Basel, Basel, Switzerland
After a PhD in cardiac physiology, ion channel electrophysiology, pharmacology, and spectroscopy in the laboratory of Ernst Niggli in Bern, I studied the role of Na+ and RyR2a channels in the generation of cardiac arrhythmias at Columbia University. After 9.5 years of preclinical research, I started my carreer in the pharmaceutical industry, first as clinical pharmacologist at Actelion, then as clinical trial leader at Novartis. In both positions I developed, managed, and reported phase I and proof-of-concept clinical studies. I then transitioned to Roche's Global Medical Affairs, as International Scientific Director in the HER2 positive breast cancer team. This was the start of a new passion, where the work we do daily directly impacts the lives of patients - and friends - and their families all over the world. In the last 5 years, I took the medical lead for Herceptin, worked on Perjeta, Kadcyla, and shaped the clinical development plan for TECENTRIQ in HER2+ breast cancer. I also developed a keen interest in epidemiology (ie., the only way to study sequencing and effectiveness) as well as on the treatment approaches to brain metastases. I am now medical director at Seattle Genetics, responsible for breast cancer and especially for Tucatinib in Europe. Specialties: Clinical: writing clinical protocols and clinical study reports, selection and management of CROs, HA / EC submissions, management of outsourced clinical trials, and PK and PD analysis, medical education, external experts and collaborative group management, adboards, oversight of commercial activities, access and pricing discussions, epidemiology, publication strategy, launch strategy, etc.
Medical Affairs Lead for Europe and Canada, colorectal cancer
In my role I represent global medical affairs within early oncology pipeline assets at Takeda.
Currently responsible for TECENTRIQ in HER2+ Breast cancer. Responsible include representation in the Life Cycle Team, Global Development Team, and International Business Team, development of the Global Medical Plan, Evaluation of new research proposal related to immunotherapy and HER2+ Breast cancer, Therapeutic Expert management, Coaching of peers, Clinical Trials medical leadership, etc.
Ad interim responsibilities: Herceptin Performance monitoring Leading the International Business Team Contributor to the Biologics Action Team Affiliate support Creation of commercial reactive guidance Creation of an internal and external marketing campaign
Therapeutical Area: HER2 positive breast cancer Drugs: Herceptin, Kadcyla and Perjeta Responsible for all medical aspects related to Herceptin. Member of the business, development and life cycle teams. Medical and scientific oversight of ongoing clinical studies and real world data activities. Development and review of protocols, publications, slide decks, oral presentations, etc. Supports the development of the global HER2 positive medical strategy.
Leading early development clinical studies (phase 1 and 2a, healthy subjects or patients) in musculo-skeletal indications. Managing studies from protocol development to publication, leveraging on internal and outsourced expertise. More specifically: I worked on 2 POCs in diseases affecting bone mineralization and a cardiac safety study and a dose ranging study with an anabolic compound. I also acted as a co-CTL for the setup of a large study in Alzheimer patients and an exercise study involving no medication in healthy young and old adults.
In charge of writing phase I protocols, clinical site selection, HA and EC submissions, management of other contracted CROs for the due course of the study, management of the actual clinical trial, PK and PD analysis and creation and finalization of the final study report.