Bioanalysis, Immunogenicity & Statistical Analysis for Biopharmaceuticals Masterclass
- March 3rd - 5th 2025
- 9.00 am - 1.00 pm EST (UTC- 5)
Trainer
Steven Walfish
Trainer
Dr. Gwen Wise-Blackman
Days
Hours
Minutes
Seconds
This course includes:
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
In the fast-evolving biopharmaceutical industry, ensuring the reliability and robustness of bioassays is more critical than ever. Are you ready to master bioanalysis, immunogenicity testing, and statistical modeling with confidence? This three-day masterclass, led by industry experts, provides actionable insights and tools tailored to meet regulatory expectations.
Course Overview
Whether you’re developing bioassays, managing validation processes, or ensuring regulatory compliance, this masterclass has you covered. From understanding the nuances of ELISA techniques to applying statistical models for assay robustness, the course takes you step-by-step through critical methodologies.
Imagine confidently addressing complex challenges like matrix considerations, neutralizing antibody assays, and data analysis while adhering to global standards such as ICH Q2(R1)/Q2(R2) and USP <1033>. With real-world examples and expert guidance, you’ll be equipped to tackle the most demanding aspects of bioassay development.
What You’ll Gain
-
Regulatory Insights
Stay ahead with a clear understanding of the latest guidelines affecting bioanalysis and immunogenicity testing in preclinical and clinical studies. -
Advanced Bioanalytical Methods
Master key techniques like ELISA, MSD, and hybrid ELISA for PK/ADA assay development, ensuring accuracy and consistency. -
Statistical Analysis for Robust Assays
Apply statistical models to validate bioassay robustness, focusing on linearity, combined estimates, and real-world case studies. -
Method Optimization with DOE
Enhance assay efficiency and reliability using Design of Experiments (DOE), tailored for method development and validation. -
Validation Readiness and Process Monitoring
Learn to assess when your methods are ready for validation and maintain assay quality through ongoing process monitoring.
Why This Masterclass?
-
Learn from Industry Leaders
Dr. Gwen Wise-Blackman and Steven Walfish bring decades of experience in bioanalysis, immunogenicity testing, and statistical applications, offering unparalleled expertise and real-world insights. -
Comprehensive and Targeted Content
From bioassay validation to statistical modeling, every session is designed to deliver skills you can implement immediately. -
Interactive Learning Experience
With case studies, Q&A sessions, and practical demonstrations, this course bridges the gap between theory and application, ensuring a deeper understanding of bioassay analytics.
Agenda Highlights
Day 1
- Overview of Biologics and Biotechnology.
- ELISA, MSD, and Hybrid ELISA techniques for PK assay development.
- GLP for Bioanalysis and disease-state matrix considerations.
Day 2
- Development and validation of ADA methods, including drug tolerance and tiered approaches.
- Neutralizing antibody assays: ligand-binding vs. cell-based.
- Statistical analysis of ADA validation data and assay trend analysis.
Day 3
- Robustness through DOE: screening studies and response surface designs.
- Statistical models for bioassay validation, including case studies.
- Validation requirements under ICH Q2 (R1) and (R2) guidelines, and USP <1033>
Who Should Attend
- Scientists developing and validating bioassays for stability or release testing.
- Professionals working on PK, PD, and immunogenicity assays.
- QA, QC, and regulatory affairs personnel focused on statistical and regulatory aspects.
- Statisticians and analysts specializing in bioassay robustness and validation.
About Trainer
Dr. Gwen Wise-Blackman
- 24+ years of expertise in bioanalytical method development and immunogenicity testing.
- Extensive experience in pharmacokinetics (PK), pharmacodynamics (PD), and neutralizing antibody assays.
Steven Walfish
- 30+ years of expertise in applying statistical methods to FDA-regulated industries.
- Renowned for his practical approach to bioassay validation and data analysis.
Access for 2 participants
Online Participation
1,690 $
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Certificate of completion and LinkedIn certificate
-
Access for 2 participants
Online Participation with Recording
2,189 $
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Recording access
- Certificate of completion and LinkedIn certificate
Request Agenda
Companies Represented By Our Participants
Proud Stories
★★★★★
Marsha Miller
Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called
★★★★★
Michael Durschlag
James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.
★★★★★
Nancy Musik
This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.
★★★★★
Vyara Kuneva
The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.
★★★★★
Walter Drexler
I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.
★★★★★
Seth Byers
Well organized presentation, very knowledgeable presenter, great atmosphere
★★★★★
Hassan Abdu Al Asmary
Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.
★★★★★
Gabriela Saucedo
The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.
★★★★★
Vassia Papakonstantinou
I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references
★★★★★
Nereus Jethro Abad
I enjoyed the class and found it informative, engaging and filled with valuable insights.
What you'll get?
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
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