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

Life Sciences, Pharmaceutical, Drug Discovery & Development, Drug Safety, Preclinical,
  • Thursday, December 13, 2018

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 3 of 3: Nonclinical Safety Assessment and Phase I Clinical Design Considerations

Join us for the final webinar in this series during which Envigo’s biologics experts will discuss the design and conduct of non-clinical study assessment studies as well as phase I clinical design considerations.

This final instalment in the webinar series following the development of an 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.


Dr. Kirsty Harper, Head of Biologics, Envigo

Kirsty leads the UK Biologics team, a role she has held since October 2017, having joined Envigo in June 2013. Kirsty and her team support customers by designing safety studies and non-clinical development programs for biologics as well as providing scientific support and advice. Prior to joining Envigo, she was employed as Principal Scientist at Oxford Immunotec Ltd.  Kirsty obtained her PhD in Immunology from the University of Bristol in 2005, after which she completed a post-doctoral position investigating peptide therapy as a potential treatment for autoimmune disease.

Kirsty obtained her PhD in Immunology from the University of Bristol in 2005, after which she completed a post-doctoral position investigating peptide therapy as a potential treatment for autoimmune disease. She obtained her BSc and MSc degrees in Microbiology at Massey University in New Zealand and worked at the Malaghan Institute where she conducted basic research in autoimmune disease before emigrating to the UK.

Message Presenter

Sanjay Jain, Principal Consultant, Biologics, Regulatory Affairs, Envigo

Sanjay has been a pharmaceutical professional with over 20 years of diverse, extensive and multicultural drug and product development experience in biopharmaceutical, pharmaceutical, CRO and academic environments with a wide spectrum of products (e.g., biologics, DDS, NCEs). He is a pharmacist with a PhD in Pharmaceutical Sciences and post graduate diploma in management of pharmaceuticals. Sanjay joined in Envigo in 2014 as the Principal Consultant of Pharmaceutical Consulting (Regulatory Affairs).

Message Presenter

Who Should Attend?

Virtual to medium sized biologics developers, with relevant job titles including:

  • Principal scientists
  • Drug developers
  • Heads of large molecule/biologic development
  • Safety assessment/toxicologists

What You Will Learn

Join this webinar to learn about:

  • Seven key steps that all biologic drug developers should consider when designing and progressing biologics through safety assessment
  • The design and conduct of a safety assessment plan for a monoclonal antibody (mAb) product 
  • Non-clinical study design and clinical design considerations  

Xtalks Partner


Envigo provides mission-critical products and research services for pharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations. Our company is founded on the principle that research partnerships depend on unmatched expertise, unwavering dedication to customer service and shared goals, Envigo is committed to helping customers realize the full potential of their products and research which contribute to enhancing the lives of people and animals as well as protecting the environment.

With over 3,300+ employees serving over 65 countries with a network of more than 25 operating facilities worldwide, Envigo provides comprehensive scientific expertise and a full service offering in non-clinical research and development, research models and services, regulatory consulting, and analytical support to our customers. Envigo is a privately held global company with corporate headquarters in New Jersey.

Register below for Part 3 of the series

About Part 1:  Therapeutic Biology and Species Selection

About Part 2: In Vivo Efficacy and Critical Preparatory Tasks for Nonclinical Safety Assessment

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