reviewed notification letters to regulators, other investigators, IRBs, and Ethic Committees, reviewed, analyzed and summarized data for Data Monitoring Committees, generated and reviewed Annual Safety Reports, protocol deviations and correspondence to health authorities, investigators, clients, and/or third parties.

Evaluated benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options, developed Safety Development Plans, Pharmacovigilance Plans, Risk Management Programs including design and conduct of safety studies.

Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely medical review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities.

THE MEDICAL COLLEGE OF CORNELL UNIVERSITY AND THE NEW YORK HOSPITAL – WEILL CORNELL UNIVERSITY MEDICAL CENTER, New York, NY Jan 2007– Dec 2015

Physician / Scientist/ Assistant Professor/ Associate Professor

Took part in the clinical and scientific activities, including medical and surgical care of Gynecological cancer patients.

Experience includes, teaching, research, medical and surgical management of patients with gynecological and breast cancers.

Sat on / chaired several committees on Drug Safety, Institutional Review board, and Quality Assurance.

Took part as a principal investigator in several clinical trials related to women’s cancers.

Supervised and managed 45 physicians and scientists.

Interacted directly with cross functional teams in the pharma and biotechnology companies.

Prepared and lead publication efforts for relevant manuscripts, abstracts and posters.

Lectured nationally and internationally in the field of clinical management t of cancer and targeted molecular therapy for solid tumors.

Lead, directed, and managed medical and scientific aspects of women’s health and oncology studies trials in our institution.

LONDON UNIVERSITY TEACHING HOSPITALS AT ST. THOMAS HOSPITAL, UNIVERSITY COLLEGE, AND WESTMINSTER/ CHELSEA HOSPITALS MEDICAL SCHOOLS Sep 1995 – Dec 2006

House Officer/ Senior House Officer/ Registrar/ Lecturer

Departments of OB& GYN.

Inpatient, outpatient and emergency medical and surgical management of women’s diseases.

Teaching and research in the fields of OB& GYN and Oncology.

Training of Junior and Senior House Officers.

Full responsibility for the rota.

EDUCATION

Fellow Royal College of OB& GYN, 2015

Fellow Royal College of Surgeons-UK, 2010

Molecular Biology Ph. D.

The University of London, Great Britain, 2005

M.B.B.S.

The University of London, Great Britain, 1995

BA, Physics

Cambridge University (Trinity College), Great Britain, 1990

LANGUAGES

French, German, Arabic

SELECTED RESEARCH STUDIES

Expression of Tumor suppressor Gene in Cervical Neoplasm: Mentor Dr. Thomas Wright, Jr.

Expression of Zinc Finger Proteins in Different Cancer Cell Lines Binding DNA Building and Gene regulation. Mentor: Dr. Allan Wolkoff.

Expression of P53 and RBI Genes in Uterine Cervical Cancer.

Response of Epithelial Ovarian Cancer Cell Lines to Herpes Simplex Type 1 Thymidine Kinase Gene (HSV-1- TK).

Exosomal Micro RNA’s Expression in Epithelial Ovarian Cancer.

Advanced Epithelial Ovarian Cancer Response to RAB25 Small GTPASE Gene Inhibitor.

Wild Type P53 Expression in Ovarian Cancer.

SELECTED PRESENTATIONS

An Efficient Method for Gene Therapy in Ovarian Carcinoma: Herpes Simplex Type (1) Thymidine Kinase Gene (HSV-1-TK) and Its Bystander Effect. The 12th International Meeting of Gynecological Oncology and, the European Society of Gynecological Oncology, Venice, Italy (April 2001)

Characterization of Tumor Suppressor Gene, Wild –Type P53 in Patients with Ovarian Epithelial Carcinomas, and Its Therapeutic Possibilities. The 16th International Meeting of The European Society of Gynecological Oncology, Belgrade, Serbia (October 2009).

Targeted Anti- Vascular Endothelial Growth Factor Therapy for Patients with Primary and Recurrent Epithelial Ovarian Cancer. The 13th Biennial Meeting of the International Gynecological Cancer Society, Prague, Czech

Republic (October 2010).

Observation on Exosomal MicroRNA’s as Ovarian Epithelial Cancer Inactivation Agents and Biomarkers. The 16th European Society of Gynecological Cancer Meeting (November 2009).

Epidermal Growth Factor ErbB3 (HER3) As A Potential Therapeutic Target in Patients with Epithelial Ovarian Cancer (EOC). The 17th International Meeting of The European Society of Gynecological Oncology, Milan, Italy (September 2011).

