Experts To Meet In Boston To Discuss Biggest Challenges In The Analytical And Clinical Phases Of Biosimilar Drug Development

IQPC has made several recent additions to the speaking faculty of the Biosimilars Clinical Studies & Analytical Similarity Summit. The lineup of keynote speakers will now include the latest regulatory updates from Health Canada and the EMA, coupled with first-hand perspectives from industry leaders like Amgen and Pfizer.

The Summit comes at a critical time following the FDA’s first approval of a biosimilar product in 2015. The stakes are higher now than ever before as pharmaceutical and biotech companies race to secure regulatory approval, and offer cheaper alternatives to a massive global market that is increasingly dependent on biologic drugs. However, the multi-year process of entering the biosimilars market is as complex as it is expensive, as companies must first navigate the rigorous gamut of pre-clinical and analytical studies, along with multi-tier clinical trials.

These pressing challenges have directly informed the design and scope of the conference, which will feature a three-pronged focus in pre-clinical/analytical studies, clinical trials and regulatory affairs. The senior speaking faculty includes leaders such as:

• Andrea Laslop, MD, Head of Scientific Office, AGES – Austrian Agency for Health and Food Safety
• Agnes V. Klein, MD, DPH, Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada
• Dr. Rakesh Dixit, Vice President, R&D Global Head Biologics Safety Assessment, Pathology and LAR, MedImmune
• Vincent Fung-Sing Chow, Principal Scientist Clinical Pharmacology, Modeling and Simulation, Amgen
• Joseph Marini, Scientific Director, PK/ADA/PD Bioanalysis, Janssen Research and Development
• Daniel Alvarez, Senior Director – Asset Lead Biosimilars Research Development Unit,Pfizer

These senior group of executives will meet in Boston from March 21-23, 2016 as they address the biggest challenges in breaking into this lucrative, emerging market. This is a can’t-miss opportunity for those companies at the cutting edge of biosimilar development, as well as those currently weighing the risks and advantages of launching a new biosimilar program.

Major topics on the 2016 agenda include:

• Establishing Structural Comparability with Effective Preclinical Characterization Methods
• Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations
• The Future of Biosimilar Approval in Europe: Increasing the Functionality of Bioassays to Reduce the Need for Clinical Trials
• Legal & Regulatory Implications of “Similarity” and “Interchangeability”
• Leveraging the FDA’s “Totality of Evidence” Methodology for Using Foreign Reference Products
• Regulatory Update on Health Canada’s New Guidance for Subsequent Entry Biologics