Biography
Dr. Chance has over 25+ years of work experience in the healthcare industry, including over 18 years in regulatory affairs at CRO, CMO, and pharmaceutical/biotechnology companies. She has spearheaded strategic global development for number of biosimilar products and has authored and/or co-authored number of articles on biosimilars. Dr. Chance has provided global regulatory strategy for number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Aranesp, Epogen, Recombinant Insulins, Forteo and Neupogen/Neulasta. Dr. Chance has authored/co-authored number of articles on biosimilars: • Investment Decisions Based on Biosimilar Programs, Part 1 • An Integrated Approach to Biosimilar Development & Commercialization • Elucidating Biosimilars Characterization • The Biosimilar Landscape: A Systematic Review of Its Current Status • Operational Challenges Associated with Biosimilar Drug Development • A Model for Expeditious Progress to a Phase 3 Trial • Biosimilars in rheumatology: understanding the rigor of their development… & many more…
Research Interest
Biosimilars, Biologics, Biosimilars Characterization, Drug Development
Biography
Dr. Iliach, Ph.D. is a Senior Director Global Regulatory Strategy and CMC at the Biosimilar Center of Excellence, QuintilesIMS. She has more than 15 years’ experience in healthcare industry, including the last 10 years in regulatory affairs. Her expertise lies in the development of global regulatory strategy for biosimilars with the focus on overall quality and CMC compliance. She has provided a global regulatory strategy and was involved in CMC development for number of products including biosimilars of Avastin, Herceptin, Humira, MabThera/Rituxan. She has a particular focus and expertise in regulatory and CMC requirements for biosimilars and regularly presents and writes on the topic. She has a PhD in Pharmaceutical Science from St. Petersburg Chemical and Pharmaceutical Academy, Russia. Oxana is also a professor at Seneca College of Applied Arts and Technology, Toronto, Canada and a member of CAPRA (Canadian Association of Professionals in Regulatory Affairs) and RAPS.
Research Interest
Biosimilars and Biologics Product Development, Characterization, Regulatory Intelligence
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