Myra Herrle

Sr. Director (Oncology), Global Regulatory Strategy

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Myra Rosario Herrle, Sr. Director Regulatory Affairs and Global Regulator Lead, has over 22years experience in pharmaceutical industry. She is a registered pharmacist, holds a PhD in Microbiology and Immunology, and a Regulatory Affairs Certificate.

After completing two post-doctoral fellowships in molecular biology at NIEHS (NIH), Myra started her professional career as a Director of Pharmacy Education for the University of North Carolina School of Pharmacy (AHEC). She worked two years as a senior medical writer for a CRO and then joined GSK where she spent 9 years. During the first half of her tenure at GSK, as a clinical research scientist she led several key phase 3 studies and authored multiple sections of NDAs for Ventolin HFA and Advair HFA. She also served for 4.5 years as the Biomarker Therapeutic Lead for GSKs Oncology franchise.

Myra joined the Novartis Oncology regulatory affairs team in 2005 and successfully completed initial negotiations with FDA for US registration of Afinitor (PNET, Carcinoid, TSC, Breast, RCC indications). Her 9 year tenure in Novartis also included positions as Respiratory Scientific Officer, Global Program Regulatory Director and Global Therapeutic Area Lead/Executive Director for all biologics for the respiratory franchise.

Myra jointed Abbvie in North Chicago in August 2014 as the Oncology Regulatory Therapeutic Head for US & Canada Area & Affiliate. In this role, which she held until Jan 2016, she managed a team of 8 accountable for the AbbVie Oncology portfolio. She had direct involvement and responsibility for the successful filing of NDA and NDS for Venetoclax in chronic lymphocytic leukemia (CLL) with 17p deletion in the US and Canada.

Over the course of her career, Myra has worked on many programs for orphan and/or pediatric diseases including peanut allergies, bullous pemphigoid, atopic dermatitis, chronic urticaria, idiopathic pulmonary fibrosis, Keloids, eosinophilic esophagitis, tuberous sclerosis (renal angiomyolipoma, subependymal giant cell astrocytoma), glioblastoma, AML, DLBCL, carcinoid and pancreatic neuroendocrine tumors.
Myra has led preparations for multiple health authority interactions globally, several FDA advisory committees, served as the Novartis representative to FNIH SPIROMICS initiative and is currently the AbbVie representative to Biotechnology Industry Organization (BIO) Pediatric Oncology Working Group.