Press Release (ePRNews.com) - TORONTO - Nov 27, 2018 - Join industry experts from Envigo for a three-part live webinar series discussing seven steps to effective biologics safety development.
Part 1 of 3: Therapeutic Biology and Species Selection – is scheduled for Thursday, Nov. 29, 2018, at 11 a.m. EST (4 p.m. GMT).
Part 2 of 3: In Vivo Efficacy and Critical Preparatory Tasks for Nonclinical Safety Assessment – is scheduled for Tuesday, Dec. 4, 2018, at 11 a.m. EST (4 p.m. GMT).
Part 3 of 3: Nonclinical Safety Assessment and Phase I Clinical Design Considerations – is scheduled for Thursday, Dec. 13, 2018, at 11 a.m. EST (4 p.m. GMT).
Understanding the biology of a therapeutic is key to effectively and efficiently progressing it from first principles, through safety assessment studies and into clinical trials. The unique characteristics and specific biology of each large molecule therapeutic make it impossible to design a “one size fits all” approach to non-clinical development, requiring instead a design tailored to each molecule. For efficient development strategies, this should include a thorough understanding of disease and therapeutic biology as well as ensuring that the most appropriate studies are conducted to progress each molecule.
Despite the need for unique approaches for each novel biologic, there are seven key steps that should be considered when developing biologics through non-clinical development in order to ensure effective and efficient progress.
This three-part webinar series reviews the key considerations for design and conduct of a development plan for a monoclonal antibody (mAb) product. Focusing on the development of a therapeutic mAb, the presenters will review and discuss key considerations on the journey from target identification and underlying disease biology, addressing key questions for successful safety assessment, through to successful delivery of a phase I clinical study to illustrate the seven steps to effective biologics safety development.
In the first event in this series of webinars, Envigo’s experts will walk through steps one and two of effective biologics development: therapeutic biology and species selection. This first installment in the series will discuss the preparatory work required to initiate successful development, focusing on the importance of a robust understanding of underlying disease biology, identification of potential therapeutic targets and the first steps to developing a therapeutic product based on this knowledge. In addition to introducing the importance of appropriate biomarkers and assessment of intended pharmacology, the presentation will also touch on CMC considerations before addressing strategies for identification of pharmacologically relevant non-clinical animal models.
In the second event, the speakers will build on the topics discussed in part one as the candidate mAb progresses further along the development pathway. Part two of this series explores in vivo efficacy (including considerations for delivery by inhalation), as well as some of the tasks required to progress non-clinical safety assessment, including tissue cross-reactivity studies to identify potential toxicity concerns and strategies to ensure delivery of appropriate bioanalytical methods.
Finally, the third event will discuss design and conduct of non-clinical study assessment studies as well as phase I clinical design considerations. This final installment in the webinar series, following the development of a mAb therapeutic, builds on the information and bioanalytical methods generated in the earlier phases of development to illustrate how this information can then be leveraged to ensure that a fit for purpose non-clinical safety assessment programme is undertaken. The results of the programme are then discussed to illustrate the importance of a robust understanding of the intended pharmacology of the therapeutic in order to interpret results and design the subsequent phase I clinical trial.
Each webinar includes a live Q&A session with the audience. For more information or to register for these events, visit the following pages:
Key Considerations for the Successful Development of a Biologic: Seven Steps to Success (Part 1 of 3)
Key Considerations for the Successful Development of a Biologic: Seven Steps to Success (Part 2 of 3)
Key Considerations for the Successful Development of a Biologic: Seven Steps to Success (Part 3 of 3)
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Sarah Hand Source :
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