With a strong background in clinical pharmacology and evidence-based medicine, Adam specializes in regulatory science and clinical development for biologic drugs. He has authored and co-developed a wide range of regulatory documents, including FDA and EMA briefing materials and responses to agency queries. His career highlights include participation in pivotal scientific advices with regulators and involvement in biosimilar drug approvals.
Articles
Innovative Biologics Expected Approvals in 2026
Antibody-drug conjugates, Biologics, Bispecific antibody, Clinical trials, EMA, FDA, Monoclonal antibody, Vaccines
Navigating Regulatory Approval of Biologics: A Guide for Emerging Biotechs
EMA, FDA, GMP, Regulatory
They understood how the immune system is kept in check: The 2025 Nobel prize in physiology or medicine
The New Era of Biosimilar Development: Seizing the Opportunity Under EMA’s Streamlined Guidelines
Biosimilars, Clinical trials, Drug development, EMA, FDA, Mabion, Regulatory
Mammalian Cell Lines as a Platform for Protein Vaccine Production
Cell culture, Drug substance, Manufacturing, Proteins, Vaccines
Innovative Biologics – Expected Drug Approvals in 2025
Antibody-drug conjugates, Biologics, Bispecific antibody, Clinical trials, EMA, FDA, Monoclonal antibody, Vaccines