Deacetylase Inhibitor alters MicroRNA Expression in Signal Transduction in Chemoresistent Ovarian Cancer. 2nd World congress on cancer Science and Therapy, San Antonio, TX (September 2012).

Proteomic Profiling in Drug Resistance to Paclitaxel in Patients with Epithelial Ovarian Cancer. The World Federation of Gynecology and Obstetrics (FIGO) Conference, Rome, Italy (October 2012).

Long Term Survival of Female Patients with Peritoneal Carcinomatosis Utilizing Robot Assisted Laparoscopic Ultra Radical Cytoreductive Surgery and Hyper Thermic Intraperitoneal Chemotherapy (HIPEC). The World Federation of Gynecology and Obstetrics (FIGO) Conference, Rome, Italy (October 2012).

BIOTINYLATED DENDRIMES NANOPARTICLES AS TARGETED SMVT RECEPTOR MEDIATED THERAPY FOR OVARIAN CANCER. 14th Biennial Meeting of the International Gynecologic Cancer Society, Vancouver, Canada. (October 2012).

TAT-ELP AS A POTENTIAL MOLECULAR THERAPEUTIC AGENT FOR PREVENTION OF INTRAPERITONEAL DISSEMIATION IN PATIENTS WITH EPITHELIAL OVARIAN CANCER. The 18th International Meeting of the European Society of Gynecological Oncology, Liverpool, United Kingdom (October 2013)

Focal Adhesion Kinase (Fak) Inhibitor Role in targeting Advanced Serous Ovarian Carcinoma. The World Gene Conference, Hainan- China (November 2014)

SELECTED INVITED LECTURES

“Current Concept and Protocol of Anti-metastatic Gene Therapy in Patients with Advanced Ovarian Cancer”

The 2nd International Conference on Drug Discovery and Therapy, Dubai, UAE

(February 2010).

“The Role of Oral Contraceptive Pills (OCPs) in Chemoprevention of Epithelial Ovarian Cancer in Women with Mutant BRCA1 and BRCA2 Genes”

The Second World Congress on Cancer, Kottayam, India (September 2010)

“Anti-Metastatic Gene Therapy in Patients with Advanced Epithelial Ovarian Cancer”

The 1st International Conference on Cancer Science and Therapy, Las Vegas, NV- USA (August 2011)

“Targeting Cancer Stem Cell as Innovative Therapy for Advanced Epithelial Ovarian Cancer “The 1st International Conference on Cell Science and Stem Cell Therapy, Philadelphia, PA- USA (November 2011)

“Novel Approaches of Stem Cell Research in Gynecological Cancers”- KEYNOTE ADDRESS. The IST International Conference on Cell Science and Stem Cell Therapy, Philadelphia, PA- USA (November 2011)

“Protein Kinase BRAF Inhibitors as Targeted Therapy for Border Line Epithelial Ovarian Tumors”. Plenary Session. Emerging Cell Therapy Conference, Chicago, IL- USA (October 2012)

“Protein Kinase BRAF Inhibitors as Targeted Therapy for Border Line Epithelial Ovarian Tumors”. Plenary Lecture. Emerging Cell Therapy Conference, Chicago, IL- USA (October 2012)

siRNA FORMULATED WITH TUMOR TARGETING scFv MODIFIED LPH NANOPARTICLES AS POSSIBLE THERAPY FOR METASTAIC EPITHELIAL OVARIAN CANCER. Plenary Lecture. The 3rd International Conference on Cancer Science and Therapy, San Francisco, CA- USA (October 2013).

EPITHELIAL TO MESENCHYMAL TRANSITION (EMT), AS A TARGETED THERAPY FOR MULTIDRUG RESISTANCE IN EPITHELIAL OVARIAN CANCER. Plenary Lecture. The 3d world Congress on Cell Science and Stem Cell Research, Baltimore, MD (November 2013).

10.“Adoptive T-Cell Immunotherapy as a Novel Therapeutic Approach for Patients with Ovarian Cancer”. Key Note Address. The 3rd Annual World Congress of Molecular Medicine, Haikou, China (November 2013)

Focal Adhesion Kinase (fak) inhibitor Role in Targeting Advanced Serous Ovarian Carcinoma. Plenary Lecture. The World Convention of Genes 2014, Hainan, China (November 2014)

Ovarian Cancer Therapeutic Vaccines: The Way Forward. The International Conference on Vaccines, Dubai, United Arab Emirates (April 2015).

