Anna Silke Hammerbacher

Vice President, Regulatory Strategy @Ssi Strategy

Munich, DE

Global regulatory leader with more than 15 years of experience in the global regulatory field and in strategic drug development from early to late-stage development and life cycle management. I specialize in bridging clinical development and market access to design innovative regulatory/access pathways for medicinal products. Furthermore, I am passionate about facilitating collaboration between R&D and commercial functions, aiding in expediting patient access to new therapies and driving business growth. I am an experienced regulatory professional, an expert in regulatory decision making, leveraging global regulatory frameworks to build fast-to-patient regulatory strategies and innovative clinical trial designs for high impact oncology programs. I have developed and executed regulatory strategies for several oncology blockbuster products together with my team, leading to some of the fastest approvals of biologic oncology drugs in the past 10 years. Based on my experience, I can provide a solid understanding of the global regulatory landscape, the regulatory and clinical requirements and pathways to fast approvals and how these translate to integrated market access strategies.I have built, scaled, and led high-performing global teams, fostering innovation, regulatory excellence, and scientific leadership and am actively mentoring the next generation of regulatory leaders.Although my focus is on oncology, I have experience across several therapeutic areas including rare diseases and advanced therapies.

The University of Bonn

Master’s Degree, Drug Regulatory Affairs

Leibniz Universität Hannover

Doctor of Philosophy (Ph.D.), Biochemistry/Molecular genetics/Microbiology

Stanford University Department of Chemistry and Biochemistry

part of the German "Diploma in Biochemistry", Biochemistry, Cell biology, Virology, host-pathogen interactions

Duke University School of Medicine

Drug Development