Amy Blawas, Ph.D., R.A.C.
Principal Consultant
NDA Group AB
Amy Blawas joined NDA Group in 2020 and has over 20 years’ experience in the pharmaceutical and regulatory industry, primarily in biologics and cell therapy. She applies her skills & knowledge to a broad range of therapeutic areas and has successfully helped clients prepare & interact with Health Authorities throughout the stages of drug development.
Dr Blawas’s therapeutics areas of expertise include personalized medicine, gene and cell therapy, oncology, rare disease, infectious disease, biomaterials, implants, medical devices, transport theory, kinetics, immunology, and cell biology. She is experienced in planning and development of clinical studies, including preparation of protocols, INDs, and Final Clinical Study Reports, regulatory action plans for post-approval commitments and continuous quality improvement and coordination of multi-disciplinary activities between clinical, nonclinical and CMC development disciplines
Before NDA, Dr Blawas worked for a vaccine company as Associate Director of Regulatory Affairs working with European and US Regulatory agencies. She has worked for CROs and Biotech companies, primarily with Biologics.
Dr Blawas has a PhD in BioMedical Engineering from Duke University and the ability to interconnect across divergent disciplines of drug development with a thorough knowledge of FDA and ICH Regulations in the pharmaceutical business.