SELECTED PUBLICATIONS

Farghaly SA. Characterization of Tumor Suppressor Gene, Wild- Type P53 in Patients with Ovarian Epithelial Carcinomas, and Its Therapeutic Possibilities. Int J Gyn Ca 2009, vol 19, supplement (2), P. 21

Farghaly SA. Anti-Metastatic Gene Therapy in Patients with Advanced Epithelial Ovarian Cancer (EOC). J Cell Sci Th 2012. P. S15-001

Farghaly S.A. Proteomic Profiling in drug Resistance to Paclitaxel in Patients with Epithelial Ovarian Cancer. Int J Gyn Ob 2012, Vol 119, 3: P.659

Farghaly SA. BIOTINYLATED DENDRIMES NANOPARTICLES AS TARGETED SMVT RECEPTOR MEDIATED THERAPY FOR OVARIAN CANCER. Int J Ca 2012, Vol 22, Issue 8, Supplement 38, P. 761

Farghaly SA. The Role of Oral Contraceptive Pills (OCPs) in Chemoprevention of Epithelial Ovarian Cancer in Women with Mutant BRCA1 and BRCA2 Genes. J Cancer Sci Ther 2013, 5:e124. doi: 10.4172/1948-5956.1000e124

Farghaly SA. ANTIANGIOGENIC THERAPY FOR PATIENTS WITH EPITHELIAL OVARIAN CANCER. Current Angiogenesis Journal. (In Press).

Farghaly SA. Ovarian Cancer: The Prospects of Developing Vaccines Therapy. IJGORMR 2014; 1(1): 3-6.

Farghaly SA. Cancer Stem Cells (CSCs) Emerging Concept and Strategy for Targeting Progression of Epithelial Ovarian Cancer. Enliven: Challenges Cancer Detect Ther. 2014, 1(1): e001.

Farghaly SA. Novel Therapies for patients with Epithelial Ovarian Cancer. J Cancer Sci Ther. 2014, vol.6.11, 1000e 133.

Farghaly SA. Current Overview of Anti-Angiogenic Therapy for Patients with Epithelial Ovarian Cancer. Current Angiogenesis Journal (October 2015).

BOOKS CHAPTERS

Farghaly, Samir A. Minimally Invasive Surgical Procedures for Patients with Advanced and Recurrent Ovarian Cancer. In Ovarian Cancer: Clinical and Therapeutic Perspectives, Farghaly SA (Ed). Feb. 2012, Chapter 9, P.167-190, DOI: 10.5772/30220

Farghaly, Samir A. Management of Patients with Early-Stage Ovarian Cancer. In Advances in Diagnosis and Management of Ovarian Cancer- First Edition, Farghaly SA (Ed). Springer US, 2014. P 155-171, DOI: 10.1007/978-1-4614-8271-0- 9

Farghaly, Samir A. "Targeted Molecular Therapy for Patients with Ovarian Cancer. In Advances in Diagnosis and Management of Ovarian Cancer- First Edition, Farghaly SA (Ed). Springer US, 2014. P 199-222, 10.1007/978-1-4614-8271-0- 12

Farghaly SA. Strategy for Treating Patients with Endometrial Cancer. In Endometrial Cancer: Current Incidence, Detection and Management. Farghaly SA (Ed). Nova Science

Publishers, 2015. PP163-188

Farghaly SA. Surgical Treatment Options for Patients with Endometrial Cancer. In Endometrial Cancer: Current Epidemiology, Detection and Management. Farghaly SA (Ed). Nova Science Publisher, 2015. PP189-206

Banno K, Lida M, Farghaly SA et al. Novel Therapeutic Agents for Treatment of Endometrial Cancer. In Endometrial Cancer: Current Epidemiology, Detection and Management. Farghaly SA (Ed). Nova Science Publishers, 2015. PP321-338

Sandra García-Nieto, Carmen Alonso, María-Carmen Rodríguez-Soriano, María-Luz Pombo, Julie Earl, Carmen Guillén-Ponce, and Samir A. Farghaly. Targeted Molecular Therapy for Patients with BRCA1 and BRCA 2 Hereditary Ovarian Cancer. In Gynaecologic Cancers: Current Basic Sciences and Clinical Perspectives. Farghaly SA (Ed)- Intech (Published in March 2016).

Farghaly SA. Adoptive Cell Immunotherapy for Ovarian Cancer. In Ovarian Cancer Immunotherapy: Current Perspectives. Farghaly SA (Ed)- Oxford University Press (published in August 2018).

