MEDICAL EXECUTIVE / ONCOLOGY
- Clinical oncology expert with 20 years of extensive pharmaceutical experience, strong analytical capabilities in multidisciplinary areas of oncology research and development, and deep expertise in pharma and biotech: academic medicine and research (from clinic to bedside), pharmaceutical drug development (from preclinical to post-marketing), and medical/regulatory oversight review (from IND to NDA).
CMO; Development / Management / Oversight / Execution of Phases 1-4 Clinical Trials; Medical Regulatory Oversight and Review; Regulatory Submissions (NDAs, MAAs); Due Diligence; Business Development; Program Budget Oversight; Vendor Selection and Management; Biotech Startups; Clinical and Business Strategy / Planning; KOL Relations / Oversight; Advisory Boards; Medical Affairs; and Medical Lead – Mergers and Acquisitions.
Therapeutic Areas: Targeted therapies in oncology, solid tumor and hematologic malignancies (colorectal, ovarian, breast, lung, renal, prostate, head and neck, melanoma, leukemia/lymphoma). MD – Cairo University School of Medicine, Cairo, Egypt; Residency-Internal Medicine and Medical Oncology training – Anglo American Hospital Association, Gezira, Cairo, Egypt; United States Medical Licensing Examination / Educational Commission for Foreign Medical Graduates Certification (1995); Tufts University School of Medicine Certification – Clinical Pharmacology, Drug Development and Regulation (1999).
Focus on targeted therapies and I-O Programs; served as medical evaluation/due diligence lead, JDC/JSC membership (preclinical to registration-enabling trials developing CDP with trial designs for small molecule TKIs and checkpoint inhibitors / CAR-T cell therapies with licensing partners). Targets: KIT D842V, D816V, FLT3, VEGF, PD1, LAG3, TIM3, CD73 and CD19 in GIST, SM, AML, NSCLC, melanoma, SCCHN and B-cell malignancies.
Strategy presentations to boards of directors; prepped slides and handled Q&A for investors and advocacy groups.
As medical lead/TA Head, conducted over 40 due diligence clinical evaluations to build Oncology Portfolios, as well as partnership evaluations, leading to securing alliances/mergers/acquisitions with Medivation ($1B), Merrimack ($900m ), Ambit ($200m), Aveo ($250m); performed M&A leading to acquiring Oncaspar ($900m), Baxalta acquisition – Shire ($32B), Ariad acquisition – Takeda ($5.1B), OSI acquisition – Astellas ($4.1B).
Established relations/led KOL meetings (IDMC, Steering Committees, advisory boards); contributed clinical/safety sections for IND/NDA/MAA/NDS/FDA briefing documents; led medical affairs team and supported IST proposal reviews, publication planning, MSL trainings, and advisory boards; and performed pharmacovigilance for conventional cytotoxic agents, small molecules, biologics, liposomal, and nanoparticles:
- Led NDA, MAA, and PMDA submission of Nal-IRI (liposomal irinotecan), provided responses to HA requests during review, and presented at the EMA and PMDA pivotal trial pre-submission meetings, resulting in successful US and EU approval.
- Led clinical and safety sections of enzalutamide in CRPC (erlotinib) in NSCLC NDA and provided responses to FDA queries during review, leading to expedited review and approval.
- Contributed to NDA of taxotere in HRPC, establishing first SOC with successful expedited review / approval.
- Led the IND and CDP for three checkpoint inhibitors (PD1, LAG3, TIM3) in solid tumors, and pre-IND submission for CD19 CAR-T in B-cell malignancies.
- As clinical lead, presented at face-to-face meetings with FDA, EMA, PMDA, and Heath Canada.
- Created clinical strategy and successfully executed Phase 1 to Phase 4 clinical trials in oncology; led multiple Phase 3 global studies in oncology.
- Participated in regulatory meeting development, including Type C and A and pre-IND.
Acting CMO, Rain Therapeutics
Clinical Development Head and Acting CMO Hematology/Oncology, MariCel Clinical Consulting
Global Medical Leader – Hematology, ARIAD (acquired by Takeda)
Global Head – Solid Tumors, Baxalta Oncology (acquired by Shire)
Senior Medical Director – Oncology, Astellas Pharma
Associate Director – Global Safety Officer, Oncology, Sanofi-Aventis, Global Pharmacovigilance and Epidemiology