Part 2 of our webinar series on evolving and improving bioanalytical and biomarker analysis to support clinical trials
Peptides were among the first classes of biotherapeutics to be developed, based on their relatively simple structures and applications in treating common diseases. To date, more than 60 peptide drugs have been approved, and more are on the way as additional innovator drugs are developed and biosimilar versions of existing drugs are launched. To bring innovator and biosimilar peptide therapies to market faster, bioanalytical technologies and methods need to be updated to provide an accurate pharmacokinetics and immunogenicity profile. This webinar will detail a stepwise analytical process that creates a robust bioanalytical strategy for even the most challenging drugs.
What will you learn?
- How to overcome the unique challenges associated with the bioanalysis of peptide biotherapeutics
- Approaches to developing bioanalytical assays to peptide biosimilars
- How to develop an effective bioanalytical strategy for peptide drugs
Who may this interest?
- Biosimilars development specialists
- Clinical safety specialists
- Regulatory affairs specialists
John Kamerud is Scientific Director at Eurofins’ St Charles, Missouri (MO, USA) site, where his role is to serve as scientific and technical advisor for both clients and internal teams for development, validation and application of assays to comply with scientific goals and regulatory requirements. He received his PhD in biochemistry in 1987 from the University of Minnesota (MN, USA) and has since had over 20 years of experience in the development, validation and implementation of immunoassay methods, holding positions with EMD Millipore, Covance Laboratories and Eli Lilly and Company.