Challenges and opportunities for bioanalytical support of new drug modalities

Dr Daniel Sikkema brings more than 25 years of experience in the biopharmaceutical, vaccine and cell/gene therapy fields supporting oncology, neurosciences, respiratory, immunology and infectious disease. He has held positions of increasing responsibility at leading pharmaceutical and diagnostic instrumentation companies. In his career, he has contributed to the licensure of numerous vaccines and biopharmaceuticals, as well as the world’s first ex vivo cell/gene therapy product, leading to more than $150 billion in sales. He has also worked with the World Health Organization, National Institute for Biological Standards and Controls, US Centers for Disease Control and Prevention, FDA and EMA in roles as an invited expert and as an advisor (specifically for gene therapy approaches for hemophilia for FDA).

Daniel holds a BS in medical technology from Northern Michigan University (MI, USA) and a PhD in microbiology and public health from Michigan State University, College of Medicine (MI, USA). He was a postdoctoral fellow in infectious disease at SUNY at Buffalo, School of Medicine (NY, USA), and a research assistant professor in infectious disease at SUNY in Buffalo. Additionally, Dan is a registered medical technologist with the American Society for Clinical Pathology. He has chaired Division V (Clinical and Diagnostic Immunology) for the American Society for Microbiology and was coordinator for an Innovative Medicine Initiative project ABIRISK, the largest funded project to study immunogenicity of biotherapeutics. He has authored 30 peer-reviewed publications and has delivered more than 80 public presentations globally at scientific symposiums.