David A. Ramies, MD

More than 25 years in the healthcare / pharmaceutical industry

Bayer Biological Products

    ○  Director Regulatory Affairs - responsible for international registration of Kogenate® (recombinant VIII)

    ○  Global Project Director - responsible for second-generation Kogenate with albumin-free formulation

Cerus Corporation

    ○  VP Clinical Research - responsible for phase 3 trials in congenital/acquired coagulapathies with the Intercept® Pathogen Inactivation System

Genentech

    ○  Sr. Medical Director in Oncology

         - Medical management of phase 3 trials in non-small cell lung cancer

         - Author of clinical study reports for registration of Tarceva® and Avastin®

         - Clinical lead for product launch activities including training presentations on disease state and results

         - Clinical lead for review of promotional materials

         - Author / review of clinical study reports for registration of Tarceva® and Avastin®

         - Clinical lead in publication planning

         - Coordinated and moderated key external advisory boards

Xencor, Inc.

    ○  Chief Medical Officer

         - Medical management of phase 1 trial in relapsed Hodgkin's Lymphoma with XmAb®2513

         - Regulatory Affairs lead and single point of contact with U.S. FDA

GlaxoSmithKline

    ○  Sr. Medical Director; Medical Affairs Oncology - solid tumor indications within North America

         - Managed group with regard to IST/CTEP activities, publications for Tykerb®, Votrient® and Hycamptin®

         - Clinical lead in interactions with key alliance partners

         - Clinical lead in coordination and moderation of key advisory boards to support new indications

Exelixis, Inc.

    ○  Executive Director, Clinical Development

         - Medical management of phase 2 signal-seeking randomized discontinuation trial

         - Medical management and oversight of core phase 1 studies with cabozantinib

         - Project / Clinical Operations Lead for the phase 3 (COMET-1) study of cabozantinib in prostate cancer

         - Lead in preparation and execution of international investigator meetings for COMET-1 study

         - Medical manager for the COMET-1 study regarding eligibility, safety and data review

         - Composing author for key cabozantinib publications

Curriculum Vitae and references available upon request.