With primary expertise in "Clinical" regulatory, I collaborate with many other functional area experts to cover all of your needs, to include regulatory operations/publishing, medical writing, biometrics, as well as collaborations with experts in supporting commercial strategies for later stage products.
BIO
Erik Poulsen has over 25 years of experience in the biotech/pharma industry providing leadership in gaining global approvals for several products. Erik has led global filings across multiple therapeutic areas for both small molecule and biological products, to include leading approvals for cell therapies during his tenure at Kite Pharma with successful IND experience at two other early-stage cell therapy companies in both the oncology and autoimmune spaces. Erik also led filings that achieved regulatory approval at Pharmacyclics, Janssen, and Amgen.
Erik received his MS in Biostatistics at UCLA and prior to becoming a regulatory professional, helped lead BLAs at Amgen as a biostatistician before moving to a formal regulatory role in 2003. Erik also has significant experience building regulatory and corresponding subgroups to support the vision of growing companies to ensure the regulatory department is robust in the areas of clinical development, through Regulatory Advertising and Promotion to support successful product launches.
AREAS OF EXPERTISE
CURRENT NEWS AND EVENTS