M.D., Diplomate Board Certified. Pharmacovigilance NDA / BLA filing experience, phase 2 and 3 to launch. Focus on later phase clinical safety and clinical development including registrational phase 2 and phase 3 clinical trials for submissions. Highly experienced M.D. with 5+ years of industry experience in implementing novel and innovative trial designs, subject matter expert of clinical protocols, IB, CSRs, summary of clinical efficacy and safety, analysis of the clinical outcome and clinical overview for regulatory submissions and publications. Spanning the life cycle of clinical development from IND to NDA / BLA.

Medical Director, Global Clinical Safety Senior Physician (GSO in TA Oncology) @ leadership roles in clinical safety. Focus on later phase drug safety development, including registrational phase 2 and phase 3 clinical trials. Involved in selecting endpoints, design study protocols and monitoring several clinical trials for submissions. Implementing novel and innovative trial designs, subject matter expert of clinical protocols, IB, DCSI/ CDS, core RMP, EU RMP, CSRs, summary of clinical efficacy and safety, and clinical overview for regulatory submissions. Spanning the life cycle of clinical development from IND to NDA / BLA. From October 2015 to Present (3 months) Medical Director, Global Clinical Safety Physician (GSP in TA inflammation and Nephrology) @ Filing experience phase 2 & 3 clinical trials to launch. Focus on later phase drug safety development, including registrational phase 2 and phase 3 clinical trials. Involved in selecting endpoints, design study protocols and monitoring several clinical trials for submissions. leadership roles in clinical safety supporting pipeline products AMG 282 (Asthma and COPD) and AMG 416 (etelcalcetide). Implementing novel and innovative trial designs, subject matter expert of clinical protocols, IB, DCSI/ CDS, core RMP, EU RMP, CSRs, summary of clinical efficacy and safety, and clinical overview for regulatory submissions. Spanning the life cycle of clinical development from IND to NDA / BLA. From March 2013 to September 2015 (2 years 7 months) Medical Director, Clinical Reseach Physician @ M.D. Medical Director, Clinical research monitor of multiple phase 2,3 and 4 clinical trials (K-ras oncogene metastatic colorectal CA) From July 2011 to March 2013 (1 year 9 months) M.D. @ Surgery Resident From July 2008 to June 2011 (3 years) M.D. @ Internship - Trauma Surgery From 2007 to 2008 (1 year) Drug Safety Physician @ Research M.D. Clinical monitor and safety of phase 3 double blind- double dummy trials in patients who have wet type ARMD From May 2001 to December 2006 (5 years 8 months)

M.D., Internship -Trauma Surgery Rotation @ State University of New York Downstate Medical Center College of Medicine From 2007 to 2008 M.D., General Surgery Residency @ New York Presbyterian Hospital, Brooklyn Hospital Center, Weill Cornell Medical College From 2008 to 2011 M.D., Ophthalmology Residency @ Cairo University School of Medicne From 1998 to 2001 M.D. @ Cairo University School of Medicne From 1991 to 1998 Bassem Elmankabadi, M.D. is skilled in: Clinical Research, NDA, Regulatory Submissions, Drug Safety, Clinical Development, Oncology, GCP, data monitoring committee (DMC), Endocrinology, Physicians, Hematology, Ophthalmology, Diabetes, Nephrology, Gastroenterology