Federico Goodsaid | SVP Regulatory and Quality
Ariana Pharma

Federico Goodsaid is Senior Vice President for Regulatory and Quality at Ariana Data Intelligence, a US subsidiary of Ariana Pharma in France. At Ariana (since 2019), he leads the alignment of AI product development and regulatory strategies of Ariana Pharma customers. Within Regulatory Pathfinders (since 2017), he is a consultant for regulatory strategy of therapeutics and diagnostics companies for precision medicine, digital, imaging, and AI products. He led MBQ Pharma (2018-2022) in the development and IND acceptance by the FDA of a first-in-class Rac/CDC42 metastasis removal MBQ-167 therapy. Before Ariana, he was VP of Product Development and Regulatory at TOMA Biosciences (2015-2017), where he coordinated the development and CDRH FDA pre-submission acceptance of a 130-gene NGS oncology panel. He was VP for Strategic Regulatory Intelligence at Vertex Pharmaceuticals (2011-2015), where he transformed informal Voluntary Exploratory Data Submission (VXDS) meetings with CDER into a tool for regulatory acceptance of an in vitro surrogate biomarker for Kalydeco efficacy and the subsequent expansion of the Kalydeco label for 24 additional CFTR mutations and 900 Cystic Fibrosis patients. At the US FDA (2004-2011), he led over 40 VXDS meetings with different pharmaceutical industry companies, developed the Biomarker Qualification Process for the universal acceptance of biomarkers by the FDA, and started, together with colleagues at NCTR, the MicroArray Quality Control (MAQC) consortium. His earlier seminal work at Applied Biosystems (1996-2000) led to the development of precision medicine platforms with the first TaqMan and SYBR qPCR master mixes and pre-developed assays, and his subsequent application in drug safety evaluation at Schering-Plough (2000-2004).