Farghaly SA. Immunotherapy for Precancerous Lesions of the Uterine Cervix. In Uterine Cervical Cancer: Current Diagnosis and Management. Farghaly SA (Ed) - Springer, USA (published in Feb. 2019).

BOOKS

Editor. OVARIAN CANCER: BASIC SCIENCE PERSPECTIVE, ISBN 978-953-307-812-0, Hard Cover and eBook. (Published in Feb. 2012 by Intech Publishers).

Editor. OVARIAN CANCER: CLINICAL AND THERAPUTIC PERSPECTIVE, ISBN 978-953-307-810-6, Hard Cover and eBook. (Published in Feb. 2012 by Intech Publishers).

Editor. ADVANCES IN DIAGNOSIS AND MANGEMENT OF OVARIAN CANCER, First Edition - Print ISBN 978-1-4614-8270-3, and Online ISBN 978-1-4614-827-1-0, eBook (Published in December 2013 by SPRINGER- Verlag GmbH).

Editor. ENDOMETRIAL CANCER: CURRENT EPIDEMIOLOGY, DETECTION AND MANAGEMENT, Print ISBN: 10:163*******- Online ISBN: 13: 978-1-63463-163-1. (Published in January 2015 by Nova Science Publishers).

Editor. GYNECOLOGCAL CANCERS: CURRENT BASIC SCIENCES, CLINICAL AND THERAPEUTIC PERSPECTIVES (Published by In Tech Publishers in March 2016).

Editor. OVARIAN CANCER IMMUNOTHERAPY: CURRENT PERSPECTIVES (Published by Oxford University Press 0n August 2018).

Editor. UTERINE CERVICAL CANCER: CURRENT DIAGNOSIS AND MANAGEMENT (Published by SPRINGER- USA in March 2019).

Editor. ADVANCES IN DIAGNOSIS AND MANGEMENT OF OVARIAN CANCER - Second Edition (To be published by SPRINGER- USA this year.).

Editor. ENDOMETRIAL CANCER: CURRENT EPIDEMIOLOGY, DETECTION AND MANAGEMENT - Second Edition (To be published by Nova Science Publishers this year).

SELECTED EDITORIAL BOARDS MEMBERSHIP OF MEDICAL JOURNALS

Editor-in-Chief, International Journal of Gynecological, Obstetrical, and Reproductive Medicine Research

Editor-in- Chief, Insights in Gynecologic Oncology Journal.

Associate Editor-in- Chief, Experimental and Clinical Obstetrics and Gynecology Journal.

Editor and Member of the Editorial Board of The European Gynecological Oncology Journal.

Gynecologic Oncology Section Editor, The Journal of The Egyptian National Cancer Institute.

Editor and Member of The Editorial Board of The International Journal of Biomedical Sciences.

Editor and Member of The Health Care (OB&GYN) Advisory Board. Medfield International.

Senior Editor and Section - Gynecological and Breast Cancers, The Journal of Cancer Science & Therapy.

Editor and Member of The Editorial Board, The Journal of Chinese Clinical Medicine.

Editor and Member of The Editorial Advisory Board of Women’s Health Journal.

Editor and Member of the Editorial Board of The Open Journal of Obstetrics and Gynecology.

Editor and Member of The Editorial Board of Carcinogenesis and Mutagenesis.

Editor and Member of the Editorial Board of Current Angiogenesis

Editor and Member of the Editorial Board of Clinical Medicine Insights: Oncology journal.

Editor and Member of the Editorial Board, European Gynecological Oncology Journal.

Editor and Member of The Editorial Board, The Journal of Gene, and Therapies.

Editor and Member of The Editorial Board of Research Journal of Women’s Health.

Editorial Consultant, Therapeutics and Clinical Risk Management Journal.

SELECTED AFFILIATION TO MEDICAL SOCIETIES

Fellow of the Royal Society of Medicine and Member of Obstetrics and Gynecology, Oncology and Urology sections. London, Great Britain

Member of the European Society of Gynecological Oncologists

Member of the European Association for Cancer Research

Member of the American Association for Cancer Research

Member of the New York Academy of Science

Member of the New York Academy of Medicine

Member of the International Gynecological Cancer Society

Member of the American Association for the Advancement of Science

Member of Clinical Investigation Committee, the National Cancer Institute, Cairo, Egypt

Member of The European Society of Clinical Oncology

Member of the International Society for Gynecologic Endoscopy

Member of the British Gynecological Cancer Society

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