This year, Pharma IQ, a division of the International Quality and Productivity Center, will be hosting the Biosimilars Clinical Studies and Analytical Similarity Summit, March 21 through the 23, in Boston, Massachusetts. Attendees to the Summit will receive key insights from industry thought leaders into some of the biggest challenges in the analytical and clinical phases of biosimilar drug development.
This Summit boasts a full agenda spanning all three days, starting with Pre-Conference events on March 21 at 9:00 am. The Pre-Conference workshop day consists of three workshops with a wide range of topics: Compare, Contrast and Comply with US and EU Regulations that Govern Biosimilar Product Development; Establishing Structural Comparability with Effective Preclinical Characterization Methods; and Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations.
Day One of the Summit gets off to a roaring start at 9:00 am with a keynote address given by Professor Andrea Laslop, the Head of Scientific Office at the Austrian Agency for Health & Food Safety, on the future of biosimilar approval in Europe. They keynote is followed by three discussions: one on the unique bioanalytical testing and clinical testing strategies for proving safety and efficacy; one on the legal and regulatory implications of “similarity” and “interchangeability”; and a third one on biosimilars regulations in the US market and where we are headed from here, presented by our very own Thomas Sullivan. The afternoon closes out with discussions on how to leverage the FDA’s “Totality of Evidence” methodology for using foreign reference products, and how to reduce or eliminate nonclinical toxicity studies from biosimilar development programs.
Day Two of the Summit again begins with a keynote address, this time a regulatory update on Health Canada’s new guidance for subsequent entry biologics, presented by Agnes V. Klein, M.D., the Director CERB, Biologics and Genetic Therapies Directorate, at Health Canada. Dr. Klein and Professor Laslop come together mid-day on Day Two to host a regulatory question and answer session, focused on similarities and differences in the market authorization of biosimilars, including regulatory, policy, and guidance background. Day Two ends with a presentation by Michael Retsky, a research associate with the Department of Environmental Health at the Harvard T.H.Chan School of Public Health, on the difficulty of using biosimilars in oncology and what can be done about it.
If you are interested in attending the Biosimilars Clinical Studies and Analytical Similarity Summit, you can register here. Those who register by February 19, 2016, could receive up to $400 off registration costs.