Speakers

Bernd is a border-crosser between the worlds of regulatory and clinical development of biopharmaceutical compounds. A seasoned executive with demonstrated experience of 25+ years’ working in academia (West German Cancer Center, University of Essen Medical School), in regulatory agencies (PEI, EMA) and in pharmaceuticals industry (Merck KGaA, Boehringer Ingelheim, Sandoz/Hexal). Strong focus on biopharmaceutical compounds, innovative therapies, as well as on biosimilars. Just recently he founded BL Consulting, focused on scientific advice management and on agreements between regulatory agencies and sponsors. Before, he served five years as Head of Clinical Development at Sandoz/Hexal, leading a team of physician-scientists. His team was committed to clinical biosimilar development across therapeutic areas, i.e. (immuno)-oncology, immunology, ophthalmology and neurology. Starting from due diligence to BLA/MAA to life cycle management and publication. Analyses of global trends and assessment of regulatory/developmental risks and risk mitigation strategies were also part of his duties. As member of portfolio management and medical affairs leadership teams, he contributed to a healthy pipeline/portfolio composition, a holistic approach taking into account perspectives from key opinion leaders (current standard of care, benefit assessment, competitive landscape), regulators, patient organizations and payers (reimbursement policies).