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Bioassays 2019: Scientific Program
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To view the online searchable program, including speaker abstracts, click here

To view the program agenda, click here


              

 

Session Abstracts 

The Mechanics of Bioassays: What’s Under the Hood?
Session Chairs: Steven Hartman, AbbVie, Inc., Thomas Millward, Novartis Pharma AG, and Adelheid Rohde, F. Hoffmann-La Roche Ltd.

To be useful in product development, amenable to release and stability testing, and acceptable to regulatory agencies, a bioassay needs to be mode of action-reflective, stability indicating, accurate and precise, robust, cost effective, and QC friendly. Clearly, fulfilling all of these diverse requirements will not always be an easy task. Sponsors may consider various cell-based bioassay formats, may in some cases use binding assays, or may include both in their bioassay strategy. Developers may wish to automate part or all of the bioassay procedure to reduce costs or improve throughput. And many still grapple with statistics in the search for a reliable, pharmacopeia-compliant method of data reduction to obtain the final potency determination.

In this session, we wish to review the current state of the art with respect to the basics of bioassays.

End-to-End: Lifecycle of a Potency Assay 
Session Chairs: Thomas Arroll, Seattle Genetics, Inc., David Cirelli, Pfizer, Inc., and Jill Crouse-Zeineddini, Amgen Inc.

The lifecycle of an analytical method spans many phases of product development and incorporates many key considerations. The potency assay used for product lot release and stability testing may change over the course of the product development lifecycle for a variety of reasons. Often, phase appropriate strategies are employed to manage the lifecycle of potency assays. In some instances, a new potency assay may be adopted via licensing of a program from another company but will be replaced because it was deemed to be incompatible with the equipment, strategy, or platforms that are already established internally. In other instances, the potency assay may change over the product development lifecycle due to an increase in product knowledge, or because new technologies are introduced that facilitate the implementation of a better performing method. The establishment and maintenance of these potency assays, as well as the reagents that support them, are critical elements of the lifecycle management. Throughout the entire lifecycle of the potency assay, assessment of the data generated by the method is integral to ensuring long-term success. Data engineering is a powerful tool that facilitates potency assay trending analyses over time, across testing sites, and across assay platforms.

This session will include the following presentations that will address some of the key potency assay lifecycle elements:

• Lifecycle of a bioassay for a gene therapy product 
• Potency assays for in-licensed programs 
• Data Engineering for Potency Assays 


Beyond Basic mAbs…Bioassays for New Complex Modalities 
Session Chairs: Bhavin Parekh, Eli Lilly and Company, Michael Sadick, Catalent Biologics, and Max Tejada, MedImmune, A member of the AstraZeneca Group

Bioassays are essential components of drug discovery, development and analytical control strategies for biologics. The ability of bioassays to reflect the relevant biologic activities is essential; however, developing such assays is increasingly challenging as newer therapeutics are being engineered with a diversity of mechanism(s) of action. These typically represent complex modalities, such as cell therapies, RNA therapies, DNA vaccines, multi-target/multi-functional antibodies and antibody-drug-conjugates

This session will focus on bioassays used for release/characterization, and the challenges for novel therapies including a general understanding from industry (industry consensus) of the entire package of bioassays needed to support the full program for the novel therapy. Talks will assess bioassay strategies/approaches/lessons learned, especially for those molecules with unusual/complex mechanisms of action.


Regulator’s Reflections: Postcards from the Edge 
Session Chairs: Evangelos Bakopanos, Health Canada, Katrin Buss, BfArM-Federal Institute for Drugs and Medical Devices, and Bruce Meiklejohn, Meiklejohn Consulting 

The biotech industry continues to grow and diversify. Biological molecules include; proteins, modified proteins, cells, DNA, RNA, vaccines, mixtures of molecules. The number of regulatory submissions is increasing at a rapid rate. 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 review a tremendous amount of information.

Regulators Reflections?
This session will include presentations from regulators describing bioassay case studies that highlight best practices and 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. 

 


 

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