Key Considerations for the Successful Development of a Biologic: Seven Steps to Success (Part 1 of 3)

Understanding the biology of your 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 makes 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 3-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.

Part 1 of 3: Therapeutic Biology and Species Selection

Join featured speakers for the first in this series of webinars in which Envigo’s experts will walk through steps one and two of effective biologics development: therapeutic biology and species selection.  This first instalment 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.

Speakers

Lee Coney, Chief Scientific Officer, Pharmaceutical, Envigo

Lee was recruited by Envigo at the end of 2004 to take a leading role in handling enquiries from those customers developing biopharmaceutical products. Lee brought to the role 15 years of hands-on experience of biopharmaceutical drug development gained in companies such as; Cantab Pharmaceuticals, Xenova and CellFactors. During his time in the biotechnology industry, he was involved in developing therapies including: vaccines, recombinant proteins; monoclonal antibodies; immunomodulatory molecules; viral and non-viral gene delivery systems; and cell-based therapies. He has a well-rounded knowledge of the regulatory environment for biopharmaceuticals and particular expertise in the analysis of protein and viral products.

In his current role, Lee is responsible for ensuring that Envigo has the resources and expertise to support the modern biopharmaceutical industry.

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Dr. Allan Watkinson, Director of Biopharmaceutical Development, Envigo

Allan joined Envigo in June 2014 as Director of Biopharmaceutical Development in order to assist the company in expanding its analytical capability. He has a degree in Biochemistry (Leeds University) and a PhD in Physiological Biochemistry (Imperial College, London).

He has extensive experience in R&D gained from over 10 years in academic research followed by 20 years in industrial research. Over the last 10 years he has been involved in Vaccine Development, with Avecia Vaccines and Pharmathene UK, specializing in formulation, analytics, cGMP manufacturing, and stability.

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