Biologics and Biosimilars

Biography

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in streamlining clinical research and developing strategic clinical regulatory pathways to product approval. Dr. Fratazzi has worked on several Biosimilars’ development with special attention to the major variables that impact costs. As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical medical device companies, and investors on optimum clinical plan development and how to design clinical trials that reduce product development risk. She is a renowned Immunologist with over 15 years of experience in Orphan Petitions in US and EU and phase 1-4 clinical programs, contributed to the registration and approval of 4 successful products.Dr. Candida Fratazzi expertise includes Drug, Device as well as Combination Products. . Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award, 2015 Cambridge Business Hall of Fame Award,and 2014 Top Ranked US Executives, National Council of American Executives. Act as Member of Advisory Board and Board of Directors in Life-science

Research Interest

Biologics and Biosimilars