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Biosimilar Development: Recommendations to Support Informed Decision-Making Earlier in Your Pipeline



March 27, 2018
11 am to 12 pm EDT

 

Sponsored by

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Webinar Description:

During a live webinar on March 27, 2018, scientists will share key learnings for biosimilar programs to gain approval in the US and EU. The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is dependent on the similarity of the products themselves, as well as on the quality of the bioanalytical assay method and the design and conduct of early PK/PD studies.

Learning Objectives:

  • US and EU Regulatory Updates
  • Considerations for full analytical characterization PK/Nab
  • Protein Characterization for early stage/pilot batches
  • The evolution of drug/target binding affinity and SPR with the Biacore platform
  • Recommendations on how to utilize services to guide a more informed decision earlier in your pipeline

Speakers:


Matthew Bentley, BSc

Scientific Director

Eurofins Bioanalytical Services

Mr. Bentley has over 24 years of experience in the Pharma industry, the past 11 years of which have been in the bioanalytical CRO industry, managing study types from non-regulated method development to regulated validation and sample analysis in the clinical and non-clinical areas. His diverse areas of experience includes PK and ADA method development, validation, and analysis and also an interest in the biosimilars arena with a particular focus on product characterization using cell based and ligand binding techniques such as SPR using the Biacore platform.

Stephanie Pasas-Farmer, Ph.D.

President and Principal

BioData Solutions, LLC

Dr. Stephanie Pasas-Farmer is the President and Founder of BioData Solutions, LLC, a consulting firm that offers R & D, regulatory and commercial consulting services to early stage pharmaceutical and biological drug development organizations in the field of bioanalysis. Their services include scientific strategy support, operational program management, data review and analysis, regulatory compliance planning in addition to market development guidance. With more than 14 years of industry experience, Dr. Pasas‐Farmer specializes in discovery and regulated bioanalysis of pharmaceutical, biologics, and biosimilars. She brings extensive expertise in both quantitative and qualitative bioanalysis using various bioanalytical techniques including LC-MS/MS, Ligand-binding assays, etc. Dr. Pasas-Farmer is a frequent contributor to industry conferences and peer-reviewed publications on current bioanalytical and pharmaceutical industry topics. Due to knowledge of the field of bioanalysis, she was selected as a Bioanalysis Zone Leader for the journal, Bioanalysis. She also is an adjunct Professor as well as a member for Board of Advisors for the Division of Pharmacy Professional Development (DPPD) of the University of Wisconsin’s School of Pharmacy. In addition, she has taken on steering committee and leadership positions for multiple professional and scientific conferences.

Glenn Petrie, Ph.D

Senior Scientific Advisor
Business Development

EAG

Dr. Glenn Petrie has more than 25 years of experience in biopharmaceutical drug development. As a director at a major CRO he served as team leader in the development, Chemistry Manufacture and Control (CMC) design and IND submissions for a wide variety of biopharmaceuticals (monoclonal antibodies, drug conjugates, enzymes, peptides, etc.). He is a subject matter expert in the analysis of proteins including UPLC, LC/MS/MS, ELISAs and CE. As an SSA Dr. Petrie has been instrumental in the growth of EAG’s Biotech Group over the last 3 years creating a state-of-the- art laboratory. Dr. Petrie received his B.A. in Biochemistry from Rice University and his doctorate in Biochemistry from the University of Illinois Urbana-Champaign, as well as post-doctoral work at the Mayo Clinic.



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