Anna is Senior Director Medical Affairs and Market Access at SFL.
Anna and her team develop regulatory documentation and communication strategies throughout product development, regulatory approval and life-cycle, including IBs, study protocols, annual reports (PSURs, DSURs, PBRERs), health authority briefing and response documents, PIPs/iPSPs, ODD applications, and regulatory submission documents (e.g. CSRs, non-clinical and clinical summaries and overviews, product labels, RMPs) within the EU, US and Switzerland.
With extensive experience in effectively communicating scientific and medical data through appropriate channels and formats, Anna leads the preparation of bespoke scientific and medical communication materials, including scientific manuscripts, literature screenings and digests, newsletters, and educational resources.
The team’s Market Access branch strategically advises on regular and exceptional access pathways to establish pricing and reimbursement of products in the EU and DACH regions, prepare payor and competitor landscape analyses, and develop value dossiers meeting national payor requirements and evidence needs. In-depth knowledge of Swiss payor perspectives have established Anna and her team as preferred partners to develop access strategies for Switzerland, prepare Swiss reimbursement applications (e.g. relating to inclusion of pharmaceuticals in the SL), and support early access solutions (e.g. reimbursement via Art. 71 a-d KVV), the FOPH’s triennial review of pharmaceuticals, as well as payor early dialogue and negotiations.
Before joining SFL, Anna conducted two years of postdoctoral research at ETH Zurich, Switzerland, after having obtained a PhD in Cell Biology at the University of Bonn, Germany.
CSR=Clinical Study Report; DACH=Germany, Austria, Switzerland; DSUR=Development Safety Update Report; EU=European Union; FOPH= Federal Office of Public Health; IB=Investigator’s Brochure; iPSP=initial Pediatric Study Plan; KVV=Verordnung über die Krankenversicherung; ODD=Orphan Drug Designation; PBRER=Periodic Benefit-Risk Evaluation Report; PIP=Paediatric Investigation Plan; PSUR=Periodic Safety Update Report; RMP=Risk Management Plan; US=United States.