Overcoming Regulatory and Statistical Hurdles of Biosimilars Drug Development: Designing Smarter Trials

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April 06, 2016

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The success of biologics for many debilitating medical conditions such rheumatoid arthritis, cancers, etc. and their spiraling costs timed with patent expiries have led biopharmaceutical companies to develop biosimilar products. Biosimilars have the potential to increase access and provide lower cost options for treatment of many medical conditions.

Biosimilars pose very different challenges than those presented by small molecule generics: higher costs and more demanding head to head similarity studies requirements in analytical, nonclinical, and clinical development. Before you consider putting your biosimilar drug through development, you need to be informed of the regulatory pathways and complexities that will be involved – as well as steps you should take to address these regulatory considerations for making important decisions about your biosimilar products.

Join Quintiles biosimilar experts Kamali Chance, MPH, PhD, RAC, and Russell Reeve, PhD, as they address the following:

  • The Patent Cliff: What happens to medicines coming off-patent and how are biosimilars capitalizing from these patent expirations?
  • Why are biosimilars important to biopharma?
  • Who are some of the top competitors in this space?
  • What are the different components of biosimilar trials?
  • How might your decisions today affect the future of your biosimilar trials and marketing success


Kamali Chance, MPH, PhD, RAC
Vice President, Head, Global Biosimilars Regulatory Strategy Biosimilars Center of Excellence

Dr. Chance advises biotechnology companies for region specific and/or global regulatory strategy for the development of biosimilars. Her overall regulatory experience encompasses developing global regulatory strategy, preparation of briefing documents, meetings with FDA, IND/CTA submissions, Marketing Applications (BLAs, MAAs, etc. She has authored/co-authored number of articles on biosimilars.

She has provided global regulatory strategy on number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Orencia, Erbitux, Epogen, Neupogen/Neulasta, Aranesp and recombinant insulins.

Dr. Chance has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs at CRO, pharmaceutical and biotechnology industries.

Dr. Chance has a PhD in Nutrition/Nutritional Biochemistry and Masters of Public Health. She has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.

Russell Reeve
Sr. Strategic Biostatics Director, Center for Statistics in Drug Development, Innovation

Mr. Reeve supports development of model-based drug development capabilities at Quintiles, manages the Innovation MBDD Advisory Board, and consults with clients on development and trial design strategies. He leads modeling and simulation projects for clients to support trial design. He is also a thought leader, engaging in research for peer-reviewed publications, and presents talks at leading scientific conferences. He is on NCSU’s College of Sciences Foundation Board, and George Mason University’s Statistics Department Advisory Board.

He has broad industry experience and has been involved in clinical modeling and simulation, designing a randomized concentration-controlled trial with Bayesian updating of the doses. He has worked on a number of biologics agents and vaccines, such as interferon-alpha, vaccines for HCV, HPV, and influenza, as well as in vitro diagnostics based on ligand-binding and bDNA technologies. He has developed designs for a number of biosimilar products, supported NDA submissions, represented clients at FDA meetings, and used MBDD methodologies to create development strategies. He leads the biosimilars statistical working group at Quintiles.

Mr. Reeve has 25 years of experience in biostatistics with almost 23 years in the pharmaceutical industry.

Mr. Reeve earned his Ph.D. in Statistics from Virginia Polytechnic Institute and State University, M.S. in Operations Research from Rensselaer Polytechnic Institute, and B.S. in Mathematics from Utah State University.