On behalf of the program planning committee and PDA, we are pleased to invite you to attend the 2018 PDA Europe 11th Workshop on Monoclonal Antibodies, to be held 27-28 November 2018 in Seville, Spain.
Since the first licensed product in 1986, monoclonal antibodies have dominated the field of biopharmaceuticals with more than 70 approved products and hundreds more currently undergoing clinical evaluation for a variety of diseases. Market evaluations for monoclonal antibodies predict no decline in interest for many years to come.
The knowledge gained over decades of discovery research, development and manufacturing has enabled tremendous advancements in the commercialization of therapeutic monoclonal antibodies. In addition to fully human and humanized monoclonal antibodies, new related modalities have been introduced such as antibody fragments, Fc-fusions, bi-specifics and antibody drug conjugates all aimed at improving pharmacological properties. Technology improvements in expression systems, cell culture and downstream purification have increased efficiency and productivity. The ability to apply common unit operations across multiple monoclonal antibodies has allowed manufacturers to develop platform processes and in turn accumulate substantial knowledge applicable to future molecules in their portfolios. Many companies are now adopting continuous manufacturing approaches to further streamline production and reduce operating expenses.
The regulatory environment has kept pace with these achievements by supporting innovation and ensuring patient access to novel monoclonal antibody products. Various guidance documents have been published outlining regulatory expectations. In addition, regulatory frameworks have been established to enable the commercialization of biosimilar monoclonal antibody products.
With so much accumulated knowledge related to monoclonal antibodies, the focus is now on how best to make use of all the information. The term Prior Knowledge is applied to describe this wealth of information and the subject is a hot topic amongst industry and regulators. For this reason, the program planning committee selected Prior Knowledge as the theme for this year’s workshop. Objectives for the workshop are to answer key questions on how product and process knowledge is being captured and transferred, and more importantly, how is the knowledge being utilized to drive continuous improvements and sustain further advancements for this therapeutic class.
The workshop program consists of sessions covering a variety of topics related to Prior Knowledge from research, development, manufacturing and regulation. Through presentations, case studies and panel discussions, workshop participants will learn the latest trends in the application of Prior Knowledge to monoclonal antibodies. In addition to the planned sessions, the program will provide abundant opportunities for networking and exchange of ideas with regulators and industry leaders. We look forward to welcoming you at the workshop in Spain!
Michael de Felippis, PhD., Eli Lilly, Chair
Martijn van de Plas, PhD., Medicines Evaluation Board, Chair