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Bioassays 2017: Scientific Program
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Monday, May 8, 2017

08:45 – 12:00
The Crossroads of Bioassays & Statistics - Where Bioanalytical Scientists and Statisticians Collaborate to Develop Great Bioassays 
Session Chairs: Thomas Arroll, Seattle Genetics, Inc., David Cirelli, Pfizer, Inc. and Sally Seaver, Seaver Associates LLC 

Bioassays are data rich systems that must be judiciously analyzed and controlled to provide meaningful information on the biological activity of our products. Development of robust, quantitative bioassays requires skilled scientists and statisticians knowledgeable of the challenges that arise from working with biological systems. Indeed, great assays are born from the crossroads of two scientific disciplines - statistics and biology. So what's behind the curtain of the bioassay curtain? Let's find out! This session will provide four examples to illustrate how biologists and statisticians frequently collaborate in bioassay design, validation, data analysis and transfer. 

13:30 – 16:45
New Bioassay Approaches and Technologies: A Brave New World
Session Chairs: Jill Crouse-Zeineddini, Amgen Inc., Stephen Hartman, AbbVie Inc. and Michael Sadick, Catalent Pharma Solutions

The range, scope and diversity of mechanism(s) of action therapeutic biologics are ever increasing. Consequently, the assays with which we assess their potencies must likewise adopt an increasing range, scope, and diversity. Bioassays are among the most complex, intricate, and challenging test methods to develop, optimize, and maintain. A single bioassay can combine the challenges of using living cells, complex growth/assay media, aseptic handling, biologically active reagents from internal and external sources, multiple procedural steps, several specific instruments, long incubation times, low sample throughput, and statistical data analysis. Furthermore, the emerging generations of biologic therapeutics pose a variety of new challenges for bioassay development and implementation. There exist many new technologies and approaches, available to facilitate and improve bioassays, but most also come with inherent challenges and risks. Presentations in this session will offer different approaches to accurately and robustly measure potency of emerging therapeutic modalities. 


Exhibitor Partner Scientific Showcase

18:15 – 19:45
Networking Reception 

 

Tuesday, May 9, 2017

08:30 – 11:45
The Bioassay Challenge: Applications in Product Development 
Session Chairs: Katrin Buss, BfArM, Thomas Millward, Novartis Pharmaceuticals and Bhavin Parekh, Eli Lilly and Company

Bioassays play an essential role in product development of biologics, guiding process and formulation development, helping to determine storage conditions and shelf-life, and ultimately being used to release product for human use. A bioassay must be relevant to the mode of action of the biologic, as well as being sufficiently precise and robust for GMP release and stability testing. Developing a bioassay that adequately reflects the mode of action (MoA) can be challenging e.g. if the pharmacology of a biologic is only partially understood at the cellular level, or if the biologic has multiple mechanisms of action. Achieving adequate control of the bioassay test system also requires that reference standards are in place whose potency is both calibrated and monitored over time.

This session will focus on the following themes:

● Bioassays for biologics with multiple MoAs (e.g. bispecifics, antibody-drug conjugates, others), or with MoAs that are poorly understood at the cellular level

● How to use reference standards and product controls to determine potency and to keep the bioassay test system under control; also use of reference standards for multi-MoA biologics

● How bioassays are used to assess the suitability of reference standards (e.g. primary) when there is no other established international standard (e.g. WHO) available

● Use of bioassays to define critical quality attributes, understand the impact of post-translational modifications, and characterize the structure-activity relationship of a biologic drug – and how to integrate these if there are multiple activities / bioassays.

14:15 – 17:30
Regulators: What's on Your Mind?
Session Chairs: Evangelos Bakopanos, Health Canada, Helena Madden, Biogen and Max Tejada, Gilead Sciences 

Biologics are very large, complex molecules or mixtures of molecules often produced using recombinant DNA technology. Consequently, the manufacture of biologics is an inherently complex process. While there are a number of regulatory guidelines for the development of biologics, their interpretation across the industry and between countries varies greatly. As a result, health regulators are faced with the daunting task of reviewing significant numbers of submissions from innovators, biosimilar, and bio-better companies each with diverse filing strategy. Regulators see and know a tremendous amount – so what’s on their mind?

This session will include presentations from regulators from four countries describing bioassay case studies that highlight deficiencies in regulatory filings and/or in company practices and the subsequent outcomes. These case studies will include various aspects of CMC including, but not limited to, the use of bioassays during manufacturing, product characterization, product control and stability, and to show mechanism of action, in order to highlight the regulators perspectives on best bioassay practices across the industry. Suggestions about what to do better and what not to do will be discussed.  Insights into what regulators are looking for will be gained through the session talks and during an interactive panel discussion workshop. 

 


 

more Calendar

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