Agenda/Scientific Program

Dean K. Smith is currently a Section Head and Senior Scientific Evaluator in the Center for Biologics Evaluation (CBE) of Health Canada, with over 20 years of experience in regulatory science in support of innovation in vaccine development, manufacturing, and quality control. He has a range of biologics-based scientific/regulatory experience from his management of CBE Divisions responsible for bacterial and viral vaccines, as well as the hemostatic agents and blood substitutes. Representing Health Canada, Smith contributes to WHO’s vaccine and vaccine stability guidance development and implementation initiatives. For the past 10 years, he has been Health Canada’s representative to the European Directorate of Quality of Medicines (EDQM), Group 15 (Vaccines), which supports the European Pharmacopeia. He also serves on the Science and Ethics Advisory Committee for VAC2VAC under the European Vaccines Initiative. Smith's PhD in immunology is from the University of Alberta, where his research dealt with vaccine antigen discovery, autoimmunity, and viral vector-based gene therapy.

Introduction to Bioassay Development: CMC Strategy and Practical Application

Monday, April 15, 2024 | 08:00 - 13:00 EDT
Facilitators: Scott Umlauf and Patrick Hussmann, AstraZeneca

The 2024 Bioassays Symposium Workshop will provide practical knowledge on bioassay method development, with a particular emphasis on potency assays. Method development and lifecycle management will be covered in the context of the unique role of bioassays in CMC control strategy of biopharmaceuticals, including monoclonal antibodies, antibody-drug conjugates, fusion proteins, such as T cell engagers, vaccines, and cell and gene therapy. 

Note: Registration for the workshop requires an additional ticket which can be added to your registration at the time of purchase. For additional information on pricing, view Registration Fees.

Introduction to Bioassay Development: CMC Strategy and Practical Application (Cont.)

Monday, April 15, 2024 | 13:00 - 17:00 EDT
Facilitator: Tara Stauffer, Bristol-Myers Squibb Company

Register for the afternoon session for an interactive experience where participants will work collaboratively on case studies relevant to current challenges in bioassay development, deployment, and lifecycle. This session will expand on the morning session and is recommended for both novice and experienced attendees.

Note: Registration for the workshop requires an additional ticket which can be added to your registration at the time of purchase. For additional information on pricing, view Registration Fees.