Professional Background

Dr. Mirakhur has held senior leadership roles at Astex Pharmaceuticals (SVP, Clinical Research and Regulatory Affairs), Celularity (EVP, Clinical Development), Amgen (Executive Medical Director, Global Solid Tumor Platform), Ipsen (Head of US Oncology and Endocrinology), GSK (Executive Medical Director), and BMS (Associate Medical Director). She has led IND, NDA, sNDA, MAA, and Type II variation submissions, managed health authority interactions with FDA, EMA, MHRA, Health Canada, and others, and directed clinical strategies for approved products like Tafinlar (dabrafenib), Somatuline (lanreotide), and Inaqovi (decitabine). Currently serving as a consultant and CMO for biotech companies, she also practices as an ER physician at VA Hospital and Grand View Hospital, bringing frontline clinical perspective to her advisory work.

Core Expertise

• Clinical development strategy from discovery through commercialization and lifecycle management.
• Global regulatory submissions (IND, NDA, sNDA, MAA, Type II variations) and health authority interactions.
• Safety management, including anaphylaxis investigation (e.g., Cetuximab/Alpha Gal Syndrome) and post-marketing commitments.
• Cross-functional team leadership, portfolio strategy, and external collaborations.
• Medical affairs, business development, and product launch execution.

Career Highlights

• Led successful global regulatory submissions and approvals for oncology drugs including Tafinlar (dabrafenib), Somatuline (lanreotide), and Inaqovi (decitabine), plus OTC products like Flonase.
• Identified the epitope causing severe anaphylaxis to Cetuximab, defining Alpha Gal Syndrome through AAAAI congress presentation and clinical protocol development.
• Directed clinical development plans for NK cells in AML, GBM, and CRC at Celularity, and solid tumor platform strategies at Amgen.
• Formulated portfolio development plans at Astex Pharmaceuticals, leading to timely study initiation, recruitment, and early-phase regulatory successes in AML and MDS.
• Recipient of ESMO Best Poster Award (2017) and multiple honors for clinical and regulatory achievements.

Education & Clinical Training

• MD, Medical Physician and Surgeon — Temple University School of Medicine, Philadelphia, PA.
• PhD, Immunology & Microbiology — Thomas Jefferson University, Philadelphia, PA.

Therapeutic Focus