Agenda/Scientific Program
The theme for WCBP 2025 is "Transformative Solutions". The Symposium will bring together industry, regulatory, and academic professionals to discuss the role of current and emerging CMC analytical technology among evolving US and international regulatory perspectives. Each day will consist of plenary and parallel sessions, workshops, an exhibit hall, and technical seminars hosted by our exhibitor partners. We look forward to an informative Symposium and hope to see you there. Be ready to network, collaborate, and expand your knowledge. WCBP 2025 will discuss the following topics:
- Alternative Potency Assays for Recombinant Biologics and Vaccines
- Global Regulatory Panel featuring the Heads of Regulatory Agencies and Health Organizations
- Hidden Potential of Established Analytical Technologies
- Integrated Control Strategies for Combination Products
- Immunogenicity Risk and Control
- LAL Assay Replacement
- Low Endotoxin Recovery (LER)
- Navigating the Small and Virtual Business Landscape
- Mutual Reliance
Sonia Vallabh
Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University
Sonia Vallabh co-leads the initiative to develop preventive drugs for prion disease at the Broad Institute. She comes to this work with a personal mission. In 2010, Vallabh watched her 52-year-old mother die of a rapid, mysterious, undiagnosed dementia. One year later, Vallabh learned that her mother’s disease had been genetic prion disease, and that she herself was at risk. Vallabh underwent predictive genetic testing and learned that she had inherited the causal mutation, placing her at very high risk of developing the same disease. There was no prevention, treatment, or cure available. Vallabh quit her previous career in law and consulting, and, together with her husband, Eric Minikel, re-trained as a scientist in order to devote her life to finding a way to stop her disease before it starts.
At the Broad, Vallabh is focused on developing preventive drugs for prion disease. Lowering of prion protein (PrP) is a genetically well-validated strategy for delaying the onset of prion disease, and it lends itself to measurement of PrP as a biomarker available before the disease process has begun. Vallabh is working on the discovery and preclinical development of PrP-lowering drugs, credentialing of PrP in cerebrospinal fluid as a pharmacodynamic biomarker for such drugs, and establishment of a clinical pathway for preventive drug development. She co-leads a natural history study at Massachusetts General Hospital devoted to the assessment of fluid biomarkers in individuals at risk for genetic prion disease, and helped to launch the Prion Registry to promote and enable research participation in her community.
Vallabh holds a BA from Swarthmore College, a JD from Harvard Law School, and a PhD in biological and biomedical sciences from Harvard University. She trained in Stuart Schreiber’s laboratory at the Broad. In 2016, she served as a patient representative in the White House Precision Medicine Initiative.
Introduction to Bioassay Development: CMC Strategy and Practical Application | Morning Session
Monday, January 27, 2025
Morning Facilitators: Patrick Hussmann and Scott Umlauf, AstraZeneca
The 2025 WCBP 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.
Practical Applications for Method Design and Performance | Afternoon Session
Monday, January 27, 2025
Afternoon Facilitators: Colleen Santoro and Tara Stauffer, Bristol-Myers Squibb Company
In this interactive session, 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.
Register Now
Save your spot for WCBP 2025 on January 28-30, 2025 in Washington, D.C., USA. Registration for in-person attendance will close January 14, 2025. Registration for virtual attendance will close January 23, 2025.
Engage with Exhibitors
WCBP 2025 is providing you with many opportunities to connect with vendor partners before and during the Symposium.
Whether you are attending in-person or virtually, there are multiple ways to engage with our WCBP exhibitors to learn how their products and services can better serve you.
"Great way to learn about challenges, future strategies and interactions between pharma and regulatory agencies."
—Lori Stansberry, WCBP 2024 Attendee"The scientific topics presented and discussed have been extremely relevant for my work beside the scientific value the conference provides excellent opportunity to exchange with industry peers and regulators."
—Christof Finkler, WCBP 2024 Attendee