VP, Regulatory, Clinical and Medical Affairs, Illumina
Mya has extensive experience in gaining regulatory approvals for novel IVDs in the United States and Europe. This work has included PMAs, 510(k)s and de novo 510(k)s in the United States for both kit and lab-based products. In the European Union, Mya has experience with working with Notified Bodies and Competent Authorities on List A, List B and self-certified products. Certified by the Regulatory Affairs Professional Society (RAPS) since 1994, Mya also received the FDA Commissioner’s Special Citation in 2009 as a member of the rRt-PCR Flu Panel Team for exceptional performance and dedication in addressing complex regulatory and scientific issues in the clearance of a CDC test to diagnose human influenza infection.
Session Abstract – PMWC 2017 Silicon Valley
Session Synopsis: Firms that develop companion diagnostics face numerous challenges. Among them are attracting a pharma partner, FDA procedures and regulations, reimbursement and engaging labs to run their tests. This panel will discuss those challenges as well as the incentives for developing and selling companion diagnostics.